Gottlieb proposes plan to simplify FDA structure

Reorganizing FDA

Dr. Scott Gottlieb, who became the 23rd Commissioner of the Food and Drug Agency (FDA) on May 11, 2017, is proposing “to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff,” as reported by Jill Wechsle of Pharmaceutical Executive. The objective is “to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains in close contact with the Center leadership,” according to Gottlieb in an email to FDA staff this week.

Gottlieb, a physician, medical policy expert, and public health advocate who has served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA Commissioner, is shifting various activities currently performed by the directorates to new and existing offices.  For the development of new drugs and medical products, a new Office of Clinical Policy and Programs (OCPP) is going to direct programs affecting multiple centers, such as orphan products, pediatric therapeutics, combination products, and good clinical practice, as well as managing new agency-wide initiatives for patient affairs and health care provider affairs to bolster FDA interactions with various stakeholders. The goal is “better coordination of functions that affect the development of complex medical products and treatments for specialized patient populations.” Nina Hunter, who now serves as deputy director for medical programs in the Office of Medical Products and Tobacco, will be in charge of OCPP.

The Office of the Chief Scientist (OCS) will oversee the Office of Minority Health, Office of Women’s Health and Office of Laboratory Safety, and ongoing programs for counterterrorism, toxicological research, scientific integrity and agency research. Denise Hinton will be its director. Deputy commissioner Rachel Sherman will supervise FDA operations and coordinate activities concerning the development of medical products.

A new Office of Policy, Legislation and International Affairs, headed by Anne Abram, is going to be in charge of policy and legislative issues affecting FDA. It will keep Gottlieb and the centers apprised of Centers issues relevant to FDA relations with Congress, state and foreign governments, and represent the agency’s view on trade and international issues.

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), is going to create an Office of Therapeutic Biologics and Biosimilars (OTBB), which will be an element of the reorganization of the Office of New Drugs (OND). She also wants to make changes in the Office of Compliance to strengthen oversight of drug compounding and drug imports.

FDA will be providing elaboration on these changes in the near future. They “will require higher level review and approval by the administration and Congress, with the aim of implementation later this year,” Wechsle’s article said.