IPEC report lays out US strategy on counterfeit medicines

The US government will not wait for a public health crisis before taking action to stem the trade in counterfeit medicines, according to a report by the Counterfeit Pharmaceutical Inter-Agency Working Group.

The body, set up by the Obama administration last year, makes the assertion in a report sent to Vice President Joe Biden and the US Congress which spells out a series of legislative 'fixes' to help tackle the issue, including the adoption of a full track-and-trace system for pharmaceuticals and related products.

The primary author of the report is US Intellectual Property Enforcement Coordinator (IPEC) Victoria Espinel, who was appointed to the role in early 2010. Last year she wrote the Obama administration's Strategic Plan on medicines counterfeiting, which among other measures called on industry to be more open in notifying the authorities about incidents.

"Whether we’re talking about a counterfeit lifestyle drug that contains dangerous chemicals or a counterfeit heart or cancer medication that contains inactive ingredients - one counterfeit in our supply chain is too many," said Espinel, noting that "this is a ticking time bomb - particularly over the Internet."

The report lays out a range of objectives, including improvement of law enforcement via a more strategic approach, helped by better data and information-sharing between government departments and agencies.

For example, the Food and Drug Administration (FDA) and Customs and Border Patrol (CBP) are asked to develop a strategic approach to intercepting illegal pharmaceuticals at ports of entry in the USA. Both agencies will also work alongside the US Customs and Immigration Enforcement (ICE) to develop a compliance management strategy for handling small shipments of illegal medicines that enter the USA via postal and express courier services and eventually air cargo.

The report also references the FDA's Secure Supply Chain pilot which aims to develop a strategy to ensure the safety of imported drugs, as well as streamline imports by expediting shipments that have met the agency's risk-based criteria.

The report also sets out a blueprint for greater collaboration with other countries, particularly those on the US Trade Representative's Special 301 Watch List for intellectual property issues, as well as international agencies such as the World Customs Organisation and Strategic Alliance Group (a partnership of enforcement agencies form the USA, UK, Canada, Australia and New Zealand).

Espinel also places tackling of the Internet trade in medicines and illegal online pharmacies at the heart of the recommendations, announcing the formation this year of a non-profit organisation "dedicated to promoting information-sharing, education and more efficient law enforcement of rogue Internet pharmacies."

The specific legislative 'fixes' proposed in the document include:

• Requiring importers and manufacturers of medicines to notify the FDA and other relevant agencies when they discover counterfeits;
• Extend the requirements for "in-person medical evaluation" for prescription medicines to include all drugs,not just controlled substances as at present, with exemptions applicable for doctors engaged in the legitimate practice of telemedicine;
• Congress should adopt a track-and-trace system for pharmaceuticals and related products, to make it more difficult to introduce counterfeit drugs into the US market;
• Set up a system of civil and criminal forfeiture under the Federal Food, Drug and Cosmetics Act (FFCDA);
• Increase the maximum penalties for offenses related to medicines counterfeiting under the FFCDA; and
• Increase the penalties for offenses related to medicines counterfeiting that present a serious risk to health.

The document has been largely welcomed by pharmaceutical groups, with the Alliance for Safe Online Pharmacies (ASOP) describing it as "an important step in the effort to protect consumers from these potentially dangerous substances."

Recent research funded by ASOP found that one in six Americans had purchased prescription medication via the Internet without a valid prescription. "That means more than 36 million Americans had the potential to be exposed to counterfeit drugs," according to ASOP.

Jeannie Salo, director of global anti-counterfeiting, international government affairs at drug major Eli Lilly and a member of ASOP, said: "IPEC has demonstrated … strong leadership and brought together the relevant US government agencies and private sector stakeholders and focused their attention on finding ways to make the Internet safer for patients."

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) commended the Obama Administration for its "commitment to protecting patient health and safety by safeguarding the closed US drug supply system from the global counterfeit medicine epidemic."

"The US government’s renewed emphasis on collaboration, information sharing, education and enforcement - as it relates to counterfeit pharmaceuticals - is warmly welcomed."

Not all stakeholders are fully on board with the report, however. The National Association of Chain Drug Stores (NACDS) welcomed IPEC's proposals on rogue pharmacies, for example, but said it " does not support the report's proposal to mandate a ‘track-and-trace’ system."

"The operational processes surrounding a mandated track and trace system are still under development and cannot achieve their desired purpose at this time, which will prove extraordinarily costly for pharmacies and other supply chain operators."