Sherrod Brown

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, I yield 2 minutes to the gentlewoman from New Mexico (Mrs. Wilson), who is the co-author of this amendment; and I thank her for the good work that she has done.

Mr. BROWN of Ohio. Mr. Chairman, will the gentleman yield?

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, I yield 30 seconds to the gentleman from Maine (Mr. Allen).

Mr. BROWN of Ohio. Mr. Chairman, I offer an amendment.

Mr. BROWN of Ohio. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman from Vermont (Mr. Sanders).

Mr. BROWN of Ohio. Mr. Chairman, I ask unanimous consent to withdraw my amendment.

Mr. BROWN of Ohio. Mr. Chairman, I yield myself 3 minutes. Mr. Chairman, I am pleased to offer this amendment with the gentleman from Maine (Mr. Allen) and the gentleman from Vermont (Mr. Sanders) and the gentleman from Arkansas (Mr. Berry) and the gentleman from Illinois (Mr. Jackson) and the gentleman from California (Mr. Waxman). This amendment fulfills a simple objective. It helps consumers decide for themselves whether prescription drug prices are fair. As it stands now, consumers know what they pay to a pharmacy for a drug, but they do not know what the manufacturer charges for that drug, what the manufacturer charges other consumers for it, what the manufacturer charges other countries for it, what similar drugs cost. My colleagues get the idea. This amendment would require manufacturers to disclose to American consumers the prices they charge here versus what they charge in other industrialized nations. The pharmaceutical industries question the accuracy of studies comparing prescription drug prices in the U.S. to those in other industrialized countries. They have questioned the accuracy of studies comparing the price seniors pay to those paid by HMOs. Drug makers could put these disputes to rest simply by disclosing their prices. Two weeks ago, I took a dozen seniors from Ohio to a Canadian pharmacy where they paid one-half, one-third, one-sixth of what it would have cost to purchase those same drugs in northeast Ohio. When confronted about price differentials like this, the industry typically tried to deflect the blame by talking about Canada's universal health care system. They imply that the only way to achieve lower prices in this country is to adopt the Canadian health care system. They imply that Canada pays less for prescription drugs because Canadians have a government-run health care program, not because of lower prices. The drug industry conveniently confuses two different issues. Seniors in my district bought prescription drugs in Canada and paid lower prices. They did not step into Canada and suddenly become eligible under that nation's universal health care system. Canada negotiates reasonable drug prices. Its 13 provinces also provide universal health care coverage. That means Canadians receive assistance towards the purchase of prescription drugs. American consumers, in spite of what people here say, in spite of the drug industry, American consumers are smart enough to know the difference. Although the drug industry tends to focus on Canada based on what we can glean from retail pricing studies, Canada is not the only nation that pays lower prices for drugs. The United States pays the highest prices in the world for prescription drugs. This amendment says to the drug industry, if those studies are wrong or misleading, just show us your prices. Prescription drug companies may argue that this is proprietary information or raise the issue of price collusion. Of course, they do provide this information to a private organization called IMS, and this company makes the information available to other companies for a price. So drug companies already know each other's prices, so price information is no secret unless one is a consumer. Americans cannot afford to purchase prescription drugs, and they cannot afford not to. Under our amendment, consumers would have the power to compare prices and quality and value to make smart purchases.

