Hamburg: FDA Needs More Anti-counterfeit Authority, International Track and Trace Cooperation

Posted 16 March 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency needs more authority to deal with counterfeit drug products like the fake Avastin that found its way into the supply chain last month.

Speaking with CNN, Hamburg noted the fake Avastin has "focused new attention and concern on counterfeit drugs," which she hopes will make it easier to work with Congress.

"They're considering some legislation that would give the FDA stronger authority and stiffen the rules around counterfeit drugs, and make it easier for us to really track drugs in the system, and enable us to quickly pull inadequate drugs," said Hamburg.

Continued Hamburg: "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. We can go to the courts, we can get an order and then take action, but that takes time. We need new authority."

Hamburg also called for an international track and trace scheme in light of an increasingly global supply chain.

While Hamburg called FDA "vigilant" when it comes to protecting the public against counterfeits, she noted work remains to be done, particularly with incentives to counterfeit increasing during drug shortage situations.

As drugs are in shortage, it creates the possibility of new gray markets or illegal markets to fill in those gaps," said Hamburg. "We need to make sure that does not happen.

Read more:

CNN - FDA commissioner talks counterfeit drugs

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