FDA Plans To Commission Institute of Medicine Evaluation To Examine Agency Prescription Drug Safety Procedures
FDA on Friday will announce plans to commission a "major evaluation" by the Institute of Medicine on agency procedures for the detection of and response to safety risks posed by prescription drugs, "mainly those that are already on the market," the Wall Street Journal reports. FDA also will announce plans to hold a series of public meetings on prescription drug safety issues; to finalize three documents that provide guidelines on how pharmaceutical companies should identify medication risks, address potential problems and minimize risks after treatments reach the market; and establish a procedure to resolve scientific disputes among agency officials.
FDA will make the announcements in part as a response to the recent withdrawal of the COX-2 inhibitor Vioxx over safety concerns and to how the agency has addressed concerns about the potential risk for suicidal behavior among children who take antidepressants. In addition, several scientists have called for more FDA research on prescription drug safety issues.
Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said, "This is a complex problem that has been around for a long time. There is no easy fix." He added, "It's very important to consider the risk with the benefit" of prescription drugs. Galson said that that the FDA budget for efforts to monitor prescription drug safety has increased to $45.7 million in fiscal year 2004 from about $21 million in FY 2000. He said that FDA is "willing to consider any recommendations" from IOM (Wilde Mathews, Wall Street Journal, 11/5).
In related news, FDA officials on Thursday announced plans to establish a system to identify potentially dangerous and mislabeled dietary supplements and promised to "aggressively" find companies that market "misleadingly labeled products," the Washington Post reports. Under the plan, FDA will require dietary supplement manufacturers to provide "competent and reliable scientific evidence" to substantiate claims made on product labels. FDA officials also said that the agency plans to improve the process for the collection of "signals" of potential adverse events in individuals who use dietary supplements.
FDA announced the plan amid criticism that the federal government has "reacted too slowly" to the health risks posed by dietary supplements such as ephedra and androstenedione, which this year were removed from the market as a result of health concerns, the Post reports. FDA acting Commissioner Lester Crawford said in a statement, "These initiatives refine the direction the agency is taking to regulate dietary supplements. We now have a clear road map to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling."
FDA on Nov. 15 also plans to hold a public meeting to discuss the evidence that the agency should require for ingredient notifications. Under a 1994 law, most dietary supplements do not require FDA review or approval; however, some new ingredients require a pre-market report on potential safety risks (Kaufman, Washington Post, 11/5).