Mr. BROWN of Ohio. Mr. Chairman, I thank the gentleman from Maine (Mr. Allen) for his good work on this. We need to know what is behind the $500 million claim from the drug industry. We need to know if marketing costs are factored in, if executive salaries are factored in, if administrative costs are factored in. If the drug company wants American consumers to buy into the premise that outrageous prices are essential for research and development, they need to show us the numbers.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, yesterday the House, for the first time ever, tackled the public health threat from antibiotic-resistant bacteria in our food supply. On Monday, during debate on the agriculture appropriations bill, the House passed my amendment to dedicate an additional $3 million to the work of the Food and Drug Administration on antibiotic resistance resulting from the use of antibiotics in livestock. Scientists and public health officials have known for decades that using the same antibiotics for food animals as for people could cause problems. Sixteen years ago my esteemed colleagues, the gentleman from Michigan (Mr. Dingell) and the gentleman from California (Mr. Waxman), introduced legislation to curtail the use of human antibiotics in animals. But this amendment, Mr. Speaker, marks the first time this House has taken legislative action to stop Boyd resistance from agricultural overuse of these precious drugs. Mr. Speaker, we thought we were winning the war against infectious diseases. With the introduction of antibiotics in the 1940s, humans gained an overwhelming advantage in the fight against bacteria. But this war is far from won. Last month, the World Health Organization issued a ringing warning against antibiotic resistance. Around the world, microbes are mutating at an alarming rate into new strains that fail to respond to drugs. The mapping of the human genome project has been lauded far and wide in the past several weeks. Indeed, mapping the genome is a triumph that will lead to many breakthroughs in health care. But in the meantime, we are slowly, and in some cases, rapidly losing our precious antibiotics and putting ourselves at risk for diseases that we thought we had licked: tuberculosis, typhoid, cholera, dysentery and on and on and on. We need to develop new antibiotics, to be sure; but we cannot give up on the ones we have and the ones that have been effective for decades. By using antibiotics and antimicrobials more wisely and more sparingly, we can slow down antibiotic resistance. We need to change the way drugs are given to people, because clearly, they are overprescribed in the developed world and often not fully taken in the underdeveloped world. But we also need to look at the way drugs are given to animals. According to the World Health Organization, 50 percent of all antibiotics are used in agriculture, both for animals and for plants. The U.S. livestock producers use drugs to treat sick herds and flocks, as they should. But they also feed a steady diet of antibiotics to help the livestock so they will gain weight more quickly and be ready for market sooner. Many of these drugs are the same ones used to treat infections in people. Prolonged exposure to antibiotics in farm animals provides a breeding ground for resistant strains of E. Coli and salmonella and other bacteria harmful to humans. When transferred to people through the food we eat, they can cause dangerous infections. A few weeks ago, an interagency task force issued a draft ``Public Health Action Plan to Combat Antimicrobial Resistance.'' The plan provides a blueprint for specific coordinated Federal actions. A top priority action item in the draft plan highlights work already underway at the Food and Drug Administration Center for Veterinary Medicine. In late 1998, the FDA issued a Proposed Framework for evaluating and regulating new animal drugs in light of their contribution to antibiotic resistance in humans. Mr. Speaker, my amendment, which is now incorporated in the agricultural appropriations bill, directs an additional $3 million toward the FDA Center for Veterinary Medicine and their work on antibiotic resistance related to animal drugs. Director Sundloff has stated the antibiotic resistance is the center's top priority. However, the ``framework document'' states the agency will look first at approvals for new animal drugs and then will look at drugs already in use in animals as time and resources permit. That is why the additional $3 million will give a significant boost to the ability of the Center for Veterinary Medicine to move forward on antibiotic resistance and to begin to look at those drugs already in use in animals. More importantly, Mr. Speaker, this body finally this week took a proactive step to protect us from resistant bacteria in our food supply. If the Senate acts quickly and decisively, many lives will be saved, particularly among young children and particularly among our elderly parents, the people who are most vulnerable to food-borne illnesses.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, this amendment concerns antibiotic resistance from the use of antibiotics in livestock. I would like to start with a story. Imagine your 7-year-old daughter is very sick from food poisoning. You take her to the hospital and antibiotics do not help. In a week, she dies a painful death. The autopsy shows that her body is riddled with E. coli bacteria which ate away at her organs from her brain down. This is a true story, and it happened to a family in northeast Ohio 2 years ago. We thought we were winning the war against infectious diseases. With the introduction of antibiotics in the 1940s, humans gained an overwhelming advantage in the fight against bacteria that cause infectious diseases, but the war is not over. Mr. Chairman, 2 weeks ago, the World Health Organization issued a ringing warning against antibiotic resistance. Around the world, microbes are mutating at an alarming rate into the new strains that fail to respond to drugs. Dr. Marcos Esponal of the World Health Organization said, ``we already have lost some of the current good antibiotics, streptomycin for TB; it's almost lost. Chloroquin for malaria, it's lost; penicillin, nobody uses it now; if we keep the same pace, we will be losing other potent and powerful drugs. So a window of opportunity is closing, and I would say if we don't act now, in 5 to 10 years, we will have a major crisis''; words from the World Health Organization. We need to develop, Mr. Chairman, new antibiotics but it is too soon obviously to give up on the ones we have. By using antibiotics and antimicrobials more wisely and more sparingly, we can slow down antibiotic resistance. We need to change the way drugs are given to people to be sure, but we also need to look at the way drugs are given to animals. According to the WHO, 50 percent of all antibiotics are used in agriculture, both for animals and for plants. In the U.S., livestock producers use drugs to treat sick herds and flocks legitimately. They also feed a steady diet of antibiotics for healthy livestock so they will gain weight more quickly and be ready for market sooner. Many of these drugs are the same ones used to treat infections in people, including tetracycline. Prolonged exposure to antibiotics in farm animals provide a breeding ground science tells us for resistance strains of E. coli, salmonella and other bacteria harmful to humans. When transferred to people through food, it can cause dangerous infections. Last week, an interagency task force issued a draft Public Health Action Plan to combat antimicrobial resistance. The plan provides a blueprint for specific, coordinated Federal actions. A top priority action item in the draft plan highlights work already underway at the Food and Drug Administration's Center for Veterinary Medicine. In December of 1998, the FDA issued a proposed framework for evaluating and regulating new animal drugs in light of their contribution to antibiotic resistance in humans. The agency proposes to evaluate the drugs on the basis of their importance in human medicine and the potential exposure of humans to resistant bacteria that come from animals. Mr. Chairman, this amendment would direct $3 million toward the Center for Veterinary Medicine's work on antibiotic resistance related to animal drugs. CVM Director Sundloff has stated that antibiotic resistance is the Center's top priority. However, the framework document states the agency will look first at approvals for new animal drugs and will look at drugs already in use in animals as time and resources permit. We think an additional $3 million would give a significant boost to the ability of the Center for Veterinary Medicine to move forward on antibiotic resistance. Our amendment directs FDA to shift these funds from within the agency, while leaving the decision on the sources of the offset to the agency itself. Please note the Committee on Appropriations, Mr. Chairman, has recommended a $53 million budget increase for FDA. Given this increase, we believe the agency can free up $3 million of that increase for its work on antibiotic resistance without harming other programs. Mr. Chairman, I ask for his support, and ask for support of Members of the House for this amendment. The lives of our young children and our elderly parents, the people most vulnerable to food-borne illness, may be at stake.

