2:28 PM
Dec 06, 2018
 |  BC Extra  |  Politics & Policy

Bipartisan bill would revamp diagnostics regulation

Champions of legislation in Congress to overhaul diagnostics legislation released a draft bill Thursday that scraps many features of a draft bill released last year and incorporates a different approach proposed by FDA.

If it is enacted, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would create a completely new system for regulating diagnostics, and would resolve controversy that has raged for over a decade about FDA’s authority to regulate laboratory developed tests (LDTs).

The VALID Act seeks to establish consistent requirements for all diagnostics, erasing regulatory distinctions between LDTs and in vitro diagnostics. Instead, tests would be regulated based on risk.

Sponsored by Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.), with Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), the VALID Act replaces the Diagnostic Accuracy and Innovation Act (DAIA), which was released as a discussion draft in March 2017.

The VALID Act adopts FDA’s proposals to deploy regulatory resources to tests with the highest risks, shift regulatory focus from premarket to postmarket oversight, and create systems for voluntary precertification of technologies and quality systems (see “Debating Diagnostics”).

Under the proposal, FDA estimates that about 90% of diagnostic tests could be marketed without premarket clearance.

Diagnostic tests, including LDTs, introduced at least 90 days prior to enactment of the bill would be exempt from premarket review.

Several provisions in DAIA that FDA objected to were dropped from the VALID Act. These include a proposal to create a new center dedicated to diagnostics, as well as deadlines for risk classification and for conducting premarket reviews. In accord with FDA’s request, the authors also discarded a proposed “moderate” risk category, and instead opted for the agency’s preference to divide diagnostic tests into low- and high-risk.

FDA Thursday released a blog post describing its proposed approach to regulating diagnostics. The blog did not mention the VALID Act, but all of the elements it describes are included in the draft bill.

The VALID Act will not be considered by Congress this year. If it is supported by key stakeholders, including the academic medical centers that have developed many innovative LDTs and large clinical lab testing companies, the VALID Act could be enacted in 2019.

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