Two Indications, One REMS: FDA Panel Debates Restricted Access For <em>Truvada</em> In PrEP

Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP

21 May 2012

FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.

Gilead Sciences Inc.’s pursuit of a pre-exposure prophylaxis claim for Truvada has raised a novel risk management challenge for FDA: whether and how to restrict access to a drug for preventing HIV infection when the same agent, and its individual components, is approved in the same dose and without restrictions for treating the disease.

The logistical challenges involved in adding distribution restrictions for a supplemental indication – and the potential ramifications on end-users, the...