Coordinating US efforts
In March 2011, several US government agencies and departments—FDA, the Office of the Intellectual Property Enforcement Coordinator,
the US Customs and Border Protection (CBP), US Immigration and Customs Enforcement, the US Departments of Justice, State and
Commerce, and the Agency for International Development—issued a joint report recommending a series of items to combat the
problem of counterfeit medicines entering the US (3). The report called for better data and information-sharing among government
agencies and departments to address counterfeit medicines entering the US. For example, as part of a process for developing
an Import Operation Strategic Plan, FDA and CBP examined the flow of imported pharmaceutical products through different ports
of entry, identified available legal authorities, and worked to develop best practices to enhance collaborative enforcement
CBP and FDA are engaged in ways to ensure that only compliant pharmaceuticals are imported into the US and that appropriate
enforcement action is taken against illegal pharmaceuticals. For example, FDA and CBP will explore ways to ensure that, under
appropriate circumstances, products are destroyed rather than returned to the sender. CBP and FDA also are exploring ways
to improve targeting of counterfeit pharmaceuticals. And CBP, in coordination with FDA, will access civil penalties to deter
repeat offenders of importation of counterfeit medicines (3).
Part of this effort also involved the development of a Secure Supply Chain (SSC) pilot program by FDA's Center for Drug Evaluation
and Research and Office of Regulatory Affairs. The program is part of FDA's risk-based approach to ensure the safety of imported
drugs. The program is designed to help expedite shipments of drugs that meet the SCC pilot criteria because FDA has greater
confidence in the drugs that are imported by a company in control of its supply chain.
The Counterfeit Pharmaceutical Inter-Agency Working Group Report also called for increased measures for improving coordination
among international bodies for combating counterfeit medicines, improving public awareness of counterfeit medicines, and improving
government-to-government enforcement training. The report also called for continued involvement and support by FDA in the
World Health Organization's International Medical Product Anti-counterfeiting Task Force (IMPACT). IMPACT brings together
private and public sector experts to address the public health aspects of drug counterfeiting and is developing technical
tools for countries to use and adopt to fight drug counterfeiting. These tools can be used to strengthen legislative, regulatory,
technological, enforcement and communication infrastructure and build capacity for surveillance, identification, and prevention
of counterfeit drugs from reaching patients. (3).
WHO and FDA are collaborating to build global rapid alert surveillance/monitoring systems for combating counterfeit and falsified
medicines and risks in supply-chain security. The goals of this effort are to generate sound and reliable evidence of where
the incidence of falsified medicines is most serious, and promote exchange of information (e.g., case reports and descriptions
of actions taken) and expertise between countries to stimulate action. Also, FDA and WHO are partnering to make available
a system to be used for collecting and disseminating information based upon the requirements shared by all partners (3).