FDA Faces Scrutiny Over Online Drug Promotions and Krazati Letter Amid FTC Report on PBMs Impact

The FDA is facing increasing scrutiny regarding its oversight of online prescription drug promotions, as highlighted by a recent interim staff report from the FTC that examines the purported impact of pharmacy benefit managers (PBMs) on drug prices. Additionally, the FDA has introduced innovative new designation programs in response to congressional mandates aimed at enhancing drug approval processes. Recent legal developments, including Supreme Court decisions and a cautionary letter regarding the promotion of accelerated approval drugs, further underscore the evolving landscape of pharmaceutical regulation. These issues reflect ongoing concerns within the healthcare and pharmaceutical sectors about drug pricing and regulatory practices.