Dive Brief:

• Lawmakers have reintroduced draft legislation for a new regulatory framework for diagnostic tests, marking the third time a form of the proposal has been put to Congress.

• The new version of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act hews closely to the draft introduced early in the pandemic. While there have been some changes, the focus is still on creating a risk-based regulatory framework specific to diagnostics and a new test product category — in vitro clinical tests, which includes lab-developed tests — while giving FDA authority to review and approve IVCTs.  

• Some trade groups cautiously welcomed the draft, which AdvaMed called "an important step" and the College of American Pathologists said “continues to move in the right direction.” Other groups that were critical of the 2020 draft, such as the American Clinical Laboratory Association, have yet to offer an opinion. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected previously to the legislation.   

Dive Insight:

The bill aims to provide clarity on a murky area of FDA authority in regulating lab developed tests. Under the Trump administration, HHS shocked the industry in August 2020 when it announced FDA would no longer require premarket review for LDTs, despite the agency long maintaining that these tests are devices and fall under its purview according to the Medical Device Amendments of 1976.   

The policy change was issued by HHS, and not FDA, drawing the attention of industry observers who saw it as evidence of internal divisions, with then-HHS Secretary Alex Azar reportedly overriding objections from FDA on the easing of rules applicable to all LDTs covering a wide range of diseases including cancer and COVID-19.   

Lawmakers first revived the VALID Act in March 2020 in response to the failures of the early weeks of the pandemic, when the U.S. struggled to scale up testing capacity to keep track of the spread of the virus. In a statement published at the time, Larry Bucshon, R-Indiana, referencing viruses such as MERS, SARS and Ebola, said the "legislation will overhaul the federal government's outdated system that is slowing down our ability to respond to these threats."

Identical bills were introduced in the House and the Senate but never made it to a vote. Now, the same four senators and representatives are trying again to pass legislation that would reshape the regulation of diagnostics in the U.S.

The core goal of the legislation remains unchanged. If passed, the VALID Act would create a distinct regulatory framework for in vitro diagnostics and laboratory-developed tests, known collectively in the draft legislation as in vitro clinical tests (IVCTs). 

The framework features a tiered, risk-based system for the regulation of IVCTs. As already happens with medical devices, FDA would typically subject high-risk IVCTs to a preapproval review but low-risk diagnostics would be able to come to market after listing with the agency. The framework features a middle tier of IVCTs that would need to obtain approval but without meeting the same requirements as high-risk diagnostics. Other provisions include the creation of a breakthrough designation.

One goal of the legislation is to enable hospitals and laboratories that have developed and validated tests to start using them before FDA grants emergency use authorization. The draft provision seeks to prevent a recurrence of the situation sites faced in February 2020, when they had SARS-CoV-2 LDTs but were unable to use them without EUA until FDA waived its requirement at the end of the month.  

The 2020 draft split the diagnostic industry. The American Association for Clinical Chemistry was one of the most outspoken opponents of the 2020 draft, which it said "introduces new and redundant regulatory hurdles." AACC has yet to publish a statement about the 2021 draft.

ACLA, a trade group that represents labs including Quest and LabCorp, published a full analysis of the 2020 draft that called the IVCT definition "incompatible with a risk-based framework for regulation" and argued it "fails to recognize the fundamental differences between LDTs and IVDs." The trade group said it is reviewing the 2021 version and is yet to provide an opinion.

AdvaMed and CAP were more upbeat about the 2020 version and were again among the more vocal proponents of the 2021 draft. In a statement, AdvaMed CEO Scott Whitaker said the proposal "calls for smart reforms that will incentivize and improve the development of the advanced, reliable tests patients depend on, regardless of where those tests were developed."