OT: Shocked! Shocked, I tell you!

[Alan Baker]

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

<https://arstechnica.com/science/2017/07/after-pharma-ceo-pushes-trump-fda-drops-request-for-more-data-on-his-drug/>

'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.'