AIPLA Comments re FDA Implementation of the Q1 Act

The American Intellectual Property Law Association (“AIPLA”) submits the following comments concerning the FDA’s implementation of Section 4 – “Incentives For The Development Of, And Access To, Certain Antibiotics” – of the “QI Program Supplemental Funding Act,” Pub. Law No. 110-379 (Oct. 8, 2008) (“the QI Act”), which amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to add Section 505(v)– “Antibiotic Drugs Submitted Before November 21, 1997”– to make Hatch-Waxman benefits available for so-called “old” antibiotic drugs (i.e., antibiotic active ingredients included in an application submitted to FDA for review under the now-repealed FDC Act §507 prior to November 21, 1997), the date of enactment of the FDA Modernization Act (“FDAMA”).