FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) gives FDA additional tools it has been seeking to better confront the challenges of regulating a global supply chain.

While the sections of FDASIA on user fees and their expansion into generics (Title III) and biosimilars (Title IV) have been garnering front-burner attention (IPQ “The News in Depth September 12, 2012 and February 13, 2012), agency officials at recent public meetings have also been emphasizing the importance and potential impact of the new supply chain-oriented provisions in Title VII.

At the National Press Club on September 28 in Washington, DC, FDA Commissioner Margaret Hamburg emphasized that the passage of FDASIA is “perhaps the most important development” in the past two years regarding safety of the drug supply chain and combating counterfeit drugs.

At a Global Outsourcing Conference sponsored by Xavier University and FDA in late September, OMPQ Director Steven Lynn commented that FDASIA “is going to help us a great deal.  It isn’t everything, but it is a lot more than we had before.”

The authorities under which FDA has been working under are “antiquated,” he stressed, and cannot address “the challenges faced by this ever-changing global environment.” FDASIA was passed, Lynn explained, to address this situation.

Of the eleven sections in the 140-page law, Title VII is viewed as particularly transformative in giving FDA mechanisms to better understand and counter the threats posed by counterfeiting, adulteration and subpar foreign manufacturing practices.

Although the law formally became effective on October 1, most of the significant provisions will not be put into place until FDA has promulgated regulations and guidance to flesh out how the provisions will be implemented.

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