Not the Usual Suspects: FDA Seeks New Advisors for Risk Communication Committee

The Food & Drug Administration is bringing a whole new constituency into the advisory committee process with the creation of an expert panel focused on improving the way the agency communicates risk information to the public. For industry, success will require even greater attention to foresee and address safety issues.

The Food & Drug Administration is bringing a whole new constituency into the advisory committee process with the creation of an expert panel focused on improving the way the agency conveys risk information to the public.

The creation of the Risk Communication Advisory Committee is the latest in FDA’s measured rollout of many of the Institute of Medicine drug safety report recommendations. But the specific timing of the announcement had a more directly political purpose: it came two days before Rep. Henry Waxman’s (D-Calif.) hearing into the safety issues with GlaxoSmithKline PLC’s rosiglitazone (Avandia).

FDA Commissioner Andrew von Eschenbach, MD, briefly mentioned the new committee in his testimony, but it did little to appease congressional discontent over the way the agency handled Avandia. (See "Tone Deaf: FDA Commissioner Hits the Wrong Note," The RPM Report, June 2007 (Also see "Tone Deaf: FDA Commissioner Hits the Wrong Note " - Pink Sheet, 1 Jun, 2007.).)

Rather than the typical academics and government officials that serve on FDA’s advisory committees, the risk communication committee will be comprised of people involved in social marketing, cultural competency and journalism, among others.

The committee will be charged with:

Advising FDA on strategies and programs designed to communicate with the public about both the risks and benefits of FDA-regulated products;

Reviewing and evaluating research relevant to communication to the public; and

Recommending ways the agency can share risk and benefit information with the public to enable people to make informed, independent judgments about the use of FDA-regulated products.

Fifteen voting members, including the chair, will be selected for two-year terms based on their backgrounds in the fields of risk communication, social marketing, health literacy, cultural competency, journalism and bioethics. Certain members—such as patients, health professionals and/or advocacy groups—will be chosen specifically to provide experience-based insight into risk communication.

Depending on the topic of the meeting, at least one non-voting member with relevant industry interests may be invited. Industry representatives on advisory committees are largely non-participatory—especially when the discussion centers on the approvability of an NDA. But the topics of discussion on the risk communication committee may prompt greater involvement from industry reps.

Given the intended makeup of the committee, FDA is unlikely to be hampered by new conflict of interest rules that will make it more challenging to fill more traditional advisory committees. A draft guidance issued in March would impose tougher CoI criteria for advisory committees—making it harder to find suitable members, especially from academia. Legislation pending in Congress could make it even tougher. (See "Reconstructing Advisory Committees: FDA Conflict of Interest Policy Will Pose Challenges for Drug Sponsors," The RPM Report, April 2007 (Also see "Reconstructing Advisory Committees: FDA Conflict of Interest Policy Will Pose Challenges for Drug Sponsors" - Pink Sheet, 1 Apr, 2007.).)

For the drug industry, the risk communications committee throws an interesting wildcard into FDA’s regulatory process, as most members will be inexperienced in giving formal opinions, relative to those serving on FDA’s more traditional expert panels. While the agency isn’t required to accept the recommendations of its advisory committees, it generally follows their advice.

The creation of the committee also heralds significant changes in the way that drug safety information is communicated to the public. Given the background of the panel members, any recommendations are only likely to increase the level of awareness about drug safety issues. Success in that environment will require even greater attention on the part of industry to foresee and address safety issues.

In the drug safety report, IoM recommended that Congress grant FDA the authority to create a risk communication committee, but the agency decided to create the panel through its administrative procedures, rather than waiting for Capitol Hill to act. (See "FDA’s Selective Response to the IoM Drug Safety Report," The RPM Report, March 2007 (Also see "FDA's Selective Response to the IoM Drug Safety Report" - Pink Sheet, 1 Mar, 2007.).)

FDA also expanded the recommended scope of the committee to all agency-regulated products. (IoM suggested a medical focus.) FDA has been hit from all sides on safety in recent months. In addition to the ongoing questions regarding the adequacy of its drug safety system, the agency has faced high-profile issues in food and animal health: tainted spinach and contaminated dog food. (See "Dog Days for FDA: Agency Weathers a Stressful Spring," The RPM Report, May 2007 (Also see "Dog Days for FDA: Agency Weathers a Stressful Spring" - Pink Sheet, 1 May, 2007.).)

FDA has not yet announced a date for the first meeting of the advisory committee, but says it is "eager to move forward" in the process of creating the panel. Nominations are due July 20, although the agency says it will accept nominations after that date as needed.