Today at 1pm ET, @ArmstrongDrew and @BrianSkorney are talking all things Sarepta, FDA and the chaos that's ensued between them. https://t.co/qWSJaJsRWs
Two easy ways for the FDA to improve transparency by @Frank_S_David https://t.co/nM0A3VVM8o
.@Frank_S_David in @statnews: How the @US_FDA can score quick wins on transparency (Yes please!) 1) integrate all public info & docs about approved drugs into the Drugs@FDA database, upgrade interface for advanced searches, downloads, and analyses 2) publish machine-readable
Sarepta Therapeutics ($SRPT) has been at the center of controversy following the FDA's public criticism over the company's handling of Elevidys shipments. Initially, the FDA issued a public relations statement shaming Sarepta for not pausing Elevidys shipments, but later reversed its stance, citing an unrelated fatality that occurred after the alleged pause period. This backtracking has raised questions about internal dynamics within the FDA and possible political influence from higher-ups in the Trump administration. Commissioner Marty Makary had previously supported the FDA's initial position, but external pressures, including criticism from political figures such as Laura Loomer and Rick Santorum, as well as opinion pieces in the Wall Street Journal labeling FDA official Vinay Prasad as a "one-man death panel," have intensified scrutiny. Discussions about transparency at the FDA have gained momentum, with experts like Frank S. David advocating for "radical transparency" measures. Proposed improvements include integrating all public information and documents about approved drugs into the Drugs@FDA database with enhanced search and analysis capabilities, and publishing machine-readable data to facilitate public access. These developments highlight ongoing tensions between Sarepta Therapeutics and the FDA amid calls for greater regulatory clarity and openness.