FDA Issues Draft Guidance Announcing a New Web-Based Process for Providing Recommendations on How to Design Product-Specific Bioequivalence Studies

Earlier this week, FDA announced the availability of a draft guidance for industry, titled “Bioequivalence Recommendations for Specific Products.”  The draft guidance describes a new process by which FDA will provide, via the Internet, recommendations on how to design product-specific bioequivalence (“BE”) studies to support Abbreviated New Drug Applications (“ANDAs”). Under this new process, FDA will make product-specific BE study recommendations available in draft form on its web site and seek public comment.  In addition to the guidance document, FDA made available the first group of about 180 product-specific draft recommendations.  Comments on the draft BE recommendations are due by September 28, 2007. 

Among other things, a generic sponsor must demonstrate that its proposed product is bioequivalent to the reference listed drug (“RLD”) (i.e., the brand product).  Two drug products are bioequivalent if there are no significant differences in the rate and extent of absorption of the drug products’ active ingredient.  BE studies are designed and conducted by ANDA applicants to demonstrate bioequivalence.  Previously, applicants could obtain recommendations on the design of BE studies by submitting a letter requesting the information from FDA’s Office of Generic Drugs.  Responding to such requests was time consuming for the Agency.  Responses came slowly, if at all.    

Under the new procedure, FDA will post recommendations for BE studies in draft form at http://www.fda.gov/cder/guidance/bioequivalence/default.htm, and seek public comment.  Users will also be able to search the web site for recommendations on specific drug products.  New draft and final BE recommendations will be announced in the Federal Register and listed monthly on FDA’s web site.  The draft guidance indicates that, as under the old procedure, BE study recommendations will be based on FDA’s understanding of the characteristics of the RLD as well as information from the scientific literature and FDA’s own research.  FDA will also consider public comment on the draft BE study recommendations in order to finalize them. 

A question left unanswered by the draft guidance is how applicants can affirmatively request BE study recommendations on specific products that have not yet been addressed by FDA through this new process.  Comments on the draft guidance must be submitted by August 29, 2007.

By Anne Marie Murphy