The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States

The pharmaceutical industry and the Food and Drug Administration (FDA) have responded for over a decade to the considerable challenges of drug development and registration, as introduced by the HIV epidemic. FDA took a variety of regulatory steps over a period of 7 to 10 years which facilitated various aspects of the process of developing antiretroviral drugs. This manuscript will discuss the various major evolutionary milestones in the paradigm for development and approval of antiretroviral drugs in the United States. Maintenance of this effort over the last decade demonstrates the dedication of FDA and industry to this field. The initiatives of FDA and the pharmaceutical industry have facilitated drug development and early access to important multiple, new antiretroviral drugs. The sections provide detailed information to support these views and suggest that consideration be given to applying these lessons to the broader challenge of expediting development of other classes of drugs.