I'm no fan of the FDA, but it's worth noting Europeans said the same about thalidomide and thankfully America didn't listen. In 1960, Kelsey was hired by the

I'm no fan of the FDA, but it's worth noting Europeans said the same about thalidomide and thankfully America didn't listen. In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs"[4] for the FDA. One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Although it had been previously approved in Canada and more than 20 European and African countries,[8] she withheld approval for the drug and requested further studies.[3] Despite pressure from thalidomide's manufacturer Grünenthal, Kelsey persisted in requesting additional information to explain an English study that documented peripheral neuritis,[9] a nervous system side effect.[4] She also requested data showing the drug was not harmful to the fetus.[9] Kelsey's insistence that the drug should be fully tested prior to approval was vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.[10][11] Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects.[7] This is why America does independent review of results obtained from Europe.