Porter Goss

Mr. GOSS

Mr. GOSS. Mr. Speaker, reclaiming my time, I strongly believe that the scope of the resolution takes care of that problem. I am not going to forgo my responsibilities as chairman of the Permanent Select Committee on Intelligence, and I am sure the gentleman is not as the ranking member to discharge the things that we have responsibility for. I would hope for very close working cooperation between the Select Committee and the other committees. And I would hope we could avoid any possible redundancy that way.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I rise in support of this resolution, which, I am pleased to say is the result of much hard work and bipartisan cooperation on the part of the leadership, the Rules Committee, and the prospective chairman and ranking member of the proposed select committee. I am very proud of the manner in which this process has been handled, and I think this resolution is a credit to all involved and to the entire House. To the minority members of our Rules Committee, who raised in their views accompanying our report repeated concerns about the manner in which this inquiry will be handled, I point to the remarks of both the chairman-designate, Mr. Cox, and the ranking member-designate, Mr. Dicks, before our Rules Committee panel. They are developing a strong bipartisan working relationship and came to the Rules Committee together in full agreement about the particulars of this resolution. They both spoke of commitment to running a professional, serious and collegial inquiry. Mr. Speaker, it's fair to say that we all would prefer not to be here today creating a select committee to review U.S. national security and military/commercial concerns with the People's Republic of China. We would certainly all prefer that we did not have before us very serious allegations of illegal foreign influence in our Democratic process, troubling concerns about the transfer of highly sensitive military information and technology to the Chinese, and the very real potential that palpable damage has been done to our national security. But the fact is that we have been presented with serious and credible allegations on these points--and the American people want us to get to the bottom of what happened, how it happened, and what the impact has been for the security of our citizens and our interests. We have an obligation to accomplish this goal in a thorough and timely manner, and I am convinced that the only good way to do that is to establish this select committee. Members know I do not take this step lightly. As chairman of the House Intelligence Committee, I am aware of the jurisdictional authorities relevant to this subject, not just in my own committee, but in as many as 7 other House committees. I know that many of these permanent committees of the House have, in fact, been pursuing pieces of this investigation up to this point. But the fact remains that we need to move on this and start getting some answers to these serious questions now. For that we need to have a relatively small, singly focused panel with the enhanced investigatory authorities provided by this resolution. The resolution provides mechanisms to ensure that the Select Committee has the clout to get its work done and has proper channels through which to have maximum cooperation with, and assistance from, the existing House committees. It certainly makes sense to me that on matters of such grave importance as the national security and the sanctity of our domestic political system, we should all pull together in a bipartisan way to shed light on the truth and, if necessary, consider means to ensure that proper protections and safeguards do exist in our policies on technology transfers and controls over sensitive information with respect to foreign nations. I agree with former Director of Central Intelligence James Woolsey who said in testimony at the Rules Committee this week that he can think of no subject that more clearly would require careful and thorough investigation by a select committee of the Congress. Finally, Mr. Speaker, let me say that I very much hope the administration will make good on its pledge to cooperate fully with this important inquiry. And by cooperate I mean not just talking about being helpful, but about actually providing all relevant material to the inquiry, helping the select committee gain access to the individuals it needs to interview, and offering a full and complete accounting of its relevant policies. I would hope that we do not see more of the practice we've become used to with this administration of attempting to change the subject, throw up roadblocks and shoot the messenger when serious questions are raised about its policies and decisionmaking. The American people expect and deserve better than that from this administration.

Mr. GOSS

Mr. GOSS. It is possible that that is a correct scenario.

Mr. GOSS. Mr. Speaker, I yield back the balance of our time, and I move the previous question on the resolution. The previous question was ordered.

Mr. GOSS. I yield to the gentleman from New York.

Mr. GOSS. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I just wanted to make a few remarks in response to the distinguished minority leader's information that he has shared with us on the floor. It is true he has just been in Russia, and I admire the energies he has put into this process. I would suggest, however, that if the only problem is timing, that we are better going ahead now rather than waiting. I would note that when we wait, bad things seem to happen. We waited in the Southeast Asia area after the Pakistanis flew a provocative missile, and we discovered that the Indians felt compelled to do some nuclear testing, which, of course, then led to the Pakistanis doing some nuclear testing, which then led to all the other proliferators in the area wanting to get in on the act. I do not think now is a time to be sitting by waiting. I think now is a time to be making a very clear, strong statement. I do not believe there should be any doubt about where the United States Congress stands on the subject of proliferation between Russia and Iran or any other proliferation of weapons of mass destruction in the world. Especially when Minister Kokoshin comes here, I think it would be most useful if we had a very strong vote so that there is a clear understanding that there are some matters in terms of cooperation that are not negotiable. Cooperation means cooperation in a meaningful way. It does not mean more appeasement. It does not mean winking. It does not mean blinking. It does not mean nodding at nuclear proliferation. It means not tolerating it, period. I believe this vote sends that message. I believe now is the right time. I am prepared to call for the vote after I yield back the balance of my time.

Mr. GOSS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 457 and ask for its immediate consideration.

