Sherrod Brown

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Lewis), who has fought human rights abuses in this country and wants to stop human rights abuses in China.

Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentlewoman from California (Ms. Pelosi) who believes that this Congress should quit rewarding China for its human rights violations, for its political oppression, and for its persecution of religious figures.

Mr. BROWN of Ohio. Mr. Speaker, I yield 3\1/2\ minutes to my friend, the gentleman from Michigan (Mr. Bonior), who has fought against labor camps in China and fought for human rights for workers and people around the world.

Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman from Maryland (Mr. Hoyer).

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, I yield back the balance of my time.

Mr. BROWN of Ohio. Mr. Chairman, I yield 1 minute to the gentleman from California (Mr. Waxman), the author of the Waxman-Hatch bill.

Mr. BROWN of Ohio. Mr. Chairman, I yield 1 minute to the gentleman from New Jersey (Mr. Pallone).

Mr. BROWN of Ohio. Mr. Chairman, I yield 3 minutes to the gentlewoman from Missouri (Mrs. Emerson), who has been a real leader in the fight to keep prescription drug prices down.

Mr. BROWN of Ohio. Mr. Chairman, I want to reiterate that these are FDA regulations that FDA claims it cannot enforce. It is not doing its job. This $1 million will help it do its job. Mr. Chairman, I yield 1 minute to the gentleman from Maine (Mr. Allen).

Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I would like to start with what the Brown-Emerson amendment does not do: It does not legislate on an appropriations bill; it does not spend extra dollars; it does not reduce legitimate patent protection for brand-name drugs; and, most importantly, it does not permit FDA to continue to squander billions in consumer savings, making excuses instead of making the brand-name drug industry abide by Federal law. Under FDA laws and regulations, a generic must certify it is not infringing on patents that are directly related to a brand-name drug as approved by FDA. Remember the phrase ``as approved by FDA.'' It is important. If a generic drug company is sued for potentially infringing on these type of patents, FDA automatically suspends approval of the generic for 30 months. Because the drug industry knows that FDA does not actually enforce its regulations, I repeat, because the drug industry knows that FDA does not actually enforce these regulations and weed out patents that under no circumstances should trigger that 30-month delay, drug companies therefore are conjuring up patents that by no stretch of the imagination fit any FDA criteria, just to trigger the 30-month delay, just to enjoy 30 months more of profits, patents on unapproved formulations of the drug, patents on unapproved uses of the drugs, patents on the shape of the pills, patents on the grooves in the pills, patents even on the bottle holding the pills. Each of these patents, when challenged, triggers the 30-month delay. These totally unnecessary delays cost consumers billions of dollars in lost savings, while the brand-name companies reap those same billions in additional profits. Seven years ago CBO estimated that generics save consumers $8 billion to $10 billion per year. Utilization and prices have both increased dramatically since 1994. So have the potential savings associated with generic drugs. Take Prilosec, for example. Prilosec generates $283 million per month in sales. Astra Zeneca has filed several unapproved use patents on Prilosec, each of which could trigger a 30-month delay in generic competition, even though under FDA regulations only patents on the approved use of a brand name should trigger the 30-month delay. Remember, generics save consumers, save employer-sponsored plans, save all levels of government 40 to 80 percent over the brand-name price. After a few years, the price differential sometimes grows to 90 percent. Over the next 10 years, brand-name drugs with sales topping $40 billion annually will reach the end of their patent life. If we do not do something to prevent drug companies from gaming the system to extend their lock on the market to make their patents grow, if you will, we are perpetuating needlessly inflated drug prices. I do not want to do that to the consumers in my district. Our amendment equips FDA to enforce its regulations and at least prevent the most blatant abuses of its 30-month delay provision and stop the gaming of the patent system by the name-brand drug manufacturers. It permits the Agency, it permits the Agency, to use up to $1 million to get its act together to enforce its laws, to stop brand-name drug companies from walking all over the Agency, and, more importantly, walking all over the public. We have an opportunity today to help our constituents without changing a word of the existing FDA statute. I urge my colleagues to take advantage of that opportunity and vote for the Brown-Emerson amendment. Mr. Chairman, I reserve the balance of my time.

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

Mr. BROWN of Ohio. Mr. Chairman, I thank the gentleman for yielding time to me. Prescription drug companies consistently depend on one argument and one argument only, to defend charging U.S. consumers two and three and four times higher prices in the U.S. than they do in other developed countries. The one argument they use to justify grossly inflated drug prices is that those prices are necessary to sustain R&D. Yet, we know that American taxpayers fund almost half of all the R&D that is done in the drug industry development in this country. It is an insult for the industry to ask American taxpayers to willingly pay the highest price in the world when they will not tell us what they spend when they are the most profitable industry in America, when they spend more money lobbying this institution than anybody else. They pay back American taxpayers by charging us more than anybody in the world. I ask support for the Allen amendment.

Mr. BROWN of Ohio

Mr. BROWN of Ohio. Mr. Chairman, I yield 3 minutes to the gentlewoman from New York (Ms. Slaughter).

