Moderna vaccine fiasco is the tip of the iceberg
The FDA has a rejection problem.
The Food and Drug Administration (FDA) recently learned what most of us learn when we’re kids: if you play with fire, you get burned. The agency—and more specifically Center for Biologics Evaluation and Research director Vinay Prasad—refused to examine an application by Moderna for its first mRNA seasonal flu vaccine. The refusal came even after the FDA previously said it had no issues with Moderna’s study design—which thoroughly tested for safety and efficacy.
Patients will pay the price for this regulatory misdeed. In an interview with the New York Post, Moderna President Dr. Stephen Hoge stated, “The rules of the game [are] being changed after the game has been played.” The move “… will make it very hard to invest in making new medicines and cures in this country.” Unfortunately, this is far from an isolated incident. The agency has repeatedly doled out bizarre rejections, and the pace has accelerated over the past year. This is certainly not Making America Healthy Again.
In the wake of the Moderna fiasco, economist and longtime agency-watcher Alex Tabarrok declared, “I Regret to Inform You that the FDA is FDAing Again.” Setting aside lofty rhetoric by FDA leadership, cures are not being accelerated. The drug development pipeline is clogged with promising treatments that are not reaching patients. The biotech data platform RxDataLab notes that active “Investigational New Drugs” currently being tested increased from around 11,000 annually pre-COVID to more than 14,000 from 2022 onward. But as Chemical & Engineering News recently noted, “2025 saw 46 new molecular entities cross the finish line to approval by the US Food and Drug Administration—that’s 4 fewer than the 50 drugs the agency approved in 2024.” The agency is approving about as many drugs now as it did ten years ago. The FDA can only keep pace by consistently increasing overall approvals, not flatlining them.
Examining individual drug rejections sheds some much-needed light on the FDA’s flawed approach. One frustrating example is Ebvallo, a T-cell immunotherapy designed to treat a blood cancer called Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). The clinical stakes for this disease are high because outcomes are often poor once patients fail initial therapies. As noted in a 2024 study in the scientific journal Bone Marrow Transplantation, “Patients who fail rituximab have poor outcomes with limited treatment options. Although results vary according to protocol, up to 50% of patients with EBV+ PTLD post-HCT may experience failure to rituximab-containing treatment.” Safety and efficacy data have been promising, and the FDA acknowledged that the current data is sufficient. However, the FDA rejected the drug in January 2025 based on manufacturing quality concerns identified “during a routine pre-license inspection of a third-party manufacturing facility.” Interestingly, this wasn’t an issue for regulators in the EU, United Kingdom, or Switzerland, which have all approved the medication.
The medication was rejected a second time by the FDA in January. While previously cited manufacturing issues were resolved, the FDA no longer considered data from the drug’s Phase 3 ALLELE study adequate in demonstrating effectiveness for accelerated approval. The agency was nitpicky—as usual—even though the medication met its prespecified primary efficacy endpoint and demonstrated an acceptable safety profile. Like the Moderna situation, the FDA has shifted the goalposts. Bureaucrats continue to deny a lifesaving therapy that is allowed in much of the developed world.
In its soon-to-be-released report on FDA reform, the Taxpayers Protection Alliance will detail more examples of agency process gone awry. The FDA simply isn’t living up to the “gold standard” status that patients, drug developers, and even other countries expect. The agency could quickly turn things around by ditching its hostility to innovation and taking a more approval-friendly approach. Patients deserve nothing less.