FDA Says Drug Companies May Be Abusing Petition Process

Law360, Washington (September 26, 2013, 4:51 PM EDT) -- Pharmaceutical companies may still be filing so-called citizen petitions to delay approval of generic versions of their drugs, and the delays caused by those petitions are keeping the U.S. Food and Drug Administration from performing other regulatory work, the agency said in a report to Congress released on Wednesday.

The FDA said it believes that pharmaceutical companies holding exclusive patents on their drugs may be filing certain citizen petitions — known as 505(q) petitions for reconsideration — to delay abbreviated new drug applications filed by generic...
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