H.R.1463 - To prohibit the use of Federal funds to implement, administer, or enforce a final rule of the Food and Drug Administration relating to Medical Devices; Laboratory Developed Tests, and for other purposes. (119th Congress)
Summary
H.R. 1463 aims to prohibit the use of federal funds to implement or enforce a Food and Drug Administration (FDA) rule concerning medical devices and laboratory-developed tests (LDTs). The bill specifically targets a final rule submitted for publication on May 6, 2024. The bill was introduced in the House of Representatives by Mr. Finstad and Mr. Crenshaw and referred to the Committee on Energy and Commerce.
The core intent is to limit the FDA's regulatory authority over LDTs by restricting the agency's funding for related activities. This action reflects concerns about the potential impact of the FDA rule on the availability and innovation of medical tests.
Ultimately, the bill seeks to maintain the existing regulatory landscape for LDTs, preventing increased federal oversight.
Expected Effects
If enacted, H.R. 1463 would prevent the FDA from using federal funds to implement or enforce its final rule on medical devices and LDTs. This would effectively block the FDA from increasing its regulatory oversight of LDTs.
The practical effect would be to maintain the status quo, where LDTs are subject to less stringent regulation than other medical devices. Laboratories could continue to develop and offer tests without complying with the FDA's proposed requirements.
This could lead to a debate about patient safety versus innovation in the LDT sector.
Potential Benefits
- Reduced Regulatory Burden: Limits regulatory burden on laboratories developing and offering LDTs, potentially fostering innovation.
- Cost Savings: Prevents the expenditure of federal funds on implementing and enforcing the FDA rule.
- Preservation of Access: May preserve access to certain LDTs that might be withdrawn from the market due to increased regulatory costs.
- Support for Small Labs: Could benefit smaller laboratories that may struggle to comply with more stringent FDA regulations.
- States' Rights: Reinforces the role of states in regulating healthcare within their jurisdictions.
Most Benefited Areas:
Potential Disadvantages
- Potential Patient Safety Risks: Reduced FDA oversight could lead to concerns about the accuracy and reliability of LDTs, potentially endangering patient safety.
- Lack of Uniform Standards: Without federal regulation, standards for LDT quality and performance may vary, leading to inconsistencies in healthcare.
- Hindered Innovation: While some argue it fosters innovation, others contend that lack of regulation could stifle innovation by allowing substandard tests to proliferate.
- Reduced Transparency: Less FDA oversight could reduce transparency regarding the performance and validation of LDTs.
- Erosion of Public Trust: If unregulated LDTs lead to inaccurate results or harm, it could erode public trust in the healthcare system.
Most Disadvantaged Areas:
Constitutional Alignment
The bill's constitutional alignment is primarily related to the balance of power between the legislative and executive branches. Congress has the power of the purse (Article I, Section 9, Clause 7), granting it significant control over how federal funds are spent. H.R. 1463 exercises this power by restricting funding for a specific FDA rule.
Arguments against the bill might cite the Commerce Clause (Article I, Section 8, Clause 3), suggesting that the FDA's regulation of medical devices and LDTs falls under the federal government's authority to regulate interstate commerce. However, the bill does not directly prohibit the FDA from regulating LDTs but rather restricts the use of federal funds for that purpose.
Therefore, the bill appears to be a legitimate exercise of Congress's spending power, although its policy implications are subject to debate.
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).