Even though Kelsey and her team kept thalidomide off the American shelves, many doctors had dispensed “investigative samples” of the drug. Because of this, and because some mothers had obtained the drug overseas, the U.S. saw an estimated 17 births of deformed babies. Still, compared with the numbers worldwide — more than 10,000 children in 46 countries — it’s clear that what FDA historian John Swann calls Kelsey’s “persistence and grit” averted a disaster.
A Job Well Done
Elsewhere in Washington, Tennessee Sen. Estes Kefauver had been holding intermittent hearings for more than two years, originally on drug pricing and marketing, but expanded into drug safety. In July 1962, a detailed story about America’s close call with thalidomide appeared on the front page of The Washington Post, under the headline “Heroine of FDA Keeps Bad Drug Off Market,” with a photo of Kelsey. (Supposedly, the story had been leaked to the Post by a Kefauver commission staffer, with the senator’s encouragement.)
The Rose Garden award ceremony for Kelsey followed in August, and an omnibus bill tightening regulations on the pharmaceutical industry and drug trials passed the Senate two weeks later. After reconciliation with a similar House bill sponsored by Rep. Oren Harris of Arkansas, President Kennedy signed the Kefauver-Harris Drug Amendments bill into law in October 1962. Standing in the half-circle of invited officials looking on was Frances Kelsey.
The Kefauver-Harris bill “changed the face of drug regulation,” says Swann, who knew Kelsey. Companies now had to prove drugs were effective as well as safe, based on rigorous, well-controlled studies by qualified researchers. Further, the FDA would establish (and monitor) good manufacturing practices, and control of prescription drug advertising would be transferred from the Federal Trade Commission to the FDA.
Later in 1962, Kelsey was named head of the FDA’s new investigational drug branch. For the next 43 years, she stayed at the FDA. On Aug. 6, 2015, Frances Oldham Kelsey, now frail, white-haired and living with a daughter in southern Ontario, was visited by the lieutenant governor of Ontario, who presented her with the Order of Canada medallion. The next day she died, at the age of 101.