S.1862 - Optimizing Research Progress Hope And New Cures Act; ORPHAN Cures Act (119th Congress)
Summary
S.1862, the ORPHAN Cures Act, aims to amend Title XI of the Social Security Act, specifically concerning the Drug Price Negotiation Program. The bill seeks to expand and clarify the exclusion criteria for orphan drugs, which are drugs developed for rare diseases or conditions. It modifies the definition of orphan drugs to include those treating "one or more rare diseases or conditions" instead of "only one rare disease or condition."
The bill also stipulates that the Secretary should not consider periods when a drug was designated as an orphan drug when calculating the time elapsed since its approval or licensure. This adjustment is intended to encourage the continued development and availability of treatments for rare diseases.
Sponsored by Senators Barrasso and Heinrich, the bill was introduced in the Senate and referred to the Committee on Finance for further consideration.
Expected Effects
The ORPHAN Cures Act is likely to incentivize pharmaceutical companies to continue developing drugs for rare diseases by providing them with more flexibility in pricing negotiations. This could lead to a greater availability of treatments for conditions that currently have limited or no options.
By clarifying the exclusion criteria for orphan drugs under the Drug Price Negotiation Program, the bill aims to protect the profitability of these drugs, which often have high development costs and small patient populations. This could result in higher drug prices for some patients, but it may also ensure that these life-saving treatments remain available.
The change in definition to include drugs treating "one or more rare diseases or conditions" could broaden the scope of drugs eligible for orphan drug status, potentially impacting the overall cost of the Drug Price Negotiation Program.
Potential Benefits
- Increased Availability of Treatments: By incentivizing the development of orphan drugs, the bill could lead to more treatment options for rare diseases.
- Protection of Innovation: Clarifying the exclusion criteria helps protect the investment made in developing drugs for small patient populations.
- Continued Access to Existing Drugs: The bill ensures that the pricing negotiation program doesn't inadvertently discourage the availability of existing orphan drugs.
- Broader Definition: The change in definition to include drugs treating "one or more rare diseases or conditions" could broaden the scope of drugs eligible for orphan drug status.
- Encourages Research: The bill could encourage further research into rare diseases and the development of new treatments.
Most Benefited Areas:
Potential Disadvantages
- Potential for Higher Drug Prices: Protecting orphan drug profitability could result in higher prices for patients who need these medications.
- Increased Healthcare Costs: Expanding the definition of orphan drugs could increase overall healthcare costs.
- Limited Impact on Common Diseases: The focus on rare diseases may divert resources from research into more prevalent conditions.
- Possible Gaming of the System: Pharmaceutical companies might try to exploit the broader definition to classify more drugs as orphan drugs.
- Uncertainty in Long-Term Effects: The long-term effects on the Drug Price Negotiation Program are uncertain.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution (Preamble), as it aims to promote the health and well-being of individuals with rare diseases. Congress has the power to legislate on matters related to healthcare and drug pricing under its enumerated powers (Article I, Section 8).
However, the bill's impact on individual liberties and rights is minimal. It does not infringe upon any specific constitutional rights or freedoms. The bill primarily focuses on economic and healthcare-related policies.
Overall, the bill seems to fall within the constitutional authority of Congress to regulate commerce and provide for the general welfare.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).