Mr. GOSS. Mr. Speaker, for the purpose of debate only, I yield my friend, the gentleman from Ohio (Mr. Hall), the customary 30 minutes, pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate on this subject only. Mr. Speaker, H. Res. 457 is a very straightforward rule designed to facilitate the last step in the legislative process for H.R. 2709, the Iran Missile Proliferation Sanctions Act of 1997. Members may remember that this legislation was overwhelmingly approved by this House on a voice vote through the suspension process in November of last year. The other body considered the House bill and passed it on a 90 to 4 vote just a few weeks ago, changing only two dates in the legislation to reflect the passage of time and intervening events that occurred since the House first acted this past November. Therefore, the purpose of this rule is to allow the House to concur in the action taken by the other body so we can send this measure on to the President, who will, we hope, sign it into law expeditiously. In technical terms, Mr. Speaker, this rule provides for a single motion offered by the chairman of the Committee on International Relations or his designee to concur in each of the Senate amendments, which are as I have just explained. The rule provides that those Senate amendments and the motion shall be considered as read. The rule then provides for 1 hour of debate in the House, to be equally divided between the chairman and ranking minority member of the Committee on International Relations. It is a very simple rule, very straightforward, very fair, and, I believe, will get the job done quickly. Mr. Speaker, in recent days and weeks Americans have been jolted back into reality from what has been a lulling period of complacency about the threat of weapons of mass destruction in this dangerous world. The President has said repeatedly and pointedly that tonight our children will go to bed with no nuclear weapons pointed at them. Unfortunately, he was wrong. The world is a more dangerous place today. Events in India and Pakistan, allegations about advances in the Chinese missile program, and the potential for serious danger to our national security dominate the news these days. We have seen that nuclear weapons remain a tremendous threat to world security and peace, and we understand quite well that those who seek to proliferate in this deadly weapons race have not learned the terrible lessons of history. Proliferation of weapons of mass destruction is a major issue of concern for the intelligence committees, for the Committee on National Security, for all the Members of the House and the other body, and, indeed, for every American. I must say that as chairman of the Permanent Select Committee on Intelligence, I continue to be more than disappointed in the Clinton administration's approach to dealing with this issue, especially as we have seen it unfold in the past few weeks. I remain dismayed that time and time again it seems that the administration is willing to place perceived economic interests ahead of national security interests. The legislation we are bringing forward today is designed to send a strong signal to the world that we do not endorse such an approach and we specifically will not condone the transfer of missile goods or technology to Iran, a rogue nation that sponsors state terrorism and is actively engaged in weapons proliferation. We know that Iran's intentions, with or without Khatemi, are clearly not in the best interests of our national security or our global stability. Yet that nation's capabilities are fast approaching the ability to produce medium- and long-range ballistic missiles. This legislation puts any foreign persons or entities who persist in providing missile technology to Iran on notice that their actions will result in stiff sanctions. We are specifically interested in signaling to Russia and Russian firms that we expect their actions to speak as loudly as their words they used when, in January of this past year, the Russian Prime Minister issued a decree tightening legal controls on Russian exports of missile technology. I think it is significant that the other body chose to use this January 22, 1998 date of that Russian decree as the effective date for the provisions of this legislation to underscore the importance of Russia implementing its stated policy. We are challenging them fairly and squarely to stop cheating, and we are saying to the Clinton administration, no more winking at violations, no more giving the benefit of the doubt to those who do not deserve it. Mr. Speaker, this is a simple and fair rule, and I urge Members to support it and support the underlying bill, which is an important and vital message. I also remain hopeful that the President will do the right thing and sign this legislation into law as soon as possible. Mr. Speaker, I reserve the balance of my time.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I thank the gentleman from Glens Falls, New York, for yielding me the time. Mr. Speaker, there is a lot I would like to say about this rule. It is a good rule and deserves Member support. It was carefully crafted. There were many amendments. It is balanced, it is fair, and I urge everybody's support. The reason I am here with what is left of my voice today is to pay some testimony to the very fine work of the gentleman from South Carolina (Chairman Spence) and ranking member, the gentleman from Missouri (Mr. Ike Skelton). The gentleman from Missouri (Mr. Skelton) is the crossover Member on the Permanent Select Committee on Intelligence, and we have, as everybody knows, on defense authorization close cooperation and coordination with the Committee on National Security. Things would not work as smoothly as they have without the gentleman from Missouri (Mr. Skelton), and I personally and publicly wanted to thank him, the gentleman from South Carolina (Chairman Spence), and the staffs of both committees that who have worked so hard to make sure we have come up with a good product. I, too, think we have underfunded, but we are doing the best with what we have. I urge support for the rule. Mr. Speaker, I rise in strong support of H.R. 3616, the Department of Defense Authorization Bill for 1999. Mr. Speaker, I wish to congratulate my friends Chairman Spence and the Ranking Member Mr. Skelton on delivering the House a sound, bipartisan defense bill that I think all the Members of this body can, and should, vote for. After 14 years of steady decline in the defense budget, they were again handed a request by the Administration that clearly asks our men and women in the Armed Forces to do ``more with less.'' Mr. Spence and Mr. Skelton's efforts, and indeed the outstanding efforts by all members of the National Security Committee, have allowed for the careful crafting of a bill that manages increasing world-wide risk in an era of shrinking forces and budgets. This is no easy task. Mr. Speaker, as the Members of this body know, the dollars for the Intelligence Budget Authorization that we here in the House passed on the 7th of May--on a voice vote--are contained in this defense authorization. I can tell you that the close coordination between the National Security Committee and the Permanent Select Committee on Intelligence--on which, I might add, the distinguished Member from Missouri, Mr. Skelton, plays a tremendously valuable role as a cross- over member--allowed us to put together a prudent defense intelligence input to this authorization bill. Together, this bill and the intelligence bill focus on the needs of our Nation. H.R. 3616 increases spending on equipment modernization, it increases the funding for National Guard and Reserve modernization not funded in the President's request, it addresses a balanced quality of life investment for our military personnel, and it improves readiness. But, Mr. Speaker, this does not mean we are looking at a ``fat'' bill. While the funding in this bill is consistent with the Balanced Budget Act of 1997, it should be pointed out that the President's defense request--according to the military service chiefs--is under- funded by more than 10 billion dollars. I wish we were spending more on our national security--on our military and our intelligence services. Not seeing the will at this point in the Administration to make this critically important--even if politically difficult--call, I believe H.R. 3616 does what can be done to limit the further ``hollowing'' out of our defenses. I urge my colleagues to vote yes on H.R. 3616.

