A little-noticed change in how Medicare counts a drug's age pushed a costly AbbVie medicine out of price negotiation eligibility for an additional seven years, according to an investigative report released by the consumer advocacy group Public Citizen. The current administration has proposed making the change permanent through a new rule.
The drug at the center of the analysis is Creon, a pancreatic enzyme replacement product used by people whose pancreas does not produce enough digestive enzymes, a condition common in cystic fibrosis, chronic pancreatitis, and pancreatic cancer. Public Citizen reports that more than 185,000 Medicare beneficiaries used Creon in 2024, costing Medicare $1.49 billion in gross spending.
This finding belongs to Public Citizen, not to the Centers for Medicare and Medicaid Services. The agency has not published an analysis of the change's fiscal effect and, according to the group, never justified the policy shift when it was made. That distinction matters for how readers should weigh the claim: the underlying eligibility rules are documented federal policy, while the seven-year figure and the characterization of its cost are the advocacy group's calculations.
The Eligibility Clock That Determines When Negotiation Can Begin
The Inflation Reduction Act of 2022 gave Medicare authority to negotiate prices for certain high-spending drugs, but only after a product has been on the market for a defined period. Small molecule drugs, the conventional chemically synthesized medicines that make up most prescriptions, become eligible seven years after FDA approval. Biological products, which are made from living systems, become eligible after 11 years.
That waiting period is not incidental. It is the mechanism Congress used to balance price relief against the industry's argument that immediate negotiation would undercut returns on research investment. Selection happens in cycles, and a drug that misses one cycle's cutoff waits for the next.
Creon sits in an unusual category. It was originally approved and regulated as a small molecule drug. Congress later required the FDA to reclassify a set of older products, including pancreatic enzymes and insulins, as biologics, with the conversion taking effect on March 23, 2020. The stated purpose of that reclassification was to open a pathway for biosimilar competition, which generally lowers prices.
The Change That Reset the Clock
Between the first and second years of the negotiation program, Public Citizen reports, CMS decided that certain drugs converted to biologic status could use their conversion or biologic deeming date rather than their original FDA approval date when calculating whether 11 years had elapsed.
The practical effect is a reset. A product approved years earlier, which would have long since cleared any waiting period, was treated for eligibility purposes as though its regulatory life began at the 2020 conversion.
Public Citizen reports that the drug selected for negotiation in Creon's place accounted for about half a billion dollars less in Medicare spending over the same period, and that Medicare was entitled to much larger mandatory discounts on Creon than on the alternative.
"The Trump administration wants to make permanent a costly Medicare mistake, which creates windfalls for AbbVie and other drug corporations by excluding some expensive biologic drugs from negotiations for years," said Peter Maybarduk, Access to Medicines director for Public Citizen.
Sarah Karlin-Smith, the group's Access to Medicines research director, argued the reclassification is being used contrary to its purpose. "Congress required the FDA to convert these old drugs to biologics so that cheaper alternatives to them could be produced, reducing government costs, not so that industry could evade price negotiations for longer," she said in the group's announcement.
The Practical Stakes for Beneficiaries and Taxpayers
The immediate effect on any individual patient's pharmacy counter is limited, and readers should be careful not to overstate it. Negotiated prices reduce what Medicare pays. Whether a beneficiary's own out-of-pocket cost falls depends on plan design, and the annual out-of-pocket cap in Part D now provides more protection than the negotiation program does for most people.
The larger consequence is fiscal. Medicare Part D spending is funded through beneficiary premiums and general revenue. Drugs that remain outside negotiation continue at manufacturer-set prices, and that spending is distributed across premiums and taxpayers. Total Medicare spending on the 40 drug products selected for negotiation so far accounted for 36% of total Medicare spending on drugs covered under Part B and Part D in 2024, according to KFF, or $125 billion out of $350 billion.
For patients who rely on pancreatic enzyme replacement, the practical concern is different and more immediate: these products are dosed by weight and meal, monthly costs are high, and the products are not interchangeable in the way generic pills often are. Anyone struggling with cost should ask their prescriber about manufacturer patient assistance programs, Medicare Extra Help, and whether an alternative enzyme product is clinically appropriate. No one should reduce their enzyme dose to stretch a prescription without speaking to their clinician, because inadequate enzyme replacement causes malabsorption and weight loss.
The Open Questions
Several things remain unresolved. CMS has not publicly explained the reasoning behind the original eligibility interpretation, and MedicalDaily found no agency response addressing Public Citizen's specific calculations. The proposed rule codifying the approach is not final, which means the policy could still change through the rulemaking process.
It is also not established what Medicare would have saved had Creon been selected earlier. Negotiated prices are the product of a negotiation, and assuming a specific discount would be speculation. What the analysis establishes is that a higher spending drug with larger available statutory discounts was not selected, and that a rule interpretation is the reason.
MedicalDaily has previously covered proposals to make elements of the negotiation program permanent. The comment period on federal rulemaking is when beneficiaries, clinicians, and organizations can weigh in.
Key Questions Answered
What is the reported change? Public Citizen says CMS decided that older drugs reclassified as biologics in 2020 could use that reclassification date, rather than their original FDA approval date, when calculating negotiation eligibility. That effectively restarted the waiting period.
Is this a CMS finding? No. It is an analysis by an advocacy organization. CMS has not published its own assessment, and according to the group, never justified the change when it was made.
How long must a drug be on the market before Medicare can negotiate its price? Seven years after approval for small molecule drugs and 11 years for biological products, under the Inflation Reduction Act.
What is Creon used for? It is a pancreatic enzyme replacement therapy for people whose pancreas does not produce enough digestive enzymes, a problem common in cystic fibrosis, chronic pancreatitis, and pancreatic cancer.
Will this change what patients pay at the pharmacy? Not directly in most cases. Negotiated prices primarily reduce what Medicare pays. Individual out-of-pocket costs depend on plan design and are now also limited by the Part D annual cap.
What should patients do if enzyme costs are unaffordable? Ask the prescriber about manufacturer patient assistance programs, apply for Medicare Extra Help, and ask whether a different enzyme product is clinically suitable. Do not reduce doses without medical guidance.
Is the policy final? No. The administration has proposed making it permanent through rulemaking, which is not yet complete.
