According to the Wall Street Journal, Johnson & Johnson
I wouldn't hold my breath hoping for a reversal.
There's no outside agency to appeal to. Companies that don't like the agency's decisions on medical devices or drug have to appeal back to the FDA. In Johnson & Johnson's case, the company is going all the way up to the commissioner, Margaret Hamburg.
The FDA's issue with Sedasys revolves around its safety, which makes it very unlikely that Hamburg would overturn the decision. The device is used to mildly sedate patients using the drug propofol, which is typically administered by an anesthesiologist. The FDA wants Johnson & Johnson to compare the use of Sedasys by doctors that are performing routine medical tests like colonoscopies to anesthesiologists administering propofol.
Sure, Hamburg could say her underlings were wrong, but wouldn't that just imply she was running an agency with unqualified reviewers? There's no incentive to overturn the decision and a lot of reason not to.
The same goes for MELA Sciences
Drug companies have the same appeals process -- Cell Therapeutics
Johnson & Johnson claims that the FDA changed the rules midstream -- welcome to the club -- but I doubt that's going to sway Hamburg. Opinions change, new reviewers pick up on something that others missed, a famous singer dies while on propofol. Whatever the reason for the rejection, the FDA has the final say.
Still, the appeal might not be completely in vain. It may be like a baseball manager yelling at the umpire; he's not trying to get this call overturned so much as hoping to get the next one to go his team's way.
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