Sixty-five years ago this fall, Dr. Frances Oldham Kelsey made history for doing something that might seem remarkably ordinary: she served as the proverbial red tape of the federal bureaucracy. She challenged a drug’s safety claims and repeatedly refused to approve its sale in the United States — a decision that saved lives and prevented widespread harm. Amid thousands of layoffs in the federal government and an ongoing shutdown, the contributions of civil servants like Kelsey are a reminder of the power of one person due to the impacts of her refusal to approve a harmful drug.

Kelsey was a new medical officer at the Food and Drug Administration in September 1960 when she received an application to market a sedative drug for pregnant people with morning sickness. The sedative was called Kevadon, but the generic drug was known as thalidomide. Kelsey's refusal to approve this harmful drug would revolutionize the way drugs are regulated in the U.S.

Kelsey, who had multiple degrees and had been trained as a doctor, was skeptical of thalidomide’s safety. Ultimately, her refusal to approve thalidomide changed the course of medical history. At the time, the FDA had a 60-day window to either approve or reject a drug, or it would automatically go to market. Kelsey, who could not prove the drug was dangerous at the time but also knew there wasn’t information shared about its safety, made repeated requests for scientifically reliable evidence from the pharmaceutical company — a process that effectively reset the 60-day window under the guise that the application was incomplete.

“Here was a drug that looked like it should be no problem, but at the same time there was just a feeling that there was something in the data or the absence of data that was a cause of concern,” Kelsey said in an interview years later, according to the Lost Women of Science podcast that featured her story. The pharmaceutical firm, the William S. Merrell Company, grew increasingly frustrated with her.

But the side effects of thalidomide began to surface in Europe and other countries. As Kelsey stonewalled at the FDA, reports were emerging about children whose severe birth deformities were linked to the drug. (This also did not fully prevent harm in the United States, where several hundred pregnant people took thalidomide through samples that had been distributed to doctors’ offices.)

Read the full article about Dr. Frances Oldham Kelsey's refusal to approve thalidomide by Barbara Rodriguez at The 19th.