Mr. BROWN of Ohio. Mr. Chairman, I demand a recorded vote.

Mr. BROWN of Ohio. Mr. Chairman, I yield myself the balance of my time. I ask my colleagues to speak to a physician or to a nurse or to a hospital administrator or to a medical researcher about this problem of antibiotic resistance. Every one of them will tell you that they know of cases, they have seen cases, they have seen the damage done by cases where antibiotic resistance is very real. Antibiotics are not as effective as they were a year ago or 5 years ago or 10 years ago. They also will tell you that we need action, we need to begin to recognize the problem, we need to anticipate the problem of growing resistance to antibiotics, and we need to do something about the problem. This amendment does not ban any antibiotics. It simply carries out the action plan that our government has suggested. I ask for support for the Brown-Slaughter amendment.

Mr. BROWN of Ohio. Mr. Chairman, I yield 2 minutes to the gentlewoman from Ohio (Ms. Kaptur), who is the ranking member of the subcommittee.

Mr. BROWN of Ohio. Mr. Chairman, I yield 1 minute to the gentleman from Ohio (Mr. Kucinich).

Mr. BROWN of Ohio. Mr. Chairman, I yield myself 3 minutes. Mr. Chairman, this amendment allocates funds to carry out the FDA's antibiotic resistance plan. On January 18, 2001, the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health unveiled an action plan developed by an interdepartmental task force that provides the United States with a comprehensive approach to combat the emerging threat of antimicrobial resistance. The plan designated 13 near-term priorities to deal with the problem of antibiotic resistance. The introduction of antibiotics in the 1940s gave the medical community an overwhelming advantage in its fight against infectious diseases, against TB and pneumonia, against cholera and typhoid, against many other long-time killers. But as bacteria have been exposed to antibiotics, resistant strains have emerged as a real threat to the efficacy of antibiotic drugs and to human health. The recent experience of the global medical community with tuberculosis is an excellent example of what can happen when an infectious disease develops antibiotic- resistant strains, and the threat that this poses to public health in the United States and around the world. Mr. Chairman, multidrug-resistant TB is as a result of antibiotic overuse, incorrect or interrupted treatment, and an inadequate supply of effective drugs. While outpatient treatment for standard TB costs a few thousand dollars, treatment of multidrug-resistant TB, MDRTB, costs as much as $250,000, and it may not be successful. Mr. Chairman, we do not want to see this scenario of increased costs and increased mortality repeated with other infectious diseases. The first step in addressing the problem of antibiotic resistance is to identify the true scope of the problem. We know that AR infections are seen more often in emergency rooms. We know that antibiotic resistance occurs wherever antibiotics are used, and we know that overuse and misuse of antibiotics exacerbates the problems of antibiotic resistance. But we need to know which drugs are being affected most, and when, how and why antibiotic drugs are being prescribed. We must educate the American public on the proper use of antibiotics, and we must encourage the development of new antimicrobial therapies. The amendment I am proposing today does not seek to ban the use of any antibiotics, it would simply appropriate the funds necessary to implement those near-term priorities of the government's action plan that would take place at FDA. These priorities were not set by me. They were not set by my colleagues. They were not set by any special interest groups. They were established by doctors and scientists and public health officials from FDA, CDC, NIH and other Federal agencies. The Committee on Appropriations has recommended a $126 million budget increase for FDA over last year. This $5 million set aside would allow FDA to begin to execute the portions of the antibiotic resistance action plan within its responsibility and would leave the decision on the sources of the offset to the Agency. Mr. Chairman, I ask for Members to support the Brown amendment on antibiotic resistance. Mr. Chairman, I reserve the balance of my time.

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

Mr. BROWN of Ohio. Mr. Chairman, I demand a recorded vote.

Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I thank the gentlewoman from Toledo. In summary, Mr. Chairman, this amendment increases funding for the Office of Generic Drugs, to speed the approval process for generic drugs, to get them on the market more quickly, because generic drugs save money; always 40 to 60 to 80 percent over the price of a name- brand drug, sometimes as much as 90 percent. Consumers deserve access to generic drugs as quickly as possible. It will save money for America's consumers; it will save money for all levels of government that provide prescription drugs to employees and to citizens of this country; it will save money for employer health care plans. Mr. Chairman, I ask for support of the Brown amendment on generics. Mr. Chairman, I yield back the balance of my time.

Mr. BROWN of Ohio. Mr. Chairman, I yield 1\1/2\ minutes to the gentlewoman from Ohio (Ms. Kaptur).

Mr. BROWN of Ohio. Mr. Chairman, how much time do I have remaining?

Mr. BROWN of Ohio. Mr. Chairman, I thank the gentlewoman from Missouri. Mr. Chairman, I yield 30 seconds to my friend, the gentleman from Texas (Mr. Green).

Mr. BROWN of Ohio. Mr. Chairman, I yield 1 minute to the gentlewoman from Missouri (Mrs. Emerson).