Urge Congress to Protect Life-Saving Blood Tests

Your Voice Matters: Take Action Now

The current system allows blood centers to use reliable, validated lab developed tests (LDTs) to quickly ensure the safety of blood products, but new FDA rule threatens to introduce unnecessary delays in this process, impacting patient care. Here's why you should care and take action:

• Save Lives: Your action can help prevent delays in critical blood transfusions and medical procedures. By urging Congress to remove redundant regulations, you're directly contributing to faster, more efficient life-saving care.

• Protect Healthcare Access: Excessive regulation threatens to increase costs and reduce the availability of vital blood tests, particularly in rural or underserved areas. Your voice can help ensure all Americans have access to essential blood services.

• Advance Medical Innovation: By advocating for the removal of unnecessary regulatory burdens, you're supporting an environment that fosters the development and implementation of new, potentially life-saving blood tests and treatments.

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Dear Office Holder (names will be automatically added on each email),

Blood centers have developed and utilized lab developed tests that are lifelines in urgent, life-saving situations. The quality and validity of these tests are already ensured by a comprehensive regulatory framework including Federal, State, or local facility licensure, Clinical Laboratory Improvement Amendments (CLIA) certification, and compliance with extensive FDA regulatory requirements, state specific requirements, and accreditation standards. Yet, despite these safeguards, in May 2024, the FDA issued a final rule subjecting in vitro diagnostic products (IVDs) to additional regulatory burden. This rule when implemented will affect lab developed tests (LDTs) utilized by blood centers, potentially impacting critical, life-saving procedures.

The current framework already includes a multi-layered approach providing rigorous oversight and regular inspections. The additional FDA regulations are redundant burdens on blood centers without providing any increase in patient care. Indeed, these regulatory burdens will likely hinder patient care by introducing unnecessary delays and reduced availability of needed tests.

We urge Congress to support 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” introduced by Rep. Finstad (MN-1) and Rep. Crenshaw (TX-2).

Thank you for your focus on this matter and for making strengthening America’s blood supply a national priority. I look forward to your prompt reply.

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Sincerely,

[Your name here]

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