Cover Story

Serving on federal advisory committees is one way psychologists shape policy decisions at agencies that apply psychological research while carrying out their missions. Most academic psychologists probably know about the advisory committees at such scientific funding agencies as the National Institutes of Health and the National Science Foundation, but many are less familiar with those at the Food and Drug Administration (FDA), which doesn't fund extramural research. While FDA isn't a grant-making agency, it has long benefited from psychologist-advisers who ensure that good science informs policy decisions.

FDA has 16 active advisory committees housed under the "Human Drug" grouping, which covers therapeutics categorically based on their applications such as anesthetic and life-support drugs and reproductive health drugs. Among the committees that will now benefit from psychologists' advice is the Drug Safety and Risk Management (DSaRM) Advisory Committee. Evaluating the abuse liability of new and existing medications is a tricky business coordinated by the FDA and the Drug Enforcement Administration (DEA). And for nearly two decades, the FDA relied on the advice of leaders in psychopharmacology and substance abuse research to guide those evaluations in the form of the Drug Abuse Advisory Committee (DAAC.)

However, in the fall of 2000, the FDA dissolved the DAAC in favor of a committee with a broader mandate-the DSaRM Advisory Committee. Although DSaRM was meant to contain a standing drug abuse advisory subcommittee, it was never populated and never convened. Over the last seven years, APA's Science Government Relations staff worked to bring that subcommittee to life, sending letters, meeting with FDA staff, requesting congressional intervention and recommending a slate of nominees.

That advocacy finally got through, when, in August 2007, the FDA picked four psychologists from the APA slate to serve on the subcommittee: Warren Bickel, PhD, of the University of Arkansas for Medical Sciences, Kathryn Cunningham, PhD, of the University of Texas Medical Branch, Dorothy Hatsukami, PhD, of the University of Minnesota Medical School, and James Woods, PhD, of the University of Michigan School of Medicine, all of whom are noted experts in various subfields of psychopharmacology and substance abuse.

Other outreach efforts haven't required such a long haul. For instance, FDA's new Risk Communication Advisory Committee will be chaired by APA Fellow Baruch Fischhoff, PhD, of Carnegie Mellon University, one of the first nominees APA discussed with FDA staff. Fischhoff's committee may help the FDA develop policies for labeling medications and using other methods of communicating health risks to the general public.

"We have a unique opportunity to help people to make the best choices for themselves among the products that FDA regulates," says Fischhoff.

Science Government Relations staff reached out to the FDA earlier this year after the agency released a statement describing its renewed commitment to risk communication:

"We are establishing a new advisory committee to obtain input to improve the agency's communication policies and practices....We will include on the committee patients and consumers as well as experts in risk and crisis communication and social and cognitive sciences."

The official charter and call for nominations was released June 4, and according to FDA staff, they received more than 225 nominations. Fortunately, the agency selected another psychologist, in addition to Fischhoff, to serve on the committee: APA member Ellen Peters, PhD, a senior research scientist at the nonprofit Decision Research.

The new Risk Communication Advisory Committee includes members with the skills needed for effective communication, says Fischhoff. That includes people who know the science of the products, who can identify the most critical facts regarding products' risks and benefits and who understand people's desires and beliefs. The group also includes experts on evaluating the effect of communications and creating and maintaining engaging message channels.

Peters likewise recognizes the potential of the committee members to improve the FDA's risk communications. As a psychologist who studies how people process information, Peters says she is particularly interested in how numerical comprehension influences decision processes. For example, many medications require people to correctly time and measure their dosages, she notes.

"As such, understanding numeracy is a basic cognitive ability critical to achieving many positive health outcomes," Peters says.

Geoffery Mumford is APA's assistant executive director for government relations.

Helping the FDA and the scientific community appreciate the evolution of drug abuse research related to regulatory issues had been the focus of recent collaborations between APA and the College on Problems of Drug Dependence. The proceedings of two conferences have already been published in the journal Drug and Alcohol Dependence: the first, on "Abuse Liability Assessment of CNS Drugs," (Vol. 70, Issue 3, Supplement 1, 2003), and the second, "Impact of Drug Formulation on Abuse Liability, Safety and Regulatory Decisions," (Vol. 83, Supplement 1, 2006). The next conference, on Risk Management and Post Marketing Surveillance of CNS Drugs, is planned for May.