Mr. GOSS

Mr. GOSS. Madam Speaker, I thank the distinguished gentleman from Illinois (Mr. Henry Hyde), chairman of the Committee on the Judiciary, with my great respect for him, and I thank him personally from my heart for getting this legislation this far. Madam Speaker, I rise today in support of H.R. 1023, the Ricky Ray Hemophilia Relief Fund Act, which is designed to respond to the tragedies of hemophilia-associated AIDS. I first became involved in this issue some nine years ago when I met the Ray family. Ricky Ray, like his two brothers, contracted HIV through the use of contaminated blood products. Ricky, the eldest of the three boys, died of AIDS in 1992 at the age of 15. Before his death Ricky and his family courageously spoke out and became national symbols of the terrible situation we are facing. He inspired many of his peers to tell their stories and begin seeking answers from the Federal Government and the blood product manufacturing industry. I am saddened that he did not live to see the day when legislation named in his honor would win the approval of this body. But we know his brothers and sisters, his parents, and the extended family of friends he established around the country recognize the enormous contribution that he made in his very short life. It is appropriate that the legislation before us bears his name, and I am pleased that Ricky's mother Louise is here with us today. Madam Speaker, hemophilia is an inherited blood-clotting disorder causing serious internal bleeding episodes that, if left untreated, can lead to disfigurement and death. People with hemophilia rely on blood products, commonly called factor, which are manufactured and sold by pharmaceutical companies. Because these products are made from the pooled blood of thousands of people, the potential for infection with a blood-borne disease among those who use them is obviously very high, something that has been known for decades. In fact, hemophilia sufferers have long been described as the canaries in the coal mine, because when something goes wrong with the blood supply it shows up in the hemophilia community first. Soon after the introduction of clotting factor in the 1970s, the hepatitis virus swept through the hemophilia community. Largely as a result of the hemophilia community's experience with the hepatitis virus, the Federal Government adopted the national blood policy, which charged the Public Health Service, including the Centers for Disease Control, Food and Drug, and the National Institutes of Health with ensuring the safety and adequacy of the Nation's blood supply. It is worth noting that the Federal responsibility for blood and blood products is indeed unique. No other product has a national policy. In the early 1980s a much more deadly disease struck as approximately one-half of the Nation's hemophiliacs, some 7,200 people at a minimum, became infected with HIV through the use of contaminated blood products. How did this happen? Why did the system that was established to safeguard the supply of blood and blood products fail to heed the early warning signs and prove so slow to respond to a dangerous threat? In 1993 I joined with Senators Graham of Florida and Kennedy of Massachusetts in asking the Department of Health and Human Services to conduct a review of the events surrounding this medical disaster. The results of that intensive and objective review are contained in a report prepared by the Institute of Medicine, an arm of the National Academy of Sciences. The IOM found ``a failure of leadership and inadequate institutional decision-making processes'' in the system responsible for ensuring blood safety, concluding that ``a failure of leadership led to less than effective donor screening, weak regulatory actions, and insufficient communication to patients about the risk of AIDS.'' While the IOM report is important, it does not begin to quantify the human dimension. For me, that is the most compelling part of this tragedy. We cannot talk to these victims without being moved by what they have gone through. It is important to keep in mind that the people with hemophilia already have to manage a sometimes debilitating disease. The average person with hemophilia spends approximately $100,000 per year on clotting factor alone. Many people with hemophilia have had a difficult time obtaining both health and life insurance, understandably. In addition to the difficulties associated with hemophilia itself, the added complication of HIV AIDS has hit the hemophilia community particularly hard. Each treatment costs somewhere in the range of $10,000 to $50,000 per year, varying on the stage of the disease and the course of the treatment. As a result of these extraordinary costs and the disproportionate impact of this tragedy on men, who most typically suffer from hemophilia and who tended to be the head of many of these households, many of these folks have been financially devastated. In some cases entire generations have been wiped out: fathers, sons, uncles. Most tragically, some men infected their wives with HIV before they became aware that they had contracted the disease. We know of cases where unborn children in these circumstances were also infected. The emotional toll on all of these families has been immense. Madam Speaker, the Federal Government cannot become involved in every tragic case that occurs in this country, but this case is unique. I believe the Federal Government can and should, for compassionate reasons, act to help the hemophilia community. While we cannot right all the wrongs in the world, we should pass this legislation to acknowledge the unique responsibility of the government to protect the blood supply and provide some measure of compassionate assistance to these victims. While I am encouraged that a final class settlement between the people of hemophilia and the blood product manufacturing companies is in fact going forward, it does not change my view that government also must act. As my colleagues know, and as the hemophilia community has learned firsthand, moving a bill through the legislative process is a slow, difficult, and sometimes frustrating experience, amen. When I first introduced the Ricky Ray bill, we had about two dozen cosponsors. Since then support for the bill has swelled to 270 cosponsors, and we have secured unanimous approval for all three committees with jurisdiction. This incredible progress is the direct result of the courage, diligence, and hard work of the hemophilia community. Of particular notice is the work of a group of high school students from Robinson Secondary School in Fairfax, Virginia. For several years these kids, as part of a marketing education program called DECA, have lobbied to pass this bill. Their efforts have been extraordinary, and they show that democracy can and does work. Finally, Madam Speaker, let me say thank you to the congressional staff that have worked with me through the years to research and understand this tragedy, explain it to the House, and get this bill moving. Madam Speaker, for too long the hemophilia community has felt that government first let them down and later abandoned them. I sincerely hope that the House action today will provide some measure of reassurance that their voices do count, that the legislative process does work, and that we have not forgotten them or the tragedy that befell their community. I only wish we had a cure for AIDS. I strongly urge my colleagues to support this important legislation. Madam Speaker, I include for the Record the following CRS report. The report referred to is as follows: CSR Report for Congress--Blood and Blood Products: Federal Regulation and Tort Liability (By Diane T. Duffy and Henry Cohen, Legislative Attorneys, American Law Division) summary Part I of this report, by Diane Duffy, Legislative Attorney, provides an overview of the Federal government's regulation of blood products. Part II, by Henry Cohen, Legislative Attorney, examines tort liability for injuries caused by defective blood or blood products. The Food and Drug Administration (FDA) regulates blood and blood products under two statutes which overlap to a certain degree: the Federal Food, Drug and Cosmetic Act [FFDCA] and the Public Health Services Act (PHSA). Regulations are issued in order to implement the provisions of these statutes. Current statutory and regulatory law operates to govern the licensing, production, testing, distribution, labeling, review and approval of all drugs and biologics. Specifically, under the FFDCA, drugs, which include biologics such as blood and blood components or derivatives, which are intended to cure, mitigate, or prevent disease, are regulated. The enforcement and penalties provisions of the FFDCA can be applied to biological product manufacturers. Within the agency, the Center for Biologics Evaluation and Review has jurisdiction over the regulation of these articles. Tort liability for injuries caused by defective blood or blood products is a form of products liability, which is governed primarily by state law. Products liability is strict liability, which means that, to recover, the plaintiff does not have to prove that the defendant was negligent, but need prove only that the defendant sold a defective product and that the plaintiff's injury resulted from the defect. However, all 50 states--48 through ``blood shield'' statutes--provide that blood transfusions are not subject to strict liability. The primary rationale for this is the belief that holding suppliers of blood or blood products strictly liability would make blood transfusions too expensive. Part I of this report, by Diane Duffy, Legislative Attorney, provides an overview of the Federal government's regulation of blood products. Part II, by Henry Cohen, Legislative Attorney, examines tort liability for injuries caused by defective blood or blood products. part i: federal regulation of blood products Issues relating to the regulation of blood products have been raised in the context of individuals with hemophilia who contracted Human Immunodeficiency Virus (HIV), the virus which causes AIDS, through the use of contaminated blood products. In the 104th Congress, bills have been introduced by Rep. Goss and Sen. DeWine which would establish a trust fund to compensate hemophiliacs, their spouses or estates, who contracted HIV through tainted blood products. This part of the report summarizes Rep. Goss' bill (H.R. 1023, 104th Congress) \1\; discusses current Federal law that directs and authorizes the regulation of blood products; and discusses regulatory issues and events which are notable in this context. In particular, it focuses issues which tend to indicate that the regulation of blood products has been different than the regulation of other articles which are within the jurisdiction of the Food and Drug Administration (FDA). --------------------------------------------------------------------------- Footnotes at end of article. --------------------------------------------------------------------------- Summary: The Ricky Ray Hemophilia Relief Fund Act of 1995 H.R. 1023, 104th Congress, introduced by Rep. Goss, establishes procedures for claims for compassionate payments with regard to persons with blood clotting disorders, e.g., hemophilia, who contracted HIV due to contaminated blood products. The bill, entitled the Ricky Ray Hemophilia Relief Fund Act of 1995, states that about half of all individuals in the U.S. who suffer from blood clotting diseases like hemophilia, were exposed to HIV through the use of blood clotting agents. The bill finds that the Federal government has a shared responsibility with the blood products industry for protecting the safety of the blood supply and for regulating blood clotting agents. H.R. 1023 finds that people with blood clotting disorders were at a very high risk of contracting HIV during the period beginning in 1980 and ending in 1987, when the last mass recall of contaminated anti-hemophilic factor (AHF) occurred. The bill states that it was during this period that the Federal government did not require the blood products industry to use means to ensure safety of blood products that were marketed for sale to people with blood clotting disorders. Moreover, it finds that the government did not require that all available information about the risks of contamination be dispensed and failed to properly regulate the blood products industry. Based upon these and other findings, the bill establishes a fund to compensate individuals in this circumstance. The fund is named after a child born with hemophilia who, like his two younger brothers and others, became infected with HIV through the use of contaminated blood clotting products.