But thalidomide was far from safe. An estimated 20,000 babies were born with severe physical disabilities, including flipper-like arms and legs. Heartbroken families were sometimes forced to institutionalize their newborns. Add to that another 90,000 miscarriages linked to the drug.

Then links surfaced that the thalidomide research originated in Nazi concentration camps from doctors who worked there.

Credit Goes To One Researcher

The thalidomide scandal did not reach the United States, something that is largely credited to Dr. Frances Oldham Kelsey, a young pharmacologist at the FDA who in reviewing the drug for approval became alarmed by the lack of rigorous scientific research supporting the drug’s safety claims.

Once she examined the research carefully, the case for thalidomide quickly unraveled. She kept asking the company for more data, delaying approval. In late November 1961, long-ignored evidence became public in Germany linking thalidomide to birth defects. Grünenthal, which in a court case years later blamed causes like nuclear fallout or botched home abortions for the children’s deformities, did not apologize to the victims and their families for more than 50 years.

Because of Kelsey’s perseverance, the drug never received FDA approval and in 1962, it was banned worldwide. But something else happened too. It ushered in a new era for the FDA, which finally forced major regulatory oversight on the pharmaceutical industry, much of which is still in place today. Now, drug approval can take between eight and 12 years, involving animal testing and tightly regulated human clinical trials.