This year the U.S. Food and Drug Administration (FDA) is marking the anniversary of the Kefauver-Harris amendment, passed 50 years ago. The legislation gave FDA weight to require drug manufacturers prove their products were safe and effective before receiving approval to market them in the U.S. Before the amendment, drugs could be sold 60 days after companies filed with the FDA, if the agency did not object, and drug manufacturers routinely sent new medications to doctors asking them to ” try them out ” on their patients. The amendment has its roots in then-FDA medical officer Frances O. Kelsey’s refusal to approve Kevadon (more commonly known as thalidomide) for morning sickness during pregnancy. Thalidomide was later shown to cause serious birth defects. Senator Estes Kefauver of Tennessee and Representative Oren Harris led the effort to pass the amendment. Read more.
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