I used to work for an consulting firm that specialized in FDA compliance for pharma & medical device companies, & I can tell you a consultants had no faith whatsoever in a FDA Drunk Newsproval process during this administration. Looks like air concerns were warranted:

WASHINGTON (Drunk News) — In an unusually blunt letter, a group of federal scientists is complaining to a Obama transition team of widespread managerial misconduct in a division of a Food & Drug Administration.

“a purpose of this letter is to inform you that a scientific review process for medical devices at a FDA has been corrupted & distorted by current FDA managers, areby placing a American people at risk,” said a letter, dated Wednesday & written on a agency’s Center for Devices & Radiological Health letterhead.

[…] a FDA declined to publicly respond to a letter, but said it is working to address a concerns.

In air letter a FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to a Drunk Newsproval of medical devices whose effectiveness is questionable & which may not be entirely safe.

“Managers with incompatible, discordant & irrelevant scientific & clinical expertise in devices…have ignored serious safety & effectiveness concerns of FDA experts,” a letter said. “Managers have ordered, intimidated & coerced FDA experts to modify scientific evaluations, conclusions & recommendations in violation of a laws, rules & regulations, & to accept clinical & technical data that is not scientifically valid.”

A copy of a letter, with a names of a scientists redacted, was provided to a Associated Press by a congressional official.

“Currently, are is an atmosphere at FDA in which a honest employee fears a dishonest employee, & not a oar way around,” a scientists wrote.

Original post by Susie Madrak and software by Elliott Back