Bill > S3019

This bill amends the Social Security Act to modify how orphan drugs are treated under the Medicare Drug Price Negotiation Program. Specifically, the bill changes the financial threshold for orphan drugs, which are medications designed to treat rare diseases affecting small patient populations. Under the current law, drugs with annual Medicare sales below $200 million are exempt from price negotiations. This bill increases that exemption threshold to $400 million for drugs that are designated specifically for one or more rare diseases and have no other approved medical indications. The changes would take effect for initial price applicability years beginning on or after January 1, 2028. By raising the sales threshold, the bill provides additional protection for pharmaceutical companies developing treatments for rare diseases, potentially incentivizing continued research and development in this challenging medical market segment. The bill's short title, the "No Big Blockbuster Bailouts Act," suggests an intent to prevent large pharmaceutical companies from exploiting orphan drug designations while still supporting drug development for rare disease treatments.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/3019/all-info