FDA update – March 1, 2011

FDA Proposes Generic Drug User Fee

Generic drugs now make up nearly three-quarters of U.S. prescriptions after rapid growth in recent years. Over the past several months, the Food and Drug Administration (FDA) has experienced a significant backlog of generic drug applications, more than 2,000. Copycat medicines now take an average of 2½ years to get approval.  As a result, with federal agency budgets under significant pressure and resources already slim, FDA recently announced that the generic drug industry should prepare for user fees. It is likely that any changes will take 12 to 24 months to complete.

  • Plant inspections are one of the main reasons for delays, because a generics maker cannot sell its products until the FDA certifies that its factory is following good manufacturing practices.
  • U.S. plants face inspections every two years or so, once they are certified, while foreign facilities may go years longer without an inspection.
  • A government report in 2010 said that about 64% of 3,700 foreign drug facilities may never have been inspected by the agency, and that the number of overseas inspections remains far lower than those done in the U.S.

FDA has identified the following issues:

  1. How, if at all, should a generic drug user fee program differ from FDA’s existing user fee programs, including PDUFA,ADUFA,MDUFMA and Tobacco Product User Fees?
  2. What should a generic drug user fee program look like or how should a generic user fee be structured?  Should the generic drug fees follow the same structure?  what are the unique aspects of the generic drug industry or market that should be considered and how might this impact a proposed user fee plan?
  3. Are performance goals recommended for FDA? If so, what performance goals would you recommend for FDA? If not, why not?
  4. Should all applications pay the same fees and be subject to the same goals?
  5. How should a generic drug user fee program address applications currently awaiting FDA review?
  6. What kind of support, if any, should a generic user fee provide for post-marketing safety? 
  7. In addition, as opposed to the NDA process, FDA usually requires a separate ANDA for each dosage strength of a product. Since much of the data is common in such applications, should not FDA either be forced to change its rules to allow bundling of dosage strengths in one application or to provide for reduced user fees where a ANDA applicant submits several ANDA’s for different dosage strengths of the same product? 
  8. FDA may require significant additional data beyond a simple BE study and CMC data to obtain approval of an ANDA of a complex drug product. Should not ANDA’s for such products, which obviously take significantly more review time, be subject to additional user fees?
  9. What about supplements? Should FDA charge user fees to expedite the review of ANDA supplements? Should the fees be determined based on the type and complexity of the supplement? 
  10. Is charging the same user fee for a company that has 1% of the market fair when another manufacturer has over 50% of the market? Should generic drug annual fees – if assessed be based on sales, rather than a figure divided equally among manufacturers?
  11. What if an ANDA is approved but the product is not marketed? Should such an ANDA applicant be charged an annual product fee?

Any questions on this new FDA rule please email us at info@mdiconsultants.com and Ref: Generic Drug User Fee.