WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) should promptly add a weight loss drug and an antibiotic to its official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective, to prevent pharmacy compounding of these banned drugs, Public Citizen said today in a petition to the agency. The consumer watchdog group also urged the FDA to implement a new policy of simultaneously initiating the process for updating the list of withdrawn drugs whenever the agency announces that a drug was withdrawn or removed from the market because of safety or effectiveness concerns.
“The FDA, in most cases over the past two decades, has taken at least several years to update the list of withdrawn drugs after the agency determined that a drug was removed from the market because it was unsafe or ineffective,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “Such foot-dragging poses unacceptable and avoidable risks to patients and public health.”
On Mar. 4 and 12 respectively, the FDA issued notices indicating that the weight loss drug lorcaserin (Belviq) and injectable forms of the antibiotic bacitracin had been withdrawn from sale for safety reasons. In both cases, the FDA had asked the manufacturers of these medications to voluntarily withdraw them from the market because the drugs were unsafe. Despite these concerns, until the agency updates the official list of withdrawn drugs, pharmacists and physicians are legally allowed to continue making compounded versions of these dangerous drugs.
Public Citizen’s petition asks the FDA to promptly initiate the notice and comment rulemaking process for adding lorcaserin and injectable bacitracin to the official list of withdrawn drug products. The petition also seeks implementation of an agency policy that would simultaneously begin such rulemaking whenever the FDA announces a determination that a drug product was withdrawn from sale for reasons of safety or effectiveness. Such simultaneous action could shorten the rulemaking process for amending the list of withdrawn drugs by several months to years.
“Such expeditious regulatory action is crucial to minimizing the period during which patients could be at risk of harmful exposure to compounded formulations of drug products that were withdrawn from the market by drug manufacturers due to safety or effectiveness concerns,” said Carome.