When Cincinnati-based pharmaceutical company William S. 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. Dr. Frances Oldham Kelsey's actions fundamentally changed the agency's testing and approval process, leading to the robust regulations that exist today.

President John F. Kennedy publicly praised Kelsey for sparing "us this terrible human tragedy which has been visited on families in Germany."

Except that wasn't entirely true.

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. "It transformed the FDA because it made it clear that more significant and serious drug testing had to take place before drugs were released on the market."

The doctors didn't tell the women they were taking thalidomide or document it in their medical records, Vanderbes said. The women "had no slips of paper that showed their prescription. They had no bottles with a label."

What many did have were children born with truncated limbs.

But even after these babies were born, and even after the scientific community understood the dangers of thalidomide, doctors did not reveal that they had given their patients the drug, Vanderbes said. Some women were specifically told they had not taken it.

Years later, many of the women's children were also told they couldn't be thalidomide survivors because their doctors believed the United States had escaped the thalidomide scandal.

Vanderbes estimates there could be around a hundred U.S. survivors.

Swann, the former FDA historian, said it's hard to know an exact number of American-born babies whose mothers took the drug, but it was certainly more than the 17 formally acknowledged by the FDA.

In 2018, Riechmann co-founded the advocacy group USA Thalidomide Survivors. The group of roughly 100 people, which includes allies as well as survivors, is pushing Congress to pass a bill that would officially acknowledge American thalidomide survivors and give each $150,000, with the possibility of additional money in the future.

"The U.S. is the only country that has not provided any kind of support or even recognition that they have thalidomide survivors," she said. "We are looking for, first, recognition that, yes, we do exist. And then, secondly, support."

Survivors are aging, and their health is deteriorating, Riechmann said, but they can't give up — even if they also can't wait long.

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