Some of medicine’s most consequential breakthroughs occur years after a treatment first reaches patients. Researchers discover that a medicine developed for one disease can also attack another—or that it can be reformulated and administered in a way that is safer, faster and far more convenient.

These advances aren’t accidents. They require enormous investments in scientific research, clinical trials, manufacturing and regulatory approval. Developing a new use or improved formulation can take years of additional work and hundreds of millions—sometimes billions—of dollars.

The U.S. has long led the world in producing these breakthroughs because we reward risk-taking and innovation. Unfortunately, a misguided Biden-era policy now threatens to undermine that uniquely American success.

Joe Biden’s misnamed Inflation Reduction Act (IRA) empowered bureaucrats at the Centers for Medicare & Medicaid Services (CMS) to impose government price controls on certain medicines covered by Medicare. Washington calls this process “negotiation,” but it’s a Tony Soprano-style negotiation. When the government dictates the terms and manufacturers have no realistic way to walk away, that’s price-setting, pure and simple.

The Congressional Budget Office (CBO) and numerous outside experts warned that these controls would discourage investment in new medicines. Those warnings were dismissed, but now the consequences are emerging. One analysis found that investment in small-molecule medicines has declined by as much as 70% since the IRA became law.

The next phase of this program could inflict even more damage.

As CMS prepares the program’s rules for 2029, the agency is proposing to broaden the criteria used to decide when separately approved medicines should be grouped together for price-control purposes. The change could sweep in follow-on treatments with similar chemical profiles—even when they require a new application and separate approval from the Food and Drug Administration (FDA).

This isn’t a minor technical adjustment. It could discourage the development of new uses and improved forms of existing medicines, including cancer treatments that can be administered more conveniently.

Consider a cancer medicine delivered through an intravenous infusion. A patient may have to travel to an infusion center, remain there for hours and arrange work, transportation and family responsibilities around repeated appointments. For patients in rural or underserved communities, the burden can be even greater.

Researchers may subsequently develop a version that can be injected in a doctor’s office in a fraction of the time. That isn’t merely a cosmetic change. It can make treatment easier for patients, expand access and free scarce infusion-center capacity for others who need it.

Such an improvement doesn’t materialize by simply changing a label. The new treatment may require extensive research, costly Phase 3 clinical trials, manufacturing changes and a separate FDA review. It carries new scientific and financial risks.

Yet CMS’ proposal would treat these breakthroughs as though little or no additional innovation had occurred. That’s economically foolish and potentially devastating for patients.

If investors and manufacturers know that a successful follow-on treatment will immediately be pulled into an older medicine’s price-control regime, many will conclude that the investment isn’t worth making. Promising research will be canceled before patients ever know what they’ve lost.

That’s the insidious thing about government price controls. Their most damaging consequences are often invisible. We see the supposedly lower price today, but we don’t see the cancer treatment, Alzheimer’s therapy or improved medicine that is never developed tomorrow.

The proposal also raises serious questions about whether CMS is exceeding the authority Congress granted it. The FDA—not CMS—determines whether a medicine is sufficiently distinct, safe and effective to receive a separate approval. CMS shouldn’t be allowed to erase that distinction through regulatory sleight of hand simply to expand the reach of federal price controls.

There are far better ways to reduce how much Americans pay for medicine. Policymakers should confront the opaque practices of insurers and pharmacy-benefit managers, increase competition and force wealthy foreign countries to stop freeloading on U.S. innovation. President Trump has correctly focused on these distortions while encouraging more than $500 billion in private-sector commitments to expand domestic pharmaceutical research, manufacturing and employment. This is the right approach: strengthen competition, expose hidden costs and encourage investment.

The U.S. didn’t become the world’s medical-innovation leader through central planning. It did so because scientists, entrepreneurs and investors were willing to take extraordinary risks in pursuit of extraordinary breakthroughs. We should reward them when they succeed—especially when an existing treatment is transformed into something that helps more patients.

The Trump Administration should reject CMS’ proposed expansion of this failed Biden-era policy. America’s goal should be more cures, more treatment options and better care, not fewer innovations dictated by Washington bureaucrats.