\2\ Specifically, the fund provides for partial restitution to people who were infected with HIV after treatment, during the period of 1980-1987, with contaminated blood products. The fund is established in the Department of the Treasury, is to be administered by the Secretary, and is to remain viable for five years after the date of enactment. The bill authorizes to be appropriated to the fund $1,000,000,000, to be disbursed by the Attorney General. H.R. 1023 provides that any person who submits to the Attorney General written medical documentation that he has an HIV infection shall receive $125,000 if each of these conditions is met: (A) 1. The person has any form of blood clotting disorder and was treated with blood clotting agency in the form of blood components or blood products at any time during the period of January 1, 1980 and ending December 31, 1987; or 2. The person is the lawful spouse of the infected person or is the former lawful spouse of the infected person at the time so described in the bill. 3. The person acquired HIV through perinatal transmission from a parent who is an individual described in the above paragraphs. (B) A claim for payment is filed with the Attorney General. (C) The Attorney General determines that the claim meets the requirements under this bill, if enacted. The Attorney General is required to establish procedures for the claims and payments and must determine whether the claim meets all the requirements. Claims are to be assessed and paid, if appropriate, within 90 days of their filing. In the case of a deceased claimant, the payment is to be made to the deceased's estate or in the manner set forth in the bill. Payments made from the fund shall be in full satisfaction of all claims of or on behalf of the individual against the United States that arise out of both the HIV infection and treatment during the period of time noted. With regard to judicial review, any person whose claim is denied may seek judicial review in a district court of the U.S. The court shall review the denial on the administrative record and hold unlawful and set aside the denial if it was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. Regulation of blood products The Food and Drug Administration (FDA) regulates blood and blood products under two statutes which overlap to a certain degree: the Federal Food, Drug and Cosmetic Act [FFDCA] \3\ and the Public Health Services Act (PHSA)\4\ and implementing regulations.\5\ Current statutory and regulatory law operates to govern the licensing, production, testing, distribution, labeling, review and approval of all drugs and biologics. Under the FFDCA, drugs intended for the cure, mitigation, or prevention of disease, which include biologics such as blood and blood components or derivatives, are regulated.\6\ Biological products are regulated by the FDA's Center for Biologics Evaluation and Review under the authority of the FFDCA, PHSA and implementing regulations.\7\ The FDA is the primary agency for protecting the nation's blood supply and it is directed and authorized to regulate blood-banking, the handling of source plasma, and the manufacturer of blood products. Investigations of a new biological product is done under investigational new drug procedures found in the drug section of the FFDCA because the PHSA specifically regulates after the product is in the stream of commerce, not before. The enforcement and penalties provisions of the FFDCA can be applied to biological product manufacturers. Under section 351 of the PHSA \8\, blood products are regulated under the category of biological products. Current law provides that no person may sell, barter, exchange or offer to sell, barter, exchange or conduct interstate commerce of the same or bring from a foreign country any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic products, or analogous products applicable to the prevention, treatment, or cure of diseases or injuries of man unless the same has been propagated or manufactured and prepared at an establishment holding an unsuspended or unrevoked license, issued by the Secretary, to propagate or manufacture and prepare the biological product. Moreover, the law provides that each package of the product must be plainly marked with the proper name of the product, the name, address and license number of the manufacturer and the expiration date. The statute prohibits the false labeling or marking of any package or container containing the biological product and authorizes department officials to inspect establishments. Current law governs licensing for both the establishment and the product. For example, the statute provides that licenses for the maintenance of the establishment are issued after a showing that the establishment and the products meet standards designed to insure the continued safety, purity and potency of the products. Further authority is provided for suspending and revoking licenses. Also, when a batch, lot or other quantity of a licensed product presents an imminent or substantial hazard to the public health, the Secretary shall issue an order, under 5 U.S.C. Sec. 554, immediately ordering the recall of the quantity. The assessment of civil money penalties is authorized for violations. Any person who violates this section or aids in the violation of this section may be punished upon conviction by a fine or imprisonment or both. In sum, the agency is authorized to enforce the law through various enforcement tools including, seizure, application for recall, injunction, criminal prosecution, or administrative techniques, e.g. suspension, revocation of license.\9\ Implementing regulations governing blood and blood products provide further detail. For example, 21 C.F.R. Part 600 addresses general standards for establishments that manufacture a product subject to licensing as a blood product. It defines critical terms, e.g., biological product, sterility, purity, establishment, etc. These regulations state that with respect to an establishment, a person shall be designated as the ``responsible head who shall exercise control of the establishment in all matters relating to compliance with the provisions'' of these regulations.\10\ This part governs inspections with respect to time of inspection, duties of inspectors and more. In addition, regulations require other actions, for instance, the post- market reporting of adverse experiences.\11\ Part 601 governs two types of licensing: the establishment and the product.\12\ The FDA is charged with issuing licenses only after all pertinent requirements and conditions are met. The agency is authorized to enforce provisions of current law through administrative measures to revoke or suspend a license. Provisions for review of the agency's decision regarding suspension or revocation are also addressed. Section 601.25 establishes the review procedures to determine that licensed biological products are safe and effective and not misbranded under prescribed, recommended or suggested conditions of use. Notably, Subpart E provides for the accelerated approval of biological products for serious or life threatening illnesses. This section permits the agency to approve products on a fast track to provide meaningful therapeutic benefit to patients over existing treatments, that is, to treat patients unresponsive to or intolerant of, available therapy. To assist the agency in fulfilling its duty to evaluate the safety and effectiveness and labeling of biological products, Part 601 also authorizes the FDA to appoint advisory review panels to (1) evaluate the safety and effectiveness of biological products for which a license has been issued under Sec. 351 of the PHSA; (2) review the labeling of such biological products; and (3) advise the Commissioner on which of the biological products under review are safe, effective and not misbranded. The members of the panel shall be qualified experts, appointed by the Commissioner, and shall include persons from lists submitted by organizations representing professional, consumer, and industry interests. Such persons shall represent a wide divergence of responsible medical and scientific opinion. The Commissioner designates the chair of each panel (for each type of biological product) and minutes of all meetings must be made. Additionally, regulations provide that interested persons can participate in the advisory panels sessions to the extent that the FDA must publish a notice in the Federal Register requesting interested persons to submit, for review and evaluation by the advisory panel, published and unpublished data and information pertinent to the biological products. To a certain extent, the industry regulates itself through the adherence to good manufacturing practices (GMPs). Part 606 sets forth these GMPs for blood \13\ and blood components and provides uniform and industry-specific guidelines and requirements to insure safety, effectiveness, purity and other important features of blood products.\14\ These regulations pertain to personnel of the establishment, e.g., requirement to designate person in control of establishment; facilities maintenance, e.g., adequate space, quarantine storage, orderly collection of blood, etc.; equipment, e.g., calibrated, properly maintained, etc.; and, supplies and reagents, e.g., storage in a safe, sanitary and orderly manner. The GMPs detail finished product controls, container labels, records and reporting procedures and importantly, the adverse reaction process. Part 607 requires the registration of establishments which include human blood and plasma donor centers, blood banks, transfusion services, other blood product manufacturers and independent laboratories that engage in quality control and testing for registered blood product establishments. The regulations also provide special standards for human blood and blood products, some of which apply directly to those being treated for hemophilia. For example, Part 640 addresses the product known as Cryoprecipitated AHF, a preparation of antihemophilic factor which is obtained from a single unit of plasma collected and processed in a closed system. The source material for this product is plasma which may be obtained by whole blood collection or plasmapheresis.\16\ The regulations establish procedures pertaining to the suitability of donors; the collection of source material; the testing of blood; processing; quality control; and further requirements. With specific regard to donor testing, the regulations provide that the blood from which the plasma is separated must be tested as prescribed in Sec. Sec. 610.40 [Test for hepatitis B], 610.45 [Test for HIV] and 640.5 [Test for syphilis, blood group, and Rh factors]. The test must be conducted on a sample of the blood collected at the time of donation and the container must be properly labeled. Manufacturers of this product are responsible for testing and record-keeping. Moreover, quality control tests for potency of the antihemophilic factor must be conducted each month on at least four representative containers of Cryoprecipitated AHF. The results must be maintained at the establishment for inspection and review by the FDA. As soon from the above examination of statutory and regulatory law, the legal requirements and procedures, as well as industry GMPs, create a complex and far-reaching regulatory structure for biological products and blood products in particular. To a certain extent, under the FFDCA and the PHSA, the licensing of biologics is more restrictive than that for other regulated articles, e.g., new drug. For example, a new drug under the FFDCA needs an approved new drug application (NDA), however, a new biologic needs to fulfill higher requirements. A generic biological product such as a serum must be approved by the FDA under the PHSA for its purity, potency and effectiveness based upon data submissions.\16\ The PHSA states that licenses for new products may be issued only upon a showing that meets these express standards.\17\ Additionally, related regulations and GMPs must be fully satisfied to ensure compliance. Second, manufacturers of the product are individually licensed as capable of making the product on the particular manufacturing site.\18\ Regulations at Part 607, discussed above, must be fully met for each establishment and for each product. Enforcement and inspection authority under the Act may be triggered to address alleged violations of the law or regulations or to insure ongoing compliance. Inspectors are authorized to examine records of the licensed establishments while GMPs guide recordkeeping, facility and equipment management, personnel regulations and similar procedures. Moreover, the FDA inspectors are granted special inspection authority for biological products and special procedures apply. For instance, as noted above, a specific person must be designated as being in control of the facility for regulatory and compliance purposes.\19\ Moreover, and particularly with regard to blood clotting agents for hemophilia, extensive and frequent testing of lots and batches is required after initial production. The FDA may exercise its enforcement authority under the FFDCA and PHSA to suspend or revoke the license for either the product or the establishment, to seize, to seek recalls, injunctions, assess penalties, and to exercise a range of impressive enforcement tools.\20\ The entire licensure process is complex and intended to insure purity, potency and prevent misbranding. Some view it as the functional equivalent to a NDA for a new drug. Regulation of biological products is more restrictive in scope and has appeared to evolve to meet the unique needs and characteristics of biological products. While there are many similarities in the regulation of the drugs, devices, and biological products during pre-market and post-market phases, there appears to be a greater emphasis on regulatory standards and requirements for biologics at the manufacturing level. Commentators have noted that the unique and separate histories of the regulation of drugs and biologics may account for the difference in regulatory approach.\21\ One reason may be attributed to the fact that the Biologics Act \22\ predates the FFDCA and that it was not enforced by the FDA until 1972, when jurisdiction for these matters was transferred to the FDA from the National Institutes of Health. Extensive government involvement and regulation of the manufacturing process grew out of early tragic incidents when it was determined that microbes contaminated vaccines.