Last year, brand-name pharma companies filed 92% of 505(q) citizen petitions, a specific type related to pending generic applications. And in turn, 92% of those petitions were ultimately rejected by the FDA. For its part, the FDA is is aware of a problem; the agency wrote it was concerned that current law “may not be discouraging the submissions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues.” Gaming the FDA’s citizen petition this way puts the agency , whose number one job is safety, in a tricky spot. They’re not designed as a competition policing agency.” The scope of the problem, is bigger than the FDA and tricky. The issue sits at the junction of several areas of law that offer anticompetitive conduct.”: antitrust law, patent law, state drug etc.
At www.theatlantic.com
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