FDA's Office of Prescription Drug Promotion issues only its third letter of 2016, although it hopes to cast wide net by targeting high-profile events like ASCO.
FDA's enforcement of promotional material has continued to dwindle in recent years, but while the volume has dropped, the pattern in many ways remains the same: The Office of Prescription Drug Promotion (OPDP) has just cited a display from the American Society for Clinical Oncology (ASCO) Annual Meeting – only the office's third letter of the year.
This time, Celator Pharmaceuticals Inc. was deemed the culprit, with the agency saying a
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.
Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.
Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.
