Frances Oldham Kelsey, the Canadian doctor who played a central role in preventing the drug thalidomide being distributed in the US, has died at 101.
She refused to approve it while working for the US drug agency in the 1960s.
It was later found that thalidomide – prescribed to pregnant women to ease morning sickness – was causing thousands of babies to be born with missing limbs or organs. Many died.
She was lauded by citizens’ groups and was awarded honorary degrees.
Dr Kelsey passed away in London, Ontario, on Friday, Canada’s CBC reported.
Her daughter Christine Kelsey was by her side.
Dr Kelsey – who worked at the US Food and Drug Administration – is seen as a hero by many across the US for raising concerns about the safety of thalidomide, which is also known as Kevadon.
Dr Kelsey continued to press the manufacturer – who complained about her attitude – for information.
The side-effects of the drug then became apparent as the battle of wills dragged on.
She was given the award for distinguished federal civilian service by President John F Kennedy.
Last month she was appointed to the Order of Canada.