Sherrod Brown

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, the Federal Power Act authorizes the Federal Energy Regulatory Commission to issue licenses for the construction of new hydroelectric power projects. Section 13 of the act establishes time limits for commencement of construction of a hydroelectric project once FERC has issued a license. The licensee must begin construction not more that 2 years from the date the license is issued unless FERC extends the initial deadline. Section 13 permits FERC to grant only one extension of that deadline for not longer than 2 additional years when not incompatible with the public interest. Accordingly, FERC lacks the authority to extend the deadline beyond a maximum of 2 years from the original deadline for commencement of construction. Therefore, a license is subject to termination if a licensee fails to begin construction within 4 years of the date of issuance. There are many reasons why construction of a project may not begin within the statutory 4-year period, including lack of a power sales contract or, in the case of the bill before us, the absence of a completed transmission line to carry power from the project to areas where it is needed. The purpose of the bill before us, H.R. 337, is to direct FERC upon the request of the licensee to issue an order staying a license of a hydroelectric project in the State of Alaska, pending the construction of an associated transmission line. Once the line is completed, the bill directs FERC to lift the stay and extend the deadline to commence construction for one additional 2-year period. The legislation also directs FERC to extend the deadline to commence construction of the project for one additional 2-year period. On January 22, 1998, FERC issued a license to the City of Saxman, Alaska, to construct and operate and maintain the 96-megawatt Mahoney Lake Hydroelectric Project. The project is located on Upper Mahoney Lake and Upper Mahoney Creek near Ketchikan in southeast Alaska. The project is not projected to be economically viable until the completion of the associated Swan-Tyee transmission line. The Cape Fox Corporation, which oversees the construction and the operation and the maintenance of the project, stands to lose a substantial investment in the project if the license expires prior to completion of the transmission line. Last year, S. 1843, a similar bill, was amended and passed the House by unanimous consent. While that bill was amended by the House, the official papers that were delivered to the Senate did not contain the amendment that passed the House. As a result, the version subsequently passed by the Senate did not contain the House amendment, and the Speaker properly did not sign the bill to clear it for the White House since the official papers did not accurately reflect the vote or the will of the House. This was the right thing for the Speaker to do. It is important that the author and supporters of this bill not be penalized unnecessarily for the clerical error that occurred in the House. I am pleased we are able to move this bill quickly to fulfill our commitment to the gentleman from Alaska (Mr. Young) and to his constituents. I urge my colleagues to support the legislation. Mr. Speaker, I yield back the balance of my time.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, yesterday 1,100 people in India died from tuberculosis. Last month in sub-Saharan Africa, 225,000 people died from AIDS. Last year, more than 1 million people died from malaria around the world. The White House understands that AIDS, in tandem with tuberculosis, is literally the most devastating epidemic the world has seen since the bubonic plague of the 14th century. These diseases have killed millions. They have their sights set on millions more. The President laid out the problem well: nearly 30 million people have the AIDS virus in Africa; yet only 50,000 of them are receiving the medicine they need. The great Black Plague of Europe killed 25 million people in the mid-1300s. Last year, there were an estimated 42 million people living with HIV-AIDS around the world. There is little question that HIV, unless we take unprecedented, dramatic action to both prevent further spread and treat all those who require treatment with antiretrovirals and other medicines, will take a much greater social, political and economic toll than even the black plague. For the first time, the United States is devoting the necessary funding and joining the global fight against these three killers. The President has committed the funding, $10 billion in new money, to stem the growing tide of this epidemic; but we are not quite there. The limited number of targeted countries under the President's initiative and the small contribution to the global fund to fight AIDS, TB and malaria, $1 billion of the $10 billion, has stifled the applause that followed the President's announcement about how this administration would fight AIDS. The President is aiming at only 14 countries, 12 in sub-Saharan Africa where the devastation is greatest, and two in our hemisphere, Haiti and Guyana. The White House plan excludes Mexico, Bangladesh, Pakistan, China, India, Russia and Brazil where half the world's people live. It excludes 15 of the 22 high-burden TB countries which account for 80 percent of the world's TB population. If the administration is committed to addressing AIDS, it