AdvaMed seeks diagnostics reform in December budget bill

Regulatory NewsRegulatory News | 13 October 2022 |  By 

When Congress passed the Medical Device User Fee Amendment (MDUFA V) last month, it did so by nixing several ancillary issues from the legislation, in an effort to gain consensus.  Reviving some of those provisions after the mid-term elections will be a priority for AdvaMed, the largest medical device lobby group, the group’s leaders told reporters 13 October.
Scott Whitaker and Michael Minogue, AdvaMed CEO and chair respectively, said the group will continue to fight for a number of those provisions including getting the Verifying Accurate Leading-edge IVCT Development (VALID) Act in the omnibus spending bill that Congress needs to pass in December. The VALID Act would allow the FDA to regulate laboratory-developed tests (LDTs) that are currently only regulated under the Clinical Laboratory Improvement Amendment (CLIA) regulation. [RELATED: Sigh of relief as Congress reauthorizes user fee agreements, Regulatory Focus, 30 September, 2022]
In addition to the VALID Act, Whitaker said AdvaMed would like to get two other key bills in front of lawmakers: one that clarifies when the FDA must issue Certificates to Foreign Governments (CFGs) to show that devices meet the agency’s requirements and another that gives the FDA authority to allow change control protocols for artificial intelligence and machine learning (AI/ML) products.
“We're very focused on trying to make sure that we get all three of these done,” said Whitaker. “There's broad bipartisan support for all of them. It's a matter really of trying to get Congress to align on all the open issues and get them done some time in December.”
Whitaker told Focus that they have not done a head count of the lawmakers who support the three bills but he’s confident that with the bipartisan support for the provisions on the committee level, they will easily make it into the omnibus bill. The bigger issue, he said, was how lawmakers in general will respond to the size of the omnibus bill.
Importantly, Sen. Richard Burr, R-NC, ranking member of the Senate Health, Education, Labor and Pension (HELP) committee, and a key champion of the VALID Act, is retiring at the end of the year.
 “I think the prospects obviously go down a little bit without Senator Burr being in Congress or leading the committee, but I think the issue remains important and so we'll continue to advocate for it,” Whitaker said.
The VALID Act is the result of years of lobbying by the FDA to get new statutory authorities to oversee LDTs. So far, the agency has used its regulatory discretion to refrain from overseeing such products because they were simple diagnoses used in localized settings such as academic labs and hospitals. However, over the years, the FDA has raised concerns that the tests have become more complex, are for more high-risk diseases and are being mass manufactured in many cases.
During the Obama Administration, the FDA initially proposed a draft guidance to use a risk-based approach to regulating LDTs, but reversed its position  before former FDA Commissioner Scott Gottlieb took the helm for the Trump Administration. The agency ignored the guidance and instead put out a white paper arguing for diagnostics reform to protect the American public.
Since then, Gottlieb has repeatedly supported the need for Congress to give the agency new authorities to regulate LDTs including co-authoring an article with former FDA Commissioner Mark McClellan in JAMA Health Forum advocating for reform of FDA oversight of LDTs, among other things.
“The existing [diagnostic regulatory] structure results in a bifurcated framework, in which the location where a test was developed, not what it purportedly does or its complexity, determines how the FDA regulates it,” the authors note. “This configuration is not well suited to facilitating predictable and timely access to increasingly important innovations.”
The main opponents of the VALID Act are medical academic centers who argue the bill would make it too burdensome for their labs to perform tests and ultimately it would diminish patient access to easy, affordable and timely diagnostics.
Whitaker said that AdvaMed might support a carve-out under the VALID Act for  academic medical centers; however, it currently is not “crystal clear” what they want.
“The important thing in VALID and in diagnostics reform is that the regulatory environment needs to be pretty consistent across the entire industry, and patients deserve the right to understand whether a product has gone through the same level of scrutiny when they're relying on it for a diagnosis,” said Whitaker. “Can some be carved out? Maybe. Should all of them be carved out? Probably not. We'll have those conversations with Congress if it's necessary as we go through the rest of the legislative process.”


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