Regulatory Focus™ > News Articles > With Eye to External Stakeholders, FDA Announces New Hire to Head up Engagement

With Eye to External Stakeholders, FDA Announces New Hire to Head up Engagement

Posted 28 October 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is constantly creating and establishing new programs. But as with any program, sometimes the biggest challenge isn't in its conception as an idea, but its realization as a practical part of the agency and obtaining the internal and external buy-in it needs to not just exist, but thrive.

In recent years, FDA has made a big push to be more transparent with its operations, blogging prolifically and frequently reaching out to stakeholder groups to gather input on prospective plans and actions. And in perhaps one of the most notable actions, it's made strides to integrate patients more fully into the regulatory process as required under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

But with so many groups involved with the agency right now, one might assume that it could be difficult for those groups to know who to contact to obtain answers.

Now the Center for Drug Evaluation and Research (CDER)-a center whose initiatives are frequently among the most highly profiled and contentious-has announced the hire of John Whyte as the director of Professional Affairs and Stakeholder Engagement.

As envisioned by CDER, the position will focus on interacting with parties with an interest in FDA, including health care professionals, patients, patient groups and anyone else with an interest in the use of medicines.

"He will work to provide them with a focal point for advocacy, enhanced two-way communication, and collaboration, and assist them in navigating the Center on issues concerning drug development, review, and drug safety," wrote Janet Woodcock, director of CDER, in an email to FDA staff on 28 October 2013.

Whyte, formerly the vice president of Health and Medical Education and the chief medical expert at the Discovery Channel, will also will oversee FDA's Safe Use program and support the Safe Use Initiative, Woodcock said.

Prior to working at Discovery, Whyte also served in roles at the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS), and holds a medical degree from Hahnemann University School of Medicine and a master's degree in public health from Harvard.

But if CDER is hoping to please external stakeholders with the hire of Whyte, it may also need to do some internal outreach first. One internal CDER source expressed displeasure that 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.

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