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Accelerated Approval and Post-marketing Commitments: A Delicate Balance

ABSTRACT # 41 Presented at HIV DART 2008

By Tracy Swan and Lei Chou

BACKGROUND

AIDS activists have focused on HIV drug development for more than two decades. In 1992, in part due to pressure from AIDS activists and pharmaceutical deregulators, FDA instituted Accelerated Approval regulations, allowing earlier approval of drugs for serious, or life-threatening diseases, based on unmet need and a surrogate endpoint. Clinical benefit and questions about optimal use are determined in subsequent trials, known as post-marketing commitments (PMCs).

AIDS activists welcomed accelerated approval, but pressed for collection of data on pharmacokinetics, drug-drug interactions, dosing, efficacy and toxicity by disease stage, and in specific populations, during registration trials. They argued that post-marketing commitments are not always required or conducted expeditiously. Often, PMC results are not available until drugs have already been on the market for years.

Valid scientific rationale, justice (as outlined by the Office of Human Subjects Research’s 1974 Belmont Report), and HIV demographics in the United States argue for adequate enrollment of women, people of color, and current and former injection drug users, many coinfected with viral hepatitis, in registration trials2.