Newly operational Intellectual Property Enforcement Coordinator (IPEC) issues report calling for drug track-and-trace, stepped-up Customs enforcement
Somewhat unexpectedly, the life sciences industry—and advocates of e-pedigree or track-and-trace programs in pharma distribution—have found support in a new quarter of Washington—the Intellectual Property Enforcement Coordinator. IPEC came into being with passage of an intellectual-property protection law passed in the previous administration. The newly appointed coordinator, Victoria Espinel, was tasked by this law to develop a “joint strategic plan” that would coordinate the efforts of various federal agencies for all types of counterfeit or intellectual-property theft issues.
That Strategic Plan was released by the IPEC office in late June. It contains a surprising number of very specific goals and activities relative to pharmaceutical distribution:
-Mandated use of electronic track and trace for pharmaceuticals and medical products--The Food, Drug and Cosmetic Act should be modified to require that manufacturers, wholesalers and dispensers implement a track-and-trace system, which allows for authentication of the product and creation of an electronic pedigree for medical products using unique identifiers for products. Effective track-and-trace systems can make it more difficult for persons to introduce counterfeit or intentionally adulterated medical products into the US market, make it easier to identify persons responsible for making a product unsafe and facilitate the recall of unsafe products by more quickly identifying where a product is located in the marketplace. Privacy concerns will be considered when deciding where the information will be housed and who will have access to the information.
-New interagency committee on drugs and medical products--IPEC will establish an interagency committee on the counterfeiting of pharmaceutical drugs and medical products, with participation of the Office of National Drug Control Policy, the National Institutes of Health (NIH), DOC, DOS/U.S.Agency of International Development (USAID), HHS/FDA, the IPR Center, CBP, ICE, FBI, the Drug Enforcement Administration (DEA), USTR, and Veterans Affairs.
-Broaden voluntary protocols to help reduce Illegal Internet pharmacies--Google, Yahoo and Bing recently updated voluntary protocols designed to prevent the sale of spon¬sored results for unlawful businesses selling counterfeit medications on-line. These protocols utilize a “white list” of pre-approved Internet pharmaceutical sellers that include verification by the National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Sites (VIPPS) or certifications from the original manufacturers of legitimate and FDA-approved pharmaceuticals. Simultaneously, the US government will explore means by which online pharmaceutical companies operating in violation of intellectual property laws can be made subject to the full reach of law enforcement jurisdiction.
It’s hard to say whether any of this will have a substantive impact, but it does seem to put the White House (and therefore FDA) strongly on the side of track-and-trace systems. There is also the possibility that more resources from law enforcement will come to bear on counterfeit investigations, both domestically and internationally.