Regulator creates new job to engage with stakeholders

The Food and Drug Administration (FDA) hired former health official John Whyte to collaborate with regulated entities, patients and advocacy groups, the agency confirmed Tuesday.

The FDA’s Center for Drug Evaluation and Research (CDER) appointed Whyte as the director of professional affairs and stakeholder engagement, a new position within the agency.

He will further its regulatory objectives, guide those “involved in the use of medicine” through drug safety issues and give stakeholders a main contact for collaboration and advocacy, according to agency staff. Whyte will also manage CDER’s drug safety program, Safe Use, including supervising the ongoing partnerships with the private sector.

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CDER Director Dr. Janet Woodcock expressed excitement about the hire.

“He is passionate about improving the health and well-being of patients and brings extensive knowledge and expertise in health care policy and stakeholder relations,” she wrote in an emailed statement to The Hill. “We are fortunate to have him serve to engage the community in our critical public health mission.”

Previously, Whyte represented the Centers for Medicare and Medicare Services (CMS) in meetings with physicians, patient groups, financial interests and drug or device manufacturers. As an acting director in a CMS office that deals with drugs and medical devices, he implemented the national Medicare coverage policies on those products.

He most recently worked at the Discovery Channel, serving as a medical expert and as the vice president of health and medical education, where he managed “strategic connections” with the government and private sector in addition to having creative control of more than 70 award-winning documentaries.

The news was first reported by a healthcare publication, Regulatory Focus, which quotes an anonymous and frustrated CDER staffer who said, “the agency is routinely able to make high profile hires in new areas, but has routine difficulties filling vacancies among the rank and file staff that allow the agency to conduct its mission.”

Asked about those concerns, the agency responded that filling necessary vacancies is a “top priority.”

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Last year, the FDA “reorganized” its human resources functions, according to spokesman Chris Kelly. As a result, the FDA and its offices “continue to see improvement in our ability to hire personnel into critical positions to support programs in need.”

CDER has exceeded hiring goals set out by Congress in the Generic Drug User Fee Amendments (GDUFA), he added. The latest changes to the law aim to expedite the approval of generic drugs, while authorizing the agency to hire more employees to reduce application backlog.

“We appreciate that staff may feel frustrated because of unfilled vacancies, and encourage them to speak directly with their managers on any concerns they may have,” Kelly wrote in an email.

 

This post was updated on Oct. 30.