In yet another Orwellian story about a federal “protection” agency skewing scientific results at the
FDA scientists have been letter-writing again—this time to the Obama transition team, pleading for help in reforming the “fundamentally broken agency.”
“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” according to scientists’ missive.
The scientists’ primary concern is with the agency’s review process for medical devices, which they say have been “corrupted and distorted by current FDA managers, thereby placing the American people at risk.” Needless to say, this aspect of the letter was particularly disconcerting to us in light of the U.S. Supreme Court’s ruling in Riegel v. Medtronic, where the Court found that if the FDA has approved certain medical devices, a reckless manufacturer can't be sued.
Ultimately, it continues to look like the FDA needs a major overhaul—here’s hoping the incoming Obama administration thinks so too.
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