Global Effort Needed to Combat Counterfeit Drugs: Report

A new report released by the Institute of Medicine (IOM) suggests that global efforts are needed to combat the manufacture and sale of low quality and fake drugs, which may pose serious risks for consumers. 

The IOM, in partnership with the FDA, assembled a committee of experts to gather information and address approaches in mitigating what the institute is identifying as a global issue.

The ad hoc committee addressed issues such as the trends, health effects, standards, identification, technology and collaboration surrounding the issue of substandard, falsified and counterfeit (SFC) medicines.

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The IOM report was released on February 13, looking at issues involving SFC pharmaceuticals as a global trend, not just a national problem. It also focused on creating careful definitions for the terms substandard, falsified and counterfeit.

Of high importance within the report was also determining similarities and differences of the SFCs within different global regions. To that end, identifying factors which can be used to accurately determine pharmaceutical genuineness also plays a major role in combating SFC medicines.

Other items addressed in the report included a focus on weaknesses within the supply chain that allow SFCs to circulate, explaining the health effects to patients, determining global standards to help create stronger regulatory actions, processes that track, trace and authenticate genuine pharmaceuticals from the fake and how technology can help in the process of identifying and analyzing SFC medicines.

The IOM report also places a strong emphasis on collaboration and finding ways the government and industry as a whole can work together to fight the global problem of SFC drugs. The report outlines collaborative methods for prevention, detection, tracking, tracing, compliance and enforcement.

The FDA and Substandard, Falsified and Counterfeit Drugs

The FDA initially commissioned the IOM for the study. In a press release issued by the FDA, Margaret A. Hamburg commends the IOM on the report and for identifying strategies for addressing SFC medicines.

“The IOM report spotlights a critical global public health issue,” said Hamburg, FDA Commissioner. “Falsified and substandard medicines adversely affect the lives of millions around the world, and the issue must be elevated to the highest levels of international discourse.”

Hamburg also noted the FDA is focusing on a more global perspective concerning pharmaceutical safety and quality. Many of the actions recommended by the IOM are already in place at the FDA, she noted, including strengthening global regulatory capacity, advancing technology, strengthening surveillance, developing science-based standards and engaging in global dialogue.

The FDA currently maintains an overseas presence in 12 countries, in seven regions, and is actively involved with the World Health Organization (WHO) new member state mechanism. Additionally, the FDA participates in the Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) roadmap. This program aims to improve the quality and supply chain integrity of global pharmaceutical products.

“The FDA recognizes that all countries need to work together to ensure safe medicinal products for their citizens due to the increasing complexity of the global economy,” said Hamburg in the statement. “The FDA remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products.”

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