Food and Drug Administration

The Food and Drug Administration (FDA), along with the commissioner of food and drugs, was transferred to the department as part of the 1953 Reorganization Plan. Its statutory origins were with the Department of Agriculture, but it had been transferred to the Federal Security Agency in 1940. In 1988, its statutory status was made explicit by section 503 of the Health Omnibus Program Extension Act (21 U.S.C.A. ­§ 393(a)) that “established in the Department of Health and Human Services the Food and Drug Administration” and the position of commissioner of food and drugs, who is appointed by the President with the advice and consent of the Senate. The secretary is to oversee the operation of FDA and to carry out his responsibility to ensure the safety of food and the safety and effectiveness of drugs through FDA.

The Food, Drug, and Cosmetic Act does not specify the internal organization of FDA. The only statutory provisions we could find relating to particular components of FDA are (1) the Best Pharmaceuticals for Children Act, adopted in 2002, which created within FDA an Office of Pediatric Therapeutics, and (2) a provision added to the Food, Drug, and Cosmetic Act in 2007 creating an Office of the Chief Scientist in the Office of the Commissioner.

National Institutes of Health

No component of the department is subject to greater statutory control with respect to its internal organization than the National Institutes of Health (NIH). NIH is established as an agency of the PHS by section 401 of the PHSA, which also specifies that there are 24 statutorily named national research institutes and national centers. As discussed below, the secretary may add new institutes or terminate existing ones, except that the total number of such institutes and centers may not exceed 27. Section 402 establishes the position of the director of NIH, who shall be appointed by the President with the advice and consent of the Senate. The statute does not require that there be a direct reporting relationship between the director and the secretary.11

Title IV of the PHSA sets forth in detail the mission, programs, and grant authority of each of the institutes and centers of NIH. It also con-

11

These sections were substantially revised by the National Institutes of Health Reform Act of 2006, section 101, which became law on January 15, 2007.



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