Our Take
Openness without standards is noise masquerading as clarity; drug developers now face the opposite problem the FDA tried to solve.
Why it matters
The FDA under former commissioner Marty Makary released complete response letters and published policy via blog posts to end regulatory guessing games. But former agency insiders say this move has backfired, leaving developers uncertain which statements represent binding policy versus individual opinions, forcing companies to rely on older, narrower official guidance instead.
Do this week
Drug developers: treat only formal FDA press releases and published guidance documents as policy until the agency clarifies standards for official announcements; flag any policy guidance found in external articles or social posts with your regulatory counsel before acting.
Transparency without guardrails created a new kind of confusion
In July 2025, the FDA announced plans to release complete response letters (CRLs), the documents explaining why drug applications fail. The stated goal was to end what former commissioner Dr. Marty Makary called "a guessing game when navigating the FDA."
But at the 2026 BIO International Convention in San Diego last month, former FDA staff pushed back. While longer CRLs and public disclosure were overdue, they said, the broader "radical transparency" push introduced a different problem: lax standards for how policy gets announced. With lower vetting requirements, drug developers now struggle to distinguish between true FDA policy and the personal views of individual officials.
The confusion stems partly from logistics. Following mass staff cuts, the agency lacks capacity to negotiate redactions in lengthy CRLs. More broadly, FDA officials including Makary and Dr. Vinay Prasad, former head of the Center for Biologics Regulation and Evaluation (CBER), have published official policy in personal articles and external forums. When Prasad departed the agency, it became unclear whether his earlier published statements represented his opinions or binding FDA positions.
Elizabeth Jungman, former FDA chief of staff now at law firm Hogan Lovells, and Hilary Marston, former FDA chief medical officer, recalled a time when FDA press releases followed stricter standards. Marston also noted that even expansive CRLs create ambiguity: citing too many concerns muddies which issues actually drove the rejection decision.
Ritu Nalubola, former FDA Europe director, highlighted a concrete example. Guidance restricting COVID-19 vaccine boosters was published via articles by Makary and Prasad. With Prasad gone and Makary ousted, developers cannot determine whether those statements reflect current agency stance or have been superseded.
Intent collided with infrastructure and staffing reality
The FDA's transparency goal was sound. Developers had long requested more detail in rejection letters. But the agency pursued the goal without establishing clear rules about where policy must appear and what vetting applies before publication.
The result inverts the original problem. Developers previously faced a guessing game because the FDA said nothing. Now they face a guessing game because the FDA says too much in too many formats without hierarchy or timestamp.
Understaffed teams cannot negotiate each redaction in detail. Officials publishing outside formal channels add signal that is not officially binding. Blog posts and articles read like policy but carry no stamp of enforcement. The absence of standards means developers cannot safely treat any announcement as dispositive without confirming it through older, narrower official guidance channels.
This forces companies backward, away from the transparency the FDA intended to provide, toward defensive interpretation of only the most formally documented guidance.
Build policy tracking into your regulatory workflow
Drug developers should implement a two-tier system for FDA guidance. First, collect all statements from official FDA channels (press releases, published guidance documents, formal notices). Second, flag any policy guidance found in external articles, blog posts, or individual official statements and route them to regulatory counsel for verification before incorporation into internal processes.
When CRLs arrive, do not assume that the length or density of cited concerns maps to the severity of each issue; request clarification from the agency on which concerns were primary drivers of the decision. If policy was recently published by departing officials, confirm its current status directly with the agency rather than treating it as standing guidance.
Until the FDA clarifies announcement standards, operate conservatively: treat official formal channels as binding and everything else as advisory unless explicitly confirmed by the agency in writing.