Connie Mack

Mr. MACK

Mr. MACK. Mr. President, I ask unanimous consent that that amendment be set aside.

Mr. MACK. Mr. President, what is the pending business before the Senate?

Mr. MACK. Mr. President, what is the pending business before the Senate?

Mr. MACK. I ask unanimous consent the Coats amendment be set aside.

Mr. MACK. Am I correct that the pending business before the Senate now is amendment 1253?

Mr. MACK. Mr. President, I have a modification to send to the desk.

Mr. MACK. Mr. President, I ask unanimous consent that Senator Reed of Rhode Island be added as a cosponsor of this amendment.

Mr. MACK. Mr. President, the amendment I have offered simply clarifies the implementation of last year's immigration legislation in one specific area, the suspension of deportation. Last year's bill imposed stricter standards to obtain suspension of deportation. While this is fine for future applicants, it is unfair to impose new, harsher standards on cases which were already in the pipeline at the time of passage. This amendment does two specific things: first of all, it clarifies that certain Central American immigrants who were in the administrative pipeline for suspension of deportation must continue to meet the standards that applied before the immigration reform law took effect. Second, the annual cap on suspensions of deportation would only apply to cases commenced after April 1, 1997. Without those two changes, we will be changing the rules midstream for a group of people who were attempting to comply with the guidelines for regularizing their immigration status. We encouraged them to come forward and play by the rules and we cannot go back on our word now. As a way of background, let me lay out some information for the Senate. Starting in the mid-1980's, Nicaraguans, Salvadorans, and Guatemalans fleeing the civil wars in their home countries started coming to the United States. Many of them made asylum claims, many of which were improperly denied as the U.S. Government acknowledged by ordering them readjudicated. In the case of Nicaraguans, this was done through the Nicaraguan review program established by Ronald Reagan. And in the case of Salvadorans and Guatemalans this was done through settlement of the ABC class lawsuit agreed to by the Bush administration. A huge backlog of asylum claims, however, then prevented their cases from being reheard for many years. Meanwhile, various temporary statuses allowed the members of this group to avoid deportation. In addition, they received authorization to work legally in the United States. During that time many members of that group established strong roots in this country. Under immigration law, there has long been available a procedure called ``suspension of deportation'' for an individual found to be of good character and who has been here for 7 years to adjust to legal status if deporting that individual would cause ``extreme hardship'' to the person or his or her immediate legal present relative. This requires a case-by-case adjudication that the person being granted this benefit meets the legal standard. Because of the asylum backlog and because conditions in the individual's home country had changed since the filing of their original asylum claims, the Department of Justice under President Clinton encouraged these central Americans to seek suspension of deportation rather than continuing to press their asylum claims or file a new lawsuit. Again, the point that I am trying to make here in laying out this history is that each step along the way this group of individuals has complied with the rules that existed at the time. In fact, we went to the extent that we encouraged these people to file for suspension of deportation, and it would just be fundamentally unfair at this point if we were to change the rules on these people who in fact have been trying to live by the rules every day that they have been here. Several other points. The reason why we believe this is important is because we believe that this in essence will deny these people the right to due process under laws with respect to suspension of deportation. I want to emphasize to my colleagues that this is not amnesty, and there is nothing automatic here. Let us assume for a moment that this amendment were to pass. We are not guaranteeing anybody anything other than the fact that they will have to comply with the rules as they existed at the time they came into the process of suspension of deportation. Again, I want to emphasize to my colleagues that this is not amnesty. Every person affected by my amendment is merely being given a chance for due process, to have their case heard. They must still meet the criteria to be granted suspension of deportation. In addition, my amendment is focused only upon an identifiable group. There are those who want to create the impression that if this amendment passes literally millions of people, millions of illegal immigrants will use this as a loophole to remain in the country. This is an extremely identifiable group. And, again, working with the INS, we have concluded that there are probably in the neighborhood of 316,000 individuals that would be included in the group, and of that 316,000 it is likely that 150,000 will receive suspension of deportation. Again, I make the point that we ought to pass this amendment from the perspective of fairness. We should not change the rules midstream for this group of people. It is unfair and, I would make the claim, un- American. On a personal note, from time to time, I have been asked why I became involved in this issue, and I will tell you that one of the memories that comes back to me is a trip to Nicaragua back in the 1980's where I went to a contra camp, and this was at a particular period of time where the concern was whether the United States was going to continue to provide assistance to those fighting for freedom in Nicaragua. And since they did not have the commitment to those financial resources, thousands of these freedom fighters came back into the camps in northern Nicaragua. I visited them. It was quite a scene--I must say, too, a very emotional scene. As the helicopter landed, off to the side of the camp two lines were formed, in essence two lines of men in fatigues at attention. As we walked through this group of individuals, where roughly 7,000 to 8,000 freedom fighters were standing at attention, three men, three of the soldiers, with guitars played the Nicaraguan national anthem. It was a tremendously emotional period. In essence I said to them that we will not abandon you, that we will continue to support you in your fight for freedom. I would make the case that fighting for freedom is not just providing resources to those engaged in battle, or fighting for freedom is not simply standing firm in the U.S. Senate for a strong national defense. But standing firm for the protection of individual rights is, in fact, standing up for freedom. And I encourage my colleagues to support this amendment. We have encouraged those people over years, not only in their fight for freedom, but afterward, telling them that if they played by the rules they could stay in this country. Mr. President, again, I encourage my colleagues to support this amendment. It is the right thing to do. It is a fair thing to do. And it would be in the best interests of our country to continue to stand up for freedom for this group of people. I yield the floor.

