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FDA Faces Calls to Pause Makary Drug Voucher Program, Reintroduce via Formal Rulemaking
Patient advocates, former agency officials, and industry players want the FDA to halt the drug voucher program and restart it through formal rulemaking.
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Patient advocates, former agency officials, and industry players are urging the FDA to pause the drug voucher program and reintroduce it through formal rulemaking. The program was spearheaded by former commissioner Marty Makary. RevMed’s experimental pancreatic cancer drug daraxonrasib has not yet achieved approval but is available through an expanded access program.
The call to pause the program appeared in reporting published June 5, 2026.
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