Mr. BROWN of Ohio. Mr. Chairman, I offer an amendment.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I thank the gentleman from Michigan for yielding me the time. Mr. Speaker, I have an idea. What if Congress broke Medicare apart? Congress would tell seniors to look to the private insurance market if they want to piece it back together, the seniors could buy one plan to cover doctors' visits, another plan to cover hospital stays, a third to cover home health services. Perhaps they could purchase an Aetna plan for outpatient care, a Kaiser plan for physical therapy, a Blue Cross plan for medical equipment. No one in this body, Mr. Speaker, would dare offer a proposal like that because it is simply absurd. But why is it any less absurd to isolate prescription drugs and require Medicare beneficiaries to carry a separate private insurance policy for that benefit? If the GOP prescription drug plan is a back-door attempt to privatize Medicare, my colleagues should tell us so. If the goal of this Congress truly is to help America's senior citizens, this bill simply is not a real option. Medicare came into being because half of all seniors could not get coverage. Medicare, a nationwide plan with a risk pool of 39 million strong, is a stable, reliable means of ensuring coverage for our seniors. Medicare works because it guarantees the same basic benefits to all beneficiaries regardless of where they live, regardless of their income, regardless of their social status, regardless of their gender. It is fair. H.R. 4680 costs $40 billion. Yet, it offers Medicare beneficiaries nothing tangible. Think about the kind of questions seniors might have about this proposal: Will I be able to buy this new coverage? How much will it cost me? How much will the Government contribute on my behalf? Which drugs will my doctor be able to prescribe? Is this new benefit a good deal for me? Under the Republican proposal, the answer to every one of these questions is ``who knows.'' When we are allegedly addressing the single most important problem for millions of people in this country, that answer, Mr. Speaker, should get them fired. Vote no on H.R. 4680.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. 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 4\1/4\ minutes to the gentleman from Pennsylvania (Mr. Klink) who has worked hard for a prescription drug benefit for Medicare beneficiaries.

Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.

Mr. BROWN of Ohio. Mr. Speaker, how much time is remaining on each side?

Mr. BROWN of Ohio. Mr. Speaker, I yield 4 minutes to the gentleman from Michigan (Mr. Dingell), who tried so hard to offer an alternative plan today, and was not allowed, on the prescription drug bill.

Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman from Vermont (Mr. Sanders), who has been very involved in fighting for parallel importation of prescription drugs.

Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I want to thank the gentleman from Minnesota (Mr. Gutknecht) for bringing attention to the fundamental issue underlying all of our efforts on prescription drugs. His efforts are admirable. Prescription drug prices are priced unreasonably, unjustifiably, outrageously high in the United States. That is the issue. Why are drug prices two times, three times, four times higher here than in other industrialized countries? Because the prescription drug industry can get away with it. We do not negotiate prices. We do not demand that drug manufacturers reduce their prices to reflect the taxpayer-funded portion of research and development. We do not make use of the collective purchasing power of 39 million Medicare beneficiaries to demand reasonably priced drugs. Two weeks ago I took a dozen seniors from northeast Ohio across the border to a Canadian pharmacy in Windsor, Ohio, where they paid one- half, one-third and in a couple of cases one-sixth of what it would have cost to purchase their prescriptions in Cleveland or Lorraine or Medina. What these seniors were doing out of desperation was engaging in a practice called parallel importing. Current law prohibits reimportation of prescription drugs manufactured in the United States. FDA, however, permits exemptions for individuals who are purchasing a limited supply of an FDA-approved prescription drug for personal use. The U.S. is the wealthiest nation in the world. Our tax dollars finance a significant portion of R&D underlying new prescription drugs. Our senior citizens should not have to leave the United States to get the medicines they need. It should never have reached this point. Why do we tolerate it? We tolerate it because the prescription drug industry has a huge stake in the status quo and spends lavishly on television and in this institution to preserve it. They pour money into political campaigns. They pour money into front groups like Citizens for a Better Medicare. They pour money into advertising campaigns, campaigns touting the GOP's prescription drug coverage proposal, which this Congress in a partisan vote passed today, all of which undercuts the plan's credibility. They try to scare Americans into believing that if we do not let drug manufacturers charge obscenely high prices that medical research and development will dry up, but drug companies could afford to spend $8.3 billion last year on marketing and advertising. Drug company profits outpace those of every other industry in this country by more than 5 percentage points. Last year, Bristol-Myers-Squibb paid their CEO $146 million in salary and benefits. The drug industry consistently leads every other industry in return on investment, in return on assets and return on equity. Thanks to huge tax breaks, the drug industry's effective tax rate is 65 percent lower than the average for other U.S. industries. Drug prices can come down in the United States without stifling research and development. Unfortunately, it does not matter whether we could take steps to make prescription drugs more affordable. The only thing that matters is whether we actually do take those steps, and if the Republicans' prescription drug coverage plan is any indication GOP leadership is not going to sneeze without asking the drug industry's permission. That leaves American consumers who need affordable medicines with imperfect options like traveling to Canada to fill their prescriptions or to Mexico in the southern part of the United States. That is what my colleague's amendment is about and I applaud him for that. It is intended to help pave the way for seniors to purchase their drugs across the border. Unfortunately, it does not fulfill that objective. It does not codify a senior's right to parallel import their prescription medications. The paperwork burden this amendment could create may force FDA to shift resources away from intercepting counterfeit or unsafe drugs. The gentleman from Arkansas (Mr. Berry), the gentlewoman from Missouri (Mrs. Emerson) and the gentleman from Vermont (Mr. Sanders) requested the right to offer an amendment during today's deliberations that would have explicitly enabled seniors to purchase their prescription drugs from countries where prices are reasonable, without compromising FDA's ability to protect consumers from counterfeit and unsafe medicines. The Republican leadership refused to permit consideration of that amendment. Once again, the Republicans have created a Catch-22 that protects the drug industry at the expense of consumers. Earlier, we were given a choice of voting for a smoke and mirrors prescription drug plan or voting for no plan at all. Now we are placed in a position of either, one, voting for an amendment that could compromise FDA's ability to protect consumers from counterfeit and unsafe medicines or, two, voting against an amendment that at least acknowledges the need to address prescription drug price discrimination and, most importantly, that asserts the right of consumers to fight back by getting their medicines outside the United States. Again, I applaud the gentleman from Minnesota (Mr. Gutknecht) for his good work and for underscoring the need to do something about the drug industry's discriminatory pricing, but regretfully I must oppose this particular bill. Mr. Speaker, I reserve the balance of my time.

Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman from Arkansas (Mr. Berry), who has been a leader on this and an absolute warrior against outrageously high prescription drug prices. (Mr. BERRY asked and was given permission to revise and extend his remarks.)

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, I offer an amendment.

