The FDA sure is approving drugs quickly
On Friday, the FDA approved a new breast cancer treatment from AstraZeneca a full four months ahead of schedule. And over the past two months, it has OK’d six treatments an average of 3.25 months before their promised decision dates.
What’s unclear is whether this means anything. When you zoom out, FDA approval timelines have been pretty consistent at the median. What swings the year-to-year average are the sporadic super-fast approvals, which almost always go to drugs that treat cancer or rare diseases.
It’s tempting to look at the past few months as a sign that the FDA is deliberately accelerating its review process. And, hey, maybe that’s true. But it’s worth noting that all of the above treatments are indicated for cancer or rare disease, and so it’s also possible that the agency is doing what it’s always done; there just happened to be a bolus of the kind of drugs that get approved quickly.
What’s unclear is whether this means anything. When you zoom out, FDA approval timelines have been pretty consistent at the median. What swings the year-to-year average are the sporadic super-fast approvals, which almost always go to drugs that treat cancer or rare diseases.
It’s tempting to look at the past few months as a sign that the FDA is deliberately accelerating its review process. And, hey, maybe that’s true. But it’s worth noting that all of the above treatments are indicated for cancer or rare disease, and so it’s also possible that the agency is doing what it’s always done; there just happened to be a bolus of the kind of drugs that get approved quickly.
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