The Federal Drug Agency (FDA) was still considering whether to allow Cincinnati drug company Richardson-Merrell to sell Thalidomide in the US. Dr. Francis Kelsey from the FDA kept on denying Merrell’s request. She was still extremely sceptical about the drug’s safety – not only about the nerve damage it could possibly cause, she was also wondering if Thalidomide was safe for a fetus.
In case the FDA was to approve the drug, Merrell was told to include a note in the instruction leaflet warning women not to take Thalidomide in case of pregnancies since there was no reliable data available in this regard.