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Congress to Pass FDA User Fee Bill Without VALID Act, Again Putting Aside LDT Regulation

NEW YORK – Congress is expected to pass a US Food and Drug Administration user fee package that does not include the Verifying Accurate Leading-edge IVCT Development (VALID) Act, meaning regulation of laboratory-developed tests will, at least for the moment, remain an unresolved issue.

Late Thursday, the Senate Committee on Health, Education, Labor and Pensions, and the House Committee on Energy and Commerce agreed to reauthorize the FDA user fee, but left out the VALID Act from the package, hurting the chances that the bill would be passed during the current Congress.

The VALID Act could still be attached to other legislation this year, but the user fee bill, named the Food and Drug Administration Safety and Landmark Advancements Act of 2022, or FDASLA, had been widely viewed as an ideal vehicle for its passage.

Congress must pass FDASLA by the end of the fiscal year, Sept. 30, when the current FDA user fee program expires, or else the agency could have to lay off workers.

VALID aims to resolve decadeslong questions around the FDA's authority to regulate laboratory-developed tests 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 significant amounts of LDT development is done.

“We’re disappointed that Congress won’t get a chance to pass these bipartisan measures this week," said Kathy Talkington, director of health programs at the Pew Charitable Trusts, which has advocated strongly for VALID. "We need to fill critical gaps in FDA’s oversight, and address issues that affect every American."

Talkington added that Pew "continues to strongly support … more consistent regulation for lab-developed diagnostic tests" and urged Congress to "find alternative vehicles to pass these much needed public health reforms before year-end."

Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., first introduced VALID in Congress in March 2020, with an identical bill introduced in the Senate at the same time, sponsored by Sens. Michael Bennet, D-Colo., and Richard Burr, R-N.C. Bucshon and DeGette and Bennet and Burr reintroduced the act in the House and Senate in June 2021.

Because FDASLA was considered "must-pass" legislation and was relevant to diagnostics regulation, it was seen as a strong opportunity for passing VALID, with both Bucshon and Sen. Patty Murray, D-Wash., chair of the Senate HELP committee, saying they hoped to attach VALID to the House and Senate versions of FDASLA, respectively.

When the House passed its user fee reauthorization bill in June, however, VALID was not included. VALID was included in the version of FDASLA that passed out of the Senate HELP committee in June, but cracks in support were apparent, with Burr voting against FDASLA and specifically questioning inclusion of VALID as well as other provisions around orphan drugs and generics.

In July, Burr introduced a "clean" version of the user fee reauthorization bill, the Food and Drug Administration Simple Reauthorization Act, that provided for FDA user fees but cut out many of the other provisions that had been added to FDASLA, including VALID.

Politico reported Thursday that Senate Minority Leader Mitch McConnell is also pushing for a clean user fee bill and has blocked the addition of provisions including VALID.