Safety advisory group gets mixed marks from members

Abstract

The FDA Drug Safety and Risk Management Advisory Committee is expected in February to meet for only the sixth time since the agency changed the group’s name in mid-2002 from the Drug Abuse Advisory Committee and recruited members from an unconnected subcommittee. At the time of the name change, FDA declared that the committee’s function was to advise the agency about risk-management plans, active surveillance methods, trademark studies, methods for risk-management communication, and related issues. Of the 13 advisory committee members, 4 are registered pharmacists: Michael R. Cohen, president of the Institute for Safe Medication Practices; Stephanie Y. Crawford, an associate professor at the University of Illinois at Chicago College of Pharmacy; Eleanor Gomez-Fein, patient care coordinator for trauma and critical care services at Jackson Memorial Hospital in Miami, Florida; and Henri R. Manasse Jr., executive vice president of ASHP. The five meetings convened by FDA so far have elicited advice on consumer medication information, look-alike and sound-alike proprietary drug names, the labeling of low-density polyethylene (LDPE) plastic containers, and the risk-management programs for alosetron, isotretinoin, and the yet-to-be-marketed oral formulation of tazarotene, a teratogenic treatment for psoriasis.