As of March 2026, Dr. Marty Makary, the FDA Commissioner since April 2025, has significantly shifted the agency's stance toward the aggressive adoption of Real-World Evidence (RWE) to accelerate drug and device approvals. His latest views and policy actions center on "unleashing" the power of big data by removing long-standing bureaucratic barriers:
Key Policy Shifts under Dr. Makary Removal of "Identifiable Data" Requirements: In December 2025, the FDA eliminated a major barrier by allowing companies to submit de-identified, macro-level data from sources like cancer registries and hospital records. Previously, the requirement for individual-level patient data made using these large databases impractical. Focus on "Big Data" over Bureaucracy: Makary has criticized previous FDA requirements as "onerous" and "bureaucratic," noting that only 12 drugs in 14 years had successfully used RWE in their applications due to these hurdles. Case-by-Case Evaluation: Instead of rigid data formats, the FDA now evaluates the reliability and quality of RWE on a case-by-case basis. If reviewers find the data insufficient, they will communicate directly with the company rather than rejecting it outright for procedural reasons. Expansion Beyond Devices: While the formal guidance change was initially implemented for medical devices in late 2025, Makary has signaled that similar updates for drugs and biologics are in development to further streamline the approval pipeline.
Strategic Goals Makary views RWE as a critical tool for "accelerating cures" and reducing the "financial toxicity" of the traditional drug development process. He has also moved the agency toward a "one-trial pathway" for most drugs—down from the standard two—supplemented by robust RWE to maintain safety and efficacy standards.
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