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IPEC Plan Maps Out Strategy to Combat Counterfeit Medications
Originally published in the December 2010 NABP Newsletter
Efforts to counteract the proliferation of counterfeit prescription medications received a boost with the federal government’s 2010 Joint Strategic Plan on Intellectual Property Enforcement, released last June by the Office of the Intellectual Property Enforcement Coordinator (IPEC). The plan includes strategies focused on fighting counterfeit pharmaceuticals and securing the United States drug supply chain, as part of a multi-faceted approach to address threats to US intellectual property in general.
The number of counterfeit drugs entering the US supply chain continues to grow, with fake pharmaceutical products accounting for 6% of seized counterfeits in 2007, and 10% in 2008. In 2007, more than 600 types of fake drugs were sold globally, including counterfeits of branded, generic, and over-the-counter medications, according to the Partnership for Safe Medicines. With comparatively low penalties in much of the world and high potential profits, counterfeiting pharmaceuticals has attracted criminal gangs capable of producing sophisticated, realistic-looking drugs and packaging, distributed through complex, difficult-to-trace supply routes. Such drugs may contain harmful substances, diluted amounts of the expected active ingredient, or no active ingredients. For example, counterfeit drugs containing heavy metals caused heart arrhythmia and subsequent death in a Canadian woman in 2006, and fake antimalarials containing low doses of the active ingredient continue to create drug-resistant forms of the disease in Africa. Recently, a Canadian man was sentenced to prison by a US district court on charges of selling counterfeits of an experimental cancer drug, with most of the product he delivered containing starch and sugar.
The IPEC plan targets counterfeit drugs entering the US supply system as well as those counterfeits finding their way directly to consumers via the Internet.
As one of its 33 “enforcement strategy action items,” the plan announced that IPEC will establish a counterfeit pharmaceutical interagency committee to “examine the myriad of problems associated with unlicensed Internet pharmacies, health and safety risks in the US associated with the distribution of counterfeits and the proliferation of the distribution of counterfeit pharmaceuticals in Africa.” The committee, composed of experts from numerous federal agencies, will release a report recommending specific government actions.
The IPEC plan also proposes several actions that would require alteration in current laws or regulations and are intended to secure the US drug supply chain. For example, the plan calls for amending federal statutes so that manufacturers and importers are required to notify Food and Drug Administration (FDA) “in the event of a known counterfeit of any pharmaceutical and other medical product,” including specifying any known potential adverse health consequences of the counterfeit. Manufacturers would also be required to provide “a list and complete description of any legitimate drug products that are currently being distributed in the stream of US commerce” biannually. Moreover, the plan recommends amending the Food, Drug, and Cosmetic Act to require implementation of a track-and-trace system that would allow product authentication and create an electronic pedigree. As noted in the plan, in March 2010, FDA issued standards for unique identification for prescription drugs, a step that will assist in implementing track-and-trace system requirements. E-pedigree laws have been passed in a majority of states, with California law mandating e-pedigree requirements for manufacturers, wholesalers, and pharmacies starting in January 1, 2011, with a gradual implementation through 2015. By amending the federal law to require e-pedigree, the IPEC plan could assist efforts to fight counterfeits across the nation.
The IPEC office also stressed the role of various collaborative efforts in its strategic plan. For example, IPEC will work with relevant federal agencies “to establish increased enforcement cooperation, coordination and information sharing” and “make certain that they have the enforcement authority that they will need to address the problems associated with counterfeit pharmaceuticals and medical devices.” IPEC will also continue working with private sector entities – including search engine operators, advertising brokers, and payment processors – to establish voluntary protocols denying paid advertising to those illegally selling pharmaceuticals online. In fact, on September 29, 2010, IPEC hosted a meeting at the White House with domain name registrars (DNRs) and senior US government officials to discuss voluntary efforts to confront the illegal sale of non-controlled prescription drugs – many of them counterfeit – online. DNRs register Web site domain names for a fee, and have the authority and ability to suspend a domain name if a registered Web site is engaged in criminal activity.
The IPEC plan’s strategies draw particular attention to those entities facilitating the connection between illegal sellers and potential customers, including Internet service providers, search engines, DNRs, and payment service providers. The IPEC plan emphasizes private sector cooperation, including such private-sector voluntary efforts as the Google, Yahoo!, and Bing search engines’ policy change to restrict US pharmacy search “sponsored results,” ie, paid advertisements that appear in response to users’ search criteria, to those accredited under NABP’s VIPPS® (Verified Internet Pharmacy Practice SitesCM) program. (Shortly after this policy was implemented NABP also developed the complementary NABP e-AdvertiserCM Approval Program to target Internet advertisers that offer limited pharmacy services or other limited prescription drug-related services online.)
The IPEC Joint Strategic Plan can be accessed in its entirety online.
