FDA Continues to Solicit Comments on Drug Supply Chain Issues

Posted: 16 Jul 2013 07:50 AM PDT By James E. Valentine* & Anne K. Walsh – Despite Congress giving FDA new powers to regulate the integrity of the drug supply chain, the globalization of the pharmaceutical market continues to present clear challenges for the Food and Drug Administration (“FDA”).  FDA’s new authorities are outlined in Title VII of the Food and Drug Administration Safety and Innovation Act of 2012 (“FDASIA”). (A comprehensive overview of Title VII can be found in our detailed summary and analysis of FDASIA here).  FDA held a meeting last Friday as part of the process for implementing FDASIA.  During the first portion of the meeting, FDA updated the public on the progress it has made to date.  Commissioner Hamburg and other FDA officials touted the recent release of two documents related to enforcement under Title VII: A proposed rule that details the procedures FDA will employ to prevent distribution or subsequent use of potentially adulterated or misbranded drugs encountered during inspections, until the Agency has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.    A draft guidance that defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection.  John Taylor III, Acting Deputy Commissioner for Global Regulatory Operations and Policy, explained the need for these enforcement tools in the face of the “staggering” increases in FDA-regulated shipments into U.S. ports in the recent decade.  continue to read at FDA Continues to Solicit Comments on Drug Supply Chain Issues