Are drugs and medical devices being approved too slowly, too quickly? Here's what the head of the FDA has to say:

FDA Chief Defends Approval Process

By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 25, 2011

WASHINGTON -- FDA Commissioner Margaret Hamburg, MD, addressed on Monday the "increasing drumbeat" of criticism suggesting that the agency is slowing innovation by requiring drug and device companies to wait excessively long periods for approval. "You may be aware of increasing drumbeat of the FDA as a 'bureaucratic regulatory agency' impeding innovation of certain industries, the drug and device industries in particular ... potentially driving U.S. companies overseas," she told a small crowd at a discussion sponsored by the watchdog group Public Citizen. Hamburg said she wanted to clear up some misconceptions, among them the notion that the FDA takes much longer to approve drugs and devices than Europe. In priority drug approval -- approval for new drugs that meet an unmet public health need -- the FDA is often the first regulatory body to award approval, she said. In any case, speed is not the most important factor, she said. "The number of new drugs, the speed of their delivery matters, but the most important foundation of all that we do and what really makes a difference ... and is the number one issue for the American people, is that they can have trust and confidence that the products we reviewed are in accordance with science and efficacy and that our agency has the commitment to that regulatory process that is unwavering," she said. The FDA has come under criticism, especially from the device industry, for not being clear enough on what it expects from device makers from the get-go, for taking too much time from application to approval, and for having poorly trained device reviewers. The head of the FDA's Center for Devices and Radiological Health (CDRH), Jeffery Shuren, MD, has said that device arm of the FDA is plagued by an "unacceptably high" turnover rate for reviewers. When asked about the cause of the turnover at CDRH, Hamburg said that the FDA's drug division used to have the same problems, but things improved when the drug division began collecting user fees from pharmaceutical companies -- the FDA's drug division collects about 10 times more in user fees than the agency's device arm. Since then, the agency's drug reviewers haven't been "stretched a million ways" and the work environment got better, she said. Although she didn't mention increasing user fees for devices, she implied that having more resources for device approvals would go a long way to help attract and retain highly skilled device reviewers. On the other hand, she said, "The more embattled FDA becomes ... the more difficult it will be to recruit more staff." CDRH's workload has increased by 26% since 2007, driven by a significant increase in requests from device makers, and nearly half of the reviewers in the CDRH have four years or less of reviewing experience, Shuren has said. Hamburg also addressed the recent reorganization at the top of the FDA, which installed Stephen Spielberg, MD, PhD, a pediatrician and pharmacologist, in a newly created position that will oversee medical products and tobacco. "We're seeing products that come before the agency that don't fit into one or the other stovepipes," Hamburg said. Spielberg's role as deputy for medical products will serve to coordinate and provide oversight for all medical products. During the discussion, Sidney Wolfe, MD, the health research director at Public Citizen, was sharply critical of Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, whom he said has been at the helm of the FDA's decision-making process on drugs that were pulled in other countries long before they were pulled in the U.S., including Darvon and Meridia. He said he was worried back in 2009 that Woodcock would be promoted to FDA Commissioner, but was pleased that the administration chose Hamburg instead because she has public health experience that other FDA officials lack, according to Wolfe. Hamburg played a crucial role in HIV and tuberculosis programs in New York City while she was health commissioner there. "I think the FDA has been better off with her at the top than it would have been with Dr. Woodcock," Wolfe said. Hamburg did not defend Woodcock or address Wolfe's comments that Hamburg was the better choice for the job. She did say that the Obama administration's selection process was a "total mystery" to her. She said she had spoken with people in the administration about possibly taking a public health role, but when she got the call asking her to be commissioner, that was first conversation she had about taking taking the helm of the FDA. Public Citizen invited Hamburg to their headquarters as part of a speaker's series commemorating the group's 40th anniversary. The group has been a highly visible and vocal presence on many public health, drug, and device issues, asking the FDA to pull 35 drugs over the past four decades. Two-thirds of those drugs are still on the market, Wolfe said. Wolfe is a familiar face at FDA advisory committee hearings, where he sometimes serves as a patient representative on advisory panels and often presents public testimony on behalf of Public Citizen. "Of course we haven't always agreed on every issue, and in many cases you wished that we would have done more or done something differently," Hamburg said, but "your efforts are much-noted and much appreciated."