\23\ Thus, where the primary focus is on the final product for drugs and devices, for biologics, it was determined that government regulation was needed much earlier and more strictly than for other articles under the various pertinent statutes. Additionally, blood and blood products are the subject of an articulated national policy. Other articles under the FFDCA and PHSA have not been focused upon nationally in such a way. In 1973, the National Blood Policy was announced and the Public Health Service, including the CDC, the FDA and NIH, was charged with responsibility for protecting the nation's blood supply. The Policy recognized that reliance on ``commercial sources of blood and blood components for transfusion, therapy . . . contributed to significantly disproportionate incidence of hepatitis, since such blood is often collected from sectors of society in which transmissible hepatitis is more prevalent.'' \24\ The Policy encouraged efforts to establish an all-volunteer blood donation system and to eliminate commercialized acquisition of blood and blood components. The Policy listed four goals: to provide an adequate supply of blood; to ensure a higher quality of blood; to facilitate maximum accessibility to services; and to achieve total efficiency.\25\ According to the Institute of Medicine's [IOM] 1995 study, the first actions under the policy included adoption of an all-volunteer blood collection system; coordination of costs; regionalization of blood collection and distribution; and, an examination of standards of care for hemophiliacs and other special groups. The Policy did not address the commercialization of plasma, the preparation and marketing of plasma derivatives, and the commercial acquisition of blood for diagnostic reagents.\26\ Contaminated blood products and brief overview of Government actions during the 1980's In the context of blood products regulation and the government's focus on the nation's blood supply, events occurred in the 1980s which led hemophiliacs and others to contract HIV from contaminated blood and blood products. The IOM study indicates that in September of 1982, of the 593 cases of AIDs reported to the CDC, 3 were hemophiliacs. Later, the CDC noted that the hemophilia patients who had AIDS had all received large amounts of a commercially manufactured anticoagulant known as AHF (antihemophilic factor) \27\ Evidence seemed to indicate that children with hemophilia were at risk for the disease.\28\ As more cases were reported, the IOM report states that a national survey indicated that 30% or more of all hemophiliacs had abnormal immunological tests. By January 1983, evidence from CDC investigations strongly indicated that blood and blood products transmitted AIDS and that it could be transmitted through sexual contact. It appeared that AIDS was occurring in individuals with hemophilia who had received AHF concentrate.\29\ In March, 1983, the PHS issued its first formal recommendations on the prevention of AIDS and with regard to hemophiliacs, the recommendation stated that work should continue toward development of safer blood products for use by hemophiliac patients.\30\ H.R. 1023 states that thousands became infected with HIV through the use of contaminated blood clotting products.\31\ The IOM report indicates that numerous measures were publicized and taken with regard to blood and plasma donations, collection and use, e.g. quarantine and disposal. The FDA announced that it approved a heat treatment to inactivate viruses in AHF concentrate, which purported to help protect individuals with hemophilia from Hepatitis B, and perhaps, AIDs.\32\ The IOM report states that: ``Government and private agencies identified, considered, and in some cases adopted strategies for dealing with the risk of transmitting AIDs through blood and blood products. The recommended safety measures were limited in scope. . . .'' \33\ In 1983, the FDA's Blood Product Advisory Committee (BPAC) met to reconsider blood and blood products policies. One company recalled AHF concentrate when it determined that the concentrate was made from pools containing plasma from a person diagnosed with AIDs. However the IOM report notes that this recall was expressly not viewed as a recall of all such products and that the agency did not initially initiate a nationwide call of the concentrate.\34\ The BPAC stated in mid-1983 that the criteria for deciding to withdraw lots of AHF concentrate should be based on evidence that plasma from a donor with AIDs had been present in the pooled plasma from which the lot was manufactured and recommended to the FDA a case-by-case decision regarding withdrawal for each lot that included plasma from a person who had AIDS or was suspected of having AIDS.\35\ Some physicians switched from AHF concentrate to cryoprecipitate in those with less severe hemophilia. The IOM concluded ``[b]lood safety policies changed very little during 1983 [and that there] were missed opportunities to learn from pilot tests to screen potentially infected donors or implement other control strategies that had been rejected as national policy.'' \36\ Inaction relating to donor screening and surrogate marker testing was emphasized in the report.\37\ BPAC served as an advisory committee for the FDA and was the forum for industry and interested entities to participate in and influence the FDA's policy regarding blood products regulation.\38\ According to the IOM report, BPAC's membership included blood and plasma organization representatives, scientists, and physicians.\39\ The report concluded that valuable screening measures were not recommended by the BPAC due to uncertainties regarding scientific data, i.e., data from CDC, and ``pressures from the blood industry and special interest groups.'' \40\ Thus, options that could have reduced infection were not pursued. HIV testing and additional donor screening procedures were implemented in 1985. The IOM concluded that the FDA relied too heavily on BPAC and did not independently assess its recommendations and statements, and did not observe principles for proper management of advisory committees.\41\ Moreover, IOM concluded that the membership of BPAC limited the information and points of view expressed to the agency and found possible issues relating to conflicts of interest. The report focused on the agency's role as being responsible for protecting the nation's blood supply, providing leadership and communication of information to those at risk.\42\ Conclusion to Part I In sum, the blood and blood products regulation under the FFDCA and PHSA are restrictive and complex, governing primarily licensing of products and sites, as well as the final product, and authorize extensive enforcement actions. The FDA is the lead agency responsible for regulation of these articles and was charged with this responsibility in 1972. The products themselves seem to have been accorded special status, to a certain degree, under the statutes for regulation. Moreover, blood and blood products have been part of an articulated National Blood Policy. Events of the 1980s resulted in individuals with hemophilia, and many others, to contract HIV through the use of contaminated blood and blood products. This spurred intense examination of the FDA, its regulatory actions, and the use of its advisory committee BPAC, during this period. H.R. 1023, and S. 1189, were introduced to provide for payments from a trust fund to those with blood clotting disorders who contracted HIV at this time. part ii: tort liability for injuries caused by defective blood or blood products ``Products liability'' refers to the liability of a product manufacturer or subsequent seller for damages resulting from an injury caused by a product defect. Products liability is governed primarily by state common (i.e., court-made) law, as modified by state statute, although federal statutes occasionally preempt aspects of state products liability law. For example, prior to filing suit under state law for injuries caused by defective vaccines, one must file a claim under the National Children Vaccine Injury Act of 1986, as amended.\43\ Products liability differs from most other liability for non-intentional torts because products liability is strict liability, which means that, to recover, the plaintiff does not have to prove that the defendant was negligent (i.e., failed to exercise due care). All the plaintiff generally must prove in a products liability action is that the defendant sold a defective product and that the plaintiff's injury resulted from the defect.\44\ Products liability suits sometimes also allege a breach of warranty, on the theory that the fact that the product was defective constitutes a breach of the implied warranties that goods shall be merchantable (fit for ordinary purposes) and fit for any particular purpose for which they are required. These implied warranties arise under Uniform Commercial Code Sec. Sec. 2-314 and 2-315, which has been enacted into law in every state but Louisiana. A suit for breach of warranty is similar to one for strict liability in tort in that in neither type of case need the plaintiff prove negligence. Breach of warranty suits predate strict tort liability suits, which came into being only in the 1960s. One situation in which strict liability is generally not applied is in suits involving unavoidably unsafe products, among which, as noted below, some courts include blood. Restatement (Second) of Torts Sec. 402A comment k, which courts generally follow, provides: ``There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. This is especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging side effects when it is injected. Since the disease itself inevitably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous'' [emphasis in original]. Case law The seminal products liability blood transfusion case was Perlmutter v. Beth David Hospital, decided by the New York Court of Appeals in 1954.\45\ It was a breach of warranty case (as it predated strict tort liability), and the issue was whether a transfusion constituted the sale of a product, in which case a transfusion of contaminated blood would constitute a breach of warranty, or whether it constituted the provision of a medical service, in which case the plaintiff would have to prove negligence to recover. This distinction was critical because there was no means to detect the presence of the hepatitis virus in blood, nor a practical method to treat the blood to eliminate the danger of hepatitis. Therefore, if the court deemed the transfusion a sale, it would turn hospitals into insurers of the risk of contaminated blood, but if it deemed it a service, then plaintiffs in most cases would go uncompensated because of the difficulty in proving negligence. The court held that the transfusion should be treated as a service, because, ``when service predominates, and the transfer of personal property is but an incidental feature of the transaction, the transaction is not deemed a sale. . . .'' \46\ The Perimutter decision was widely followed by the courts, and extended to blood banks as well as hospitals. In Community Blood Bank, Inc. v. Russell, however, a Florida court found it ``a distortion to take what is, at least arguably, a sale, twist it into the shape of a service, and then employ this transformed material in erecting the framework of a major policy decision.'' \47\ This policy decision, of course, is whether ``the social utility of an abundant blood supply outweighs the risks to individuals'' \48\ The Florida court, needless to say, found the transfusion to be a sale, and a transfer of contaminated blood to be a breach of warranty. ``Community Blood Bank thus paved the way for the greatest assault on the Perlmutter citadel, which came in Cunningham v. MacNeal Memorial Hospital,\49\ where the defendant once again was a hospital, not a blood bank.'' \50\ The plaintiff, who had contracted serum hepatitis from defective blood supplied by the hospital during a transfusion, asserted a claim in strict liability and won, with the court refusing to allow the hospital the defense that there was no means to detect the existence of serum hepatitis in whole blood. The court wrote: ``To allow a defense to strict liability on the ground that there is no way, either practical or theoretical, for a defendant to ascertain the existence of impurities in his product would be to emasculate the doctrine and in a very real sense return to a negligence theory.'' \51\ Some courts, even if they treated a transfusion as the sale of a product and not as a service, found for the defendant under Restatement (Second) of Torts Sec. 402A comment k, mentioned above. They ``considered whether liability without fault was applicable in view of a claim that blood containing hepatitis is a product which is unavoidably unsafe and thus is not an unreasonably dangerous product for which the blood bank could be held liable without fault. With some authority to the contrary, the courts have reasoned that blood infected with hepatitis virus is such an unavoidably unsafe product, since there is a great need for blood for operations and surgical procedures, but the possibility of blood being infected with hepatitis cannot be totally eliminated despite due care being taken, and therefore they have held that a blood bank cannot be held liable without fault for injuries to a patient who contracted hepatitis from the blood it supplied.'' \52\ Blood shield statutes; negligence suits The Illinois legislature responded to the Cunningham decision by enacting a statute that provides, in part: ``The procuring, furnishing, donating, processing, distributing or using human whole blood, plasma, blood products, blood derivatives and products, corneas, bones, or organs or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body is declared for purposes of liability in tort or contract [i.e., breach of warranty] to be the rendition of a service . . . and is declared not to be a sale of any such items and no warranties of any kind or description nor strict tort liability shall be applicable thereto, except as provided in Section 3 [which imposes liability for negligence].'' \53\ A subsequent Illinois case upheld the constitutionality of this statute, writing: ``[I]t was predicted at the time Cunningham was handed down that the imposition of liability without fault on the distributors of blood would cause the cost of transfusions to skyrocket. . . . Moreover, implicit in the legislature's declaration of public policy is the fear that the imposition of strict tort liability would cause the financial considerations arising out of increased exposure to tort litigation to impinge on the exercise of sound medial judgment in a field where an individual's life might be at stake.'' \54\ Illinois' approach is now the approach of all 50 states, with 48 states having enacted blood shield statutes, and Minnesota, New Jersey, and District of Columbia courts having reached the same result on their own.