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Jill Wechsler is Pharm Exec's Washington Corespondent
Scott Gottlieb is proposing to flatten out FDA’s structure by having Center directors report directly to him, giving more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs.
Most FDA commissioners look to leave their imprint on the agency by making structural changes that update the roles and functions of lead operations. After more than a year at the agency’s helm, Scott Gottlieb now proposes 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. This change aims 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,” Gottlieb said in an email to FDA staff announcing the reorg plan.
Certain cross-cutting activities now handled by the directorates will shift to new and existing offices. Of particular importance for the development of new drugs and medical products, a new Office of Clinical Policy and Programs (OCPP) will oversee programs that affect multiple Centers, including orphan products, pediatric therapeutics, combination products, and good clinical practice. OCPP also will manage new agency-wide initiatives for patient affairs and for health care provider affairs to strengthen FDA interactions with key stakeholder groups. Nina Hunter, currently deputy director for medical programs in the Office of Medical Products and Tobacco, will head this operation with the aim of better coordinating functions that affect the development of complex medical products and treatments for specialized patient populations.
FDA’s Office of the Chief Scientist (OCS) under Denise Hinton will supervise the Office of Minority Health, Office of Women’s Health and Office of Laboratory Safety, as well as ongoing programs for counterterrorism, toxicological research, scientific integrity and agency research. Deputy commissioner Rachel Sherman will manage agency operations and coordinate activities related to medical product development.
Policy and legislative issues affecting FDA will be monitored and managed by a new Office of Policy, Legislation and International Affairs, headed by Anne Abram. It will advise Gottlieb and Centers on topics affecting agency relations with Congress, state and foreign governments, and represent FDA’s perspective on trade and international issues to all entities.
Separately, organizational changes are underway at the Center for Drug Evaluation and Research (CDER) and other Centers. CDER director Janet Woodcock recently announced plans to form an Office of Therapeutic Biologics and Biosimilars (OTBB) as part of a broader reorganization of the Office of New Drugs (OND). Woodcock also plans changes in the Office of Compliance to strengthen oversight of drug compounding and drug imports.
All these changes will be disclosed more formally in the coming days, and will require higher level review and approval by the administration and Congress, with the aim of implementation later this year.