Mr. BROWN of Ohio. Mr. Chairman, malaria killed 1.1 million people last year; 2.2 million people, mostly children, died of diarrheal infections; 2.3 million died of AIDS; 1.5 million of tuberculosis. Mr. Chairman, we know how to treat each of these diseases. We could have saved the lives of many of these people. Countries around the world are attempting to expand access to desperately needed prescription drugs by pursuing competitive strategies explicitly permitted under international trade agreements. The USTR, on behalf of the global prescription drug industry, has made a practice of pressuring these nations to forsake legitimate strategies that can achieve lower prices; strategies like parallel importing and compulsory licensing.

Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. Both of these practices, parallel importing and compulsory licensing, are explicitly permitted under a world trade agreement commonly referred to as TRIPS. The WTO TRIPS accord sets global norms for patents, for trademarks, for copyrights, and for other types of intellectual property. It is a tough set of requirements. For example, it requires all WTO member countries, including the United States, to adopt 20-year patents on medicines, even though under our patent law our patent length was 17 years. The WTO TRIPS agreement requires many poor countries to adopts rules that actually raise the price of their medicines. The USTR, on behalf of the prescription drug industry, is pushing countries to abandon fully sanctioned actions, like parallel importing and compulsory licensing. It is difficult to believe the U.S. is participating in efforts to prevent developing countries from fighting back when drug companies ignore the dire consequences of their actions and abuse their monopoly power, for example, when they impose higher prices in developing countries than in industrialized nations, as in the case with AIDS drug Fluconazole. U.S. trade officials have pressured South Africa, Thailand, Indonesia, the Philippines, India, Pakistan, Costa Rica, the Dominican Republic, and many other poor nations, threatening sanctions unless they forsake rights they have under the TRIPS agreement. In many of these countries, the average income is less than $1 a day. In December last year, President Clinton told the WTO it was time to change U.S. trade policy, to consider the issue of access to medicines. In May, the President issued an executive order prohibiting the USTR from pressuring sub-Saharan African nations into giving up legitimate competitive strategies aimed at expanding access to HIV/AIDS drugs. In justifying his decision to reign in the USTR, the President asserted ``it is in the interest of the United States to take all reasonable steps to prevent further spread of infectious disease, particularly HIV/AIDS. The TRIPS agreement recognizes the importance of promoting effective and adequate protection of intellectual property rights and the right of countries to adopt measures necessary to protect public health.'' Our amendment is grounded in that same logic. The United States should enforce the TRIPS agreement to ensure the proper protection of property rights to be sure, but it should not undercut the balance TRIPS strikes between protecting intellectual property and promoting the public health. The President's executive order applies only to AIDS drugs and only to sub-Sahara Africa. Our amendment says the United States should not interfere in legitimate efforts to expand access to essential medicines in developing countries in health crises. This amendment does not undercut in any way intellectual property protections. It permits the U.S. to insist on tough provisions of the WTO TRIPS agreement, but it prevents the U.S. Government from seeking to impose so-called ``TRIPS Plus'' protections on countries when these more onerous protections would have a negative impact on access to medicine. Not only is this policy appropriate from a public health point of view, it is also consistent with the WTO TRIPS agreement itself. Article I of the TRIPS agreement says ``Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement.'' The key phrase is ``not obliged to.'' The United States should honor, in fact we should applaud, policies in other countries that place the health and well-being of people ahead of the profit goals of the prescription drug industry. Hindering efforts to combat debilitating and fatal diseases on behalf of the global prescription drug industry is an unjustifiable and counterproductive use of our Nation's power and influence. This amendment, Mr. Chairman, helps us to put a stop to it. Mr. Chairman, I yield back the balance of my time.

Mr. BROWN of Ohio. Mr. Chairman, I ask unanimous consent to modify my amendment such that it explicitly applies only when the United States Trade Representative is engaged in a Special 301 process established under the 1974 Trade Act and that it applies only to developing countries.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, as you know, the Commerce Committee shares jurisdiction over this legislation to the extent it pertains to state regulation of the health insurance market. Church plans provide health benefits for many clergy and laypeople across the country. They represent a wide range of denominations. Current law has created some uncertainty regarding the regulatory authority under which church plans operate. This bill, which the Senate has already passed, clarifies the legislative language so that State Insurance Commissioners, Federal Regulators, and Church Plan Administrators can do their respective jobs with certainty. I am pleased that the National Association of Insurance Commissioners and Church Plans, with the assistance of federal regulators, have been able to reach a compromise on this matter. By clarifying the various roles each party plays, I hope this bill reinforces the success church plans have achieved in providing reliable, high quality health coverage to their enrollees.