must also be committed to TB, the biggest killer of people with AIDS. We cannot fight one without fighting the other. Dr. Richard Feachem, executive director of the Global Fund, told me last week that a go-it-alone bilateral plan simply will not work. While economist and AIDS expert Jeffrey Sachs acknowledges the significance of the President's plan, he questioned the decision to limit support for the Global Fund. ``What has not worked is each individual donor planting a separate flag,'' and trying to solve the problem alone, he said. The Global Fund is a public-private partnership begun last year by U.N. General Secretary Kofi Annan, which draws contributions from governments, private corporations, faith-based organizations and foundations. The Global Fund already shows signs that it works. Government entities, in coordination with nongovernment organizations, submit 5-year plans. Each plan is unique to each country, not a one- size-fits-all design which traditional foreign aid programs have too often been. The Global Fund recognizes cultural differences. What works in Christian Uruguay might not work in Moslem Bangladesh. No overriding, international political agenda is attached to the Global Fund's assistance. No litmus tests, only a judgment by the fund in collaboration with local citizens and health workers of what works best in each country. The Global Fund demands quantifiable results. The money supports activities, including access to health care services and purchase of drugs. If a country or an NGO fails to show results within 2 years, the money is cut off. Although 60 percent of the Global Fund's money goes to HIV-AIDS, 20 percent goes to TB and another 20 percent roughly to fight malaria. Fighting these diseases together is a cost-effective approach. For example, the infrastructure created in the treatment of TB has been proven to help in the treatment of AIDS, malaria and other diseases. To cure TB, a patient takes medication every day for about 6 months given to him by a health care worker at a clinic or by a health care worker who has traveled to his home. Unlike a smallpox vaccine, regular interaction between health care workers and patients is necessary to cure TB. If we fully commit to the Global Fund, that means a minimum of $500 million per year, 2 million patients will be treated for TB over the next 5 years, most of them for less than $100. Our investment in the Global Fund, rather than a unilateral U.S.-waged effort, will help leverage support from other countries. Funneling U.S. dollars through U.S. programs alone will not do much to promote a united global front against this global killer. In a very short time, the Global Fund has shown it is capable of tremendous progress. In the first two rounds of grants, the fund has approved 160 proposals in 85 low-income countries. With significant U.S. funding, the fund will continue to support countries committed to addressing the epidemics killing their people. Without U.S. leadership, it will be a fund in name only and AIDS, TB, and malaria will remain a virtual death sentence in the developing world.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, Secretary Powell's address today reiterated that Saddam Hussein is an evil dictator, but he did not explain how a preemptive war is in the best interests of the American people. Will a preemptive attack on Iraq without United Nations support make America safer? How will attacking Iraq prevent the proliferation of weapons of mass destruction? What will preemptive war do to stability in the Middle East? Are we ready to commit to a decade of American troops policing Iraq and the billions of dollars needed to rebuild and stabilize that country? Before we start a war that could kill thousands of civilians, could create hundreds of new al Qaeda recruits, could increase the potential of blow-back aimed at innocent American citizens, we must think through the consequences of our actions and be prepared for a long, difficult road in Iraq. One thing is certain: Any action against Iraq will be much more difficult, much more costly, much more dangerous if we take preemptive action against Iraq without the support of the United Nations Security Council.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, last night the President said that seniors deserve enhanced preventative benefits and prescription drug coverage. Seniors do deserve these benefits. What they do not deserve is being patronized, manipulated, and short-changed, particularly when the quality of their health care and their future financial security are at stake. When the President said that seniors happy with the current Medicare system should be able to keep their coverage just the way it is, we all applauded. What he obviously means is this: If they are unwilling to leave Medicare and join an HMO, then they actually do not deserve preventative benefits and drug coverage, and they will not get any. The President has every right to push his privatization agenda, Medicare privatization, Social Security privatization, but not by co- opting an issue as emotional and as important as prescription drug coverage. The President cannot go unchallenged when he mischaracterizes Medicare as a failed program. My friends on the other side of the aisle continue to lambast, continue to criticize, continue to ridicule the Medicare program as a failed program so that then they can