The FDA is escalating its ongoing push for transparency and tougher enforcement, including publicizing complete response letters, seeking new authority over DTC drug advertising, and tightening expectations around external controls in rare disease trials. Don’t miss the latest in the industry.
The FDA’s Shame Game
Source: PharmaVoice
The FDA’s push for “radical transparency” is reshaping its relationship with pharma companies by publishing once-confidential complete response letters, enhancing public warning letters, and spotlighting deceptive promotion. While investors and regulators welcome greater visibility into FDA decisions, manufacturers worry about heightened legal, financial, and reputational risks.
FDA Seeks to Bite Back Against Misleading DTC Drug Ads
Source: Fierce Pharma
The FDA pushes for new legislative authority to more forcefully police misleading direct-to-consumer prescription drug advertising, including classifying certain deceptive promotions as drug misbranding. The request, folded into the 2027 budget proposal, follows a wave of enforcement letters and would tighten rules around risk disclosure and compounded drug ads that fail to clearly note they are not FDA approved.
FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls
Source: BioSpace
Recent FDA reversals on rare disease therapies have created uncertainty about when external or natural history controls are acceptable, despite guidance encouraging innovative trial designs. Case studies underscore a gap between high-level support for real-world data and tougher scrutiny at review, prompting calls for early, frequent FDA engagement to align on endpoints and statistical plans.