Mr. MACK

Mr. MACK. Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet during the session of the Senate on Tuesday, September 30, 1997 at 2 p.m. in room 226 of the Senate Dirksen Office Building to hold a hearing on the nomination of Raymond C. Fisher, Jr., of California, to be Associate Attorney General.

Mr. MACK. Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet during the session of the Senate on Tuesday, September 30, 1997 at 3 p.m. in room 226 of the Senate Dirksen Office Building to hold a Judicial Nominations hearing.

Mr. MACK. Mr. President, I ask unanimous consent that the Subcommittee on Constitution, Federalism, and Property Rights of the Senate Committee on the Judiciary, be authorized to meet during the session of the Senate on Tuesday, September 30, 1997, at 10:30 a.m. to hold a hearing in room 226, Senate Dirksen Building, on ``Unconstitutional Set-Asides: ISTEA's Race-Based Set-Asides After ADARAND.''

Mr. MACK

Mr. MACK. The amendment in S. 462 would allow HUD, subject to the rulemaking process, to give this performance indicator enough weight in the PHMAP system so that it can appropriately affect the determination whether a PHA is designated ``troubled.''

Mr. MACK. Mr. President, I am pleased to bring to the floor S. 462, the Public Housing Reform and Responsibility Act of 1997. This bill is similar to public and assisted housing reform legislation, S. 1260, that was introduced in the 104th Congress and passed unanimously by this body. The Public Housing Reform and Responsibility Act of 1997 addresses a public housing system fraught with counterproductive rules and regulations that make it impossible for even the best run public housing authorities [PHA's] to operate effectively and efficiently. It will help to make public housing a platform from which residents can achieve the goal of economic independence and self-sufficiency. In addition, it promotes increased residential choice and mobility by increasing opportunities for residents to use tenant-based assistance. The following reforms contained in the Public Housing Reform and Responsibility Act represent significant improvements in current public and assisted housing policies. First, the bill consolidates a multitude of programs into two flexible block grants to expand the eligible uses of funds and allow more creative and efficient use of resources. The bill also repeals a number of current programs that are obsolete, unused, or unfunded. Second, it institutes permanent rent reforms such as ceiling rents, earned income adjustments, and minimum rents that provide PHA's with the tools to develop rental policies that encourage and reward work and further the goal of creating mixed-income communities. The bill also removes the floor on rents that may be charged under the Brooke amendment, while assuring that poor families will not pay more than 30 percent of their income for rent. Third, S. 462 requires tough, swift action against PHA's with severe management deficiencies and provides HUD or court-appointed receivers with the necessary tools and powers to deal with troubled agencies and protect public housing residents. Fourth, it requires intervention with respect to severely distressed public housing developments that trap residents in deplorable living conditions and are costly to operate or maintain. It provides residents with alternative housing using vouchers or other available housing. Fifth, the bill permanently repeals the one-for-one replacement requirement and streamlines the demolition and disposition process to permit PHA's to demolish or sell vacant or obsolete public housing. Sixth, it gives PHA's broad flexibility to develop or participate with other providers of affordable housing in the development of mixed- income, mixed finance developments. Seventh, it repeals Federal preferences that have had the unintended consequence of concentrating the poorest of the poor in public housing developments and allows PHA's to operate according to locally established preferences consistent with local housing needs. The bill still maintains the requirement that most housing assistance be targeted to very low-income households. Eighth, the Public Housing Reform and Responsibility Act calls on PHA's to increase coordination with State and local welfare agencies to ensure that welfare recipients living in public housing will have the full opportunity to move from welfare to work. Ninth, the bill provides residents with an active voice in developing the local PHA plans that will govern the operations and management of housing and for direct participation on housing authority boards of directors. It also authorizes funds for resident organizations to develop resident management and empowerment activities. Finally, S. 462 merges the section 8 voucher and certificate programs into a single, choice-based program