Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.
The US Food and Drug Administration’s emergency use authorization for remdesivir includes boilerplate language limiting what Gilead Sciences Inc. can say about the drug – language that was absent from the only other EUA granted for a potential COVID-19 therapeutic.
The agency issued the EUA to Gilead on 1 May, authorizing the use of remdesivir for hospitalized, severe COVID-19 patients
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
