FDA abruptly drops request for more drug data after maker’s CEO meets Trump

Enlarge / WASHINGTON, DC - JANUARY 31: US President Donald Trump meets with representatives from PhRMA, the Pharmaceutical Research and Manufacturers of America, in the White House. (credit: Getty | Pool)

In a rare and surprising reversal, the Food and Drug Administration gave Amicus Therapeutics Inc. the greenlight Tuesday to submit its rare-disease drug, Galafold, for an accelerated review process. That's despite the agency previously saying that the drug maker needed to run another clinical trial to better evaluate side-effects-which it hasn't-before the agency would consider reviewing the drug.

The reversal is raising eyebrows-and stocks-amid speculation that the FDA's about-face on Galafold was political and a sign of easier times for the makers of lucrative rare-disease drugs.

Central to that speculation is a meeting back in February between President Trump and Amicus' CEO, John Crowley, STAT reports. Crowley got the president's ear following the FDA's request for more data last year, which spurred Crowley to publicly campaign for the FDA to lower its standards for bringing drugs for rare diseases to market.

Read 7 remaining paragraphs | Comments