Plaisier Takes Over Regulatory Affairs at FDA

The FDA has a new sheriff in charge of regulatory compliance and enforcement.

On September 3, 2013, FDA Commissioner Margaret Hamburg, M.D. announced in an email to FDA staffers that Melinda Plaisier would become the agency’s new permanent Associate Commissioner for Regulatory Affairs (ACRA). She had been the acting commissioner since last October.

Inspections, Investigations, Compliance and Enforcement

The position has responsibility for over 4, 000 staff and operations in the Office of Regulatory Affairs (ORA), Global Regulatory Operations and Policy. ORA has responsibility for imports, inspections and investigations, compliance and enforcement, and field laboratory operations.

ORA supports FDA’s product centers by inspecting regulated products and manufacturers, analyzing samples of regulated products, reviewing imported products offered for entry into the U.S., and responding to public health emergencies. ORA also works with other Federal, State, Local, Tribal and Territorial, as well as foreign regulatory counterparts to further FDA’s mission.

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

“As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012, ” Hamburg reportedly 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.”

Hamburg added, “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. 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 will report to the deputy commissioner for global regulatory operations and policy (GO), a position that remained unfilled after it was vacated by Autor.

According to her FDA bio, Plaisier began her career in public policy, working in the U.S. Congress for over a decade. After joining the agency in 1995, she spent more than 13 years in the Office of the Commissioner, where she served as the Associate Commissioner for Legislation, providing executive leadership in directing and managing the agency’s congressional relations and legislative activities.  She also served as the Associate Commissioner for International Programs, where she focused on negotiating international agreements and working with developing nations.

Before becoming the Acting ACRA, Plaisier served as the Regional Food and Drug Director (RFDD) for the Central Region. As the RFDD, she provided executive leadership in directing and managing the programs of FDA within the 15 states of the Central Region. She has been recognized for her leadership and management contributions with numerous agency honor awards, including FDA’s highest award, the Award of Merit. In 2004 and again in 2009, she was awarded the Presidential Meritorious Rank Award for exceptional long-term accomplishments in the Senior Executive Service.