justify their goal of privatizing it. The President in his budget, in his orders from the White House at HHS, recently dropped provisions to serve the general public, the Medicare public, in seminars asking questions, learning more about Medicare so that when seniors were overcharged, they would have some recourse. The President and his people at HHS are doing all they can to cut those Medicare services to make Medicare function more poorly so that Medicare does not serve the public as well, justifying their privatization of Medicare. The retirement safety net was not put in place by Democrats because we wanted to make the Federal Government bigger, and it should not be dismantled by conservatives just because they want to make Federal Government smaller. The safety net was put in place because the private sector could not make a profit offering health insurance to seniors; so they did not offer it. That is why when Medicare was begun in 1965 by a Democratic President, Democratic House, Democratic Senate, with only 11 Republicans supporting the vote on Medicare. That is why it was created, because 35 years ago 50 percent of seniors in this country had no health insurance. Today almost every senior has health insurance because of one of the greatest programs in American history: Medicare. But what the President of the United States basically said last night as he sat in this Chamber looking in this direction, looking out at Members of Congress, looking at the Ambassadors, looking at his Cabinet, the Supreme Court, looking at people in the gallery, the President said basically if they want prescription drug benefits, they have got to join an HMO to get it. And that is the story of the President's Medicare privatization. If they want prescription drug coverage, if they want preventative care, then they have got to join an HMO, and that is the President's efforts to privatize Medicare. So I ask my friends on the other side of the aisle, I ask people listening today in this Chamber to understand that the President's plan to privatize Medicare, that the President is using the prescription drug benefit to try to get his plans to privatize Medicare into place. Again, Mr. Speaker, this whole debate is about the President saying if you want a prescription drug benefit, then you have to drop out of regular Medicare and join one of those HMOs. In some parts of the country there are no HMOs available. In many parts there are. It means you have to give up your choice of physician. The President talks about choice, but when you are talking about real choice, it is all about fee-for-service traditional Medicare. You can choose your doctor, you can choose your hospital, you can choose your provider. Under the President's plan, you have a choice. Your choice is stay in Medicare and not have a prescription drug benefit, or you can take a prescription drug benefit and join an HMO. The Democrats' prescription drug plan is to include a prescription drug benefit inside traditional Medicare. Medicare works very well for the public. It works even better if there is a decent voluntary prescription drug plan as part of Medicare. Mr. Speaker, I ask this House to reject these privatization plans and instead put a prescription drug benefit inside Medicare, and continue to serve the Medicare population as well as Medicare has in the past.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I move that the House do now adjourn.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I thank my friend from California for yielding me the time. For 40 years our policy was to contain and deter Joseph Stalin and the Soviets, to detain and deter Fidel Castro and the Cubans, to detain and deter and restrain Communist aggression by the Chinese, always without invasion. We were able to detain and deter the Soviets and the Chinese and the Communists in Cuba without invasion, but if we go first strike into Iraq the message to the world and to Putin is he can go into Georgia and chase down the Chechnyan rebels and the message to China is they can go into Taiwan and they can come down harder on Tibet and the message to the Pakistanis and the Indians is they can go into Kashmir, maybe even with their nuclear weapons. Mr. President, go slow. Mr. President, we need aggressive, unfettered inspections in Iraq, complete, thorough, aggressive, unfettered inspections. Then go back to the United Nations. War should be a last resort. Mr. Speaker, I support the Lee amendment. Announcement by the Speaker Pro Tempore

Mr. BROWN of Ohio. Mr. Speaker, I thank the gentleman for yielding me this time. In the Committee on International Relations, I offered this language embodied in the Kucinich recommittal motion: if we give the President the authority to radically change, to radically change, our decades-old military doctrine of containment and deterrence, we need answers to questions the American people are asking. If we strike Iraq on our own, will our coalition against terrorism fracture? Most of our allies in the war on terror oppose U.S. unilateral action against Iraq. And what will a unilateral strike tell the world? Does it embolden Russia to attack Georgia to chase down Chechneyan rebels? Does it set an international precedent for China to go into Taiwan or to deal even more harshly with Tibet? Does it embolden India, Pakistan, or both, each with nuclear weapons from going to war to protect their interests in Kashmir? And if we win a unilateral war, will we be responsible for unilaterally rebuilding Iraq? This Congress should not authorize the use of force unless the administration can detail what it plans to do and how we deal with the consequences of our actions. Vote ``yes'' on the recommittal motion.