Current Food and Drug Administration (FDA) user fees for prescription drugs, generic drugs, biosimilars, and medical devices are set to expire at the end of September and draft legislation for their reauthorization is moving forward in both houses of Congress. The looming deadline for passage is important not only in terms of the user fees’ potential $1.9 billion impact, but also for those trying to tie diagnostic testing reform to FDA user fee legislation.
As Applied Policy reported in March, two pieces of legislation, representing decidedly different perspectives on the longstanding—and sometimes heated—debate over which federal agency should exercise oversight of diagnostic testing, have been vying for passage in Congress.
The bipartisan Verifying Accurate Leading-edge IVCT Development (VALID) Act, originally introduced by Sens. Michael Bennett (D-CO) and Richard Burr (R-NC), would give the FDA sole authority over in vitro clinical tests or IVCTs—a new category of products, which would include both in vitro diagnostic products and laboratory developed tests (LDTs).
By contrast the Verified Innovative Testing in American Laboratories (VITAL) Act, which was introduced by Sen. Rand Paul (R-KEN), would give the Centers for Medicare & Medicaid Services (CMS) sole authority over the regulation of laboratory-developed testing procedures, specifying that “no aspects of laboratory-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act… including during a public health emergency.”
Observers have long expected that linkage to the reauthorization of FDA user fees would be the vehicle for one bill to succeed and, based upon committee outcomes in May, the VALID Act seems to be inching forward.
The Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA) released by the Senate Committee on Health, Education, Labor and Pensions (HELP) on May 17 incorporates a slightly modified version of the VALID Act as its Subtitle C, noting that the subtitle may be cited as the ‘‘Verifying Accurate Leading-edge IVCT Development Act of 2022’’ or the ‘‘VALID Act of 2022.’’
The inclusion of the original VALID Act’s model for a risk-based framework for the FDA’s regulation of LDTs in FDALSA was not surprising given that the HELP Committee’s ranking member, Sen. Burr, was one of the original sponsors of the bipartisan legislation.
Inclusion of the VALID Act in the Senate bill came despite the request of a coalition of healthcare and public health professionals, including the American Medical Association and Medical Group Management Association, which had advocated for the act to be considered independent of any other legislation.
The House Energy and Commerce Committee voted unanimously to advance its own FDA user fee reauthorization legislation on May 18. In contrast to the Senate legislation, H. R. 7667 does not incorporate either the VALID Act or the VITAL Act, although it does include other riders. Committee Chairman Frank Pallone, Jr. (D-NJ) described the bill as having “been crafted with consensus in mind from the start.” During its markup, committee members Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IND), co-sponsors of the VALID Act in the House, noted the omission of VALID language and expressed hope that the VALID Act would be part of the final legislation as agreed to by both chambers through reconciliation.
The VITAL Act, which has previously been endorsed by the Association for Molecular Pathology and the Association of Pathology Chairs, appears not to have gained traction. However, it is reasonable to expect that discussion of the inclusion of the VALID Act in the Senate bill will spark renewed debate over regulatory jurisdiction of diagnostic testing in the coming weeks.
Applied Policy will continue to watch developments on the Hill and to keep our readers informed.
Further information: An overview of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA), including a breakdown of the VALID Act as incorporated, is available here.
There are some important differences between the original Verifying Leading-edge IVCT Development (VALID) Act, and the VALID Act as incorporated in FDASLA:
- While the original version of the VALID Act would have established a two-tiered framework—high risk or low, the new version specifies three levels of risk with the inclusion of “moderate risk”.
- The new version of the legislation expands the scope of eligibility for “technology certification” under which the FDA’s approval of a representative test can be carried forward to its subsequent iterations.
- As incorporated in FDASLA, the new version of the VALID Act provides for five years before implementation, rather than the three years specified in the original bill.
- Section 829 of the FDASLA establishes “requirements for the collection of user fees to review IVCT submissions” and authorizes the FDA to collect these fees, an important change in funding from the original version.