What does Preamble of Old Drugs, New Cures Act do?

This bill aims to amend the Social Security Act It affects the calculation of manufacturer rebates under Medicare and Medicaid Priority research drugs would not be treated as line extensions of existing drugs

What does SHORT TITLE. of Old Drugs, New Cures Act do?

This bill is formally titled the Old Drugs, New Cures Act

What does PRIORITY RESEARCH DRUGS. of Old Drugs, New Cures Act do?

This section amends the Social Security Act to establish a process for designating 'priority research drugs'. Manufacturers can request the Secretary to designate a covered outpatient drug as a priority research drug within 90 days of enactment. A drug qualifies for designation if it has been approved for at least 10 years, the manufacturer is investigating a new indication for it, and the new indication addresses a significant unmet medical need. The new indication must also be for a disease or condition with a high prevalence among beneficiaries of Federal health care programs (at least 33% of claims paid under specified programs). The section excludes priority research drugs from certain Medicaid and Medicare definitions and special rules related to line extension and best price. The Secretary must designate a drug within 60 calendar days of receiving a request if it meets the criteria.

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Old Drugs, New Cures Act

Last updated: 4/1/2025 · Introduced: 4/1/2025

Author: Donald Davis (D-NC)

TL;DR (AI)

The bill establishes a process for designating 'priority research drugs' that have been approved for at least 10 years and are being investigated for new indications that address significant unmet medical needs.
Manufacturers of priority research drugs are excluded from certain Medicaid and Medicare definitions and special rules related to line extension and best price.
The Secretary must designate a drug as a priority research drug within 60 calendar days of receiving a request if it meets the specified criteria, including a high prevalence among beneficiaries of Federal health care programs.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

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