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I thank my friend for yielding me time. Mr. Speaker, for years our policy in this country has been one of containment, of deterrence, of collective security, of diplomacy. We contained and we deterred Joseph Stalin and the Soviets for decades. We have contained and deterred Fidel Castro and the Cubans for 40 years. We have contained and deterred Communist China in its expansionist tendencies for 5 decades. Now this President wants to radically change our decades-old foreign policy of containment and deterrence to a policy of first strike. What does that tell the world? Does it embolden Russia to attack Georgia to better deal with Chechnya? Does it set an international precedent for China to go into Taiwan or deal even more harshly with Tibet? Does it embolden India or Pakistan, or both, each with nuclear weapons, from going to war in Kashmir? The whole point of the Security Council is to prevent member states, including veto-wielding permanent members, perhaps especially veto- wielding permanent members, to prevent those member states from launching first strike, unilateral, unprovoked war. Resolution 678, which authorized the Gulf War, called explicitly for countries cooperating with the exiled Kuwaiti loyals to create a coalition to use force. No country, no country in international law, has the unilateral right to decide Iraq has not complied with U.N. requirements, let alone what the U.N. response should be. A couple of weeks ago, three retired four-star generals testified in the other body, stating that attacking Iraq without a United Nations' resolution supporting military action could limit aid from allies, would supercharge, in the general's words, supercharge recruiting for al Qaeda and undermine our war on terrorism. There are too many questions the administration has yet to answer. If we strike Iraq on our own, what happens to our campaign against terrorism? Most of our allies in the war on terror oppose U.N. unilateral action against Iraq. Will our coalition against terrorism fracture? And if we win a unilateral war, will we be responsible for unilaterally rebuilding Iraq? I am not convinced this administration possesses the political commitment to reconstruct the damage after we defeat Saddam Hussein to bring democracy to that country. It will entail appropriations of hundreds of millions of dollars a year, year after year after year. Do we have the political will and the financial commitment to do that in that country, in that region? Should a new enemy arise while we are paying for the campaign against al Qaeda and the reconstruction of Iraq, will our resources be so overextended that we will not be able to address this new threat? This Congress should not authorize the use of force unless the administration details what it plans to do and how we will deal with the consequences of our actions, namely, what will the U.S. role be after military action is completed? We should set stronger conditions before any military action is permitted. The President should present to Congress a comprehensive plan that addresses the full range of issues associated with action against Iraq: a cost estimate for military action, a cost estimate for reconstruction of Iraq, along with a proposal for how the U.S. is going to pay for these costs. We are going more into debt. Will there ever be a prescription drug benefit? Will we continue to underfund education? Will the economy continue to falter if we do this war? We should do an analysis of the impact on the U.S. domestic economy of the use of resources for military action and the use of resources for reconstruction of Iraq. We should answer the questions. We should have a comprehensive plan for U.S. financial and political commitment to long-term cultural, economic, and political stabilization in a free Iraq if the President is going to talk about Iraq being a model of democracy in the Middle East. We should have a comprehensive statement that details the extent of the international support for military operations in Iraq and what effect a military action against Iraq will mean for the broader war on terrorism. We should have a comprehensive analysis of the effect on the stability of Iraq, and the region, of any regime change in Iraq that may occur as a result of U.S. military action. And, finally, we should have a commitment that the U.S. will take necessary efforts to protect the health, safety, and security of the U.S. Armed Forces and Iraqi civilians. Mr. Speaker, before we send our young men and women to war, before we put our young men and women in harm's way, we must make certain in every way that this is the best course of action.

Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman from California (Mr. Thompson), a member of the Committee on Armed Services and a combat veteran from Vietnam.

Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman from Massachusetts (Mr. Capuano).

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Madam Speaker, I yield 5 minutes to the gentlewoman from California (Ms. Eshoo).

