FDA Nixes REMS for Truvada and Its Generics

The FDA is scrapping the risk evaluation and mitigation strategy (REMS) for Gilead’s blockbuster HIV drug Truvada and its generics — so manufacturers will no longer have to include educational materials on the drug’s use.

The agency said it has evidence that healthcare professionals and at-risk individuals understand the risks of developing a resistant strain of HIV while using Truvada for pre-exposure prophylaxis (PrEP). In addition, the CDC offers treatment guidelines and educational material that patients can easily access.

The FDA has “reinforced to healthcare professionals and at-risk individuals that before starting PrEP with Truvada or [its generics], and during its use, health care professionals should routinely screen patients for HIV at least once every three months,” said Debra Birnkrant, director of FDA’s Division of Antiviral Products.