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Half of all drugs that received accelerated approval by the FDA from 2009-2013 failed to complete required post-approval studies within three years of going on the market, according to a study published Tuesday in JAMA. Another study, also in JAMA, found that less than half of all high-risk medical device modifications underwent rigorous testing before entering the market.

Since 1992, drugs that treat serious illnesses have had the option of fast-tracking their FDA approval. Instead of completing rigorous clinical trials that can take years, the FDA would allow companies to put promising drugs on the market on the condition that they continue to conduct studies that prove that the drugs actually work.

What they did: The first study looked at 38 trials for 22 drugs, and found that only 19 of those trials were completed within three years. The ones that were finished were frequently not as rigorous as the studies that would have been required had the drug been approved via normal channels. There was also evidence of missing or lost data and selection bias.

It's not all bad, notes STAT's Damien Garde, who writes that a study published this week in Health Affairs concludes "that the agency is consistently singling out the most promising therapies [for] speedy review."

Go deeper

Dave Lawler, author of World
2 hours ago - World

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Photo illustration: Aïda Amer/Axios. Photo: Drew Angerer/Getty Images

Four more years of President Trump would almost certainly kill the Iran nuclear deal — but the election of Joe Biden wouldn’t necessarily save it.

The big picture: Rescuing the 2015 Joint Comprehensive Plan of Action (JCPOA) is near the top of Biden's foreign policy priority list. He says he'd re-enter the deal once Iran returns to compliance, and use it as the basis on which to negotiate a broader and longer-lasting deal with Iran.

Kamala Harris, the new left's insider

Photo illustration: Eniola Odetunde/Axios. Photo: Joe Buglewicz/Getty Images     

Progressive leaders see Sen. Kamala Harris, if she's elected vice president, as their conduit to a post-Biden Democratic Party where the power will be in younger, more diverse and more liberal hands.

  • Why it matters: The party's rising left sees Harris as the best hope for penetrating Joe Biden's older, largely white inner circle.

If Biden wins, Harris will become the first woman, first Black American and first Indian American to serve as a U.S. vice president — and would instantly be seen as the first in line for the presidency should Biden decide against seeking a second term.

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Illustration: Sarah Grillo/Axios

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