National Defense Authorization Act For Fiscal Year 2010--Continued

Floor Speech

NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 2010--Continued -- (Senate - July 13, 2009)

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Mr. BROWN. Mr. President, this week, the Health, Education, Labor, Pension Committee is planning to finish marking up our health care reform legislation. A vital part of this legislation is ensuring that Americans have access to affordable generic versions of brandname biologic drugs. These medicines are crucial to those suffering from Parkinson's, from multiple sclerosis, from arthritis, from diabetes, from cancer, and from all kinds of debilitating and deadly diseases. Yet for countless Americans, these drugs are simply too expensive.

More than 190,000 new cases of breast cancer will be diagnosed in American women in 2009. To treat these cases using the biologic drug Herceptin costs approximately $48,000 a year. That is almost $1,000 a week to treat breast cancer with this drug. Each year, more than 1.3 million Americans are afflicted with rheumatoid arthritis. To treat these cases using the brandname biologic drug Remicade costs more than $20,000 a year. And here is another number. Between 350,000 and 500,000 people in the United States suffer from multiple sclerosis. To treat these cases using brandname biologic drugs, either Avonex or Betaseron, costs more than $24,000 a year.

To put these numbers in perspective, the average annual household income in my State of Ohio--whether you live in Dayton, in Cleveland, in Akron, Cincinnati, or Youngstown--is $46,000. For far too long, Ohioans such as Jerrold, from Miami County, have had to choose between paying for their medication or their mortgage.

Jerrold, who served in the Marines, had to retire early because he was experiencing severe seizures. Soon after, his wife had to retire early because she was diagnosed with leukemia and was battling other medical problems. Between the expensive medications needed to treat their conditions, Jerrold and his wife were forced to put their house up for sale. Jerrold wrote to me saying he didn't expect his golden years would be losing his home because of unaffordable health care costs.

Health care reform must include an FDA approval process for generic biologics comparable to the process that ensures access to traditional generic drugs. Remember that only 15 years ago the most effective, best known cancer drug was a chemical drug, with ingredients that were not considered live ingredients, but was a chemical drug known as Taxol. Taxol cost about $4,000 a year. We thought that was outrageously expensive. But because of Hatch-Waxman, because of the generic approval process, because we can bring generic drugs to market, we have been able to get those costs under control.

But $4,000 for a drug for cancer only 15 years ago--Taxol--today, a drug for cancer costs upwards of $40,000, and there is no Hatch-Waxman, there is no generic process, there is no road to keep those prices in check.

The companies that make those drugs can charge whatever they want.

Absent that generic process, there is no free market exerting downward pressure on biologic prices, so prices remain high for families such as Kimberly's, also from Miami County. Kimberly wrote to me explaining how her brother depends on Remicade infusions every 6 to 8 weeks to treat ulcerative colitis. The annual cost of Remicade can top $31,000 a year. Again, there is no competition, there is no generic equivalent allowed to be developed under U.S. law. Kimberly is worried if her parents lose their insurance her brother will no longer be able to get his infusions and his conditions would not be covered by a new insurer.

Biotechnology is a high-risk and high-cost business, but we cannot give companies open-ended protection from generic competition. With no protection from generics, pharmaceutical companies have enjoyed profits of the tens of billions of dollars after they recoup their R&D costs.

I say absolutely they should recoup their R&D costs. They should have a generous profit for the risks they undertook and the investment they made and even for the opportunity costs of their investment. But when you look at the kind of returns they are making, the number of years they can continue to charge these high prices, what good is it to develop these wonderful drugs, these wonderful biologic drugs, if people such as Kimberly and Jerrold and others can't afford them?

If you divide the total R&D budget of a typical biotech by the number of biotechs that actually make it to market--the number of biologics that make it to market, the R&D cost per successful drug is about $1.2 billion. That counts all the drugs including the ones that do not make it to market, including the ones that are failures, including the ones where the research is dead end--$1.2 billion.

The top biologic companies are able to make up their costs in as little as a year and a half and go on to make profits worth billions, year after year--after decade, for that matter--because there is no generic path. There is no path to follow in biologics.

