Don't let technical rule thwart delivery of cutting-edge drugs to Valley patients
OPINION — For years, some of the most effective cancer and immune therapies came with a hidden cost: an afternoon in an infusion chair. That is changing. Scientists have found ways for patients to receive the same benefits of IV treatments in a fraction of the time with a quick shot under the skin. This is an incredible step in medical innovation, giving patients and the clinics that care for them more freedom and flexibility.
Sadly, a proposal pending at the Centers for Medicare and Medicaid Services could put that progress at risk.
A bit of background: Under the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, once a drug has been on the market for a set number of years, Medicare sets the price it pays for a small number of the costliest medicines. The clock starts at FDA approval.
This debate often overlooks that medicine development doesn’t stop the day the FDA first approves it. That approval is closer to a beginning than an end. Much of what we eventually learn about a drug — such as which patients it helps, which conditions it treats and how to administer it safely — comes from research in the years after it reaches the market.
In its proposed rule for the 2029 cycle, CMS would treat certain new combination medicines as the same drug as the IV infusion treatments rather than a new product.
They are not the same drug.
FDA correctly treats these combinations as new drugs, rather than relabeled products as CMS is suggesting. Each requires its own application, its own clinical data and its own manufacturing review.
Companies spend years and significant sums to earn that approval.
The practical effect of this proposed rule is that a newer product, approved years later, could become eligible for price setting on the older product’s timeline.
Unbelievably, the investment clock on the new medicine could effectively start before that medicine even exists. Telling them the finished product is the same as a product that was approved years ago sends a clear message: Don’t bother.
A therapy that takes minutes instead of hours is not the old drug in a new box. It is a physical and chemical improvement in how patients experience care.
CMS wants to ensure that companies cannot use minor changes to game the program and extend a product’s runway. The answer to a narrow risk is a narrow fix, not a broad rule that sweeps in genuine advances along with any bad actors.
The drugs in question are new products that would not have been made available to the public without going through the same thorough process as every other new drug. If developers cannot recoup the immense cost of that process, they will be forced to invest their time and money elsewhere, and patients will suffer.
This matters because investment follows signals. I served at the Department of Health and Human Services in two administrations, and I saw firsthand how quickly companies read Washington’s rules.
In a peer-reviewed study in Therapeutic Innovation & Regulatory Science, researchers found industry-sponsored post-approval trials fell by 38.4% after the IRA passed, with small-molecule drugs down 47.3% because the Medicare Drug Price Negotiation Program now treats small-molecule drugs differently from biologics. Small-molecule drugs become eligible for Medicare price setting seven years after approval, compared with 11 years for biologics. That gives companies four fewer years to earn back what they invest in a pill, including research into new uses.
The reverse is also true. When Washington sends a positive signal, investment follows. For example, in the decade before 1983, fewer than 10 drugs for rare conditions reached the market. Then, Congress passed the Orphan Drug Act without a single recorded objection, and President Reagan signed it into law. Since then, the FDA has approved nearly 800 drugs through its pathway.
Another example is Pediatric Exclusivity,(passed in 1997 and extended in 2002. Congress offered six extra months of market exclusivity to companies that studied their drugs in children. And here’s the good news: When these bills offered drugmakers six extra months of market exclusivity to study their medicines in children, companies responded. FDA and NIH reports (2009, 2016, respectively) show that studies have produced more than 600 updates to drug labels, giving pediatricians real guidance on dosing and safety where they once had to extrapolate from adults. Unlike the IRA, these examples had either unanimous or nearly unanimous votes.
History shows us that when you add more uncertainty to follow-on innovation, fewer of those improvements will reach patients. The converse is true: More innovations follow certainty.
The proposal also runs against principles, such as innovation, patient empowerment and lower costs for seniors. In April 2025, President Trump directed the Department of Health and Human Services to minimize the negative effects of Medicare price setting on American pharmaceutical innovation. HHS now gives patients more control over how and where they receive care. Easier-to-take treatments are more likely to be taken as prescribed, and patients who stick with their treatment tend to avoid costly hospital stays and complications. A rule that discourages the next generation of patient-friendly medicines works against all three.
These new drugs also support lower costs for seniors. CMS has done serious work to bring more predictability to this program. As it finalizes the 2029 rule, it should keep its current approach of treating separately approved products as the distinct medicines they are. That choice would protect the incentive to make the treatment easier and keep the focus on the patient.
Jack Kalavritinos is the founder of a government affairs and strategic communications firm. He wrote this for InsideSources.com. Please submit comments at yourvalley.net/letters or email them to azopinions@iniusa.org. We are committed to publishing a wide variety of reader opinions, as long as they meet our Civility Guidelines.
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