Regulatory Focus™ > News Articles > FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

FDA Looking to Improve the Generic Drug Regulatory Process, Wants Industry Input

Posted 08 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its research priorities as it looks to fulfill its statutory goals under the FDA Safety and Innovation Act (FDASIA).


In July 2012, FDASIA-a massive piece of legislation containing numerous FDA reform provisions and user fee bills-was passed into law, and with it the Generic Drug User Fee Act (GDUFA), which provided FDA with new authority to collect user fees from the generic pharmaceutical industry.

Those fees were to go toward several goals, among them the elimination of a massive backlog of abbreviated new drug applications (ANDAs), faster reviews for ANDAs, more inspections of generic and active pharmaceutical ingredient (API) manufacturing facilities, and general improvements in regulatory science meant to improve the efficiency of FDA's regulatory processes.

Regulatory science, apart from being one of the main initiatives launched by FDA Commissioner Margaret Hamburg, is essentially the various scientific tools and methods employed to evaluate a product-in this case generic pharmaceuticals-to ensure that it is safe, effective and manufactured to a certain standard of quality.

Regulatory science has been an important subject to generic drug regulators in recent months after some generic equivalents of a well-known antidepressant, Wellbutrin XR 300 mg (bupropion), were found not to be bioequivalent to the drug. In the aftermath of that revelation, FDA has scrambled to figure out what factors were at the root cause of the bioequivalency discrepancy and how to prevent it from happening in the future.

Update on Current Initiatives…

But that's just one drug. GDUFA, meanwhile, calls for FDA to institute regulatory science initiatives on a broader, more holistic level that benefits the entire generic drug space, and not just a small subset of generics of a particular product.

FDA now says it wants to update the public and industry at a June 2013 meeting on how its current regulatory science projects are progressing, and to collect ideas for what it should be working on next.

It noted that it has been working on 13 projects that had been identified in its Fiscal Year 2013 Regulatory Science Plan, a set of projects contained within a commitment letter FDA signed during the GDUFA negotiation process. Those projects are:

  1. bioequivalence of local acting, orally inhaled drug products
  2. bioequivalence of local acting topical dermatological drug products
  3. bioequivalence of local acting gastrointestinal 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 combinations
  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. develop a risk-based understanding of potential adverse impacts to drug product quality resulting from changes in active pharmaceutical ingredients manufacturing and controls.

… And Looking to Future Ones

Looking forward in time, FDA says it is looking at five core questions to guide the development of further regulatory science initiatives:

  1. What challenges currently exist that serve to limit the availability of generic pharmaceuticals?
  2. What approaches can be taken to improve how generics are evaluated in terms of therapeutic equivalence?
  3. How can therapeutic equivalence be monitored post-approval?
  4. Which projects are most important for FDA to act on?
  5. Which areas could benefit from additional draft guidance or further clarity?

The meeting will take place on 21 June 2013 at FDA's White Oak Campus in Silver Spring, MD.

FDA: Generic Drug User Fee Amendments of 2012: Regulatory Science Initiatives Public Hearing

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