Pharmaceutical Commerce: FDA Counterfeit Drug Investigations Reach New High in 2009

In the December 23rd online edition of Pharmaceutical Commerce, they reported on the FDA’s statistics on Counterfeit Drug Investigations. It is believed that the number of investigations is an indicator of the increase in counterfeit drug activity and represents a fraction of the overall activity within the United States. The entire online posting appears below:

At the HDMA Track & Trace Seminar (National Harbor, MD, Nov. 30-Dec. 1), David Dorsey, Acting Deputy Administrator for Policy at FDA, revealed the FY 2009 (which ended last September) figure for counterfeit-drug investigations opened by FDA’s Office of Criminal Investigations: a new record of 65.

FDA cautions that this count is not a direct measure of the volume of counterfeit activity—but on the other hand, where there’s smoke there’s fire. Dorsey also said that the agency is working toward its mandated March 2010 deadline for making recommendations on a “serial numeric identifier” program for drug tracking, as specified in the FDA Amendments Act of 2007.

Meanwhile, newer legislation, such as the Buyer-Matheson bill from the 2008 session (H.R. 5389) is expected to be re-introduced in the current Congress. That bill would mandate a national track-and-trace system to prevent counterfeiting and diversion.

Visit Pharmaceutical Commerce and read the story online at: www.pharmaceuticalcommerce.com/frontEnd/1339-counterfeit_drugs_FDA_Office_of_Criminal_Investigations_OCI.html