1998

FDA approves Celgene’s application to market thalidomide (Thalomid) in U.S. for treatment of ENL (leprosy). “Some observers have noted the FDA’s deft political move in the thalidomide case: the FDA showed its sensitivity to the needs of patients, while taking responsibility for the outcomes of a minute number of leprosy cases and avoiding responsibility for the estimated thousands of off-label prescriptions [e.g., for AIDs/HIV “wasting disease”] (Timmermans & Berg, ch 6, quoted at p. 188). “Instead of a horror drug of the past, thalidomide appeared through the scientific work as any other chemical compound with known toxicological parameters, and . . . this picture proved less alarming than some other drugs currently approved by the FDA and widely available by prescription (e.g., Accutane). . . Thalidomide is the most regulated drug in U.S. History” via the standardized S.T.E.P.S. program (190- 191). The designers of the program preserved and enhanced the professional autonomy of the key actors: “Physicians’ off-label prescription prerogatives were left untouched, and pharmacists were given desired counseling responsibilities. The federal regulators were satisfied that the proposed drug system set a new precedent for restricted distribution” (192). “By marking women’s reproductive behavior as the most important safety valve, the designers [of the program] perpetuated a distorted view of women as untrustworthy decision makers and delegated control to physicians and pharmacists.”