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Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

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By Alexander Gaffney

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve “more severe consequences.”

Hamburg’s 10 April statement on FDA Voice, FDA’s blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. “The FD&C Act was enacted in 1938, long before there was a truly global marketplace,” explained Hamburg. “Under current law, there’s a steeper penalty for counterfeiting a designer purse than a drug product.”

The FDA Commissioner also called for new requirements for industry, including mandatory reporting of incident that “could create a drug safety issue or disrupt supply,” “stronger rules requiring importers to provide information at the border demonstrating their compliance with FDA product standards,” and “a robust system to track and trace all drugs throughout the supply chain.”

“In our increasingly complex and globalized world, these additional authorities would help ensure that the FDA can continue to protect the public health of our citizens from risks of exposure to unsafe, ineffective, and poor quality drugs,” concluded Hamburg.

Hamburg added FDA is working closely with foreign regulatory agencies to uncover pharmaceutical counterfeiting, but called upon healthcare professionals to step up their vigilance when purchasing drugs. The recent cases of counterfeit bevacizumab were uncovered with the help of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Hamburg noted the agency is also working to “increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by manufacturers and other stakeholder, and enhancing collaboration with international regulatory counterparts.”


Read more:

FDA - Improving the Integrity of the Drug Supply in a Global Marketplace

Regulatory Focus - Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

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