Published Report: FDA on GDUFA

February 21 03:12 2014 Print This Article

gdufasmallThe FDA has released its Performance Report for the first year of the Generic Drug User Fee Amendments (PDF downloadable at According to Commissioner of Food and Drugs Margaret Hamburg, M.D., FDA met all of its GDUFA commitments for that span. GDUFA’s key goals for its initial five-year period are to speed the review process, reduce the massive backlog of generics applications, and inspect the facilities that make APIs and final dosage forms for generic products.

In FY13, covering October 1, 2012 to September 30, 2013, the FDA hired 291 GDUFA-related staffers, or exceeding its goal of hiring 25% of the needed staff. The agency also implemented a number of IT improvements, including a CMC database and the migration of all ANDAs to “an existing, more robust system to support tracking, regulatory review processes, and user fee payments of these and future applications.”

The report notes that FDA made significant progress towards meeting the backlog requirement for pre-GDUFA applications (i.e., those that were pending on October 1, 2012). Of the 2,866 ANDAs and 1,882 prior approval supplements (PASs) in that category, first action was taken on 868 (30%) and 752 (40%), respectively, by Sept. 30, 2013.  First action consists of approval, tentative approval, complete response (CR), refusal to file (RTF), or withdrawal. Overall GDUFA requires FDA to review and act on 90% of those submissions.

However, no original ANDAs submitted in FY2013 were approval. Fifty-three PASs from that time were approved.

One of the achievements listed in the report, “Facilitated industry self-identification efforts, enabling fee calculation and improving the quality of generic industry supply chain information,” raises a few question marks, as several companies have told Contract Pharma that they have been put on a GDUFA “self-identified facilities” list despite not identifying their facilities as generic manufacturing sites.

According to the report, 82% of ‘self-identified’ domestic final dosage form (FDF) facilities were cGMP inspected in the previous two years, compared to 65% of non-U.S. FDF facilities.  For API facilities, 80% of domestic ones were inspected in the previous three years, while 67% of non-U.S. ones were. “As human generic user fees allow FDA to increase inspection capacity in subsequent years, the gap between domestic and foreign inspection frequencies should narrow,” said the report.

During FY13, FDA’s Office of Generic Drugs awarded $17 million in grants and contracts to initiate new research in identified program areas, as well as $4 million for the internal research-enabling purchase of equipment for FDA labs and support for research fellows at FDA. There were 13 research topics for 2013:

  1. Bioequivalence of local-acting, orally-inhaled drug products
  2. Bioequivalence of local-acting, topical dermatological drug products
  3. Bioequivalence of local-acting, gastro-intestinal drug products
  4. Quality by design of generic drug products
  5. Modeling and simulation
  6. Pharmacokinetic studies and evaluation of anti-epileptic drugs
  7. Excipient effects on permeability and absorption of Biopharmaceutics Classification System Class 3 Drugs
  8. Product- and patient-related factors affecting switchability of drug-device combination products
  9. Postmarketing surveillance of generic drug usage patterns and adverse events
  10. Evaluation of drug product physical attributes on patient acceptability
  11. Postmarketing assessment of generic drugs and their brand-name counterparts
  12. Physicochemical characterization of complex drug substances
  13. Developing a risk-based understanding of changes in API manufacturing and controls

The five science priorities for GDUFA’s current year are:

  1. Post-market Evaluation of Generic Drugs
  2. Equivalence of Complex Products
  3. Equivalence of Locally Acting Products
  4. Therapeutic Equivalence Evaluation
  5. Standards Computational and Analytical Tools

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This article contributed by Contract Pharma