Arguing patient safety is at risk, an advocacy group is urging the Food and Drug Administration to create a new policy for updating an official list of medicines that are withdrawn after being deemed unsafe or ineffective.
In a petition filed with the agency, Public Citizen noted that the FDA has, in most cases over the past two decades, taken “at least several years” to update this list. Meanwhile, patients could be potentially harmed by compounded formulations that physicians and pharmacists are legally permitted to make in the interim.
“Such foot dragging poses unacceptable and avoidable risks to patients and public health,” Michael Carome, who heads Public Citizen’s Health Research Group, said in a statement. In regulatory terms, the advocacy group wants the FDA to issue a notice that would propose to amend FDA regulations to include each medicine that is withdrawn for such reasons.
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A good example was Rezulin (troglitazone). Most of the world had it off in 6-12 months due to the hepatotoxicity and deaths. U.S. took a little over 2 years. Fortunately my drug committee did not allow coverage of it for our health plan after reviewing it. It was obvious it was going to be a problem from the beginning.