(HealthNewsDigest.com) – CHICAGO – As a result of its longstanding commitment to medical innovation to enhance patient care, the American Medical Association (AMA) yesterday submitted comments to the Food and Drug Administration (FDA) expressing concern that the agency’s proposal to impose a new 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 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 the practice of medicine as it is proposing,” said Chief Executive Officer and Executive Vice President of the American Medical Association, 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.”

Laboratory developed testing services and procedures represent the majority of advanced laboratory tests used in patient care and are a critical part of the practice of medicine, supporting physician diagnosis and prognosis and guiding treatment options for patients. They continue to drive innovation in all areas of medicine and provide a critical safety net to detect and combat bio-threats and infectious disease outbreaks. The current regulatory system of oversight, which is dictated by an interlocking framework of federal laws, state laws and peer-review deemed authorities, has allowed for the development of thousands of tests that are consistently accurate, reliable and clinically relevant. They also offer flexibly in meeting a wide range of varied patient-specific needs.

If the proposed FDA framework and accompanying guidance is finalized, physicians will be precluded from offering or discussing alternative testing services that often reflect more recent advancements in medical knowledge than commercial, pre-packaged test kits, which would reduce their ability to provide high quality, personalized care to their patients. The new regulation would also 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.

“If implemented, the FDA’s framework will prevent patients from accessing established testing services representing the standard of care, leave the country vulnerable to bio-threats and potentially infectious disease outbreaks, and hamper public health programs like newborn screening,” said Dr. Madara. “The new regulation would also inhibit the use of precision medicine, an innovative approach to preventing and treating disease, which physicians and the President of the United States believe will improve the health of the nation.”

In order to ensure physicians can continue to provide patients with the best care possible and innovate to improve upon that care, the AMA urges the FDA to:

• Withdraw the proposed “Framework for Regulatory Oversight of Laboratory Tests” and the proposed “FDA Notification of Medical Device Reporting for Laboratory Developed Tests”;
• Collaborate with the Centers for Medicare and Medicaid Services (CMS) to modernize the existing Clinical Laboratory Improvement Amendments regulations;
• Conduct a comprehensive environmental scan to identify key concerns; and
• Streamline and reform the agency’s regulation of manufacturers of commercial testing kits.

For more information and examples of real world implications of the FDA’s proposed framework, please click here.

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