More Counterfeit Medicines Follow-up

The Hill reports that Senate Judiciary Committee Chairman Patrick Leahy (D-VT) recommitted himself to helping stop the flow of counterfeit medicines into the U.S. Here's some of what Leahy had to say:

"Last night's '60 Minutes' investigation on the counterfeit drug trade calls further attention to the harm caused to American consumers by counterfeit products. To an everyday consumer, these medicines, which are packaged in convincingly labeled bottles and imprinted with an authentic looking brand name, are easily mistaken for the real thing. For patients relying on medicines to treat serious conditions, counterfeit drugs are life threatening.

"Often these counterfeit pharmaceuticals are manufactured overseas and sold to American consumers through rogue websites on the Internet. This must be stopped. I plan to continue my work this Congress to enact legislation that provides the Justice Department with more effective tools to combat online infringement and counterfeits, including the sales of counterfeit drugs."

Speaking of the worldwide counterfeit medicine threat, Kendra Martello, Assistant General Counsel at PhRMA is part of a Pew roundtable discussion today on the safety of the U.S. drug supply system. She will highlight the fact that America's biopharmaceutical companies, whose lifeblood is the safety and integrity of the products they develop, are working closely with FDA and law enforcement to help protect patients' health and safety by cracking down on this dangerous global trade.

Following up on a comment that FDA Commissioner Margaret Hamburg made on the 60 Minutes segment about active pharmaceutical ingredients (APIs), she will also stress that biopharmaceutical companies must adhere to strict FDA guidelines that help ensure the quality, integrity and safety of foreign-sourced APIs that go into FDA-approved medicines. Check out this short web video of Kendra explaining the difference between foreign-sourced active pharmaceutical ingredients in FDA-approved medicines and imported drugs from foreign countries that have not been approved by FDA.

Finally, Kendra will reinforce the fact that PhRMA supports additional efforts to help safeguard our supply chain such as allowing FDA to utilize a risk-based approach to foreign inspections, increasing criminal penalties for counterfeiters (average jail sentence is 3 years but we believe 20 years minimum fits the crime) and also ensuring that FDA has sufficient appropriated resources to fulfill its mission of protecting patient health and safety.