SAN FRANCISCO—Advances in biologic and nonbiologic DMARDs have transformed the lives of many patients with rheumatic diseases. At the same time, balancing the risks of these therapies with the benefits has rendered treatment decisions more complex. The ACR’s Drug Safety Subcommittee, in partnership with the ARHP, sponsored an afternoon panel discussion at the October 2008 ACR/ARHP Annual Scientific Meeting. The session, “The Big Picture—Balancing Risk and Benefit fro the U.S. Food and Drug Administration, Physician and Patient Perspectives,” updated rheumatologists about current Food and Drug Administration (FDA) postapproval safety monitoring activities and clarified techniques for helping patients weigh risks and benefits of treatment choices.
The impetus for presenting the panel came from results of an ACR member survey, reported subcommittee chair and co-moderator Daniel J. Lovell, MD, MPH, interim director of the division of rheumatology at Cincinnati Children’s Hospital Medical Center, in his introduction. (Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, also a subcommittee member, shared moderator duties with Dr. Lovell.) Results of the survey showed that 85% of survey respondents were “highly” or “extremely” concerned about drug safety, while 65% were less than “satisfied” about their own knowledge about drug safety.
FDA’s Current Initiatives
Paul Seligman, MD, MPH, associate director of safety, policy, and communication at the FDA Center for Drug Evaluation and Research, began by noting that the FDA recognizes that there are practical as well as ethical constraints in the agency’s ability to answer all questions related to a product prior to its approval. Among those constraints: all drugs have risks, premarket clinical trials are not large enough to detect rare safety events, and uncertainty is inherent in clinical trials.
Responding to increasing demands for more transparency and timeliness about postmarket safety issues, the FDA, in the past two to three years, has stepped up its outreach to consumers and providers. The Consumer Health Information Web site (www.fda.gov/consumer) disseminates information about a wide range of food, health, and safety topics; also, the FDA now partners with WebMD (www.Webmd.com/fda) to expand its public health advisories and ongoing safety reviews. For providers, the FDA publishes a quarterly Drug Safety newsletter (www.fda.gov/cder/dsn); maintains a MedWatch listserv (www.fda.gov/medWatch.elist.htm) with a current subscriber list of over 120,000; and partners with healthcare organizations to distribute electronic product safety updates. A recent example of information for providers was a September 4, 2008, FDA Alert regarding inconsistent recognition of histoplasmosis and other invasive fungal infections in patients taking TNF blockers, prompted by a case report and a subsequent FDA search of the Adverse Event Reporting System (AERS) database.