FDA's Office of Regulatory Affairs Announces Appointment of Permanent Director

The US Food and Drug Administration (FDA) has announced that effective immediately, Acting Associate Commissioner for Regulatory Affairs (ACRA) Melinda Plaisier will be assuming the role on a permanent basis.

Background

Plaisier , who has been with the agency since 1995, was made acting ACRA in October 2012 after Dara Corrigan announced she was assuming the position of director of FDA's Europe Office and as senior advisor for global operations.

Prior to serving as acting ACRA, Plaisier was director of ORA's central region office. Prior to that role, she had served as the associate commissioner for international programs and the associate commissioner for legislation.

Plasier's Promotion

But one question has remained over the course of the last year: Would FDA ultimately appoint Plaisier to the position, or would it select another candidate, perhaps one from industry?

Now FDA Commissioner Margaret Hamburg has put those questions to rest, writing in a 3 September 2013 email to FDA staff that Plaisier has been made ACRA on a permanent basis.

"As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012," Hamburg wrote. "During that time, Melinda has led the Office of Regulatory Affairs (ORA), utilizing her deep operational knowledge, her proven leadership skills, and her professional and collaborative demeanor."

Plaisier will be reporting directly to the deputy commissioner for global regulatory operations and policy (GO), a position that remains unfilled after it was recently vacated by Deborah Autor.

Plaisier will also oversee one of the largest staff contingents at FDA, consisting of 4,300 employees of the Office of Regulatory Affairs (ORA).

"Going forward, Melinda will play a critical role in helping FDA adapt to the continuing program-based specialization within FDA's regulated industries and in implementing FDA's expanded authority in recent groundbreaking legislation in many important areas," Hamburg explained. "I am confident that Melinda will help position FDA as a public health regulatory agency fully prepared to deal with the many challenges of an increasingly complex global regulatory environment."

Plaisier's legislative experience, which includes experience as a congressional staffer prior to working at FDA, may well come in handy as the agency continues to press for additional regulatory authority with which to go after deficient pharmaceutical compounding practices. While legislation to do just that has seen relatively easy passage in the Senate, its passage in the House of Representatives has been markedly more contentious. A voice for regulatory enforcement with deep-seated knowledge of the legislative process, then, may be a strong asset in making sure the legislation ultimately sees passage.