Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
Drug advertising policy will be developed in a new division within the US Food and Drug Administration following a small reorganization.
A new Division of Promotion Policy, Research and Operations (DPPRO) has been created within the FDA Center for Drug Evaluation...
The bolus of untitled letters signals the FDA's approach to enforcement of the final rule on the presentation of the major statement in direct-to-consumer TV ads in a clear, conspicuous and neutral matter.
Just eight of the 68 warning letters posted by the FDA to date went to innovator companies, but GLP-1 agonists still were a focus.
Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.
FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.
Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.
Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.
FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.
