FDA commish suggests putting more bite in laws for counterfeiting

FDA Commissioner Margaret Hamburg called on drugmakers to be "accountable for the integrity of their supply chains" to help fight counterfeit drugs, a reference to the need for a track and trace system in the U.S. She also called for stronger penalties for traffickers.

In an interview with The Financial Times, Hamburg said, "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."

Her remarks came as the House and Senate will reconcile their separate versions of the bill reauthorizing the FDA to collect user fees to help fund nearly half its 5-year budget. The FDA wants the final law to have a track and trace system with unique identifiers on each drug container and requirements that they be scanned along their distribution route. The industry has agreed to the unifiers but wants only lot scanning.

It also comes after two recent high-profile cases of counterfeits being found in the U.S. Just last week, the FDA sent out an alert that fakes of Teva Pharmaceutical Industries' ($TEVA) attention-deficit drug Adderall, were being sold over the Internet. In February, the agency discovered counterfeits of Roche's ($RHHBY) cancer drug Avastin had been sold directly to physician clinics.

Hamburg also called for harsher penalties for those trafficking in fakes, saying that criminals are now viewing drug counterfeiting as a lucrative enterprise with no more threat of jail time than selling fake purses. The FDA reauthorization bill would give drug counterfeiting penalties more punch.

"We need legal authorities to give teeth to our actions," Hamburg said. "We are increasingly concerned that this is becoming an attractive area for bad guys, including organized crime."

The International Journal of Clinical Practice warns that increasing numbers of fakes are getting into legitimate supply chains, and global sales of fake meds doubled from 2005 to 2010, to $75 billion.

- read the Financial Times interview (reg. req.)

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