e-Profile Login and ID Quick Search
FDA Commissioner Stresses Need for Strengthening Anti-Counterfeiting Laws and Requirements
With the recent incidence of counterfeit cancer drugs in the United States supply chain, Margaret Hamburg, MD, commissioner of US Food and Drug Administration (FDA) published a statement stressing the need for stronger laws to deter counterfeit drug activity and enhanced means for preventing counterfeits from entering the country.
Hamburg indicated support for the following:
- enhancing criminal and civil penalties for counterfeit drug crimes,
- requiring manufacturers and other supply chain participants to notify FDA when they become aware of drug safety issues, and
- requiring importers to provide documentation of compliance with FDA product standards at the border.
Hamburg also stated that FDA needs “authority to require a robust system to track and trace all drugs throughout the supply chain.”
Additional information is available in the FDA blog post, “Improving the Integrity of the Drug Supply in a Global Marketplace.”
