Senator Bill Nelson (D-Fla.) has introduced the Drug Price Competition Act of 2009, a bill that could potentially impact how generic-drug makers are awarded 180-day exclusivity for their ANDA products . The bill, introduced on June 25, 2009, would allow a subsequent filer to qualify as a first applicant and trigger the 180-day exclusivity period. Chad Landmon, Chair of the FDA Practice Group at Axinn, spoke with Drug Industry Daily about the potential impact of the bill if it becomes law, saying, “Ultimately, I think a bill like this will certainly devalue the exclusivity period while at the same time providing opportunities for certain later filers . ”
The article, titled, “Senate Drug Price Bill May Alter 180-Day Exclusivity Awards,” was published on June 25, 2009. Click here to view a copy of the article.
From Drug Industry Daily, copyright © 2009 by Washington Business Information, Inc. (FDAnews). All rights reserved. www.fdanews.com, (888) 838-5578, +1 (703) 538-7600.
Axinn's Chad Landmon Speaks with Drug Industry Daily About the Drug Price Competition Act of 2009
June 25, 2009
Drug Industry Daily