Mr. BROWN of Ohio. Madam Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, the medical device legislation we are considering today is the product of lengthy, bipartisan negotiations. It is a good compromise bill. I appreciate the majority's willingness to work with us to ensure the legislation promotes timely access to medical devices without compromising FDA's ability to do its job, that is, to ensure medical products, both drugs and devices, are safe and effective for their intended uses and to make sure these products are promoted to the medical community and to the public in an accurate manner, and for the benefit of the FDA's general counsel, who has repeatedly questioned FDA's authority to regulate the advertising associated with drugs and devices. When I say promoted in an accurate manner, I mean accurate labeling and accurate balanced advertising. After all, a product is no longer safe and effective if it is being marketed as something it is not. I mentioned Dan Troy, who is not unlike other Bush appointees to FDA, HHS, OMB, former drug company employees, people like Ann Marie Lynch, who was with PhRMA and now is a deputy assistant of HHS; Mitch Daniels, in the cabinet, OMB, a former executive with Eli Lilly; Linda Skladany, a deputy commissioner for the Food and Drug Administration; all people from PhRMA, all people from the big drug industry who are positioned throughout this administration, unfortunately making drug policy and, frankly, turning the FDA into a little bit too cozy an agency in its relationship with drug companies when it is supposed to be protecting the public interests. But that is a story and a battle for another day. I want to thank the gentleman from Louisiana (Chairman Tauzin); the gentleman from Florida (Chairman Bilirakis); the ranking member, the gentleman from Michigan (Mr. Dingell); the gentleman from Pennsylvania (Mr. Greenwood); and my friend, the gentlewoman from California (Ms. Eshoo); for their work on this bill and extend a special thanks to Brent Delmonte and Steve Tilton with the majority and John Ford and David Nelson on our staff. It is clearly in the public's interest for Congress to promote timely access to safe and effective medical devices. This bill advances that goal. This legislation establishes a user fee to provide FDA added funds for the review of medical devices. It is no secret that resource shortfalls have hindered the review process in the past, and additional resources are crucial to ensure the timeliness and quality of device reviews. However, as we learned in the Prescription Drug User Fee Act, it is crucial to couple expedited review of new medical products with effective postmarket surveillance of these products. When we speed up approval of medical products, be they prescription drugs or medical devices, we owe it to the people of the country, the users of these products, the medical devices and the prescription drugs, to make sure these products are watched for safety and effectiveness problems after approval. Again, under the Bush administration, under Republican control of FDA, we have seen an agency that has gotten cozier with the industry, from its statements to our committee, from its public statements and, most importantly, from the appointees to that agency from the industry. It is particularly important we have this postmarket surveillance so we can see how these drugs and medical devices operate once in the general population. While I believe a portion of the device user fees should be used to support postmarket surveillance activities, I appreciate the majority's willingness to try to accommodate the underlying concern by establishing an increased authorization specifically for postmarket surveillance activities. This legislation initiates third-party inspection of medical device facilities. Allowing device manufacturers to pay private parties to carry out required inspections of their plants, rather than be inspected by the FDA, is controversial. Like the user fee program, it raises, again, with an FDA that is a little bit too cozy with industry, it raises significant conflict of interest issues. Ideally, FDA would be given sufficient resources to carry out its review and inspection responsibilities without needing to rely on either user fees or delegation of its responsibilities to private parties. I recognize, however, that FDA has not received sufficient resources to carry out all their responsibilities that we have given it. In the absence of adequate appropriations, the agency is not conducting required inspections in a timely manner, nor meeting statutory deadline lines for some device reviews. Given this reality, it is appropriate to explore alternatives. While Congress and FDA will need to carefully monitor the user fee and third- party inspection programs to ensure that the public is being well served by them, it makes sense to give these programs a chance. I urge my colleagues' support for the bill. Madam Speaker, I reserve the balance of my time.