Article Summary:
This week, the FDA announced major efforts to crack down on misleading prescription drug advertising. The Department of Health and Human Services (HHS) also released a report outlining the Trump administration’s strategy to address childhood chronic illnesses, which includes initiatives for the FDA.
The HHS report called for the FDA, FTC, and DOJ to increase oversight and enforcement of direct-to-consumer drug advertising. Shortly after, the FDA said it will issue rulemaking to end the use of “adequate provision,” which allows companies to obscure risk information. The agency has also sent over 100 cease and desist letters to drugmakers regarding deceptive ads.
Additionally, the director of the FDA’s drug center said the agency wants to move away from using advisory committees to evaluate individual drugs, calling the panels redundant. Meanwhile, the administration plans to link 25 children’s deaths to COVID-19 vaccines, despite CDC warnings about the limitations of the VAERS reporting system.
The FDA also published new guidances this week, including one on good clinical practices for clinical trials. The agency’s biologics center will also host a virtual town hall to discuss manufacturing issues. New drug approvals include Koslugo for neurofibromatosis type 1, Filspari for focal segmental glomerulosclerosis, and Inlexzo for bladder cancer.
Lastly, Apple received clearance for a hypertension notification feature on its new Apple Watch, and the FDA’s Digital Health Advisory Committee will discuss the use of generative AI in mental health devices.