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Pharmaceuticals / Regulatory Affairs

Gottlieb Features Compounding in Farewell Congressional Testimony

April 11, 2019
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Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators.

“We are committed to develop new policies for outsourcing facilities, including policies to improve the quality of outsourcing facilities’ compounded products,” Gottlieb told the House Appropriations agriculture subcommittee. The agency is requesting $76 million for compounding activities for fiscal year 2020, including $14 million to “catalyze” policies and regulations for outsourcing facilities, he said.

in a joint statement with Deputy Commissioner Anna Abram ahead of Wednesday’s testimony, Gottlieb said the agency recognizes that “there are still compounders that are not in compliance” and said the FDA will continue risk-based inspection and “pursue other enforcement efforts to identify compounders who produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm.”

Gottlieb also featured combatting opioid addiction as one of the agency’s highest priorities and said the FDA is taking “a much more aggressive approach to regulatory action.”  The agency is committed to taking “more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl,” he said.

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