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, this goes to the question of the integrity of the House and its proceedings; and by building this case, it will be clear to all Members how this in fact has happened. The Patent and Trademark Office cannot prevent drugmakers from securing indefinite periods of exclusivity under Hatch-Waxman. It only determines whether a drugmaker should receive a patent, not whether this patent claims an existing prescription drug product. Under Hatch- Waxman, neither FDA nor any agency or branch of government can prevent intellectual property protection from being conferred over and over again, in other words, indefinitely for the same product, a violation of the Constitution. This problem is not theoretical; it is real. Neurontin, a $1.1 billion-a-year drug, is a prescription drug for seizures. Its two main patents, one on the drug's ingredients, one on the use of the drug, expired in 1994 and 6 years later, respectively. Right before the second patent expired, the company listed two new patents, one of which was an unapproved use to treat Parkinson's. The drugmaker did not ask FDA to approve the drug for Parkinson's patients. The drugmakers did not do any research to assert whether the drug actually is effective for Parkinson's patients, but the generic drugmaker still had to go to court to argue that its product is not intended for Parkinson's patients. When the generic and brand-name company go to court, FDA is automatically required to withhold approval of the generic for 30 months, or 2\1/2\ years. That is why this goes to the integrity of the House and its proceedings. After those 30 months, the industry filed a new patent, forcing the generic industry to go back to court, starting the 30- month clock again. The two delays, equal to 5 years, delayed generic entry and additional patent protection illegally and unconstitutionally, costing consumers a million and a half days in potential savings. It is our responsibility, Mr. Speaker, to restore the original intent of Hatch-Waxman and meet our constitutional obligation to limit intellectual property protection afforded to drugmakers. Our failure to act on pending legislation impugns the integrity of this House and impugns the integrity of Congress. In failing to act, we play a complicit role in a looming health care crisis. We know what that is: rising prescription drug costs fuel double-digit increases in health insurance premiums, they put State budgets in the red, and they force seniors to choose between medicine and food. My question of privilege, Mr. Speaker, regards the integrity of our proceedings as a House as prescribed by the Constitution. The Constitution conveys upon this body the power to secure for limited, underscore limited, times to authors and inventors the exclusive rights to their writings and discoveries. Hatch-Waxman confers intellectual property protection without limit, and therefore it is our obligation to remedy this constitutional breach. The other body has passed legislation already that fulfills this obligation bipartisanly and overwhelmingly. This House has three pieces of legislation before it, H.R. 1862, 5272, and 5311, with several sponsors from both parties, that would enable the House to meet its constitutional obligation. This resolution urges the House to take up one of these measures in keeping with our constitutional obligations and to restore the integrity of our proceedings. I ask the Speaker to recognize any Member wishing to speak on the resolution.

Mr. BROWN of Ohio. Mr. Speaker, I appeal the ruling of the Chair and ask to be heard on the ruling.

Mr. BROWN of Ohio. Mr. Speaker, I rise to a question of the privileges of the House, and I offer a privileged resolution, that I noticed yesterday pursuant to rule IX, and ask for its immediate consideration.

Mr. BROWN of Ohio. Mr. Speaker, I object to the vote on the ground that a quorum is not present and make the point of order that a quorum is not present.

