Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101
Source: The New York Times
The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration in September 1960. The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.
But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the F.D.A. job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Company of Cincinnati, for more information.
Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.
Dr. Kelsey, who died on Friday at the age of 101, became a 20th-century American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.
Read more: http://www.nytimes.com/2015/08/08/science/frances-oldham-kelsey-fda-doctor-who-exposed-danger-of-thalidomide-dies-at-101.html?_r=0
Note: Long article.
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in prominent positions in medicine and science.
. .Not just for her long, inspiring life (besides her work -which she continued to age 90!- she married and raised two children, too while she garnered her multiple degrees), but also to learn the history of thalidomide and her key role in keeping thalidomide off the US market, standing firm against pressure from Big Pharma to get the drug on the market.
"Fussy bureaucrats" (albeit one with an MD and Ph.D. in pharmacology) save the day! It's because of her work, and particularly her role in the thalidomide incident, that the FDA no longer lets pharmaceutical companies release drugs to doctors for "testing" with patients before the drug receives approval from the FDA for commercial distribution (can you imagine that that should have ever been OK?!); and why the FDA insists, and should always insist, on solid scientific and clinical trials of new drugs .
What an inspiring woman. Here's to you, Frances Oldham Kelsey. 
Thanks for the thread, Little Tich.
Not that there's anything wrong with that. 
[url]http://www.cbc.ca/news/health/frances-oldham-kelsey-canadian-doctor-and-thalidomide-hero-dies-at-101-1.3183014[/url]
Canada and the UK in the early late fifties. For a time our family lived in Germany while my father traveled all over England and the Continent speaking to groups of distraught parents, helping them see that a normal life, not institutionalization, would be best for the kids, and showing by his example how they might be inspired to do so despite the hardships.
Dr Kelsey showed great courage to stand up to the big pharma companies and keep the drug from this country. The numbers of affected kids here would have been so many times greater.
Rest in Peace Dr Kelsey.
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Thank you
and RIP
Frances Oldham Kelsey.
That name better not be lost to history. This is a person that should be pointed to as an example to others - of an excellent value system - one to be admired and emulated. Rest in peaceful slumber, Frances.