She felt there was a significant lack of scientific evidence to prove the drug’s safety, so despite the pressure to approve it, she refused to.
Just one year after making her decision, researchers in Germany and Australia discovered a link between thalidomide and severe birth defects. Many children had been born with congenital limb anomalies, and the one thing they all had in common was that their mothers had taken thalidomide for morning sickness early in their pregnancies.
Frances was right, and she was a lifesaver.
Frances may not have received the credit she deserved for her outstanding work for the FDA if investigative journalist Morton Mintz hadn’t portrayed her as a hero in his front-page piece on the incident for The Washington Post in 1962.
That same year, President John F. Kennedy awarded Frances the President’s Award for Distinguished Federal Civilian Service by President John F. Kennedy.
She also witnessed President Kennedy sign the Kefauver-Harris amendments into law, which granted the FDA the power to demand a company submit sufficient proof of effectiveness for their drugs before they can be approved.
After her fascinating achievement, Frances continued working for the FDA for 45 years. She retired at the age of 90 and lived to be 101 years old, passing away in 2015 in London, Ontario, Canada.
It’s hard to imagine what could have happened if Frances didn’t trust her knowledge and instincts during her first year with the FDA, and we should be thankful for her to this day.
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