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

Inter-Industry Summit Discusses Import Safety in Washington DC

A representative from XStream Systems attended a unique event in Washington DC this week. The event, titled the Inter-Industry Import Safety Summit, was an unusual partnership of twelve industry associations and their membership. The impetus behind the summit was an effort to promote a “robust exchange of ideas and information that will further help our industries assure the safety of consumer products regardless of where they are made.”

The gathering of nearly 350 people included speeches by government officials including Michael Leavitt, Secretary of Health and Human Services and Andrew von Eshenbach, Commissioner of the Food and Drug Administration.

Secretary Leavitt, at the Summit, made a significant announcement regarding the U.S. collaborating with the European Union and Australia on inspections of overseas manufacturers of drug ingredients as a way to check more plants. Regulators from the countries will inspect different plants and then share their findings under a pilot program to alleviate duplication and inefficiencies in this process.

In a Medical Products Panel discussion during the Summit, executives from J&J, HDMA, Barr Labs, MedImmune, Schering-Plough and Bayer discussed pharmaceutical safety and the effects of counterfeit and adulterated medications within the Global Supply Chain. The Panel was chaired by Commissioner von Eshenbach from the FDA.

Significant in the Panel discussion was that most were of the opinion that technology needed to be part of the solution of counterfeit and adulterated products within the supply chain and those current initiatives to date with Track and Trace technology is effective to a point but only tracks the transaction of the product.

The industry associations which sponsored the Summit were:

• American National Standards Institute
• Biotechnology Industry Organization
• Consumer Healthcare Products Association
• Food Marketing Institute
• Generic Pharmaceutical Association
• Grocery Manufacturers Association
• Healthcare Distribution Management Association
• National Fisheries Institute
• National Restaurant Association
• Pharmaceutical Research and Manufacturers of America
• Retail Industry Leaders Association
• Toy Industry Association, Inc