Pharma supply is elastic
The crux of the problem is that the IRA imposes price caps that shorten the effective life of a patent and applies those price controls even to later-approved uses. Thirteen years after FDA approval, biologics, which are typically infused or injected, become subject to price controls. For small-molecule drugs, typically pills or tablets, the window is only nine years. The clock starts at a drug’s first approval, leaving a follow-on or alternative use, approved years later, an insufficient period to make up the cost of research.
Two weeks ago, a study I conducted with colleagues at the University of Chicago appeared in Health Affairs. It reveals how much these provisions harm cancer research. In reviewing every Food and Drug Administration-approved cancer drug between 2000 and 2024, we found a large part of innovation in cancer treatment takes place after a therapy is first approved. About 42% of the 184 cancer therapies that were initially approved during that period had follow-on approvals—involving new uses or “indications” for an existing drug—such as treating additional cancer types or being used earlier in the disease, when treatment outcomes tend to be better.
This cumulative progress through follow-on discoveries is a big driver of new cancer treatments, the largest drug class making up about 35% of the overall FDA pipeline. Cancer drugs are generally first tested in patients with late-stage disease, after which the drug is studied for use in earlier stages of that cancer and for new uses, including treating other cancers. Our study found that 60% of follow-on drugs treated earlier stages than the initial drugs. This is important because treating earlier stages is often more successful than when a cancer has spread more.
But that cumulative progress depends on incentives for sustained research well after the first FDA approval—often years of additional trials and investments. And those incentives were killed by the IRA.