Keep FDA Out of Drug Pricing Equation: Woodcock
FDA should not have much say in drug pricing issues, such as expediting new applications for a competing product once a pricing spike has occurred in the marketplace, according to CDER director Janet Woodcock. Testifying at a Senate Health, Education, Labor and Pensions Committee hearing on the generic drug user fee program 1/28, Woodcock said that her Center does not have the economic expertise to get involved with pricing issues and monitoring for price spikes in the marketplace.
Speaking to reporters after the hearing, Woodcock said that if Congress legislatively gave FDA directions to prioritize certain applications based on criteria that someone has developed “then we could do that. But it is a slippery slope to get us involved in the pricing part of it. We need to stick to science and safety and effectiveness, and level playing field concerns.”
Woodcock said she was confident that the generic drug review program is on stable footing, and the ANDA backlog that existed in 2012 at the beginning of the user fee program will be gone by 2017. “Getting to where we are today has taken an enormous amount of work and above-and-beyond dedication by many people over the past three years. I have no doubt that we will exceed the goals initially established for this program,” she said in her testimony. “GDUFA 2 discussions between the agency and industry are underway and constructive. We are excited and positive about the opportunity to make significant program improvements.”
Woodcock told the media that she understands people’s frustrations about FDA performance the last few years, “but we redid everything about the program and built it to a modern review process. And we are just going to crank over the next two years.” Already, she told the hearing, applications received over the past year have been reviewed in less than the 15-month goal currently in place. One ANDA was approved in nine months, she said, and in October all ANDAs submitted going forward will have a 10-month review target.
Ranking member Patty Murray (D-WA) asked Woodcock if it is fair for some to say that the ANDA backlog is one reason for high drug costs. “High costs are driven by multiple factors,” Woodcock responded, “and one would be lack of competition.” She said there are no “first generic” submissions that haven’t been dealt with in the backlog. First generics are expedited and get fast tracked because they have an impact on lowering prices.
Asked by Sen. Al Franken (D-MN) whether drug compounding is a solution or a concern for the agency for high-priced products lacking competition in the marketplace, Woodcock said there are “great risks” in relying on compounding. “In the last two months we have dealt with two outbreaks,” she said. One was vitamins that were compounded with high ingredient quantities, and the other was a hormone that was made 1,000 times more potent than it should be. Some patients ended up in the hospital. Compounding a mass production of drugs to substitute for high priced drugs under non-controlled conditions can be a problem, she said, “especially if alternative drug sources that don’t have good manufacturing practices are going to go into that mass production.”
Earlier this week, Pew Research Center wrote the HELP committee leaders about the importance of generic competition for off-patent drugs, which can keep price increases in check. “To function well, the generic market depends on timely FDA approvals,” the letter said. “But it also depends on the presence of generic drug companies that wish to compete. Allowing compounded drugs – which do not go through approvals – to enter the market runs the risk of undermining incentives for drug companies to develop generic drugs. Moreover, it exposes patients to drugs that have not met the bioequivalence standards or manufacturing quality standards required for FDA-approved products.”
The letter said that as the committee considers “mechanisms to ensure that patients have access to essential medicines at sustainable prices, we urge you to consider the importance of bioequivalence testing and manufacturing quality in protecting patient safety and drug efficacy, and to recognize the long-term importance of ensuring that manufacturers continue to take their products through the FDA approval process.”
Asked by Sen. Elizabeth Warren (D-MA)whether FDA expedites ANDAs when a price spike occurs in the marketplace, Woodcock said the agency usually doesn’t know about such spikes and it doesn’t have the expertise to determine pricing problems. “We wouldn’t know if it is a spike if it went from 10 cents to 20 cents a pill,” she said.
A skeptical Warren saw little FDA can do to help pricing. “Let’s not kid ourselves,” she said, “making some tweaks won’t solve the drug pricing problem. The market for prescription drugs has little transparency, it has broken price elasticity, and it has very long legal monopolies. Sure, we can make small changes to how FDA approves generics, but real change will require us to face the fact that the market for prescription drugs is not working and to rethink the overall structure of drug pricing.”