FDA aims to have no more than 10% of its advisory seats vacant in 2012 but is not yet achieving that, though some may say it is getting better. As of October 2011, vacancies were at 19%, down from 23% in July 2011 and 25% in January 2011.
The agency is allowed to grant waivers to panelists if it deems that the panelists’ afford a certain expertise to the advisory committee. Waivers, however, cannot be issued if an advisor is the principal investigator on a clinical trial of a product about which the committee will provide advice.
FDA’s goal for 2012 is to issue 12.78% or fewer waivers. This percentage has fluctuated between October 2010 and October 2011 from a high of 4% right down to zero. “In recent years, waivers for FDA advisory committees have not exceeded five percent annually,” Liscinsky pointed out. Dr. Hamburg also cited this fact saying that FDA is no longer “bumping up against our cap in terms of waivers.”
Dr. Hamburg’s comments are a change from a July 2011 address before the public health watchdog group Public Citizen, when she cited vacancies on advisory committees in contending: “We have to be sure that FDA has subject-matter experts that we need for our important decision making,” according to a quote published by Bloomberg. Dr. Hamburg and FDA have been squeezed by two sides of the political spectrum: Republicans want more help and less red tape for industry, while progressives like Public Citizen say that the current rules work and no change is needed at all.
“Although I don’t think that reason is always the number one feature of the way our Congress acts, there isn’t going to be any reason to say we need to relax the financial conflict of interest rules for FDA advisory committee members,” Sidney M. Wolfe, M.D., Director of Public Citizen’s Health Research Group, told GEN. Dr. Wolfe, a member of FDA’s Drug Safety and Risk Management Advisory Committee whose term ends May 31, pointed to the decrease in vacancies over the past year as evidence of improvement. He said that the agency is slowly but surely filling its advisory panel positions, which is also how the FDA now feels.
The views of FDA and Dr. Wolfe contrast with those of some industry speakers at the recent PDUFA hearing. For example, David E. Wheadon, svp, scientific and regulatory affairs at Pharmaceutical Researchers and Manufacturers of America (PhRMA), and Richard F. Pops, chairman and CEO of Alkermes, said the quality of scientific discourse on FDA advisory panels had suffered.
He said that since conflict rules for experts were tightened, the agency sometimes relied on panel members lacking relevant expertise, particularly in rare diseases. “In recent years, arbitrary limits and unnecessarily restrictive interpretations of conflict of interest rules have created barriers that have prevented FDA from consistently recruiting highly qualified scientific advisors,” said Pops, who spoke for BIO; he serves on BIO’s Health Section Governing Board.
Last October two bills surfaced in Congress that aimed to ease how conflicts were defined, but neither bill has been heard yet. Rep. Michael Burgess (R-TX) introduced the Cultivating Scientific Expertise to Foster Innovation Act (HR 3206) to eliminate limits on the number of conflict of interest waivers FDA can issue. Also, Sens. Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO) introduced the Medical Device Regulatory Improvement Act (S.1700) to subject FDA to the same conflict policy as the rest of the federal government.
Should FDA relax conflict of interest guidelines governing advisory panels?