FDA's Hamburg Lauds IOM Report on Countering Falsified and Substandard Drugs
Food and Drug Administration Commissioner Margaret Hamburg lauded a new Institute of Medicine report on “Countering the Problem of Falsified and Substandard Drugs” for its “thorough discussion and recommendations.” IOM’s report identifies causes and public health consequences of substandard and falsified drugs and recommends strategies to address the problem.
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“The IOM report spotlights a critical global public health issue,” Hamburg said. “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.”
"In order to meet the challenges of today’s global marketplace, the FDA is transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world,” Hamburg said. Many of the report’s recommendations mirror existing FDA efforts, she said, such as global capacity building, heightened surveillance, and development of science-based standards.
According to the report, modern manufacturing and trade are aggravating the problem of adulteration and fraudulent manufacture of medicines. While national agencies are responsible for the safety of their countries’ drug supply, no single country can guarantee drug safety today. Instead, action depends on international cooperation, the report said. Specific recommendations of the report include:
- Governments should establish or strengthen systems to detect substandard, falsified, and unregistered medicines, and surveillance should be integrated with established public health systems. Analysis and reporting should describe the product’s quality, packing, and registration.
- The International Finance Corporation and Overseas Private Investment Corporation (OPIC) should create separate investment vehicles for pharmaceutical manufacturers in developing companies that want to upgrade to international standards.
- A larger generic drug market would reduce shortage-related price spikes that encourage distribution of substandard drugs. Regulators in developing countries should use the International Conference on Harmonization Common Technical Document format for product registration to reduce application costs for generic drug manufacturers. They should also conduct joint inspections and use a common inspection report.
- To account for complicated supply chains and reduce drug diversion, Congress should authorize the FDA to establish a mandatory track and trace system. While the system is being developed, FDA should work with stakeholders to develop voluntary track and trace programs.
The IOM report is available here.