National Defense Authorization Act For Fiscal Year 2010
Floor Speech
NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 2010 -- (Senate - July 16, 2009)
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HEALTH CARE REFORM
Mr. BROWN. Madam President, yesterday was a wonderful day for this institution but, more importantly, it was a spectacular day for hundreds of millions of Americans who are concerned about our health care system. The Health, Education, Labor, and Pensions Committee completed the markup of its health care reform legislation. The first rule of thumb was that if you are satisfied with the health insurance you have today, you can stay in it. The whole point of health reform is to reduce health care costs and expand access to quality care for all Americans.
Earlier this week, the HELP Committee had a historic opportunity to cut costs for millions of Americans by creating a commonsense pathway for generic versions of what are called biologic drugs. Biologic drugs are live cells, unlike the more old-fashioned but still very, very common chemical drugs that are made and that we have known of for many years. Biologic drugs treat cancer, Parkinson's, diabetes, arthritis, rheumatoid arthritis, Alzheimer's, and other serious conditions.
Earlier this week, the HELP Committee could have limited what are called around here exclusivity rights--better known as monopoly rights--could have limited monopoly rights for biologics to 7 years instead of enabling that monopoly for 12 years. Earlier this week in the committee, consumers lost and the biotech industry won. How can we improve access to health care if people cannot afford their biologic drugs? How can we reduce costs if we don't inject competition into the marketplace, if we grant monopolies and
block any competitors from coming in and competing for these drugs? During the debate, we heard a lot of numbers on how many years the big drug companies should have unchecked monopolies. We heard it should be 13 years or one of them was 13 1/2 years or 12 years or 10 years. I wanted 5 years or maybe 7 years at the most.
Let me include some other numbers as we debate the minutia of health care reform. Let me include some other numbers that are too often yet sometimes deliberately overlooked.
Some 190,000 women will be diagnosed with breast cancer this year. Herceptin is the brand-name biologic that treats breast cancer. It costs $48,000 a year. That is $1,000 a week. If you are lucky enough to have insurance, you might get part of this paid for, but you probably have a 20 percent copay, so then it is $200 a week. That is if you are lucky. If you are not so lucky, you simply can't afford it.
More than 1.3 million Americans live with rheumatoid arthritis. Remicade is the brand-name biologic that treats rheumatoid arthritis. It costs $20,000 a year. If you are lucky enough to have insurance, you are probably paying a 20 percent copay. That would be $4,000 a year just for the biologic drug for your treatment--not counting lost work, not counting paying doctors' bills, not counting trips to the hospital, not counting tests. That is $4,000 a year for that drug, if you are lucky enough to have insurance.
This year, more than 148,000 people will be diagnosed with colon cancer. Avastin is the brand-name biologic that treats colon cancer and costs $100,000 a year, which is $2,000 a week. So if you are lucky enough to have insurance, you pay a copay of $400 per week, which is an awful lot of money.
To put these numbers in perspective, the average annual household income in Ohio is $46,000. So when you look at these drugs--one I mentioned, Herceptin, is $1,000 a week; Remicade for rheumatoid arthritis is $20,000 a year; Avastin for colon cancer is $100,000 a year, $2,000 a week--again, if you are lucky enough to have insurance, your 20-percent copay for that $100,000 a year is $20,000, and an average income in Ohio is $46,000.
Brand-name biologics, these relatively new kinds of treatments, will make up 50 percent of the pharmaceutical market by the year 2020. The prices for most of these drugs are increasing far faster than inflation--far faster even than medical inflation--and we know what that is all about--about 9.3 percent each year. The price for biologic drugs for multiple sclerosis increased by 23 percent last year.
I remember about a dozen years ago, if you had a family member who was suffering from cancer, we were outraged and just so surprised and shocked and upset that Taxol, the chemical cancer drug, in those days cost $4,000 a year. We thought that was outrageous, exorbitant, unaffordable, out of reach, $4,000 a year. But this cancer drug now is $40,000 a year; Herceptin is more than $40,000 a year. So where is the outrage now?
