Decision is a victory for patient care and laboratory innovation
Washington, DC – America’s Blood Centers (ABC), the national organization of community-based, independent blood centers that supply 60 percent of the nation’s blood supply, released the below statement, following the Trump Administration’s decision not to appeal the March 31st federal court ruling that invalidated the Food and Drug Administration’s (FDA) final rule regulating laboratory-developed tests (LDTs). FDA had 60 days to appeal this decision, but that May 30 deadline passed, indicating the Trump administration has chosen not to support the rule. ABC has been working as part of its Advocacy Agenda to exempt LDTs used by blood centers from new diagnostics regulations to protect patient access to life-saving care while maintaining a safe and reliable blood supply.
“The fact that this ruling will stand ensures that vital testing for patient care remains accessible and affordable, marking a significant victory for the laboratory community and the patients they serve,” said Kate Fry, Chief Executive Officer at ABC. “The court’s decision, now final, prevents unnecessary regulatory burdens that would have hindered innovation and potentially limited patient access to critical diagnostic tests. This outcome allows community blood centers to continue focusing on their primary mission: providing safe, reliable blood products to patients in need.”
Founded in 1962, America’s Blood Centers (ABC) is the national organization bringing together community-based, independent blood centers across North America. These organizations operate in more than 1,100 communities and provide close to 60 percent of the U.S. and a quarter of the Canadian blood supply. ABC member organizations serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities. All ABC U.S. members are 501(c)(3) organizations licensed and regulated by the U.S. Food and Drug Administration or Health Canada. For more information, visit www.AmericasBlood.org.
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