Why should there be--under the proposals of some people in this body--why should there be a 13-year monopoly period, as some of my colleagues want? That is a good question. President Obama has said 7 years is enough and the FTC has directly stated that 12 years or more of exclusivity would--counterintuitively, perhaps--actually harm new innovation by discouraging biotechs from searching for new sources of revenue. Why should they, when they are raking in dollars from their current monopolies, giving them exclusivity for far more years than either the FTC or the President or the AARP or the bipartisan legislation sponsored by Senators MARTINEZ, VITTER, SCHUMER and me--why should these companies, with that kind of long exclusivity period, even bother to do innovation? That is what the FTC says. That is clearly true.

AARP says 12 years, much less 13 years, is too long. Insurance companies say it, patient advocates say it, disease groups say it, major consumer groups say it--that 12 years is much too long. The only group advocating for 12 years or greater is, no surprise, the drug industry.

With their army of lobbyists and their deep pockets that produce spectacular campaign contributions, the drug industry is all over Capitol Hill, trying to convince Members of Congress that drug companies are different from other companies. The drug companies want us to believe that they deserve something special, they deserve decades-long monopolies for their products. No one else has that in the entire consumer market, even if those monopolies leave patients without access to the lifesaving medicines.

I might add that much of the research that these companies have done, much of the research they build upon, is taxpayer funded through the National Institutes of Health.

I know in the State of the Presiding Officer, as in mine, there are all kinds of NIH dollars spent by startup companies, by universities, by people developing spectacular drugs. That is a good thing. But, understand, taxpayer money goes into a lot of this at the beginning. Taxpayers at least deserve competitive prices after the product has been developed.

A biotech industry group called the Biotech Industry Association, a lobbying group, spent nearly $2 million in the first quarter alone lobbying on this issue that prevents generic drugs from making their way to people in Gallipolis and Zanesville and Springfield and Xenia and Findlay and Lima, OH. The drug industry is a profit-making enterprise, of course. It is going to lobby Congress to do whatever is in the drug industry's best interests, of course. There is no reason to believe it would selflessly advocate for patients. It never has, it never will. It is all about the bottom line, which it should be. It is their responsibility to argue for the bottom line. It is their responsibility to maximize profits. But it is our responsibility in this institution--in the House of Representatives, in the Senate--it is our responsibility to bring in competition to restrain costs so that through competition--not through rules but through competition--American consumers have the opportunity to buy these drugs that our tax dollars helped to develop.

I want to tell you about a letter I received recently from one of my constituents. A registered nurse from Cleveland, Mary, wrote to me that she works with families who often must decide between visiting a doctor and buying their child's medication to manage seizures or other diseases. Mary is a nurse, as I said. Mary writes that drug costs keep many parents from doing what they know is right. Safe and effective generic biologic drugs will bring billions of dollars of savings to consumers, the health care community, and to our economy.

It will help Ohioans such as Brynna, from Cleveland, who wrote to me how, after being diagnosed with a rare immunological disorder, she lost her job and lost her insurance.

After receiving Social Security disability, Brynna had to rely on sample medications from her doctor--a doctor who obviously cared about her patient because Brynna cannot afford the expensive medications she needs to stay healthy and stay strong.

Get this. Brynna juggles her medications depending on which part of her immune system is the weakest and what she can afford.

Why should that happen? That only happens because this institution has abdicated its responsibility. The drug industry, of course, is going to maximize its profits. It is up to us--100 Members of the Senate, 435 Members of the House of Representatives and President Obama to inject competition, to allow competition so these prices come down.

Of course it would be irresponsible not to pursue a safe and efficient path to generic versions of name-brand biologic drugs. It would be irresponsible to pursue a pathway that gives biologic manufacturers more than a decade of monopoly rights over a market that provides lifesaving products to American patients.

That is how high the stakes are. Every year we give to highly profitable drug companies inflates taxpayer costs for health care, causes businesses struggling with paying for health care for their employees more onerous, burdensome costs, and prevents Americans from obtaining medicines that can treat disabling and life-threatening conditions.

We must not kowtow to the drug industry. We can and we must stand up for patients. We must and we have an opportunity to do what is right on the follow-on biologics issue.

I yield the floor.

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