Gilead’s REMS Resubmission Delays FDA Action On Truvada For PrEP
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA extends the user fee deadline for the supplemental indication of HIV pre-exposure prophylaxis to Sept. 14. Although Gilead is not saying what changes it made to the Risk Evaluation and Mitigation Strategy, FDA advisory committee members had recommended making prescriber education mandatory and linking prescribing to documentation of a negative HIV test.
You may also be interested in...
Two Indications, One REMS: FDA Panel Debates Restricted Access For Truvada In PrEP
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.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.
ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.