A cooperative agreement between the U.S. Food and Drug Administration and the World Health Organization aims to construct a sound evidence base on counterfeit, falsified, and substandard medicines. The recent project proposal was developed by WHO in response to a call for a proposal on counterfeit medicines from FDA, but the two organizations will work closely together on the project.
The cooperative agreement aims to benefit patients and consumers in the United States and abroad. This evidence base will underpin planning and implementation of policies and programs to tackle this global threat. According to an FDA (fda.gov) spokesperson, FDA and WHO have mutual interests in combating counterfeits and surveillance, communication, and exchange of information is an essential part of global efforts in this area.
“The agreement commits FDA to provide funding support; scientific input and technical assistance in design and development of the approach; and collaboration in management and oversight,” FDA’s spokesperson says.
Jacqueline Sawyer, liaison officer, WHO Prequalification of Medicines Programme, WHO (who.int), explains that medicines counterfeiting continues to grow in complexity and scale, while data for defining this problem is scarce and difficult to share while the variety of information sources that are available complicates the compilation of statistics. Few countries systematically collect data and the lack of a universally accepted definition makes the global information exchange problematic.
“We cannot develop a clear and accurate picture of the incidence of counterfeit medicines, or define the actions that would be most effective in eliminating them, or identify where those actions are most needed,” Ms. Sawyer says. “But recent identification technology and IT advances demonstrate that great potential now exists for improving collection and validation of information on counterfeit and substandard medicines.”
The project’s objective is to improve the quantity, quality, and analysis of data on counterfeit medicines through the creation of a global surveillance and monitoring system, so that all stakeholders have a sound basis on which to build and collaborate on strategies for reducing the incidence of counterfeit medicines and ensuring the security of the supply chain. Increased quality of data will enable more efficient information exchange between countries and facilitate regulatory action to protect patients and consumers.
The project aims to create surveillance and monitoring systems for collecting, disseminating, and analyzing information on counterfeit and substandard medicines; help regulatory authorities identify counterfeit and substandard medicines; collect data and reports on counterfeit and substandard medicines; and promote exchange of information.
“WHO envisages implementing the project for four years, and then handing it over to a global group for continued management and support,” Ms. Sawyer says. “It plans for the active involvement of WHO Regional Offices and the regulatory authorities of selected WHO Member States.” ?