Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical tests from premarket review.
In technical assistance sent at lawmakers’ request on Aug. 3, FDA suggests the following specific revisions to the draft bill, Diagnostic Accuracy and Innovation Act (DAIA): remove review timeframes; add a precertification program, rely on a robust third-party reviews; narrow the bill’s risk categories from three to two; and scrap the idea of a new FDA center to review clinical laboratory tests.
Remove review timelines: FDA suggests removing language that would require the agency reach a decision about a submission within a given number of days. While the industry representatives did not comment directly on FDA’s omission of timeframes, they stressed that timely access to new tests would be vital for patients.
“The devil is in the details, but supporting timely access will be very important,” industry representatives told Inside Health Policy about FDA’s suggested legislative revisions, sent to DAIA sponsors Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO).
Add precertification program. The industry officials said that one concept in FDA’s technical assistance document that was not originally in the DAIA discussion draft is a precertification program, where precertified test developers would not be subject to premarket review. Industry reps said FDA recommended a precertification program for diagnostic tests in their initial comments on DAIA in May.
In some ways, they said, the program already exists for certain firms. In March, FDA announced it would exempt from premarket review future tests from the direct-to-consumer genetic health testing service 23andMe. The industry reps said use of a precertification program would expand upon one of the DAIA discussion draft’s fundamental concepts, to provide “a predictable and timely path to market for these increasingly important clinical tests,” as described by the bill’s sponsors in a 2017 summary of the draft.
Use third-party reviewers. Industry reps said another concept in FDA’s Aug. 3 technical suggestions, which is already in motion, is the use of third party organizations to review new tests. In November 2017, FDA announced the accreditation of the New York State Department of Health as an FDA third-party reviewer of in vitro diagnostics. The state health department’s prior review of a tumor profiling test developed by The Memorial Sloan Kettering Cancer Center expedited FDA’s review and authorization of the test, the agency said in November.
“Between 23andMe and Memorial Sloan Kettering, we’re seeing this happening,” the industry reps said. FDA’s inclusion of precertification and third-party review in its Aug. 3 submission to the lawmakers, the industry reps said, represents the agency working to cement those concepts within its regulatory authority.
“Third-party review has always been a priority for stakeholders,” one industry rep said. “I think what FDA’s done is to say: ‘We want a really robust and meaningful program.’”
Establish fewer risk categories. Another difference between the concepts included in FDA’s Aug. 3 submission to the lawmakers and the DAIA discussion draft is how the two documents handle risk classification for tests. The lawmakers’ draft bill would set up three risk categories of tests: high, medium and low. FDA’s plan envisions just two risk categories: high and low. Industry representatives interpreted the suggested change as FDA grouping medium-risk and low-risk devices into one category that could be reviewed more quickly through the use of special controls and pathways such as the precertification program. That way, more resources could be devoted to the swift evaluation of high-risk tests, they said.
Scrap idea of a new FDA center. FDA also suggested several other changes to the draft bill, such as eliminating lawmakers’ idea of setting up a new agency center to oversee clinical laboratory tests.
Industry representatives said differences between FDA’s approach and that of the lawmakers are part of the process.
“I think we would expect that there would be some differences. We know this is going to be an iterative process,” one rep said.
The industry reps said they have not yet finished reviewing all of FDA’s suggested legislative changes to the draft bill, but so far they are encouraged by what they see.
To show widespread stakeholder excitement regarding FDA’s suggestions, the industry reps referred to a letter written to the heads of the House Energy & Commerce and Senate health committees on Wednesday (Aug. 8) by 12 diverse stakeholder groups, including Friends of Cancer Research, American Clinical Laboratory Association, AdvaMedDx and Biotechnology Innovation Organization.
The stakeholders wrote that the FDA proposal “represents an important and necessary next step in the pursuit of comprehensive legislative reform.”