FDA censoring of manufacturers' postmarketing commitments in HIV/AIDS drug approval letters.
BACKGROUND
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.


METHODS
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.


METHODS
Accelerated approval has been expanded to other disease conditions in the past decade.


METHODS
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.


METHODS
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.
Unalp
A
A
Center for Clinical Trials, Department of Epidemiology, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland 21205, USA. aunalp@jhsph.edu
Shafer
C
C
Tonascia
S
S
Meinert
C
C
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy; D007255:Information Services; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration
D019380:Anti-HIV Agents