Merrell applied for Food and Drug Administration approval for a German-made sedative in late 1960, it expected the application to sail through the process and be on store shelves in time for Christmas. The drug, thalidomide, was not approved that year or the next. A persistent medical reviewer at the FDA kept the drug from being approved for general use.
Frances Oldham Kelsey's actions fundamentally changed the agency's testing and approval process, leading to the robust regulations that exist today. Kennedy publicly praised Kelsey for sparing "us this terrible human tragedy which has been visited on families in Germany." Doctors were already giving thalidomide to thousands of U.S. patients, including pregnant women. Some children whose mothers were given the drug during pregnancy were born with severely deformed limbs.
Those children are now adults, and they want the federal government to formally acknowledge their existence. "We go to doctors today who say it didn't happen here in the United States. Oh yeah, it did," said Gwen Riechmann, who was born with phocomelia, the signature shortened limb deformity caused by thalidomide.
Phocomelia is rare, but slightly more common outside the United States in countries such as Britain and Germany, where thalidomide was more widely sold. When Riechmann's mother was pregnant with her in the early 1960s, the doctor gave her a new sedative to help with her nausea. She was unwittingly part of an unregulated U.S. clinical trial for thalidomide.
Merrell handed out thousands of unlabeled doses, telling doctors it was perfectly safe for treating a range of issues from insomnia to morning sickness, according to Jennifer Vanderbes, whose book Wonder Drug details the history of thalidomide. She said the company didn't require the doctors to track the medication or report back on side effects. "This was such a sloppy investigation," said John Swann, retired FDA senior historian.
As the FDA drilled into Merrell's records, Swann said, the amount of thalidomide that couldn't be accounted for was striking. "When you have a problematical product, you trace back to where it's been distributed," Swann said. When the FDA did that, it found, "and certainly the company had admitted, that there was just a great deal that was unaccounted for." "It's probably the most iconic toxic drug of all time because of its signature injuries," Vanderbes said.
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