\55\ Blood shield statues ``expressly characterize blood transfusions as services or explicitly state that blood transfusions will not be subject to strict liability.'' \56\ A 1990 Washington case articulated the policy justifications for blood shield statutes: ``First, the societal need to ensure an affordable, adequate bloody supply furnishes a persuasive reason for distinguishing between victims of defective blood and victims of other defective products. Second, strict liability cannot provide an incentive to promote all possible means of screening the blood for HIV. Third, although the producers may be in a better position to spread the costs, it is not in society's best interest to have the price of a transfusion reflect its true costs.'' \57\ Blood shield statutes do not preclude all lawsuits alleging injuries caused by contaminated blood. Even in a state with a blood shield statute, one commentator notes, ``It seems likely that an action in express warranty or innocent tortious misrepresentation would lie if a supplier of a blood product misrepresented the product's safety, and a plaintiff relied on the misrepresentation to his detriment in the purchase of use of the product.'' \58\ Another commentator addresses a different situation in which strict liability may remain: ``So blood shield statutes were expressly enacted to address only the threat of serum hepatitis, and it was not until after it was discovered that the HIV virus was transmittable through blood that legislatures amended these statutes to deal with potential AIDS liability. Courts have held that these amendments are not to be applied retroactively. Consequently, plaintiffs who received contaminated transfusions before the amendment are not barred by the blood shield statutes from bring strict liability actions.'' \59\ A blood shield statute was also held inapplicable in a suit against a pharmaceutical company where the relevant statute (Indiana Code 16-41-12-11) applied to the distribution of blood by a ``bank, storage facility, or hospital.'' The Indian Court of Appeals wrote: ``[W]e simply cannot conclude that our legislature intended to include a pharmaceutical company, which commercially produces blood products for mass distribution, as an entity within the same class described as an organ or a blood ``bank or storage facility.'' The manufacture and distribution of blood products by pharmaceutical companies is better characterized as the sale of a product rather than the provision of a service. . . . It is quite unlikely that our legislature intended to include pharmaceutical companies in its definition of ``bank or storage facility'' simply because the manufacture or production of blood products incidentally involves their storage.'' \60\ Finally, blood shield statutes do not, of course, preclude suits for damages caused by negligence, and, ``[w]ith strict liability effectively eliminated as a possible remedy [in transfusion cases], negligence remains the only viable alternative.'' \61\ ``To recover under a negligence cause of action a transfusion-related AIDS victim must prove that a standard of care existed, that the defendant's conduct fell below that standards, and that this conduct was the proximate cause of the plaintiff's injury. Plaintiffs who have contracted AIDS through transfusions of blood and blood products have alleged negligence in both blood testing and donor screening.'' \62\ It is relevant to note here that, in 1985, the Food and Drug Administration (FDA) licensed the enzyme-linked immunsorbent assay (ELISA) test, which ``has proven 98.6% effective in detecting exposure to AIDS [in blood], and when coupled with a second test, the Western Blot Analysis, the rate of detection rises to 100%.'' \63\ The existence of this test enables plaintiffs to argue that a failure to use this test constitutes negligence. A federal court of appeals wrote: ``We believe that the FDA's recommendation of February 19, 1985, that blood facilities begin testing all donated blood as soon as testing supplies become commercially available imposed a duty on [the blood bank] to test all its blood supplies for antibodies to the AIDS virus.'' \64\ One commentator reports: ``As the rampant spread of AIDS continues and its devastating effects, both socially as well as personally, are being publicized, courts are weighing the consequences of the AIDS epidemic against the necessity of assuring an adequate supply of blood. . . . In the past several years, courts have started to rethink their position on denying recovery to victims of AIDS-tainted transfusions. Several approaches [to proving negligence] have been utilized with some success. These approaches include: (1) failure of the blood supplier or doctor to adequately warn the blood recipient of the inherent dangers associated with a blood transfusion [thus denying] the patient the opportunity to make an informed choice; (2) inadequate screening of blood donors [thus] allowing high-risk individuals to continue donating blood; and (3) using a blood transfusion when an alternate, safer method of sustaining life was available.'' \65\ Selected recommendations in the legal literature; The National Childhood Vaccine Injury Act of 1986 One commentator writes: ``Although absolute protection for these entities [blood banks and blood product manufacturers] may have been logical or desirable when the HIV virus was undetectable in blood, the better view based on current medical and scientific knowledge would be to allow post-1985 recipients of contaminated transfusions to recover under the theories of strict liability and breach of warranty. This would place the burden on the blood banks and blood products manufacturers to ensure the safety of the products they distribute.'' \66\ The same writer adds: ``Moreover, court and legislatures should distinguish between hospitals, blood banks, and blood products manufacturers. Blood banks, and especially blood products manufacturers, are active players in the economic marketplace, selling goods rather than providing services.'' \67\ These views are echoed by another commentator: ``While hospitals may be characterized as service-providers, it is merely a legal fiction to so characterize blood and blood products providers. To hold them liable only in negligence-- and then to allow the blood industry itself to set the standard of care accepted in the community, thus requiring innocent plaintiffs to shoulder an extraordinary burden of proof--violates all notions of fair play. It is time that blood products purchased for a price, and particularly manufactured blood derivative products, be recognized for the products they are. Even under the 402A comment k exception for ``unavoidably unsafe'' products, it would be unthinkable to term blood contaminated by the HIV virus as not ``unreasonably dangerous.'' It would be hard to think of anything more unreasonably dangerous.''\68\ An advocate of the blood shield statutes could respond to these arguments by quoting the justifications various courts have proffered for the statutes.\69\ Finally, one commentator proposes: ``The National Childhood Vaccine Injury Act (NCVIA) should serve as the structural model for ``alternative legislation.'' . . . [P]otential claimants should seek capped [no-fault] compensation in a court of claims on waiver of potential tort claims against blood products manufacturers. Petitions should receive compensation from a fund financed by both congressional appropriations and revenue raised through an industry tax based on the sale of blood products.'' \70\ The National Childhood Vaccine Injury Act of 1986,\71\ was enacted because Congress feared that some vaccine manufacturers might leave the market, which could create a genuine health hazard in the United States. The Act provides federal no-fault compensation to persons who suffer injury or death from specified vaccines. It allows more limited recovery than is generally allowed against manufacturers under state tort law, but it was hoped that ``the relative certainty and generosity of the system's awards will divert a significant number of potential plaintiffs from litigation.'' \72\ The Act established a National Vaccine Injury Compensation Program funded by a manufacturers' excise tax on certain vaccines. Persons injured by a vaccine administered after October 1, 1988, with claims of more than $1,000, may not sue the vaccine administrator or manufacturer unless they first file a petition in the United States Court of Federal Claims for compensation under the Program. Upon the filing of a petition, the court must issue a decision within a specified period. Under the Program, compensation is limited to actual reimbursable expenses, up to $250,000 for pain and suffering and emotional distress, $250,000 in the event of a vaccine- related death, actual and anticipated loss of earnings, and attorney's fees and other costs, but no punitive damages. A petitioner dissatisfied with his recovery under the Program may reject it and file a tort suit (state statutes of limitations are stayed during the pendency of the federal petition), which is governed by state law, with some limitations, such as that there are rebuttable presumptions that manufacturers who comply with federal regulations are not subject to failure to warn suits or to punitive damages. Treatment of blood and blood products in 104th Congress products liability legislation On May 2, 1996, President Clinton vetoed H.R. 956, 104th Congress, the Common Sense Product Liability Legal Reform Act of 1996. On May 9, the House failed to override the veto.\73\ The vetoed bill had been agreed upon in a House-Senate conference, which adopted the Senate version of the provision that dealt with blood and blood products. Both the House and Senate versions addressed blood and blood products in their respective definitions of ``product.'' Section 108(8)(B) of the House-passed bill provided: ``The term [``product''] does not include . . . ``human tissue, human organs, human blood, and human blood products.'' Section 101(13)(B) of the Senate-passed bill, by contrast, provided: ``The term `products' does not include . . . tissue, organs, blood, and blood products used for therapeutic or medical purposes, except to the extent that such tissue, organs, blood, and blood products (or the provision thereof), are subject, under applicable State law, to a standard of liability other than negligence. . . .'' The Senate bill, in others words, did apply to blood and blood products in strict liability and breach of warranty actions, although these actions are precluded by all state laws, except apparently in the limited instances noted on page 15 of this report.\74\ The Senate-passed bill did not apply in blood and blood products that are the subject of negligence actions. The House-passed bill did not apply in any suits involving blood or blood products. The committee report that accompanied the House bill states merely, with respect to the exclusion: ``Tissue, organs, blood, and blood products--that are human in origin--. . . are explicitly excluded from the product definition.'' \75\ The committee report that accompanied the Senate bill goes into more detail: \76\ ``Claims for harm caused by tissue, organs, blood and blood products used for therapeutic or medical purposes are, in the view of most courts, claims for negligently performed services and are not subject to strict product liability.\77\ The Act thus respects state law by providing that, in those states, the law with respect to harms caused by these substances will not be changed.\78\ In the past, however, a few states have held that claims for these substances are subject to a standard of liability other than negligence, and this Act does not prevent them from doing so.\79\ See, e.g., Cunningham v. MacNeal Memorial Hosp., 266 N.E.2d 897 (Ill. 1970) (overturned by Ill. Ann. Stat. Ch. 111\1/2\, sections 2 and 3).\80\ Such actions would be governed by the Act. . . .''\81\ The conference committee version of H.R. 956, as noted, adopted the Senate provision that dealt with blood and blood products (renumbered as Sec. 101(14)(B)). The joint explanatory statement of the conference committee, did not, however, discuss the provision.\82\ Recent settlement \83\ On August 14, 1996, a federal judge gave preliminary approval to a settlement between hemophiliacs infected with AIDS and four pharmaceutical companies that allegedly had manufactured blood clotting products contaminated with HIV.\84\ Judge John F. Grady of the U.S. District Court for the Northern District of Illinois tentatively certified a settlement class, preliminarily approved the settlement agreement, and authorized the parties to begin notifying class members. The plaintiffs contended that the companies sold tainted blood clotting products from 1978 until 1985, when new heat sterilization procedures came into practice. Under the settlement, each class member would receive $100,000, regardless of the number of class members; the total number of class members reportedly could range as high as 10,000. A fairness hearing is scheduled before Judge Grady on November 25, 1996.

