Work at the FDA and thalidomide Frances Oldham Kelsey

kelsey received president s award distinguished federal civilian service president john f. kennedy, 1962

in 1960, kelsey hired fda in washington, d.c. @ time, 1 of 7 full-time , 4 young part-time physicians reviewing drugs fda. 1 of first assignments @ fda review application richardson merrell drug thalidomide (under tradename kevadon) tranquilizer , painkiller specific indications prescribe drug pregnant women morning sickness. though had been approved in canada , more 20 european , african countries, withheld approval drug , requested further studies. despite pressure thalidomide s manufacturer, kelsey persisted in requesting additional information explain english study documented nervous system side effect.

kelsey s insistence drug should tested prior approval vindicated when births of deformed infants in europe linked thalidomide ingestion mothers during pregnancy. researchers discovered thalidomide crossed placental barrier , caused serious birth defects. hailed on front page of washington post heroine averting similar tragedy in u.s. morton mintz, author of washington post article, said [kelsey] prevented… birth of hundreds or indeed thousands of armless , legless children. kelsey insisted assistants, oyam jiro , lee geismar, fda superiors backed strong stance, deserved credit well. narrative of dr. kelsey s persistence, however, used pass rigorous drug approval regulation in 1962.

after morton mintz broke story in july 1962, there substantial public outcry. kefauver harris amendment passed unanimously congress in october 1962 strengthen drug regulation. companies required demonstrate efficacy of new drugs, report adverse reactions fda, , request consent patients participating in clinical studies. drug testing reforms required stricter limits on testing , distribution of new drugs avoid similar problems. amendments, first time, recognized effectiveness [should be] required established prior marketing. new laws not without controversy.

as result of blocking american approval of thalidomide, kelsey nominated president s award distinguished federal civilian service john f. kennedy, becoming second woman honoured. after receiving award, kelsey continued work @ fda. there played key role in shaping , enforcing 1962 amendments. became responsible directing surveillance of drug testing @ fda.

kelsey retired fda in 2005, @ age 90, after 45 years of service. in 2010 fda established kelsey award, awarded annually employee.