Last year, FDA approved 50 novel drugs. While that number is a little lower than the previous year, it’s still an impressively high number of innovative medicines. And the 2025 pipeline is full of first-in-class therapies that tackle challenging diseases.
However, six weeks after a reduction in force and earlier voluntary buyouts excluded drug reviewers and support staff at the FDA, signs are emerging that the agency’s policies may change, or even derail, the approval process. The FDA has missed a few key decision deadlines, and former Commissioner Robert Califf posted on LinkedIn that “the FDA as we’ve known it is finished.”
Before a company can start testing drugs in humans in the United States, it must file an investigational new drug application (IND). The FDA reviews INDs and uses them to decide whether to approve or reject a drug for clinical testing. The agency typically issues a decision within 10 months of the IND submission date, unless it gives the therapy an expedited review.
But a study by industry analysts at Leerink Partners found that many of the offices responsible for developing FDA policy and guidance were eliminated by the April 1 reduction in force, and new hires aren’t filling key roles as quickly. This could affect the timeliness of drug approval decisions, particularly when a nuanced dialogue is needed between the agency and sponsors on specific technical questions. For example, when a manufacturer of a generic drug wants to show that its medicine is equivalent to the brand-name drug it is copying, the FDA typically provides clear guidelines on how to do so.