BOX B-2

Summary of Recommendations for The Future of Drug Safety: Promoting and Protecting the Health of the Public

Organizational Culture

3.1

The committee recommends that the Food, Drug, and Cosmetics Act (FDCA) be amended to require that the Food and Drug Administration (FDA) Commissioner currently appointed by the President with the advice and consent of the Senate also be appointed for a 6-year term of office. The Commissioner should be an individual with appropriate expertise to head a science-based agency, demonstrated capacity to lead and inspire, and a proven commitment to public health, scientific integrity, transparency, and communication. The President may remove the Commissioner from office only for reasons of inefficiency, neglect of duty, or malfeasance in office.

3.2

The committee recommends that an external Management Advisory Board be appointed by the Secretary of Health and Human Services (HHS) to advise the FDA Commissioner in shepherding the Center for Drug Evaluation and Research, or CDER (and the agency as a whole) to implement and sustain the changes necessary to transform the center’s culture—by improving morale and retention of professional staff, strengthening transparency, restoring credibility, and creating a culture of safety based upon a lifecycle approach to risk–benefit.

3.3

The committee recommends the Secretary of HHS direct the FDA Commissioner and director of CDER, with the assistance of the Management Advisory Board, to develop a comprehensive strategy for sustained cultural change that positions the agency to fulfill its mission, including protecting the health of the public.

3.4

The committee recommends that CDER appoint an Office of Surveillance and Epidemiology (OSE) staff member to each New Drug Application (NDA) review team and assign joint authority to the Office of New Drugs and OSE for postapproval regulatory actions related to safety.

3.5

To restore appropriate balance between the FDA’s dual goals of speeding access to innovative drugs and ensuring drug safety over the product’s lifecycle, the committee recommends that Congress should introduce specific safety-related performance goals in the Prescription Drug User Fee Act IV in 2007. (See Chapter 3 for suggested goals.)

Science and Expertise

4.1

The committee recommends that in order to improve the generation of new safety signals and hypotheses, CDER should take the following actions:



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