CLN Article
The U.S. Department of Health & Human Services (HHS) is floating a seismic plan to reorganize the Food and Drug Administration (FDA) into five broad offices, with all its product review divisions merged into one. The proposal appears to fit in with HHS Secretary Robert F. Kennedy Jr.’s call for a new holistic approach to tackling chronic disease that looks beyond pharmaceuticals to include nutrition and dietary supplements.
The main focus of the proposal appears to be to separate the various functions of FDA’s regulatory centers and to reorganize them as centralized offices. Each of these offices would be focused on one of the agency’s broad functions and would presumably report directly to the FDA commissioner.
The reorganization plan includes combining FDA’s review divisions into a new “Office of Product Evaluation and Regulation” that would serve as a “central hub for product review and regulatory decision-making across drugs, biologics, devices, tobacco, and foods.” The office would be formed from the offices that review drugs, biologics, medical devices, tobacco products, human foods, and veterinary products. The HHS email on the proposed reorganization says the move “streamlines evaluation processes.”
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), wrote to Robert Kennedy Jr., to urge the U.S. Department of Health & Human Services (HHS) Secretary to reinstate the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The ACHDNC plays an indispensable role in U.S. efforts to detect, diagnose, and treat asymptomatic babies with serious congenital conditions through newborn screening.
ADLM strongly recommended that Secretary Kennedy reinstate the ACHDNC to allow it to continue its work for parents and children. The letter went on to suggest that, if HHS decides not to restore the advisory panel, the agency should provide guidance on how new newborn screening tests will be evaluated for efficacy. The agency should also determine what process will be used to update the list of disorders that should be screened for.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) joined 218 members of the CDC Coalition and other supporting state, national, and academic organizations to urge the House Appropriations Subcommittee and the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies to include $11.581 billion in funding for the Centers for Disease Control and Prevention’s (CDC) programs in the FY 2026 Labor, Health and Human Services, Education and Related Agencies appropriations bill.
In a letter addressed to the chairs and ranking members of these subcommittees, ADLM expressed serious concern for several recent actions by the administration that will significantly weaken CDC, the rest of the nation’s public health system, and the efforts of organizations nationwide to combat many of the leading causes of death and disability in the nation. These actions include the claw back of more than $11 billion in previously appropriated funding to state and local health departments and an unworkable reorganization of the CDC that eliminates thousands of important positions and critical programs at the agency.