FDA Requests More Comments on Generic Exclusivity Forfeiture

Thanks to the FDA Blog for pointing out the FDA’s letter requesting comment on 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning at least one ANDA submitted to the Agency containing a paragraph IV patent certification invloving a generic version of Bayer Pharmaceuticals’ PRECOSE (acarbose) tablets:

Under changes made to the FDC Act by the 2003 Medicare Modernization Act (“MMA”), generic applicants that are “first applicants” are eligible for 180-day exclusivity, unless such eligibility is forfeited. 180-day exclusivity eligibility may be forfeited if, among other reasons, a “first applicant” “fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed” (FDC Act § 505(j)(5)(D)(i)(IV)), or if such applicant fails to market the drug “30 months after the date of submission of the application” (FDC Act § 505(j)(5)(D)(i)(I)(aa)(BB)). Although FDA was previously confronted by a potential forfeiture case involving a company's failure to obtain tentative approval within 30 months of ANDA submission, the Agency ultimately did not have to resolve the situation.

. . . FDA’s letter requests that comments be submitted to the Agency by October 10, 2007. FDA’s decision to request comment on Acarbose Tablets exclusivity issues is part of an increasing trend at FDA to ask for input to help resolve complicated exclusivity issues. In March 2007, FDA requested comment on amlodipine besylate 180-day and pediatric exclusivity issues, and in August 2007, FDA requested comment on midodrine HCl three-year exclusivity issues. Presumably FDA will continue this trend as new issues crop up, particularly post-MMA 180-day exclusivity issues.