Obama strategy on counterfeits calls for industry transparency

gavel and lawbookThe Obama Administration has unveiled an ambitious set of measures to tackle the trade in counterfeit and pirated products, including pharmaceuticals, both domestically and internationally.

Among the measures laid out in the document includes a requirement for pharmaceutical manufacturers and importers to notify the FDA in the event of a known counterfeit of any pharmaceutical and other medical product, as well as any potential health consequences from the case.

Under the plan, the FDA will also maintain a database of all medicines and medical devices on the US market, and will require drugmakers to provide details on their product lines twice a year.

The Strategic Plan has been drawn up by the Intellectual Property Enforcement Coordinator (IPEC) office, which was set up in 2008 to address perceived weaknesses in the federal government’s intellectual property enforcement efforts.

"We will make sure our law enforcement has the authority it needs to secure the supply chain and also encourage industry to work collaboratively to address unlawful activity on the internet, such as … illegal internet pharmacies," said Victoria Espinel, who heads up IPEC.

The proposal also calls for a mandatory track and trace system for pharmaceuticals and other medical products, via an electronic pedigree system that will use unique identifiers to allow traceability of drugs from manufacturer through wholesaler to the dispenser.

The FDA has already started down this route with the recent publication of a standard serial number format which can be used to track and trace medicines through the supply chain, while states such as Florida and California are also developing regulations in this area.

The IPEC will also establish an interagency committee on the counterfeiting of pharmaceuticals and medical products to examine issues such as "unlicensed Internet pharmacies, health and safety risks in the USA associated with the distribution of counterfeits, and the proliferation of the distribution of counterfeit pharmaceuticals in Africa."

It will also increase enforcement efforts by encouraging federal agencies to work together to combat the proliferation in counterfeit pharmaceuticals and medical devices, and increase penalties for those found guilty of exporting counterfeits to other countries.

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