Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices.
The latest draft of the bill appears to adopt many of the technical suggestions submitted by FDA, but an agency official recently told clinical lab test makers that FDA would be willing to entertain a new approach for precertification.
Laboratory-developed test (LDT) makers generally want to see their tests regulated as lab services by CMS, while in vitro diagnostic (IVD) test makers see a role for FDA oversight.
The 80 health care companies and organizations representing patients, providers, laboratories and diagnostic manufacturers that signed the letter argue that refining and passing the bill would ensure health care providers and patients have access to innovative and high-quality clinical in vitro clinical tests (IVCTs). They say the Verifying Accurate, Leading-Edge In Vitro Clinical Test Development (VALID) Act, if revised, could be enacted this Congress.
In the letter, the stakeholders urge Senate health committee chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA) and House Energy & Commerce Chair Frank Pallone (D-NJ) and ranking Republican Greg Walden (OR) to convene public forms with stakeholders and FDA this spring to discuss ways to revise the draft.
However, Congress is swamped with other health care discussions at the moment. Several days before the letter emerged, a device and diagnostics expert said at the annual Food and Drug Law Institute conference that lawmakers appear to be preoccupied with drug pricing and Affordable Care Act reforms.
“Things like that that seem to be dominating the health care discussion,” said Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, at a panel discussion on diagnostics regulation.
Josephson also noted that some of the initial proponents of the VALID Act discussion draft are no longer on the House and Senate health subcommittees. The draft was initially introduced by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) and Sen. Michael Bennet (D-CO) and former Sen. Orrin Hatch (R-UT).
Of those four, only Bucshon remains on a congressional health subcommittee. While DeGette is still on the greater House Energy & Commerce Committee, Josephson pointed out that stakeholders did not send their letter to Bucshon, DeGette or Bennet.
“Notably, the letter was sent to the chairs of FDA’s committees of jurisdiction rather than the Members who have been working on this,” he said. “That suggests to me the industry is looking for Congressional leadership to step up to keep this moving.”
The expert also pointed out that the VALID Act calls for a user fee program for IVCTs.
“It would be ideal to align [that user fee program] with MDUFA V (which needs to be enacted by 2022 to avoid a lapse in MDUFA funding), and for which negotiations begin next year,” he wrote to Inside Health Policy.
The strength of test makers’ appeal may be in numbers. Susan Van Meter, executive director of AdvaMedDx, told IHP that the range of stakeholders who signed the letter is significant. The list includes test makers such as AdvaMedDx, 23andMe and the American Clinical Laboratory Association; patient advocacy groups such as Friends of Cancer Research and the Society for Women’s Health Research; and physician groups such as the American Society of Clinical Oncology.
“As stakeholders, we remain steadfast in our alignment on the need for diagnostics regulatory reform,” the groups wrote in the letter.
Van Meter told IHP that AdvaMedDx and ACLA agree Congress should create a new regulatory framework for diagnostics that is separate from the framework for medical devices.
AdvaMedDx represents IVD test makers and ACLA represents labs, which produce LDTs. In its comments on the VALID discussion draft, ACLA argued that LDTs should be considered as services and regulated under CMS, not FDA.
However, VALID combines LDTs and IVDs into one new category, IVCTs. In its comments on VALID, AdvaMedDx called for regulating all diagnostic tests under a unified approach, regardless of where a test is developed. However, Van Meter said AdvaMedDx does agree with ACLA on the fundamental principle that diagnostics need a new regulatory framework that is separate from devices.
“I think that’s the important criteria to keep in mind, and we agree on that with ACLA for sure,” she said.
Still, the issue of what counts as a test and what counts as a service continues to be debated. In its press release about the letter, ACLA calls for “continued recognition of diagnostics as distinct services.” Van Meter explained that ACLA wants to ensure there is no overlap of authorities between FDA and CMS.
“But I can see how that language is less precise,” she said, referring to ACLA’s use of the word “services” to describe diagnostics. “But we’re really pleased we’re in agreement with ACLA on these large variables when it comes to modernize the framework.”
Josephson had a similar assessment of the letter.
“The two organizations may have different ideas about what the new framework looks like, but they have both committed publicly to a framework that’s separate from the medical device model,” he said.