Mr. GOSS

Mr. GOSS. I yield to the gentleman from California.

Mr. GOSS. Mr. Chairman, reclaiming my time, I believe that the formula that the gentleman from Ohio (Mr. Portman) and the gentleman from California (Mr. Condit) have come up with in fact does that. It just proves it shifts the burden in the debate, that is all.

Mr. GOSS. Mr. Chairman, I move to strike the requisite number of words. Mr. Chairman, I rise in very strong support of H.R. 3435, but equally strong support against the amendment of the distinguished gentleman from California (Mr. Waxman), which I think will seriously gut this particular piece of legislation. Mr. Chairman, I used to be an independent businessman and I used to be a former local official with the local government, and I can tell you unfunded Federal mandates are real, they do have an impact, and generally they harm the folks back home. I think that everybody understands these mandates are sort of a hidden tax. They fall on business, they fall on consumers, and I think we need an effective deterrent. In the 104th Congress we started this process, and we dealt with the public sector. After a lot of refinement, thanks to the gentleman from Ohio (Mr. Portman) and the gentleman from California (Mr. Condit) and some others, we have got a much improved bill now for the private sector which will do the same thing. I think that H.R. 3435 in its present form supplies more information to Members on the impact of what these mandates are all about without enabling those intent on dilatory mischief. I think that is where we are right now, frankly. Essentially it would permit the House to have a separate debate and vote on whether or not it wants to impose a private sector mandate greater than $100 million. That is reasonable, I think it is appropriate, it is good government, and I cannot see the problem. Now, I have heard many environmental groups are opposed to this bill and support the Waxman amendment. I am an environmentalist. I have served on very distinguished environmental groups and boards, the National Audubon Society at the national level, and I have done local things and State things. I have my fingerprints all over environmental legislation, in Florida and elsewhere. I am certainly not going to sell out on the environment. But I think it is pretty clear that what we have got here is somehow we are trying to bring the environment into this, that it is going to be a casualty because we are going to deal with unfunded mandates in the private sector. By some great, long stretch, we are no longer going to be able to have environmental legislation, because, somehow or other, we are going to weaken benefits to health, safety or environmental standards. I think H.R. 3435 establishes a mechanism for Members to receive objective cost information that CBO can provide, and then have a debate and a vote on that particular issue. That is what we tried to do in this. As I say, it has been much crafted, and I think they have it right. I know they have a lot of good folks over at CBO that could do a lot of things, they are very talented, but I do not think they have anything in terms of structure or expertise to begin to quantify the nature of ``benefits.'' Balancing the merits of potential mandates with the overall benefits to Americans is important if we know what the benefits are. I think we have set up the normal debate process to do that in this particular legislation. I frankly think that transparency is great. We are going to let the sun shine in. We should welcome it. I do not think the Waxman amendment, no matter how well intended, is really about protecting the environment. I think it tends more to be an obstruction and probably more in the line of going back to some other legislation we have seen which has been litmus test type legislation, which simply says one cannot do anything with private property rights because somehow or other it therefore makes all other environmental legislation unenforceable, too expensive, too extreme or something along those lines. My line on the environment is this: This is a country that is going to take care of the environment, but this is also a country that is going to protect private property rights. It says so in the Constitution of the United States of America, which is where I am standing right now. I do not believe either the private property people or the environmental people are ever going to win the whole battle. It is going to take working cooperation between the two. I think the working cooperation of the gentleman from California (Mr. Condit) and the gentleman from Ohio (Mr. Portman) has shown that the environmental interests in this bill have been properly balanced. I am convinced, having sat on the Committee on Rules, that we got it right. I do not think the environment comes out second best anywhere along the line.