designed to operate more effectively in the private marketplace. It repeals requirements that are administratively burdensome to landlords, such as ``take-one, take- all,'' endless lease and 90-day termination notice requirements. These reforms will make participation in the section 8 tenant-based program more attractive to private landlords and increase housing choices for lower income families. The reforms contained in this legislation will significantly improve the Nation's public housing and tenant-based rental assistance program and the lives of those who reside in federally assisted housing. The funding flexibility, substantial deregulation of the day-to-day operations and policies of public authorities, encouragement of mixed- finance developments, policies to deal with distressed and troubled public housing, and rent reforms will change the face of public housing for PHA's, residents, and local communities. Reform of the public housing system has been and remains a bipartisan effort in the Senate. I want to thank the chairman of the Banking Committee, Senator D'Amato for his strong and steadfast support of public housing reform. Further, I appreciate the commitment of the ranking member of the Committee, Senator Sarbanes, and the ranking member of the Housing Subcommittee, Senator Kerry, to the reform effort. S. 462 represents the input of many members of this body as well as the administration. Since the unanimous approval of this legislation by the Banking Committee on May 8, we have worked to make a number of needed technical changes to the bill. In addition, the managers amendment to the bill reflects a number of policy changes that have bipartisan support. First, the amendment revises the income targeting provisions for public and section 8 tenant-based housing contained in the committee- passed bill. Most important, the amendment would increase the percentage of section 8 tenant based assistance that would be targeted to families with very low incomes. Second, the managers amendment modifies an amendment initially approved by the Banking Committee, which permits housing authorities to require applicants for public housing to sign a release for information concerning the applicant's illegal drug use. I appreciate the willingness of the sponsor of the amendment, Senator Grams, to work with Senators Leahy, Kennedy, Kerry, and Jeffords to address their concerns about the confidentiality of medical records and potential conflicts with other statutes. As reflected in the managers amendment, the Grams amendment will not supersede the Public Health Service Act, and is not intended to abrogate or otherwise limit any provision of the Public Health Service Act, or the regulations issued pursuant to the Public Health Service Act. Any action pursuant to this provision must be taken in conformance with the Public Health Service Act. Finally, the bill contains an amendment proposed by Senator Gramm, along with Senator D'Amato, to prohibit the admission of sexually violent predators into public and assisted housing and provide housing authorities access to records on past convictions. One of the important purposes of S. 462 is to incorporate measures which reduce crime and increase the safety and security of residents of public and assisted housing. This amendment is an important and useful contribution to meeting the goals of the legislation. I urge the passage of S. 462, so that we can begin the process of reconciling our differences with the House-passed version of public housing reform.

Mr. MACK. I agree.

Mr. MACK. That is the type of scenario I envision. The legislation was carefully crafted so that residents will have a significant voice in the policies and programs that will affect them. I agree that the only way their interests can truly be served is to provide them with as much advance notice and information about the public hearings as possible--and to incorporate their recommendations where appropriate.

Mr. MACK. I am aware that this problem exists, Senator, and I am very sympathetic.

Mr. MACK. I thank the Senator from California for her concern. I share her desire to prevent displacement of these good tenants and I have every intention of working with her during conference to assure that this problem is appropriately addressed.

Mr. MACK. I agree that these should be the primary factors that a public housing authority takes into consideration when providing relocation assistance. It is our intention that the interests of residents be protected to the maximum possible extent during the demolition and relocation process. Amendment No. 1257 (Purpose: To provide a substitute)

Mr. MACK

Mr. MACK. Mr. President, I ask unanimous consent that both the first- and second-degree amendments be temporarily set aside.

Mr. MACK. Mr. President, I send a second-degree amendment to the desk.

