FDA regulatory policy chief to take on compounding question

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Shutdown dims lights at FDA, NIH and CDC
Shutdown dims lights at FDA, NIH and CDC

FDA's Jane Axelrad is leaving the Office of Regulatory Policy, which she headed for more than 15 years, to lead the agency's response to the recent meningitis outbreak caused by contaminated drugs from a compounding center. As senior advisor to Center for Drug Evaluation and Research director Janet Woodcock, she will also handle “various other high-priority projects that cut across office lines,” said the agency.

Deputy director Denise Esposito will serve as acting director of the Office of Regulatory Policy until February, when she's due to assume a management role elsewhere in the agency. Nancy Hayes will serve as acting deputy director.

Coalition for Healthcare Communication head John Kamp said Woodcock “is putting her most experienced and respected staffer on the compounding issue, demonstrating that it is a serious priority that will be getting proper attention. This is a good move for CDER and for Jane, and will assure that clear, decisive action is taken.”

“It's important to have an efficient Office of Regulatory Policy at CDER, because all the CDER regulations and guidances go through this office,” said Wayne Pines, president for healthcare at APCO Worldwide. “Hopefully, the guidances being drafted on social media by the Office of Prescription Drug Promotion will not be delayed by this change in personnel.”

Another source close to the agency, who spoke on condition of anonymity, suggested that it might mean a consolidation of power at FDA's Office of the Chief Counsel: “It's a signal that CDER is moving on to a new way of looking at things, and means a more flexible view on a variety of issues. It's especially interesting in light of the recent court ruling on off-label promotion.”

In that ruling, on US vs. Alfred Caronia, a federal appeals court asserted that the government could not prosecute a Jazz Pharma rep for truthful speech about off-label uses of its CNS drug Xyrem without violating First Amendment protections.
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