Boosting Lifesaving Operations, Opening Donation Centers Act; BLOOD Centers Act
Summary
H.R. 5791, also known as the BLOOD Centers Act, aims to expedite the approval process for biologics license application (BLA) supplements for blood centers. This would allow blood centers to more quickly add apheresis collection devices to existing licenses at new locations. The bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to establish this expedited process.
Expected Effects
The primary effect will be faster approval times for blood centers seeking to expand their apheresis collection capabilities. This could lead to increased blood donation capacity and improved access to blood products for patients. The expedited process has specific conditions related to the safety record and accreditation of the blood centers.
Potential Benefits
- Faster approval times for blood center expansions.
- Increased blood donation capacity.
- Improved access to blood products for patients in need.
- Streamlined regulatory processes for qualified blood centers.
- Potential reduction in administrative burden for both blood centers and the FDA.
Potential Disadvantages
- Potential for reduced scrutiny of BLA supplements due to the expedited process.
- Risk of overlooking safety concerns if the expedited process is not carefully implemented.
- Possible inequities if smaller blood centers without existing licenses or accreditations are disadvantaged.
- Could create a two-tiered system where some centers benefit from faster approvals while others do not.
- Potential for unintended consequences if the expedited process leads to unforeseen issues with blood product safety or quality.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution (Preamble), as it aims to improve public health by increasing access to blood products. Congress has the power to regulate interstate commerce (Article I, Section 8), which includes the regulation of blood centers and biologics. The bill does not appear to infringe on any specific constitutional rights or limitations.
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).