CONFIDENCE IN THE U.S. DRUG APPROVAL AND REGULATORY PROCESS

To support and foster legislative and regulatory initiatives designed to improve public and professional confidence in the drug approval and regulatory process in which all relevant data are subject to public scrutiny.

Rationale

Patients, healthcare providers, and private and public payers need objective, authoritative, and reliable evidence about drugs in order to make the best treatment decisions. The basis of the trust in the Food and Drug Administration (FDA) drug approval and regulatory process is public scrutiny of the data used in its decision-making. ASHP supports efforts to improve public and professional confidence in the FDA’s drug approval and regulatory process by expanding public access to relevant data used in FDA decision-making.