250252 Improving the FDA's Advisory Committee Process; The View of a Consumer Advocate

Tuesday, November 1, 2011: 11:30 AM

The FDA relies on advisory committees to assist them in carrying out the agency's responsibilities with regard to the approval of medical products. The vast majority of advisory committees is organized around either clinical or scientific foci, and operates under formal charters, which describe their composition and mission. A very few are not product oriented and have broader sets of responsibilities usually as advisors to the Commissioner.

While the FDA is not bound to follow the recommendations of advisory committees they do so more often than not. Advisory committees are mostly drawn from the relevant clinical and research communities that would have expertise in the matter under consideration. In recent years there has been greater emphasis on having more expertise in biostatistics, pharmacoepidemiolog and pharmacovigilance among members of an advisory panel. FDA also requires that a consumer representative serve on each advisory committee and in the last decade, patient representatives have been occasionally added to the mix as well.

The FDA has traditionally relied on the standard federal conflict of interest policy in vetting potential committee members as Special Government Employees and as panelists for each advisory committee meeting and topic. More often that not, panelists that the FDA deems essential by reason of their receive a waiver so they can participate despite conflicts of interest, providing those conflicts are with what the FDA feels are reasonable bounds. Through recent legislation FDA been directed to do more to seek out non-conflicted advisory committee members.

I served as the Consumer Representative member of the Drug Safety and Risk Management Advisory Committee (DSaRM) when it was first created in 2003 through 2007. In addition I have been a consultant expert on numerous advisory committee panels where there is a drug safety and/or risk management issue.

Based on my years of experience with FDA's advisory committee process I will propose that there are several issues of equal import to conflict of interest that also threaten the integrity of the advisory committee process.

These include clinical or specialty bias, and the lack of a bias declaration policy; a physician-centric panelist preference; and the corollary, lack of nurse, pharmacist and other health professional input into advisory committee process; a failure to provide briefing materials well in advance of meetings and a myopic view of accommodating meaningful public comment as a FACA duty rather than a source of critically important information about the patient experience.

Learning Areas:
Ethics, professional and legal requirements
Public health or related public policy

Learning Objectives:
Describe experience with the FDA advisory committee process and discuss the unaddressed issues that threaten the integrity of the process.

Keywords: Drug Safety, Medical Devices

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to present because I have spent over three decades as a consumer advocate and working with FDA to advance medical product safety
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.