Mr. GOSS. Mr. Chairman, I move to strike the last word. Mr. Chairman, I would be very happy to advise the distinguished gentleman from Ohio, whose championship of workers rights is well known, that I see no reason not to accept this amendment. I think it causes no problem. I would not oppose it.

Mr. GOSS. Mr. Chairman, I understand what the distinguished gentleman is saying. I understand, and I do not want to get into opening up this whole debate because we could go on endlessly doing that and we only have a minute. The point I would simply make is that the gentleman is trying to shift the burden with his amendment. I do not think the burden should be shifted. I think we have it right to say that the unfunded mandate should be recognized for what it is and dealt with for what it is in fair debate. The gentleman wishes, by his amendment, to shift the burden to prove the other part of that. I think the reason we are putting the legislation out is to get the burden the way we want it.

Mr. GOSS. I yield to the gentleman from California.

Mr. GOSS

Mr. GOSS. Madam Speaker, as Chairman of the House Committee on Intelligence, I sadly report to my colleagues today that today we are faced with a more dangerous world. The nuclear arms race is on again, and it has intensified. That is a tragedy. How did it happen? We have reports now that the Indian government has acknowledged that India's concern about Chinese capabilities and Chinese support for Pakistan nuclear development were critical factors in India's decision to proceed with testing. So our national security has been weakened, our children go to sleep less safe tonight. The administration has much explaining to do about its failed policy, but two steps seem very obvious: first, an appointment of an independent counsel now that there is clear and credible evidence of illegal foreign intelligence participation; and, second, cancellation of President Clinton's scheduled June visit to China, which would only further destabilize the region and intensify the problem.

Mr. GOSS

Mr. GOSS. Mr. Speaker, our borders are the last line of defense between our Nation's cities and towns and the organized drug smugglers who market their poisons. We must make the United States border a perilous obstacle for those engaging in this destructive trade. That means stepping up border enforcement and keeping one pace ahead of the traffickers. The Drug Free Borders Act represents the first step toward that end by providing for new special agents and inspectors at the U.S. Department of Customs, as well as for the purchase of valuable new detection technologies. Troubling trends like an 85% drop in customs drug seizures in the past year, declining prices and increasing availability, clearly show we are losing the battle to stop these poisons at our borders. There are miles upon miles of American border which we actively encourage people to cross every day for trade and tourism and the criminals we are fighting have the deftness to exploit any weak link in our defenses. Therefore, in stopping the drug supply we must create a barrier that extends from our shores out to the original source of the drugs. Keeping ahead of the drug smugglers is a daunting task and requires reliance on the eyes and ears of a strong intelligence capability. To win this war we need to know where the traffickers are headed before they get there and the networks they use to move their contraband. This is doable if we make the commitment. The end result will be to make involvement with drug trade a dangerous occupation from the fields where the drugs are produced to the street corners of our cities and neighborhoods, and all points between. MR. GILMAN. Mr. Speaker, I rise today in strong support of H.R. 3809, the Drug Free Borders Act. This legislation provides a much needed increase in the authorization for the U.S. Customs Service to fight the entry of illegal drugs at our borders. The last four years have shown a steady increase in the number of drug users, particularly in adolescents. Teenage drug use has sharply risen every year since 1993, and shows no sign of abating soon. This rise in drug use has paralleled an emphasis on the part of the Federal Government with regard to interdiction and with regard to treatment. The end result today is a readily available supply of drugs that is both inexpensive and of the highest purity in history. If our Nation wants to successfully reduce teenage drug use, we need to adopt a bilateral approach of simultaneously reducing both supply and demand. This bill beefs up our interdiction efforts on our borders, particularly with Mexico. Mr. Speaker, it is time for our Nation to get serious on the issue of reducing drug use. We have given treatment a chance over the last five years, and the results have shown that treatment alone is not enough. Unless our interdiction efforts are increased and improved, no treatment program will be able to avoid being overwhelmed in the deluge of cheap, highly pure drugs that currently exists. Accordingly, I urge my colleagues to support this worthwhile legislation.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I thank my friend, the distinguished gentleman from greater metropolitan San Dimas, and my equally good friend from the Commonwealth of Massachusetts for their graciousness in allowing me to speak this morning on this subject. Obviously, I think it is an important issue. I think this is a good rule, an open rule. I congratulate the leadership for these open rules, especially on things like the Mandates Information Act of 1998. I think this bill takes the next step on the issue of unfunded mandates that we need to take. It recognizes the need for greater accountability in this Congress for the impact that our actions have on the lives of real people outside the Beltway. Those are the people we work for. In the 104th Congress, the new majority broke ground on this subject, implementing changes in our House rules to make sure that Members are aware of the fiscal impact on State and local governments of legislation when we pass it. At that time, we included illustrative provisions relating to so-called, quote, ``private sector mandates'' or ``Federal actions and requirements'' that impose significant costs on elements of the private sector. Today we move that commitment on private sector mandates to a par with what we are already doing vis-a-vis the public sector. It makes sense. It is what we said we were going to do. This legislation is technical, and it sounds a little complicated, but what it really boils down to is a straightforward concern to American businessmen, consumers, workers, taxpayers, that is, all of us across the country. The Congress should take prudent steps and exercise due diligence in passing laws that impact upon the lives and pocketbooks of average citizens in reasonable ways only. Sometimes there are real costs associated with legislative changes, costs that may not always be obviously stated in the text of a bill or even realized. Sometimes, believe it or not, we have unintended negative consequences from some of our legislation. This legislation sets up a process to force some added scrutiny and hopefully ensure that we minimize costly, unintended consequences. I have long supported this type of change because it strengthens accountability and promotes sunshine, two fundamental principles of government that should be the hallmark of everything we do.

Mr. GOSS

Mr. GOSS. If the gentlewoman would further yield, that is certainly the intent of the committee.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I ask unanimous consent that it may be in order on Wednesday, May 13, 1988 for the Speaker to declare a recess, subject to the call of the Chair, for the purpose of receiving in this Chamber former members of this Congress.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I ask unanimous consent that the business in order under the Calendar Wednesday rule be dispensed with on Wednesday next.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I ask unanimous consent that when the House adjourns on Tuesday, May 12, 1998, it adjourn to meet at 9 a.m. on Wednesday, May 13, 1998 for the purpose of receiving in this Chamber former Members of Congress.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I take this time for the purpose of making an additional announcement. Mr. Speaker, the Committee on Rules is planning to meet early in the week of May 18 to grant a rule which may restrict amendments for consideration of H.R. 3616, the Defense Authorization Bill for Fiscal Year 1999. Any Member contemplating an amendment should submit 55 copies of the amendment and a brief explanation to the Committee on Rules in H-312 of the Capitol no later than 2 p.m. on Thursday, May 14. Amendments should be drafted to the text of the reported version of the bill, a copy of which will become available during the day tomorrow at the Committee on National Security. The report will be filed early next week. Members should use the Office of Legislative Counsel to ensure that the amendments are properly drafted and should check with the Office of the Parliamentarian to be certain that amendments comply with the Rules of the House.

Mr. GOSS

Mr. GOSS. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on H.R. 3694, the bill just considered and passed.