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VALID Act's Passage Now Likely to Hinge on Inclusion in End-of-Year Federal Spending Package


NEW YORK – The passage in Congress last week of a "clean" US Food and Drug Administration user fee bill could mean the longstanding question of laboratory-developed test (LDT) regulation will continue to go unresolved.

Many industry observers saw the user fee bill as a likely vehicle for passing the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give the FDA oversight of LDTs. Legislators instead included the user fee bill without VALID in a short-term continuing resolution, giving VALID opponents a victory (at least temporarily) and leaving advocates looking for a new bill to which they might attach the law.

VALID aims to resolve decadeslong questions around the FDA's authority to regulate LDTs by placing them within the agency's purview. The legislation creates a risk-based framework for in vitro clinical test (IVCT) regulation, with high-risk tests, such as novel assays, required to go through premarket review, while lower-risk tests could go to market after passing through technological certification. VALID would grandfather in LDTs currently in clinical use.

The bill has generally been favored by the in vitro diagnostics industry — which sees it as ending certain regulatory advantages enjoyed by LDTs and providing new flexibility around diagnostics regulation — and opposed by clinical labs, especially those at academic medical centers where a significant amount of LDT development is done.

VALID was one of a number of provisions, including riders addressing dietary supplement and cosmetics regulation and dealing with accelerated drug approvals, that lawmakers sought to attach to FDA user fee renewal. Ultimately, though, they were unable to agree on which of these provisions to include and, facing a Sept. 30 deadline for the user fee bill, they decided to pass it without most of these riders.

The likeliest route for VALID passing in 2022 is now as part of a year-end spending package.

"We see a potential pathway forward for [VALID] and other FDA-related policies in any large end-of-the-year package," said Susan Van Meter, president of the American Clinical Laboratory Association (ACLA). Though ACLA has not advocated for VALID specifically, it has advocated for reform of diagnostics regulation more generally and has not opposed VALID as the bill has moved through the legislative process this year. The organization has provided a number of recommendations on the law to Congress.

Kathy Talkington, director of health programs at the Pew Charitable Trusts, which has strongly supported VALID and greater oversight of LDTs, continued to push for the bill, urging Congress to "find alternative vehicles to pass these much needed public health reforms before year-end."

An industry observer, who asked not to be identified, said that Congress appears likely to take another stab at some of the provisions left out of the user fee bill, noting that while FDA user fees won't be up for consideration again until 2027, several high priority programs that were included in last week's continuing resolution will need to be renewed by Dec. 16, giving lawmakers reason to revisit these and other provisions — potentially including VALID — that were discussed as part of the user fee bill. The programs needing renewal include orphan drug grants and children's pharmaceuticals and device programs.

In VALID's favor is the fact that Congress' decision to pass a "clean" user fee bill was not primarily driven by disputes over VALID. For instance, while Sen. Richard Burr, R-N.C., who, with Sen. Patty Murray, D-Wash., introduced VALID in the Senate, voted against the user fee bill in the Senate Committee on Health, Education, Labor, and Pensions (HELP) and introduced a clean user fee bill in July, his opposition appeared more focused on other riders that lawmakers had sought to attach, such as provisions dealing with disclosure of brand-name drug ingredients to generic pharma manufacturers and with orphan drug exclusivity. Burr also cited Democrats' efforts to pass legislation through reconciliation that would allow Medicare to negotiate drug prices.

"There were many larger political dynamics in play," said Van Meter.

Another potential point in VALID's favor is the fact that Murray and Burr are, respectively, the chair and ranking member of the relevant committee, HELP, and have made passage of the bill a priority. Burr is retiring at the end of his term, meaning this is his last chance to push VALID through.

It is less clear that VALID is a priority for House leadership. Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., introduced the bill in the House, but it was not included in the user fee reauthorization bill that passed the House by a vote of 392-28 in June.

In a statement issued last week, Rep. Frank Pallone, D-N.J., and chair of the House Energy and Commerce Committee, said that E&C and HELP committee leaders are "committed to returning to the negotiating table ahead of the December government funding deadline to revisit" provisions left out of the continuing resolution, and added that he planned to "continue pushing to advance as much of the House-passed legislation as possible" — legislation that, again, did not include VALID.

Van Meter said that if VALID doesn't pass this year, she and ACLA will continue to support reform of LDT oversight along the lines laid out by the bill.

She cited as essential principles for ACLA that the reform be done legislatively, that regulation is done in a risk-based manner, and that it operates in a diagnostic-specific framework.

This last principle has been key to the IVD industry's support of VALID, as well, with stakeholders in that space seeing the bill as a chance to move their tests out of a medical device regulatory framework that they say is poorly suited to diagnostics.

Features like VALID's provision for a "technology certification" pathway, which would allow test developers to launch low-risk tests on certain certified technology platforms without going through premarket review, could offer IVD manufacturers more flexibility to iterate and update their products than they enjoy under current FDA regulations.

"We have so much in front of us for the rest of 2022," Van Meter said. "If VALID doesn't move forward this year, we'll be looking to work in collaboration with our members and bipartisan leaders in the Congress to contemplate what could come next."

Among the bills that could get caught up in the end-of-year legislative logjam is one that is especially high priority for the lab industry, the Saving Access to Laboratory Service Act, or SALSA, which would modify the Protecting Access to Medicare Act (PAMA) by instituting a sampling-based approach to collecting lab test pricing data and placing caps limiting the maximum price cut or rise a test could see under PAMA to 5 percent a year.

While VALID enjoys mixed support at best from the lab industry (with organizations like the College of American Pathologists for it and others like the American Association for Clinical Chemistry and the Association for Molecular Pathology opposed), SALSA is supported by a wide swath of laboratory and medical provider organizations.

The bill's advocates argue that the sampling-based approach would both ease administrative burdens on labs and ensure the price data is collected from a more representative slice of the industry. It would also stop price cuts scheduled under current law to go into effect at the start of 2023, making the matter an urgent one for the lab industry.

"It's definitely a challenge to work on two major pieces of legislation; there's no question about that," Van Meter said of trying to ensure SALSA's passage while also working to move VALID forward. "But we are very much geared up to be fully engaged on both of those issues. We are going to expend significant resources and focus on the work we need to do to stay constructively engaged on VALID and to see SALSA included in the end-of-year package."