FDA’S PUBLIC HEALTH ROLE

To affirm that the Food and Drug Administration’s public health role is to ensure the safety and effectiveness of drugs, biologics, and medical devices through risk assessment, appropriate product approval and labeling, manufacturing oversight, maintaining consumer confidence in medications, and consultation with health professionals, while deferring to state regulation and professional self-regulation on matters related to the use of drugs, biologics, and medical devices; further, 

To support the allocation of sufficient federal resources to allow FDA to meet its defined public health mission; further, 

To support the appointment of practicing pharmacists to FDA advisory committees as one mechanism of ensuring that decisions made by the agency incorporate the unique knowledge of the profession of pharmacy for the further benefit of the patient; further, 

To support an ongoing dialogue between FDA and ASHP for the purpose of exploring ways to advocate the best use of FDA-regulated products by consumers and health care professionals. 

Rationale

ASHP recognizes the critical importance of the FDA in protecting public health by ensuring the safety of drugs, biologics, and medical devices. Strong federal oversight of drug safety is vital and requires robust federal funding to allow FDA to fulfill its mission, particularly in a rapidly evolving healthcare landscape. Public health would also benefit from the inclusion of practicing pharmacists, particularly those with hospital or health system experience, on FDA advisory committees, which would ensure that the agency has benefits from pharmacists’ unique clinical and pharmacotherapeutic expertise, ultimately enhancing patient care. FDA’s stakeholder engagement, including its long history of collaboration with ASHP and other pharmacy organizations, is integral to fostering shared efforts to promote medication and device safety, and must be protected from political interference.