CMS Counted a 2020 Reclassification Date for Creon, Delaying Medicare Price Talks by Years, Report Says

A report released by the consumer advocacy organization Public Citizen around August 5, 2026, says CMS quietly gave AbbVie's pancreatic enzyme drug Creon a longer runway before it can be selected for Medicare drug-price negotiation. Under the Inflation Reduction Act, the clock on when a drug becomes a negotiation candidate starts at its first FDA approval. For small-molecule drugs, the threshold is 9 years; for biologics, it is 13 years. Creon was originally approved as a small molecule, but the FDA reclassified it as a biologic on March 23, 2020, the date Congress designated for converting older drugs under the Biologics Price Competition and Innovation Act. Public Citizen says CMS determined that the 2020 reclassification date, rather than the original approval date, starts Creon's eligibility clock. Using that later date effectively extends the period during which AbbVie can set its own price by roughly seven years compared with using the original approval date. More than 185,000 Medicare beneficiaries used Creon in 2024. CMS has not publicly addressed the methodology behind its eligibility determination for Creon. The outcome for Creon may foreshadow how CMS handles other biologics that were reclassified under the same 2020 deeming process in future negotiation cycles.