At HELP Hearing on Prescription Drug Affordability, Senator Collins Questions Expert on Generic Drug Competition

Senator Collins highlighted how her bipartisan bills, the "INSULIN Act" and the "Ensuring Timely Access to Generics Act," would streamline generic and biosimilar drug approvals, lowering prices for the medications Americans rely on.

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Click HERE to watch and HERE to download video of Senator Collins' questioning

WASHINGTON, D.C. - At a hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee yesterday, U.S. Senator Susan Collins questioned Dr. Brian Miller, Associate Professor of Medicine at Johns Hopkins University, on barriers to bringing lower-cost generic and biosimilar drugs to market, including misuse of the Food and Drug Administration's (FDA) citizen petition system and FDA's convoluted process for approving new biosimilars.

Senator Collins highlighted bipartisan legislation she has introduced this Congress to directly address these challenges. Her INSULIN Act would cap the cost of insulin at $35 per month for Americans with private or employer-sponsored insurance, create a pilot program to provide insulin at the same cost to those without insurance, and establish an expedited pathway for the approval of biosimilar insulin to increase competition and lower costs. Additionally, her Ensuring Timely Access to Generics Act would increase competition for generic drugs by cracking down on the misuse of the FDA's citizen petition process, which is sometimes used by drug manufacturers to delay approval of lower-cost competitors.

A transcript of their exchange is as follows:

Senator Collins: Dr Miller, many Mainers with diabetes have struggled to afford the cost of their insulin, and in doing so, they often stretch out the amount of insulin, not taking the full amount they need, which jeopardizes their health and even their lives. I'm thinking in particular of a young woman named Bek Hoskins from Chelsea, Maine, who ended up in the emergency room in very serious condition because she simply couldn't afford to take the full amount of insulin that her physician prescribed. As part of our broader legislation to cap the cost of insulin at $35 a month for those covered by private insurance and the uninsured, Senator Jeanne Shaheen and I also included a provision to create a new competitive biosimilar pathway at FDA, under which biosimilar drugs could achieve an expedited review. You referred to this concept in your testimony. Could you give us some idea of how long it usually takes a biosimilar to get through the process now, and speak further on the importance of developing an expedited pathway?

Dr. Miller: Thank you. Your principles are right-old drugs should be cheap. No one's paying $200,000 for a 20-year-old Honda Civic. That's not a marketplace. Old drugs should be cheap. Insulin is an old drug; insulin should be cheap. Prices should not be a barrier to access for therapy for old drugs. With biosimilars, right now, it takes on average nine years, $300 million. If you're a small molecule generic, it can take a couple years, $250,000 to $25 million. We need to basically streamline those entry requirements. I agree wholeheartedly. Require pharmacokinetics-so what the drug does to the body-that should be the basic entry requirement. Give the FDA the authority to require more or require less. For some products, you'll need less evidence. For a few products, you might need a little more evidence. Then you'll have massively lower costs to develop biologics, for old biologics, and you'll have a hugely competitive biosimilar marketplace, just like we have a competitive generic marketplace. Make old drugs cheap again.

Senator Collins: I want to ask you about another reform that Senator Shaheen and I have been pushing, and it would reform the FDA citizen petition process. Now, that sounds great-who would be against citizens' petitions? But in fact, they've often been used to delay the approval of generic drugs or biosimilars. Could you talk about this anti-competitive process that has a good intention but can be misused?

Dr. Miller: Absolutely-the citizen petition process allows anyone to, basically, functionally, write a letter to the FDA asking for a review, or express a safety or efficacy concern. Sometimes, some manufacturers use that as a way to delay entry and sort of gum up the works. There was an FTC case where a company filed, I think it was 43 citizen petitions to delay entry. That's blatantly anti-competitive. The FDA should have the authority to dismiss those. And then we should also have a referral channel to the competition authorities, the Federal Trade Commission and the Department of Justice, and the FDA should regularly refer bad actors to our competition authorities for oversight and enforcement. And in fact, we could actually require the FDA and FTC to file an annual report about anti-competitive abuses of the FDA regulatory process. 100 percent agree with you.

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