Final PDUFA Package Offers FDA More Supply Chain Security Powers

As House and Senate leaders agreed on a final Prescription Drug User Fee Act (PDUFA) reauthorization package, members of Congress provided the agency with most of the increased supply chain oversight powers it asked for. Those wishes included new authority to stop drug imports by uncooperative foreign manufacturers and an OK to share information with other international regulators.

Months of debate failed to produce language that would give the FDA explicit authority to require and enforce a national track-and-trace system for prescription drugs, however. Agency officials requested the system, arguing it would help reduce incidents like the recent counterfeit Avastin (bevacizumab) scandal.

Consensus could not be reached on a method for implementing a U.S. track-and-trace system that would allow identification of drugs at the unit level throughout the supply chain and the requirement failed to make its way into the FDA Safety and Innovation Act, P.L. 112-144, the final law signed by President Barack Obama July 9.

However, the law does give the FDA some of the enhanced import authority it has long sought. The bill clarified the 1938 FD&C Act’s “appearance standard” governing the agency’s import authority over prescription drugs — a key request of Deborah Autor, FDA deputy commissioner for global regulatory operations and policy.

The provision empowers the agency to make a quick and final decision whether a cargo of goods imported from a foreign country is adulterated or misbranded. Thereafter, the goods could be set aside for destruction or returned to sender without further investigation or power of review. Such a decision can be based on a manufacturer’s delay or denial of FDA facility inspections.

Other measures aimed at bolstering the supply chain call for:

• The registration of domestic and foreign drug establishments and commercial importers;
• Allocation of FDA inspection funding toward registered sites with “known safety risks”;
• Early drugmaker notification on manufacturing changes that could create drug shortages;
• Allowing increased data-sharing ability with the agency’s regulatory partners; and
• A broadened definition of current good manufacturing practices (cGMP).

The expanded definition of cGMP also appears to give the agency new authority to require drugmakers to make supplier quality agreements, compliance experts say.

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