I benefited from Medical Innovation. Thanks to the IRA, Future Patients May Not.

By John Czwartacki, Founder & Chairman

More than three years after the Inflation Reduction Act (IRA) was signed into law, the consequences of its drug pricing provisions are no longer hypothetical warnings. For the hopes of patients like me, the impact on the development of cures is already devastating.

I’ve participated in the Centers for Medicare & Medicaid Services’ (CMS) “listening sessions” on the IRA’s drug pricing provisions for the past several years. Each time, I’ve made my stance clear: this program, which is effectively government price-setting, puts future innovation at risk. Even though the format and tone of these sessions have changed annually, my concerns have remained.

This year, CMS once again invited stakeholders to provide their feedback. Always ready and eager to share the patient experience with policymakers, I once again offered to participate. However, my offer was rebuffed for reasons I’m not privy to.

My absence doesn’t change what needs to be said. Nor will I ever stop alerting Washington to the downstream consequences of the IRA on patients.

If I had been granted the opportunity this round, I would have made one thing clear from the outset: in just three years, the IRA is already choking the innovation that fuels our hope by stifling and redirecting the research and development of new treatments and cures. For patients, that’s not just a cold fact on an industry cap table: it’s a life-altering reality.

I know this because I have been on the other side of it.

As someone who has lived with multiple sclerosis (MS) for more than 30 years, I have experienced life with limited (or in my case, zero) treatment options. I am fortunate that public policy once encouraged innovation and incentivized American discovery to attack my disease’s progression. It made it a viable pursuit to seek medical breakthroughs that gave me, and millions of other patients, the opportunity to live our best lives. The development of treatments for my condition did not happen by accident. These breakthroughs occurred thanks to a systemic and bipartisan posture that sought better health for all American citizens… until the IRA made it official policy to find fewer cures and derail decades of progress.

Now, thanks to the IRA’s Medicare Drug Price Negotiation Program (MDPNP), today's patients will not have the same hope of the previous generation.

The IRA took an idea that has only resulted in shortages and despair and made it its hallmark: price fixing and government drug price-setting policies. What Washington calls “negotiation” is nothing more than an involuntary arrangement in which one party, the federal government tells manufacturers to submit to predetermined, artificially-set prices. When the government sets the price of a medicine, it directly alters how capital markets allocate investment into medical research.

The meddling of Washington now makes investing in cures too risky. That was our fear, and it’s now our reality.

Early reporting and industry tracking suggest a pullback in investment, particularly in high-risk areas like cancer, rare diseases, and chronic conditions. These are the exact fields where innovation is the hardest and most necessary. Right when the IRA was passed, experts expressed concerns about its impact on research and development capabilities. As of 2021, bringing a new drug to the market costs billions of dollars in investment, and only 12 percent of all drugs entering clinical trials became approved by the FDA. Price-setting policies, like those in the IRA, suppress investment funding and innovation. This has a substantial real-world impact: a life sciences tracker now indicates 26 drugs and 56 research programs have been discontinued since the IRA’s passage.

And when innovation is not prioritized in the U.S., developers must look elsewhere. The global community no longer relies solely on the United States for biopharmaceutical innovation. Countries like China are aggressively positioning themselves as more attractive environments for research and development. With fewer pricing constraints and more predictable policy, China is drawing in capital, clinical trials, and scientific talent because domestic price-setting policies make the United States an unattractive home base for developers.

This is the part lawmakers seem unwilling to confront: unfavorable conditions at home push innovation abroad. When innovation is pushed elsewhere, American patients face delays in cutting-edge treatments, if they receive them at all.

CMS continues to solicit feedback, but the IRA is already causing unretractable harm to innovation. We are already seeing warning signs in domestic investment trends and global competitors filling the gaps. If we stay on this path, we will continue to see the devastating consequences of fewer new treatments reaching the patients who need them most.

The Medicare Drug Price “Negotiation” Program needs to be reevaluated or halted altogether to protect America’s development pipeline. Once innovation slows, restarting it isn’t as simple as flipping a switch. Missed opportunities rarely return, and patients cannot afford that risk.

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