{"id":6358,"date":"2022-06-02T02:32:18","date_gmt":"2022-06-02T07:32:18","guid":{"rendered":"https:\/\/www.appliedpolicy.com\/staging\/7403\/?p=6358"},"modified":"2022-06-02T04:46:09","modified_gmt":"2022-06-02T09:46:09","slug":"valid-v-vital-update","status":"publish","type":"post","link":"https:\/\/www.appliedpolicy.com\/staging\/7403\/valid-v-vital-update\/","title":{"rendered":"VALID v. Vital update"},"content":{"rendered":"

[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text]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\u2019 potential $1.9 billion impact, but also for those trying to tie diagnostic testing reform to FDA user fee legislation.<\/p>\n

As Applied Policy reported<\/a> in March, two pieces of legislation, representing decidedly different perspectives on the longstanding\u2014and sometimes heated\u2014debate over which federal agency should exercise oversight of diagnostic testing, have been vying for passage in Congress.<\/p>\n

The bipartisan Verifying Accurate Leading-edge IVCT Development (VALID<\/a>) 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\u2014a new category of products, which would include both in vitro diagnostic products and laboratory developed tests (LDTs).<\/p>\n

By contrast the Verified Innovative Testing in American Laboratories (VITAL<\/a>) 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 \u201cno aspects of laboratory-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act\u2026 including during a public health emergency.\u201d<\/p>\n

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.<\/p>\n

The Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA<\/a>) 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 \u2018\u2018Verifying Accurate Leading-edge IVCT Development Act of 2022\u2019\u2019 or the \u2018\u2018VALID Act of 2022.\u2019\u2019<\/p>\n

The inclusion of the original VALID Act\u2019s model for a risk-based framework for the FDA\u2019s regulation of LDTs in FDALSA was not surprising given that the HELP Committee\u2019s ranking member, Sen. Burr, was one of the original sponsors of the bipartisan legislation.<\/p>\n

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.<\/p>\n

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 \u201cbeen crafted with consensus in mind from the start.\u201d 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.<\/p>\n

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.<\/p>\n

Applied Policy will continue to watch developments on the Hill and to keep our readers informed.<\/p>\n

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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<\/a>.<\/p>\n

There are some important differences between the original Verifying Leading-edge IVCT Development (VALID) Act, and the VALID Act as incorporated in FDASLA:<\/p>\n