February 8, 2007 – The Food and Drug Administration (FDA) is charged with protecting the U.S. food supply and ensuring that our drugs, biologics and medical devices are effective and safe. These responsibilities are constantly evolving along with changes in medicine, medical technologies, and food distribution systems. The Project on Scientific Knowledge and Public Policy (SKAPP) is convening a meeting of experts to discuss ways that the FDA can be strengthened to meet the challenges it faces in the years ahead.
On February 21st, a panel discussion at George Washington University will feature several former FDA Commissioners:
Donald Kennedy, PhD (Commissioner 1977 – 79)
Frank E. Young, MD, PhD (Commissioner 1984 - 89)
David A. Kessler, MD (Commissioner 1990 -97)
Jane E. Henney, MD (Commissioner 1999 - 2001)
This event is open to the public and the press; download the event flyer (PDF) for more information. Kaisernetwork.org will make a webcast of the event available starting on February 22nd.
On February 22nd, an invitation-only workshop will bring together leading experts to discuss forward-looking ideas to improve the use of science at the FDA and strategize about policies that can strengthen the agency in the future.
“Congress will be taking up major legislation affecting FDA this year, so now is the time to explore some of the new paths the agency could take,” explains Susan Wood, PhD, who joined SKAPP in 2006 and is organizing the conference. Wood drew national attention to the issue of science being disregarded in the FDA decisions in 2005 when she resigned from her post as the FDA's Director of the Office of Women’s Health and Assistant Commissioner for Women’s Health.
Background on FDA Issues
IOM Report – In response to increasing concerns about its Center for Drug Evaluation and Research (CDER), the FDA commissioned an independent evaluation from the Institute of Medicine (IOM). The IOM’s report, published in September 2006, called for major reforms and provided a list of 25 specific recommendations in the areas of organizational culture, science and expertise, regulation, communication, and resources. In January 2007, FDA issued a report that responds to the IOM recommendations and details initial steps the agency plans to take to strengthen its drug safety system.
Read more:
IOM report: The Future of Drug Safety: Promoting and Protecting the Health of the Public
FDA press release on its report
“Protecting the Health of the Public – Institute of Medicine Recommendations on Drug Safety” (New England Journal of Medicine article)
PDUFA Reauthorization – In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA). This legislation sets up a system in which drug companies pay annual fees and fees for each prescription drug product they market, and these fees help fund the FDA's process of reviewing new drug applications. PDUFA programs have to be reauthorized every five years, and FDA has suggested changes to the program for the 2007 reauthorization. The agency would like to increase user fees in order to implement these changes, which include broadening and upgrading its drug safety program and increasing resources for review of television drug advertising.
Read more:
FDA’s PDUFA information page
FDA’s press release on its new PDUFA proposal ()
“A Proposal For Financing Postmarketing Drug Safety Studies By Augmenting FDA User Fees” (Health Affairs article)
PDUFA posts on The Pump Handle blog
Use of Science – In 2006, the Union of Concerned Scientists and Public Employees for Environmental Responsibility surveyed nearly 6,000 FDA scientists, and hundreds of them reported significant interference with the FDA’s scientific work. They noted instances in which political appointees inappropriately injected themselves into FDA actions, agency scientists were asked to provide incomplete or misleading information to the public or media, and agency scientists feared they could not publicly express their concerns about public health without fear of retaliation. Nearly two in three FDA scientists recommended that changes be made to the laws and regulations governing the agency so that it could better serve the public, and more than four in five agreed that strengthening the independence and authority of the FDA’s post-market safety systems would better serve the public.
Read the UCS report
Food Safety Issues – Recent outbreaks of E. coli from spinach, tomatoes, and green onion have drawn attention to the gaps in the nation’s food safety system. The FDA, through its Center on Food Safety and Applied Nutrition (CFSAN), is largely responsible for the safety of produce, but CFSAN’s budget has fallen in recent years.
Read more:
CFSAN website
"Outbreak Reveals Food Safety Net's Holes" (Washington Post article)
