The Accelerated Approvals Process: Are Drugmakers Fulfilling Their Promises?

Short Wave

NPR

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4.7 • 6K Ratings

🗓️ 22 July 2022

⏱️ 13 minutes

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Summary

The Food and Drug Administration allows faster drug approvals based on preliminary study data if the drug fulfills an unmet medical need. But the speedy approval comes with a promise that the drugmaker does another clinical trial once the drug is on the market to prove it really works. If not, the FDA can rescind the approval. How are the companies doing and how well does the agency enforce that system?

Pharmaceuticals correspondent Sydney Lupkin investigated the 30-year track record for accelerated approvals. Today, her findings on stalled trials and missing evidence.

Transcript

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0:00.0	You're listening to Shortwave from NPR.
0:05.6	In the summer of 2013, Michael Aulkiaga was a high school student on the basketball team
0:10.8	and the baseball team.
0:12.6	He had friends, a girlfriend, an Xbox.
0:15.9	Things were pretty good.
0:17.6	But he kept getting these nose pleads, and they were getting worse despite medical procedures
0:22.0	to fix them.
0:23.0	I woke up in the morning and I went to go wake him up and I went in his room and it looked
0:27.2	like a crime scene.
0:28.8	He had his shirt off and he was sleeping, sitting up in his bed and he had blood all over him,
0:35.7	all over his pillow, all over his bed.
0:37.6	And I just woke him up and I was like, Michael!
0:40.5	That's his mom, Kristi Aulkiaga, of Everett Washington.
0:44.1	She said he didn't want to wake her so he fell asleep like that.
0:48.0	Eventually, Michael was diagnosed with acute lymphoblastic leukemia or ALL.
0:53.4	But he was optimistic.
0:55.0	He went to school, bald head and all, and was determined to be healthy enough to play
0:59.1	baseball in the spring.
1:00.4	He goes, wow, well, I can't wait to be able to say that I beat cancer.
1:06.0	The cancer had other plans.
1:08.6	Six months later, it wasn't responding well enough to multiple rounds of chemo and an
1:13.1	experimental treatment that they were trying.
	...

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