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# Senate Draft User Fee Bill Sets IVD Regulation
- URL: https://www.fdaweb.com/senate-draft-user-fee-bill-sets-ivd-regulation/
- Published: 2022-05-17T12:00:00.000Z
- Updated: 2026-09-14T17:44:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151835

Senate Health, Education, Labor and Pensions Committee chair **Patty Murray** (D-WA) and ranking member **Richard Burr** (R-NC) have released a [discussion draft](https://www.help.senate.gov/chair/newsroom/press/senators-murray-burr-release-legislation-to-support-fda-programs-to-lower-costs-and-spur-innovation-?ref=fdaweb.com) of a bill that would reauthorize FDA user fee programs for another five years and enhance certain other program areas, like the regulation of diagnostic tests and stronger oversight of cosmetics and dietary supplements. Feedback on the discussion draft should be submitted to helpuserfeebill@help.senate.gov by 5/22.

Compared to a House bill to reauthorize user fees and modernize certain programs ([see earlier story](https://www.fdaweb.com/house-subcommittee-unanimously-votes-out-user-fee-bill/)), the Senate measure is significantly less aggressive in its attempts to revamp the agency. For example, the House bill contains provisions to enhance post-approval studies for accelerated approval drugs, boost FDA’s inspection authorities, and address two disconnects caused by a court decision affecting the orphan drug program and another decision that disrupted how FDA regulates contrast agents. The Senate draft is silent on these topics.

The most significant reform contained in the Senate version appears to be a provision entitled Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022, which would amend the Food, Drug & Cosmetic Act to define regulations for *in vitro* clinical tests (IVCT). It provides details for the premarket, abbreviated premarket, and supplemental application review and approval process, and it outlines the information required in such submissions.

The Senate draft also contains a section on improving the regulation of drugs and biologics, such as clarifying that drug sponsors can use alternative testing methods to animal testing in evaluating the safety and effectiveness of human drugs and biologics. The section also clarifies FDA’s authority to tentatively approve a subsequent interchangeable biosimilar biological product while a first interchangeable product’s period of exclusivity is pending.

Additionally, the measure includes a section on enhancing existing flexibilities and authorities for FDA to simplify and expedite the process for hiring individuals to scientific, technical, and professional positions.