Bills of Congress by U.S. Congress

No Big Blockbuster Bailouts Act

Summary

The "No Big Blockbuster Bailouts Act" (S. 3019) aims to amend Title XI of the Social Security Act, specifically concerning the Medicare Drug Price Negotiation Program. The bill focuses on the treatment of orphan drugs, which are drugs designated for rare diseases or conditions. It seeks to modify the financial thresholds that trigger price negotiation for these drugs under Medicare.

Specifically, the bill adjusts the calculation of the revenue threshold for orphan drugs, potentially allowing for higher revenue before negotiation is triggered. This adjustment is intended to support the development and availability of treatments for rare diseases. The changes would apply to initial price applicability years beginning on or after January 1, 2028.

Expected Effects

The primary effect of this bill, if enacted, would be to alter the financial incentives surrounding the development and pricing of orphan drugs under the Medicare program. By raising the revenue threshold that triggers price negotiation, the bill could lead to higher prices for some orphan drugs, at least initially. This could impact patient access and healthcare costs.

However, it could also encourage pharmaceutical companies to invest in research and development for treatments for rare diseases, as the potential for higher returns may offset the risks associated with developing drugs for smaller patient populations. The long-term effects on drug pricing and availability will depend on how pharmaceutical companies respond to the changed incentives.

Potential Benefits

  • Encourages Orphan Drug Development: By increasing the revenue threshold before negotiation, the bill incentivizes pharmaceutical companies to invest in developing treatments for rare diseases.
  • Potential for More Treatment Options: Increased investment could lead to the development of more drugs for rare diseases, providing more treatment options for patients.
  • Supports Pharmaceutical Innovation: The bill supports innovation in the pharmaceutical industry by providing a more favorable financial environment for orphan drug development.

Potential Disadvantages

  • Potential for Higher Drug Prices: Raising the revenue threshold could lead to higher prices for orphan drugs, increasing healthcare costs for patients and the Medicare program.
  • Reduced Negotiation Power: The government's ability to negotiate lower prices for some orphan drugs may be weakened.
  • Limited Impact on Overall Healthcare Costs: The focus on orphan drugs means the bill's impact on overall healthcare costs may be limited, as these drugs represent a relatively small portion of total drug spending.

Constitutional Alignment

The bill appears to align with the general welfare clause of the Constitution (Preamble), as it aims to promote the development of treatments for rare diseases. Congress has the power to regulate healthcare through the Social Security Act under the powers granted in Article I, Section 8, which allows Congress to collect taxes and provide for the general welfare of the United States.

However, the specific provisions related to drug pricing and negotiation are policy choices that fall within the purview of Congress's legislative authority. There are no apparent constitutional conflicts arising from this bill.

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).