Sen. Enzi: FDA Must Improve Its Oversight of Drug Supply Chain

WASHINGTON, D.C. – Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee, today called for the Food and Drug Administration (FDA) to improve its oversight of the pharmaceutical supply chain.  The Government Accountability Office (GAO) has repeatedly found that FDA does not police the drug supply chain effectively.

“It is clear that the pharmaceutical supply chain is becoming increasingly globalized,” said Senator Enzi.  “The question is, how effectively is the FDA protecting consumers? GAO has highlighted FDA mismanagement in a series of reports. In fact, the GAO has put the FDA on its high risk watch list due to the ongoing risk to our nation’s public health. FDA has not implemented GAO’s recommendations, some of which date to the late 1990s.” 

Enzi said he looks forward to working with Chairman Harkin, other HELP Committee Members and stakeholders to improve FDA’s performance.  He suggested the Committee should carefully evaluate FDA’s current authorities and programs, be as specific as possible about the problems it is trying to solve, craft narrowly targeted solutions, and not over-reach. 

“We all want to make sure FDA has the tools it needs to ensure supply chain security,” Senator Enzi said. “At the same time, I am concerned about FDA over-regulating in a way that threatens jobs and patient access to therapies.”

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