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# Report on Petitions Raises Concerns About Diverted Resources
- URL: https://www.fdaweb.com/report-on-petitions-raises-concerns-about-diverted-resources/
- Published: 2019-02-07T12:00:00.000Z
- Updated: 2026-09-15T01:01:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143324

A [new report](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM630922.pdf?ref=fdaweb.com) on citizen petitions submitted to FDA to delay or prevent a drug/biosimilar approval finds that only one product was delayed approval due to such a filing, but the agency is concerned about the number of resources re-directed to meet statutory response timelines.

In the report that examined fiscal year 2017, FDA says it approved 763 ANDAs, 57 505(b)(2) applications, and three 351(k) biosimilar applications. During FY 2017, FDA received 25 505(q) petitions. “Based on its analysis, FDA 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 says. “However, the statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns. Although FDA has generally met the statutory deadlines for 505(q) petitions, it did so in part by redirecting efforts that otherwise would have been directed to other work, including responding to other citizen petitions... Accordingly, as part of the Drug Competition Action Plan, FDA is reviewing what actions can be taken to address these issues.”