No, the FDA's Expedited Drug Review Programs Are Not New — And They Approve Far More Than a Few Drugs

The claim suggests the FDA has a brand-new fast-track approval program that has pushed through only a handful of drugs in recent months. That picture is wrong in almost every detail, though it contains a small grain of truth worth acknowledging.

The FDA actually runs four long-standing expedited pathways: Fast Track, Breakthrough Therapy designation, Accelerated Approval, and Priority Review. According to the FDA's own website, these programs have been in place since the late 1980s through the early 2000s — not introduced recently. They were created largely in response to the HIV/AIDS crisis, when patients and advocates pushed hard for faster access to life-saving treatments.

The scale of approvals is also far larger than 'a small number.' The FDA's drug approvals database shows 55 novel drugs were approved in 2023, many through these expedited routes. A peer-reviewed study in JAMA Internal Medicine found that a substantial and growing proportion of all FDA approvals use at least one expedited pathway. Research from the Milken Institute's FasterCures program confirms hundreds of drugs have used these pathways over the years.

The grain of truth: Congress did pass a real update in late 2022. The Consolidated Appropriations Act of 2023 gave the FDA stronger authority to require follow-up confirmatory trials for drugs approved under Accelerated Approval, as reported by STAT News. That is a meaningful reform — but it is a refinement of a decades-old program, not the launch of something entirely new.

This kind of claim spreads because the details of drug regulation are genuinely complicated, and vague phrases like 'new program' and 'small number' sound specific enough to seem credible without being precise enough to check easily. When you see a claim about the FDA, look for the actual program name and approval numbers — both are publicly available on the FDA's website and easy to verify.