Testimony on accelerated approval.
In 1994, Carlton Hogan testified before an FDA Antiviral Advisory Committee about the risks of letting drugs loose in the population without a rigorous method to detect and report late emerging toxicity. In 2003, AIDS activists met with FDA and repeated many of the concerns that Hogan outlined: the need for post-marketing follow-up, the failure of drug companies to live up to commitments made to study drugs after they are approved, the inadequacy of penalties available to FDA for enforcing those commitments. Hogan's testimony seems especially prescient as it was made before the advent of truly effective antiretroviral therapy--and well before lipodystrophy and other complications associated with the new regimens had come to light. Carlton Hogan was an intellectual and moral leader in the AIDS treatment activist movement at a critical time and these excerpts from his testimony remain provocative today.
Hogan
Carlton
C
D019380:Anti-HIV Agents / Q000627:therapeutic use; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015658:HIV Infections / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration
D019380:Anti-HIV Agents