Food and Drug Administration
Before new drugs are made available to consumers, the Food and Drug Administration (FDA) reviews them for safety and effectiveness. The Prescription Drug User Free Act (PDUFA) allows some funding of these reviews from companies submitting drug applications. In exchange, the FDA agrees to meet product review performance goals and undertake initiatives to improve review efficiency.
PDUFA III required the FDA to evaluate the impact of recent initiatives on the review process. The FDA asked Booz Allen Hamilton for assistance.
Drawing on its experience in life sciences, Booz Allen conducted a comprehensive four-phase study for the FDA. In Phase 1, the firm analyzed drug applications approved between FY 2002 and 2004 to determine which factors contributed to FDA’s ability to make approval decisions in single versus multiple review cycles. The team also examined the impact of pilot programs that increased FDA and manufacturer interaction during the submission process.
In later phases, the firm extended the study through FY 2007 and examined the public health impact of post-market commitments between product sponsors and FDA to define a product’s safety, efficacy, or optimal use.
Booz Allen’s analysis confirmed that communication between FDA and manufacturers resulted in higher first cycle approval rates. Fifty-two percent of companies that met with FDA at the end of Phase 2 clinical trials received approval during the first cycle.
Booz Allen’s unique understanding of the FDA and pharmaceutical manufacturers helped identify steps that can expedite application review and ensure medical products reach patients.
Download the Full Case Study
Download a PDF version of the case study entitled, "Food and Drug Administration: Evaluating the Approval Path for Safe and Effective New Drugs and Biologics."