FDA and Drug Regulation

The article reports that FDA Commissioner Marty Makary has launched the Commissioner's National Priority Voucher program, an unprecedented effort to approve certain drugs in as little as one month if they are deemed to support "U.S. national interests," prompting alarm inside the agency about legality, ethics and patient safety. Seven current or recently departed FDA staff tell AP that reviewers have been instructed to skip normal regulatory steps on at least one highly anticipated anti‑obesity drug, and that scientists had to rush voucher paperwork for Eli Lilly and Novo Nordisk after the White House tied their participation to obesity‑drug price cuts President Trump wanted to announce. At the top levels of FDA there is still confusion over who actually has the legal authority to sign approvals under the voucher scheme, which has never gone through the normal public rulemaking and sits atop a half‑dozen existing, congressionally authorized fast‑track programs that already give the U.S. the world’s fastest reviews. Outside experts like Harvard’s Aaron Kesselheim warn that a one‑to‑two‑month review "does not have scientific precedent" and cannot match the depth of standard six‑ to ten‑month assessments, while Reuters has already documented two voucher drugs being delayed amid safety issues, including a patient death. HHS insists the program maintains "gold standard" science, but former FDA lawyers say its opaque application process and pricing‑linked White House rollouts make it highly vulnerable to politicization, feeding broader concerns that Trump‑era health policy is subordinating independent drug oversight to short‑term political goals.