EPIC Act of 2025

The EPIC Act of 2025 extends the required time period for negotiating drug prices under the federal program for biologic drugs. It changes the rule so that biologic drug manufacturers must wait at least 11 years after FDA approval before their drug can be included in price negotiations, starting with the 2028 initial price applicability year. This specifically affects biologic drug manufacturers, as the change applies only to biologics (not small-molecule drugs, which already have different rules). The bill modifies Section 1192(e)(1)(A)(ii) of the Social Security Act to implement this longer waiting period. This is a concrete policy change to the timing of drug price negotiations, not a new program or broader policy shift.