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Gottlieb Outlines New Diagnostics Regulatory Framework

FDA commissioner Scott Gottlieb says the agency is working on a new framework for appropriate regulation of diagnostics so that doctors and patients can get more of the information they need to pursue the right treatment at the right time and for the right patient. In a 9/13 speech to a Friends of Cancer Research forum, he said the agency recognizes that it must be “flexible and open-minded to new approaches that best meet the needs of patients so that patients can have confidence in the results and the treatment that comes from it.”

According to Gottlieb, CDRH has taken such an approach in providing feedback to Congress on proposed diagnostics legislation. “We have embraced a more modern, flexible approach to promote the extraordinary innovation that’s already well underway in this space, while ensuring patient protections,” he said.

Four regulatory concepts that FDA has provided Congress are: 

  •          a consistent approach for all in vitro clinical tests;
  •          a general FDA premarket review focus on evaluating the analytical and clinical validity of a subset of tests that are higher risk, or highly novel and used in circumstances where they can present greater uncertainties that can affect patients, with the possibility that under a new framework, most tests would be exempt from individual premarket review;
  •          a more efficient route to market for technologies that can transform healthcare; and
  •          an efficient approach that leverages, rather than duplicates, the current framework, including requirements that apply to clinical laboratories under the Clinical Laboratory Improvement Amendments, and leverages the laboratory test experience of third-party organizations.

Under such a framework, Gottlieb said, most laboratory-developed tests currently being offered to patients would be grandfathered. All in vitro clinical tests would fall under a unified set of requirements that would also exempt from premarket review many categories of new or subsequently-modified tests, including manual tests, tests for rare disease, and low-risk and low-volume diagnostics.

A proposed precertification pathway would build on an approach that the agency has applied to direct-to-consumer genetic health risk tests. Gottlieb said that for developers that qualify for such a path, precertification would allow for review of a single test, and the validation procedures associated with that test, to serve as an umbrella for clearance of a suite of related tests.

“These accommodations would enable FDA to take a risk-based approach that would focus our resources and expertise on the individual premarket review of certain categories of tests where it’s most needed, including tests that are higher risk and novel, and many companion diagnostics and home-use tests,” Gottlieb says. “Overall, the pathway we’ve described also would allow for earlier patient access to breakthrough technologies, those that are analytically valid and can demonstrate probable clinical validity and have the potential to change the way we identify and treat some of the most challenging conditions to diagnose. We’d work to make these technologies available to patients who might benefit, while taking steps to make sure that these tests meet the standard for full approval to stay on the market. To balance the change in premarket reviews, it’s critical the agency be able to protect patient safety with strong postmarket oversight and enforcement authorities. FDA would require post-approval data as needed and would efficiently monitor the market for adverse events that can identify problematic tests.”

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