Mr. BROWN of Ohio. Mr. Speaker, this resolution goes to the question of the integrity of the House and its proceedings, and failure to act impugns the integrity of the House. Under article 1, section 8 of the Constitution, Congress has two obligations in regard to intellectual property protection: to provide authors and inventors a period of exclusivity, and to place a defined limit on that exclusivity. Both obligations are crucial because they accommodate a delicate balance between promoting new innovation and promoting broad scale access to that new innovation. In the case of prescription drugs, the balance is especially crucial. It is in the public interest to promote the development of new medicines. Every day, however, that competition in the drug market is delayed means fewer Americans with access to that medicine. The only thing more tragic than a life-threatening or debilitating illness is knowing that one cannot afford the medicine that would cure that illness. In accordance with its obligations under the Constitution, Congress has enacted a number of laws intended to provide inventors and authors limited intellectual property protection: the Patent Act, the Copyright Act, the Bayh-Dole Act, the Hatch-Waxman Act, and licensing laws for atomic energy and anti-pollution devices. Unfortunately, Hatch-Waxman confers intellectual property protection without limit. This was clearly not the intention of the authors, and Congress has impugned its integrity by failing to address this constitutional breach. Under Hatch-Waxman, drug makers can trigger an automatic 30-month period of exclusivity for their products above and beyond the 14 to 17 years of patent protection they already receive by taking two simple steps: first, the drugmaker notifies FDA that it possesses an additional patent that claims the drug, meaning that it covers an essential aspect of the drug as approved by FDA. This typically occurs at just about the time when the drugmaker's original patents on the drug are about to expire. Then, if any generic drug companies have filed on application with FDA to market a generic version of that drug, the brand-name company then sues the generic for patent infringement. Under those circumstances, FDA is obligated to place a 2\1/2\-year stay on the approval of the generic drug application regardless of the merit of the patent, regardless of whether the drugmaker's new patent actually claims the drug. In fact, FDA has no authority under Hatch- Waxman to assess whether a patent is actually in any way relevant to the underlying drug patent. The agency must take the drug industry's word for it and award the drugmaker an additional 30 months of exclusivity. While the Judicial Branch tries to step into the breach, the courts have repeatedly curtailed the 30-month exclusivity by ruling that a drug company's patent does not claim a drug, the courts cannot prevent drug companies from repeating this process over and over again, filing new patents with FDA, triggering 30 months of exclusivity, then enjoying that exclusivity until the courts rule against them.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, pursuant to House rule IX, clause 1, I rise to give notice of my intent to present a question of privileges of the House. The form of the resolution is as follows: A resolution, in accordance with House Rule IX, expressing a sense of the House that its integrity has been impugned due to the failure of the House to fulfill its obligations under Article I, Section VIII of the Constitution Whereas Article I, Section VIII, of the Constitution states Congress shall have Power to promote the progress of Science and the useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; Whereas such protections on Writings and Discoveries have been promulgated by patent, copyright, and other laws, including Public Law 98-417, affording Authors and Inventors the exclusive Right to their respective Writings and Discoveries for a limited period of time; Whereas Public Law 98-417 breaches this constitutional requirement by failing to impose such limitation on the protection of certain medical inventions; Whereas provisions of Public Law 98-417 imbue the Food and Drug Administration with the authority to secure for limited time for Inventors the exclusive Right to their respective Medical Inventions; Whereas public Laws 98-417 fails to provide the Food and Drug Administration the authority to refrain form securing this exclusive right for inventors if the conditions for such exclusivity are not met; Whereas due to the failure of Congress to provide the Food and Drug Administration with the proper authority to fulfill obligations under the Act, certain medical inventions have received the exclusive Right to their respective Inventions without limitation; Whereas the unlimited exercise of exclusivity by prescription drug manufacturers subjects healthcare consumers and third party payers to no-competitive prices and results in significantly higher prescription drug costs for purchasers; Whereas health care costs increased by 5% in 2001, 3.7 times faster than overall inflation rate; Whereas prescription drug cost spending is the fastest growing component of health care costs, and rose 17% in 2001; Whereas health insurance premiums rose by 11% in 2001, driven largely by the increased cost of prescription drugs; Whereas state Medicaid spending increased by 11% in Fiscal year 2002, driven primarily by increased prescription drug spending and enrollment growth; Whereas the number of individuals with health insurance declined by 1.4 million in 2001, a function of the faltering economy, rapid health inflation, and a growing number of states in which public insurance programs are outpacing budgets; Whereas prescription drugs are prescribed by licensed healthcare professionals to consumers as a non-discretionary purchase essential to their welfare; Whereas it is in the public interest to grant a limited period of exclusivity to inventors of prescription drugs, but