FDA Policy/General

More FDA Operational Changes Coming: Makary

In a 6/11 email to FDA staff, commissioner Martin Makary said he wants to consolidate many agency operations to streamline its work. The Regulatory Affairs Professionals Society (RAPS) said it obtained a copy of the email for its report.

The email indicated Makary wants to consolidate operations such as human resources, acquisitions, travel, budget, Freedom of Information Act operations, facilities management, and communications. “By aligning these services under a unified approach, we seek to eliminate duplicative services, increase cross-communications across FDA, and deliver more consistent, efficient, and responsive support, empowering FDA’s Centers, Offices, and Programs to focus more directly on their mission-critical work,” he wrote.

Makary said some operational subject matter experts will be temporarily reassigned to the Office of Operations to help the agency figure out how to make it more integrated and agile. He noted this is only the beginning of the process and no final decisions have been made.

Recognizing that news of more change can cause staff uneasiness, Makary said, “Change, especially at this scale, can bring questions and uncertainties, but it also brings opportunity to improve how we work to support one another more effectively and to better serve the public. I encourage you to approach this period of change with openness and optimism. With your help, FDA will restore public trust through radical transparency, gold-standard science, judicious operational management, and common sense.”

Several agency officials who spoke to RAPS anonymously said they were uncertain what Makary is planning and how it will affect the agency.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome