Not a Lexis+ subscriber? Try it out for free.

Public Policy

FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate

In response to the U.S. Supreme Court's holding in Pliva v. Mensing, 131 S. Ct. 2567 (2011), [enhanced version available to subscribers], that federal laws and regulations preempted state failure-to-warn claims, the U.S. Food and Drug Administration (FDA) in 2013 proposed to allow generic drug manufacturers to update their warning labels unilaterally. However, last week, the FDA agreed to consider additional industry feedback, opening a new period of public comment that will run until April 27, 2015. The FDA also scheduled a hearing on March 27, 2015, to debate alternative plans for the "communication of important newly acquired drug safety information to health care professionals and the public." This hearing will take place from 8:00 a.m. to 5:00 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 20993-0002.

Registration to attend the hearing must be received by March 20, 2014. Interested parties may also provide FDA with comments on the proposed rule at: by following the instructions for submitting comments; or by written submission to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD, 20852. Submissions must include Docket No. FDA-2013-N-0500 for the proposed rule.

For Further Information

If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

© 1998-2015 Duane Morris LLP. Duane Morris is registered service mark of Duane Morris LLP.

For more information about LexisNexis products and solutions connect with us through our corporate site