extending that exclusivity places an inappropriate fiscal burden on consumers, insurers, and pubic sector payers; Whereas generic drugs are sold as alternatives to medical inventions for which exclusivity is no longer available; Whereas generic drugs have the same dosage, safety, strength, quality, and performance as the medical inventions for which they serve as substitutes, according to the Food and Drug Administration; Whereas limitations on exclusivity have allowed prescription drug prices to drop 40-80 percent when generic drugs enter the market; Whereas limitations allowing generic drugs to enter the market saved consumers $8-$10 billion in 1994 alone, according to the Congressional Budget Office; Whereas the failure to apply limitations to the Exclusive rights granted under Public Law 98-622 has afforded widely used medicines, including Prilosec and Paxil, an indefinite period of exclusivity; Whereas Prilosec and Paxil were among the 50 medicines seniors used most in 2001; Whereas the Senate has passed S. 812, which amends Public Law 98-417 to restore constitutionally mandated limitation on medical inventions; Whereas the House has not considered Legislation to amend Public Law 98-417 to restore constitutionally mandated limitations in medical inventions; Whereas it is the obligation of the House to consider such legislation in keeping with its constitutionally mandated obligations to secure for Limited Times to Authors and inventors the right to their Writings and Inventions; Whereas the failure of the House to restore limitations on the exclusivity afforded to the inventors of prescription drugs, if not remedied, will cost consumers and other purchasers $60 billion over the next ten years, according to the Congressional Budget Office; Whereas the failure of the House to restore limitations on the exclusivity afforded to the inventors of prescription drugs, if not remedied, will leave more seniors and other Americans without access to needed medicines; Resolved, that it its the sense of the House of Representatives that the House should consider pending legislation to amend Public Law 98-417 to restore constitutionally mandated limitations on medical inventions on behalf of American consumers, including seniors, American businesses, and tax-funded federal and state health insurance programs.

Mr. BROWN of Ohio. Mr. Speaker, I ask to be heard at the appropriate time on the question of whether this resolution constitutes a question of privilege.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I want to thank the Chairman of the Energy and Commerce Health Subcommittee, Mr. Bilirakis, for his hard work on this bill. And a special thanks to staff members Steve Tilton, Erin Okunzzi, and Pat Morissey, on the Republican side, and David Nelson and John Ford on ours. Community Health Centers and the National Health Service Corps provide health care to an underserved and uninsured population. A population that faces poverty, hunger, poor living conditions--all of which exacerbate the need for health care and all but guarantee disenfranchisement from the private health insurance system so many of us take for granted. Community Health Centers and the National Health Service Corps serve populations that otherwise would fall through the cracks of our patch-work public/private healthcare system. In Ohio, over 217,000 patients receive services through Community Health Centers. Life-saving services like treatment for dehydration and for exposure to extreme heat and cold. Services as fundamental--and fundamentally important--as immunizations, child health exams, and breast and cervical cancer screening. And services as sophisticated as treatment for heart disease, diabetes, asthma and mental illness. Since 1972, the National Health Service Act has reach millions of Americans living in areas where health care is scarce. The Corps has encouraged health professionals to go where other health professionals would not, providing access to health care and working to eliminate health disparities in underserved areas. Reauthorization of the Corps will only make this public program stronger. Health centers and the National Health Service Corps continue to improve the quality of life for so many uninsured families. I urge my colleagues to support this popular bill. While the committee did not report the bill, I have discussed interpretation of certain provisions with the Chairman, and the explanation follows. We recognize the critically important role that translation and interpretation services, as well as health care services provided in a culturally competent manner, play in ensuring the delivery of appropriate health care services to patients who have limited ability to speak English, and applaud the efforts of health centers to deliver linguistically and culturally appropriate care. We recognize that health centers serve increasing numbers of patients speaking a variety of languages and representing a variety of racial and ethnic backgrounds. We also recognize that the particular community health centers that serve limited English proficient populations bear a disproportionate financial, administrative and clinical burden above and beyond costs associated with providing health services and other general enabling services. It is our expectation that the Secretary will work with health centers to enable them to provide, to the maximum extent feasible, appropriate translation and interpretation services for all of the patients they serve.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentlewoman from the Virgin Islands (Mrs. Christensen).

Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentleman from New Jersey (Mr. Andrews). (Mr. ANDREWS asked and was given permission to revise and extend his remarks.)

Mr. BROWN of Ohio. Mr. Speaker, how much time is remaining and who actually is going to close?

Mr. BROWN of Ohio. Mr. Speaker, I yield our final 3 minutes to the gentlewoman from Colorado (Ms. DeGette), who has been a leader for patient's rights.