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by BostonEnginerd 2036 days ago
"The US FDA refused to approve thalidomide for marketing and distribution. However, the drug was distributed in large quantities for testing purposes, after the American distributor and manufacturer Richardson-Merrell had applied for its approval in September 1960.[citation needed] The official in charge of the FDA review, Frances Oldham Kelsey, did not rely on information from the company, which did not include any test results. Richardson-Merrell was called on to perform tests and report the results. The company demanded approval six times, and was refused each time. Nevertheless, a total of 17 children with thalidomide-induced malformations were born in the US. Oldham Kelsey was given a Presidential award for distinguished service from the federal government for not allowing thalidomide to be approved for sale in the US.[42] "

Although not perfect, the FDA seemed to do the right thing in the case of Thalidomide.

1 comments

Yeah, it was a bigger problem in other countries. Point still stands - the Thalidomide birth defect crisis was largely a result of poor regulation for pharmaceuticals.