ORPHAN Cures Act

Bill 119 HR 946, also known as the Orphan Drug Exclusion Act, aims to make changes to title XI of the Social Security Act in order to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.

Orphan drugs are medications that are used to treat rare diseases or conditions that affect a small percentage of the population. These drugs are often expensive to develop and produce, and as a result, they can be costly for patients who need them.

The Drug Price Negotiation Program was established to help lower the cost of prescription drugs for Medicare beneficiaries by allowing the government to negotiate prices with drug manufacturers. However, there has been confusion and inconsistency in how orphan drugs are treated under this program. This bill seeks to address these issues by expanding the exclusion for orphan drugs, which would allow them to be exempt from certain pricing regulations under the Drug Price Negotiation Program. This would help ensure that patients who rely on orphan drugs have continued access to these medications without facing exorbitant costs. Overall, the Orphan Drug Exclusion Act aims to provide clarity and support for the development and accessibility of orphan drugs for patients with rare diseases, while also working to lower overall prescription drug costs for Medicare beneficiaries.