ORPHAN Cures Act

The ORPHAN Cures Act aims to modify the Medicare Drug Price Negotiation Program by expanding and clarifying the exclusion for orphan drugs. This legislation amends the Social Security Act to ensure that drugs designated for one or more rare diseases or conditions are eligible for this exclusion, broadening the current definition which limited it to drugs for only one rare disease. A key provision also clarifies that any period during which a drug holds orphan drug status will not be counted when determining the time elapsed for its eligibility in the drug price negotiation program. This effectively pauses the negotiation clock for drugs while they are being developed or marketed for rare diseases, potentially extending their period of exclusion from price negotiation.