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The regulatory authorities in East Germany never approved thalidomide. [52] One reason for the initially unobserved side effects of the drug and the subsequent approval in West Germany was that at that time drugs did not have to be tested for teratogenic effects. They were tested for toxicity on rodents only, as was usual at the time. [53]
A group of 120 Canadian survivors formed the Thalidomide Victims Association of Canada, the goal of which is to prevent the approval of drugs that could be harmful to pregnant individuals and babies. [39] [40] The members from the thalidomide victims association were involved in the STEPS programme, which aimed to prevent teratogenicity. [41]
Thalidomide victim, right; Sen. Kefauver and President-elect Kennedy, 1960 Associated Press and Joun Rous/Associated Press. A key provision of the new law made it a crime for drug companies to promote drugs to doctors for patients with illnesses for which the drug, according to its FDA-approved label, was not intended and approved for use.
East German regulatory authorities did not approve thalidomide, and the U.S. Food and Drug Administration (FDA) also declined to approve the drug. [7] One reason for the initially unobserved side effects of the drug and the subsequent approval in Germany was that at that time drugs did not have to be tested for teratogenic effects. Thalidomide ...
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Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American [1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. [2]
Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey, about thyroid toxicity. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA.
In contrast, the decade prior to 1983 saw fewer than ten such products come to market. From the passage of the ODA in 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds. As of 2010, 200 of the roughly 7,000 officially designated orphan diseases have become treatable. [13]