A new proposal from the Food and Drug Administration (FDA) to impose a regulatory framework for laboratory-developed testing services and procedures would hinder medical innovation and result in reduced patient access to essential testing services and procedures, the AMA told the agency.
The FDA last year proposed a risk-based, phased-in approach to regulating laboratory-developed tests—services and procedures that represent the majority of advanced laboratory tests used in patient care. This is a critical part of the practice of medicine supporting physician diagnosis and prognosis and guiding treatment options for patients, the AMA said in comments to the FDA.
Laboratory-developed testing services and procedures are already performed under conditions regulated by an interlocking framework of federal laws, state laws and peer-review deemed authorities, which has allowed for accurate and reliable test design, development and performance with flexibility in meeting patient needs.
“The FDA has offered little evidence of systemic test failure that would justify these sweeping regulatory changes and it does not have the statutory authority to regulate physicians engaged in practice of medicine as it is proposing,” said Chief Executive Officer and Executive Vice President of the AMA James L. Madara, MD. “The agency also does not have the resources to successfully implement its proposal without impeding on the current standard of care and creating marked delays in medical advancement.”
If the proposed FDA framework is finalized, physicians will not be able to offer or discuss alternative testing services, also known as off-label use, that often reflect more recent advancements in medical knowledge than commercial, pre-packaged test kits. This could reduce physicians’ ability to provide high-quality, personalized care. Further, the framework would increase administrative costs for physicians and clinical laboratories, potentially forcing them to limit the number of testing services and procedures they are able to offer.
Read more about the changes the AMA proposed to the FDA’s framework.
