FDA’s Dr. Califf Calls for Diagnostic Regulatory Reform, a Long-Time AdvaMed Priority

  Following a Congressional hearing on “Preparing for and Responding to Future Public Health Security Threats,” AdvaMed, the Medtech Association, released a statement from President and CEO Scott Whitaker echoing the testimony of FDA Commissioner Dr. Robert Califf on the need for a modernized regulatory framework for all in vitro diagnostics.

“Congress has the opportunity this year to pass comprehensive diagnostics reform that assures patients and health care providers that the tests they rely on to make life-changing medical decisions are accurate and reliable,” Whitaker said. “The pandemic made clear the urgent need for a long-overdue modernization of the regulatory framework for all in vitro diagnostics to improve patient health outcomes. AdvaMed will continue working with lawmakers and regulators to develop and implement this framework, and we thank Commissioner Califf for calling on Congress to act.”

Zach Rothstein, Executive Director of AdvaMedDx, the division of AdvaMed that represents manufacturers of vitro diagnostic (IVD) tests and equipment, said, “We agree with Dr. Califf that now is the time for Congress to pass comprehensive diagnostics reform. A modern, tailored regulatory program for diagnostic tests will not only benefit public health but will also position the country to better respond to future public health threats.”

During his testimony, Dr. Califf said, “A modern oversight framework that is specifically tailored to assuring tests work is critical to position ourselves for the future – whether it is to prepare for the next pandemic or to realize the full potential of diagnostic innovation.

“Such a system can balance innovation with assurance of accuracy and reliability for tests. For example, a technology certification approach could provide assurances for most tests without individual FDA review of the tests. These assurances are critical. We have seen many examples of tests that do not work – from COVID-19 tests marketed during the pandemic, to tests that are the sole determinant of which treatment a cancer patient receives. In particular, we are concerned that there may be inaccurate laboratory developed tests, or LDTs, in use today. This puts patient health at risk, undermines our health care system, and hinders the country’s ability to effectively address PHEs.”

Earlier this year, AdvaMed, the world’s largest trade association representing medical technology companies, endorsed the reintroduced Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which creates a modern regulatory oversight of in vitro clinical tests (IVCTs). AdvaMed has long championed passage of the VALID Act, last year urging Congressional leaders to include it in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 and submitting RFIs to lawmakers this month ahead of introduction of the bill.

Additionally, former FDA Commissioners Dr. Scott Gottlieb and Dr. Mark McClellan, in an op-ed in the Journal of the American Medical Association last year, called for an overhaul of diagnostic test regulations. From the op-ed: “The proposed FDA legislation creates a modern framework uniquely tailored to diagnostic tests and the rigor taken by the entities that develop them, including a new pathway to allow the FDA to take a laboratory- or company-based approach to regulation. The FDA would oversee the process used to develop and validate tests, rather than regulating only the tests themselves. Laboratories with good procedures for ensuring the reliability of their tests would, in many cases, be able to market new tests and iterations of existing platforms without undergoing the same premarket adjudications. At the same time, the new pathway would give the FDA clear authority to oversee tests and ensure that all tests meet certain common requirements for demonstrating that they reliably produce the molecular and genomic findings that they are intended to generate.”