I understand drug companies need to protect their investment and their profit. However, many of these biologics that have been developed came initially from research that all of us as taxpayers funded. We appropriate every year about $31 billion for the National Institutes of Health, something I fought for when I was in the House. I was part of the group that doubled funding for NIH, in those days, from about $12 billion to $25 billion a year. It was a wonderful investment. As we invest in these drugs, invest in this research that is the foundation for these drugs, it is a good thing. Then these companies, at their expense and at their risk, develop them into wonderful medicines and medication. But after building their foundation on taxpayer research, they are charging this much for these biologics, and even if you are lucky enough to have insurance, you simply can't afford them. So I want these drug companies to protect their investment and their profit, but we can't give companies open-ended protection from competition.
The committee voted earlier this week to grant 12 years of monopoly. Orphan drugs get a 7-year monopoly protection. Standard drugs, which have been wonderful for so many people in this country--very important, very complicated drugs; pretty much as complicated as these biologic drugs--get 5 years of monopoly protection. So orphan drugs get 7 years, standard drugs get 5 years. Other products on the market that have patents, as these do, and have those protections don't get additional monopoly protections. But this committee this week--I thought outrageously so--gave 12 years of monopoly protection. That is unacceptable to many of us. President Obama says it should be 7 years. The AARP says it should be 5 to 7 years.
The Federal Trade Commission reported that additional years of monopoly protection actually crimps innovation, that giving these extra years of monopoly protection actually hinders innovation. I would argue that this monopoly protection harms innovation because it discourages biotechs from searching for new revenues.
Let me give an example. If a drug company produces a biologic that can matter a lot in an important treatment and they got a 12-year monopoly protection and consider that the biologic might be administered by injection in a doctor's office; that those same scientists who have created that biologic that you inject, after 5 or 6 years, come up with a new way to do it, to take it by aerosol. Everybody I know would rather do that than stick a needle in their arm every day or so, however often they need the treatment. But do you know what. That new innovation is not going to come until the 12 years are up.
That is why the committee erred so extravagantly when it gave 12 years of monopoly protection to the drug industry. It hinders innovation. That means patients are going to keep getting the shot every day for 12 years. They will have to wait until the 12 years are up before they introduce the new aerosol way of administering this drug. If there had been for 4, 5, 6, or 7 years, they would have brought that new drug on the market much quicker.
The only argument that the biotechs' allies on the HELP Committee used was simple: This hurts innovation.
It only hurts their profits. It clearly doesn't help innovation. The only study put forward, other than a study from PhRMA, the big drug company lobbyist or study from biologic companies--and many are the same companies--other than their studies, the only one out there was a Federal Trade Commission study on this 12 years. What good are these biologics if nobody can afford them?
The Hatch-Waxman Act, which introduced generic versions of chemical drugs, has proved we can still lead the world in biologic innovation with competition from generics. Twenty-five years ago, the drug industry said the same line they are using now--that there is no way we will innovate, and this will put them out of business.
Patients in Akron, Bowling Green, Chillicothe, and Dayton understood that this law from 25 years ago worked to keep prices down. Those same people around my State, people in Xenia, Springfield, Mansfield, and Portsmouth need that same access to generic versions of these biologics.
The vote this week was not in the best interests of patients suffering from multiple sclerosis, arthritis, cancer, Alzheimer's or heart disease. It was not in the best interest of taxpayers. Who is paying the bill? Either people are paying out of their pockets--and most cannot afford it--and insurance companies are going to raise rates to employers and to patients or the taxpayers are going to pay for it. The beneficiaries are not patients. It hurts innovation. The beneficiaries are the drug executives and the biologic company executives. It is not in the best interest of taxpayers. An article in Roll Call today or yesterday pretty much said that biologic industry--they spent $500,000 in ads in the last few days. The health care industry spends a million dollars a day lobbying, and they were rather successful in what they did.
I am proud to have been part of the historic health debate that passed a bill as good as we passed. I am also proud to have been part of this debate that continues to talk and educate the people on biologics.
Clearly, the fight for affordable generic drugs is not over. I will fight and do whatever is best for taxpayers and patients, and that means a continued effort to make this law work, as Hatch-Waxman worked for so many Americans.
I will fight for the breast cancer patient who has to spend $1,000 a week for biologic Herceptin or the colon cancer patient who spends $2,000 a week or the person with rheumatoid arthritis who spends $2,000 a month for medicine they desperately need.
I applaud groups such as AARP that put families and consumers first. I look forward to working with Members in the House and Senate and the administration who are fighting for what is right.
I yield the floor and suggest the absence of a quorum.
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