FDA Update
FDA Announces Improved Policies on Transparency, Public Disclosure
The Food and Drug Administration announced on August 4 several improved policies and procedures aimed at strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. “The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum,” said Dr. Randall Lutter, FDA’s deputy commissioner for policy in a release. “It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. Today’s announcement strengthens our processes.”
Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings. Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA’s web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also recommends a timetable that sponsors should follow when submitting such documents. FDA also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. Finally, the agency proposed new criteria to clarify when the agency should refer a matter to an advisory committee. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days.
New Bills Introduced to Provide Doctors With Independent Drug Information
Legislators in the House and Senate have introduced new bill on July 31 which would provide physicians with independent information on prescription drugs that is based on scientific research as an alternative to the information supplied by drug companies. The Independent Drug Education and Outreach Act of 2008 (S. 3396 and HR 6752) would both give federal grants for prescription drug education and outreach to health care providers and would provide objective, unbiased information to doctors on drugs.
“Academic detailing ensures that physicians have access to the most comprehensive data available on drug safety of the full array of pharmaceutical treatment options, including low-cost generic alternatives,” said the Senate bill’s lead sponsor Sen. Herbert Kohl (D-WI) in his introductory statement on the floor. Other sponsors of the Senate measure include Sens. Richard Durbin (D-IL), Edward Kennedy (D-MA); and Bob Casey (D-PA). Rep. Frank Pallone (D-NJ) along with Rep. Henry Waxman (D-CA) introduced the House companion measure. With little time left in the Congressional year, a spokesperson for Sen. Kohl described the legislation as part of a larger effort by lawmakers to change the relationship between the pharmaceutical industry and doctors. If the bill cannot be passed this year, the sponsors will seek to reintroduce it in the next Congress.
Congressional Duo Lead Calls for FDA Overhaul
A story in the July 30 Wall Street Journal looked into the efforts of two powerful members of Congress and their efforts to “remake” the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. The efforts of House Energy & Commerce Committee Chairman Rep. John Dingell (D-MI) and Senate Finance Committee ranking member Sen. Charles Grassley (R-IA) come after a number of highly criticized failures by the agency to adequately protect American consumers from several food and drug contamination crises that have resulted in deaths and injuries. Separately, each man has called FDA leaders on the carpet numerous times this year to explain these failures and discuss the plan for solutions.
Rep. Dingell harshly questioned FDA’s funding levels and operations to safeguard drugs entering the country after the contaminated Chinese heparin scandal and his questions about food safety after cases of salmonella linked to jalapeño peppers emerged. He is also working on a bill to add new drug-import registration fees and mandate certification of purity for incoming drug ingredients. "There's a total inability of the FDA to carry out" its mission," said Rep. Dingell. At the same time, Sen. Grassley has repeatedly asked FDA about problems with drug safety going back to his efforts in 2004 about links between popular antidepressants and teen suicides and FDA reaction. Sen. Grassley is also pursuing a number of inquiries into FDA operations including its approval of the antibiotic Ketek. The lawmakers told the Journal that an FDA restructuring should build a much taller wall between the agency and the industry it regulates. FDA officials "are too cozy with the companies they regulate," Sen. Grassley said, adding that new leadership must "fix the culture."