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FDA was ‘lax’ and kowtowed to drugmaker in review of controversial blood thinner, watchdog says
The Washington Post: The Food and Drug Administration was “lax” and “permissive” in its review of a blood-thinning drug designed to prevent strokes and clots in patients with a heart condition affecting millions of Americans, a watchdog group said Thursday.
The federal regulator made questionable calls to “accommodate” the manufacturer of the anticoagulant Pradaxa, the Project on Government Oversight says in a new investigation, from setting loose standards for the drug’s company-sponsored clinical trial to a lack of proper warnings to patients about its potential health hazards.
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