Michael Keeley and Chad Landmon discussed FDA's 2008 letter rulings relating to the 180-day generic marketing exclusivity period during an FDAnews audioconference on March 28, 2008. In particular, they addressed issues relating to the forfeiture of the exclusivity period under the 2003 Medicare Modernization Act and the antitrust issues that can result from the settlement of patent disputes between brand and generic pharmaceutical companies. Click here for a transcript of this audioconference. If you have any questions about the issues that were discussed, please contact Michael Keeley at (212) 728-2200 or Chad Landmon at (860) 275-8100.
FDAnews provides regulatory, legislative and business news to executives in industries regulated by the FDA. Their audioconferences feature top level speakers from law firms around the country and executives from the FDA and the drug industry.