Brian McMahon Published in the Kentucky Law Journal
COJK litigation attorney Brian McMahon published an article explaining The Biologics Price Competition and Innovation Act of 2009 (BPCIA) and its impact on the current regulatory approval of biologics by the Federal Drug Administration. The Hatch-Waxman Act of 1984 played a significant role in the efficient approval process of generic synthetic drugs, but with the introduction of biologics, a reform to the original act was required, resulting in the BPCIA. In the article, Brian outlines the BPCIA litigation processes applied to the approval of a biologic, identifies some flaws of the new act, and suggests possible solutions. The article appears in volume 100, issue number three of the 2011-2012 Kentucky Law Journal.
