Changing evidentiary standards and partial shift of the investigational phase of drug approval process to the postmarketing phase. Objective: To determine the availability of information for independent researchers needed to examine accelerated drug approvals to determine how they differ from traditional drug approvals in the HIV/AIDS domain. Design: Identification of all approved HIV/AIDS and AIDS-related conditions drugs between 1987 and 1999. Follow-up of postmarketing study requirements in the approval letters addressed to the manufacturers. Setting: Accelerated approval has been expanded to other disease conditions in the past decade. Intervention: Request of approval letters from the U.S. Food and Drug Administration for 76 regulatory actions including expanded access and accelerated and traditional approvals for 42 drugs under the Freedom of Information Act (FOIA) between September 1998 and October 1999. Main Outcome Measure(s): Obtainability of approval letters and uncensored postmarketing study requirements. Results: Fifty-five approval letters were received. Postmarketing study commitments of manufacturers were censored in 25 letters received. We were unable to obtain uncensored copies of those approval letters as of May 2000. Censoring was associated with whether (1) the Prescription Drug User Fee Act of 1992 was applicable to the drug (odds ratio (OR) = 5.7,95% confidence interval (CI) = 1.4-23.7) and (2) the new drug application was for a new molecular entity or new drug formulation (OR = 4.2, 95% CI = 1.3-13.6). Conclusions: Continued secrecy may stifle independent research and hinder health care providers and patients in making informed decisions.
1Center for Clinical Trials, Department of Epidemiology, The Johns Hopkins University School of Hygiene and Public Health, Baltimore;
2University of Baltimore Law School, Baltimore, Maryland, USA.
*Address for correspondence: The Johns Hopkins University Center for Clinical Trials, 615 North Wolfe Street, Room 5010, Baltimore, MD 21205, USA. E-mail:[email protected]
© 2000 Lippincott Williams & Wilkins, Inc.