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President Signs Drug Quality and Security Act

President Barack Obama talks with Chief of Staff Denis McDonough,
National Economic Council Director Gene Sperling and Miguel Rodriguez, Director of Legislative Affairs.
Image courtesy of The White House via Flickr.

On November 27, 2013, President Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA). The new law established a national track-and-trace system to secure the medicine supply chain. The program will reduce the ways that criminals can infiltrate the legitimate supply chain with counterfeit, adulterated, diverted or contaminated drugs. Additionally the law gives the FDA authority to regulate specialty compounding drugs. Federal legislation has been needed to create an national track-and-trace system because the varied laws between states allowed for holes exploited by opportunitistic middlemen. Learn more about track-and-trace here.

Dr. Ilisa Bernstein, who was the keynote speaker at the 2013 Interchange, and Cara Tenebaum of the Food and Drug Administrations held a public stakeholder call on December 3, 2013, to discuss the new law. Dr. Bernstein summarized the goals of the law and its key provisions. The FDA is developing a guidance process, a set of milestones, and a public interface over the next two years in order to implement the law for 2015. A recording of the call is available at 866-431-2989, passcode: TRACE.

Dr. Bernstein discussed the law in her remarks at the Interchange, emphasizing the way that “the three pillars of supply chain security, prevention, detection and response,” are supported by the legislation. Said Dr. Bernstein, “For over 10 years, FDA has been calling for a meaningful and enforceable track & trace system to protect the public from counterfeit, stolen, diverted, or otherwise unfit drugs that may enter the supply chain. That bill is currently before the U.S. Congress and it provides protections over our nation’s drug supply that reduce the opportunities for counterfeit and substandard products to get into the system and reach patients.”

The legislation has been endorsed by research and generic pharmaceutical manufacturers, as well as the pharmaceutical distributors. The Institute of Medicine and the Pew Charitable Trust both support the law. Said Allan Coukell on April 25, 2013 in testimony before the House of Representatives Committee on Energy & Commerce, “Based on our analysis of the risks to the drug distribution system and the feasibility of addressing those risks, Pew supports the creation of a strong national system to protect American patients from the risks of counterfeit, stolen and diverted drugs.”

By S. Imber

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