Mr. MACK. Mr. President, I ask unanimous consent that reading of the amendment be dispensed with.

Mr. MACK

Mr. MACK. Mr. President, I thank Senator Jeffords for yielding. First of all, I want to commend him for a tremendous amount of work. This is an incredibly complicated piece of legislation. It has involved a lot of different interest groups in some issues that have become very charged. So I again want to thank the Senator from Vermont for his willingness to work with Senator Frist and I as we worked on the so-called off- label issue. I also want to express my appreciation to Senator Kennedy. He had some deep concerns about the legislation, and as a result of extensive discussions we were able to find a compromise. I think it was one of the reasons that this bill was able to move forward. So I thank Senator Jeffords and Senator Kennedy. And I also want to put in a comment with respect to Mark Smith, my staffer who has worked on this issue for more than some 2\1/2\ years. Again, I thank Senator Jeffords for what he has done.

Mr. MACK

Mr. MACK. Mr. President, I want to add my strong support for S. 830, which will reauthorize the Prescription Drug User Fee Act as well as provide much-needed reforms to the FDA, and the approval process for prescription drugs and medical devices. I want to specifically address one area of FDA reform which has become one of the most controversial, and most often misunderstood, provision of this legislation. I'm referring to the issue of off-label information dissemination. This is an issue I've worked on for more than 2 years. Joining me in this effort have been Senators Frist, Dodd, Wyden, and Boxer. We come from different political parties. We have different political philosophies. But, there is one principle upon which we strongly agree. Physicians, and other health care professionals, should have the ability to receive credible scientific information from reputable medical journals and medical textbooks in order to make informed treatment decisions with their patients. However, because of an FDA policy--not a law, not a regulation, but a policy--that is not happening today. Let me explain. When the FDA approves a prescription drug or medical device, it does so for specific uses. Frequently, scientists find the FDA-approved prescription drug or medical device is also effective for other uses. Doctors are legally able to prescribe drugs or use devices for these new uses, which are called off-label uses. According to the American Medical Association, between 40 and 60 percent of all prescriptions written are for off-label uses. For cancer patients, up to 80 percent of prescriptions are for off-label uses. For example, the prescription drug Intron A has been approved by the FDA for the treatment of melanoma, hepatitis B, and other diseases. Additional studies, which were published in such prestigious publications as the New England Journal of Medicine and the Journal of Clinical Oncology, have shown the drug is also effective for such diseases as kidney cancer, myeloma--cancer of bone marrow--and bladder cancer. However, since 1991, the FDA has maintained a policy which prohibits manufacturers from giving doctors and other health care professionals scientific data about new uses of FDA-approved drugs and medical devices. That's simply bad public health policy--and the bipartisan agreement we have reached will correct this intolerable situation. The agreement will permit the dissemination to health care professionals of balanced, peer-reviewed articles from reputable medical journals and medical textbooks about new uses of FDA-approved prescription drugs and medical devices. It will also ensure that the important research on these important new uses of prescription drugs and medical devices moves forward. We ensure that only the highest quality of information can be disseminated by defining the specific criteria for medical journals and medical textbooks. It is important to note this legislation does not permit the dissemination of marketing materials, brochures, promotional materials, newspaper or magazine articles, or other industry-generated materials. Our legislation ensures that a balance of material about the use must be disseminated. Sixty days prior to dissemination, manufacturers must submit the article it desires to disseminate to FDA along with a bibliography of other medical journal articles about that off-label use. The Secretary has the option of adding an objective statement which describes additional scientific findings about that off-label use of the prescription drug or medical device. The intent is that the statement be limited to objective and scientific information, and not present an opportunity to editorialize about independently derived scientific information. That statement, along with the required bibliography, must accompany the article or textbook. In addition, companies must also submit and disseminate a detailed statement which discloses that the article being disseminated describes a scientific study about an off-label use; any potential conflict of interest of the authors of the article; the source of funding for both the study and the dissemination of the article; and a statement which discloses if other products or treatments have been approved by the FDA for the use described in the article. In other words, in addition to the article the company wants to share, the doctor will also receive: the disclosure statement; a statement of additional scientific findings from the Secretary of HHS; any previous FDA notices about that off-label use; a bibliography of other articles about that off-label use; and a copy of the FDA-approved labeling for the drug or device described in the article. In order to disseminate the medical journal articles and textbooks, manufacturers must agree to conduct the required clinical trials in order to