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Pharmaceuticals / Regulatory Affairs

FDA Says 505(q) Petitions Pull Resources From Safety Activities

Feb. 15, 2019

Petitions aimed at delaying approvals of competing drugs are diverting resources away from the agency’s public health efforts, the FDA said in a report to Congress.

The agency is required, under section 505(q) of the Food, Drug and Cosmetic Act, to prioritize such petitions and says it has met its statutory deadlines, but only by redirecting resources away from other work.

The FDA received a total of 25 505(q) petitions in fiscal year 2017 and responded to them within the 150-day statutory timeframe. The agency “continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the report states. No approval for a BLA or ANDA was delayed due to a 505(q) petition in fiscal 2017, but one NDA application was delayed, the agency said.

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