Regulatory Focus™ > News Articles > Hamburg Continues to Call for More Anti-Counterfeiting Authority

Hamburg Continues to Call for More Anti-Counterfeiting Authority

Posted 07 June 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters. For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain.

Speaking on Wednesday, 7 June to The Financial Times, Hamburg said she is "increasingly concerned that this is becoming an attractive area for bad guys, including organized crime.

"We need to really strengthen the integrity of the supply chain to really be able to assure safe passage of products through the complex network of packagers and distributors and redistributors and importers," Hamburg said.

Hamburg called for similar authority in a statement on the agency's FDA Voice blog in April 2012, claiming the Federal Food, Drug and Cosmetic Act (FD&C Act) was woefully outdated given the increasingly globalized economy.

"[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."

"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," continued Hamburg.

In an earlier interview with CNN, Hamburg said much of the problem comes down to a gap in its statutory authorities.

"At the present time, the FDA actually doesn't have the authority when we find counterfeit drugs coming into the country, to just seize and destroy them," explained Hamburg. "We can go to the courts, we can get an order and then take action, but that takes time. We need new authority."

This leaves a gap where fast-moving counterfeiters can get around FDA's regulatory and legal authorities, said Hamburg.

The problems are coming to light increasingly often as counterfeiters seek to take advantage of drugs experiencing shortages, expensive drug products and cost-conscious consumers, said Hamburg. While the agency is looking to, among other things, increase port inspections and work with foreign regulatory authorities, there is only so much it can do without being able to go after counterfeiters proactively, Hamburg said.


Read more:

The Financial Times - US regulator calls for action on fake drugs


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