apply for a supplemental new drug application. Companies must either certify they will file an SNDA within 6 months, or they must submit a clinical trial protocol and time schedule for conducting the needed studies to apply for an SNDA within 3 years. The Secretary of HHS may grant a 2-year extension to comply with this requirement if the company is acting in due diligence to conduct the studies in a timely manner. Periodic progress reports are required to be filed with the Secretary. Companies may apply for an exemption under very limited circumstances. The manufacturer is also required to share with the Secretary new information about that same off-label use of the drug or device. If the Secretary determines the new information demonstrates that the drug or device may not be effective or may pose a significant risk to public health, then the Secretary shall, in consultation with the manufacturer, take corrective action to ensure public health and safety. The provision provides the Secretary of HHS with strong oversight authority, including the ability to stop dissemination of articles and the ability to require manufacturers who violate the provisions of this legislation to either take corrective action or return to compliance. The Secretary can order a manufacturer to cease dissemination if the SNDA application is denied. We also require that two future studies be performed. One study will examine the impact this legislation has had on FDA resources. The other study will assess the quality of the information disseminated and it will examine how useful the information has been to doctors and other health care providers. It is important to note that this legislation will expire in 2006, unless Congress acts to continue it. This legislation has earned the enthusiastic support of the American Medical Association. Let me quote from the AMA's Council on Scientific Affairs report: It is imperative that physicians have access to accurate and unbiased information about unlabeled uses of prescription drugs. Dissemination of independently derived scientific information about unlabeled uses by manufacturers to physicians can help physicians have access to the latest, scientifically credible information. A Roper poll of oncologists released in July 1997 found that 70 percent of doctors believe FDA rules about off-label information stand in the way of doctors' efforts to get the most credible information about cancer treatments. The poll also found that 99 percent found peer-reviewed medical journal articles is a source they use when making prescription decisions. In addition, numerous patient organizations also support the dissemination of scientific information regarding off-label uses of prescription drugs and medical devices. These organizations include the American Cancer Society, the Leukemia Society of America, the American Osteoporosis Foundation, the American Society of Clinical Oncology, the Cystic Fibrosis Foundation, the A-T Children's Project, the American Liver Foundation, and the National Alzheimer's Association. Mr. President, for the past 2 years, this bipartisan group of Senators--myself and Senators Frist, Dodd, Wyden, and Boxer--have worked together to craft legislation which will permit health care professionals to receive important scientific information while ensuring consumer safeguards. This bipartisan effort is based upon the belief that health care professionals should be able to receive scientific data while ensuring patient protections. Most importantly--and this is key--from a patient's point of view, this legislation will greatly increase one's odds of getting state-of- the-art treatment which could cure a disease, slow the progression of a disease, or, at minimum, improve one's quality of life. It is simply wrong to continue this policy which denies the ability of a health care professional to receive an article from a medical journal or medical textbook. Doctors, nurses, and other caregivers help patients make life or death decisions every day. They need access to credible scientific information to discuss with patients. We must take this commonsense step to make sure they are able to receive accurate, unbiased information, including information about off-label uses, which will help them make informed treatment decisions with their patients. I am very pleased to report this agreement has received the support of our colleague, Senator Ted Kennedy, the ranking member of the Senate Committee on Labor and Human Resources. It also has the support of the Secretary of Health ad Human Services, Donna Shalala. I would like to thank them, along with Richard Tarplin, Assistant Secretary of HHS, and Bill Schultz and Dianne Thompson of the FDA, for their cooperation in reaching this historic agreement on what has been a very contentious issue. Finally, I want to thank my colleagues who worked with me on this agreement, Senators Frist, Dodd, Wyden, and Boxer. It's been a pleasure to work with each of you, and I look forward to working with you on other public health issues in the future. Mr. President, I suggest the absence of a quorum

Mr. MACK

Mr. MACK. Understand that this technology provides a flexible means to control the amount of light and heat that passes through a glass surface. This is a superb energy savings opportunity important to the Nation. In recognition of the importance of this technology, Florida has provided $1.2 million in State funds to develop this technology in cooperation with the University of South Florida and a licensee of a technology developed by the National Renewable Laboratory in Colorado. Is it the Chairman's understanding that the Committee intends that this project be a priority for the use of this $500,000 addition?

Mr. MACK

Mr. MACK. I thank the chairman for his work on behalf of Florida's environment and for his help here today. I yield the floor.