H.R.946 - Optimizing Research Progress Hope And New Cures Act; ORPHAN Cures Act (119th Congress)
Summary
H.R.946, the ORPHAN Cures Act, aims to amend Title XI of the Social Security Act to refine the exclusion criteria for orphan drugs under the Drug Price Negotiation Program. The bill seeks to broaden the definition of 'rare disease or condition' and to clarify how the approval timeline for orphan drugs is calculated, specifically regarding periods when a drug held orphan status. This adjustment intends to encourage pharmaceutical companies to continue developing treatments for rare diseases by ensuring more predictable market exclusivity and pricing considerations.
Expected Effects
The primary effect of this bill would be to modify the Drug Price Negotiation Program to provide more incentives for the development of orphan drugs. By expanding the definition of rare diseases and adjusting the timeline calculations, the bill could lead to increased investment in treatments for conditions affecting smaller patient populations. This could result in more available treatment options for individuals with rare diseases.
Potential Benefits
- Increased Investment in Orphan Drug Development: By clarifying and expanding the exclusion criteria, the bill incentivizes pharmaceutical companies to invest in developing treatments for rare diseases.
- More Treatment Options for Rare Diseases: The changes could lead to more available and affordable treatments for individuals with rare diseases.
- Reduced Financial Burden on Patients: By ensuring that orphan drugs are not prematurely subject to price negotiation, the bill helps maintain market incentives that support continued research and development, potentially leading to lower long-term costs through competition.
- Support for Innovation: The bill supports pharmaceutical innovation by providing a more predictable regulatory and pricing environment for orphan drugs.
- Improved Healthcare Access: By encouraging the development of orphan drugs, the bill improves healthcare access for patients with rare diseases.
Potential Disadvantages
- Potential for Increased Drug Prices: Delaying price negotiation for orphan drugs could result in higher drug prices in the short term.
- Limited Impact on Overall Healthcare Costs: The focus on orphan drugs may not significantly impact overall healthcare costs, as these drugs typically affect a smaller patient population.
- Complexity in Implementation: The changes to the Drug Price Negotiation Program could introduce complexity in implementation and enforcement.
- Risk of Gaming the System: There is a potential risk that pharmaceutical companies could exploit the expanded definition of rare diseases to maintain market exclusivity for longer periods.
- Uncertainty in Long-Term Effects: The long-term effects of the bill on drug development and pricing are uncertain and may require further evaluation.
Constitutional Alignment
The bill appears to align with the Constitution's general welfare clause (Article I, Section 8), which allows Congress to enact laws that promote the well-being of the population. By encouraging the development of treatments for rare diseases, the bill aims to improve public health. There are no apparent conflicts with specific constitutional provisions regarding individual rights or federalism. The bill operates within the established framework of the Social Security Act and the Federal Food, Drug, and Cosmetic Act, which have been subject to constitutional scrutiny and generally upheld.
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).