When the House passed the VALID Act back in June, regulatory reform of FDA regulation of laboratory developed tests (LDTs) seemed so close. But it now appears that Congress is going to dash the lab industry’s hopes yet again by reauthorizing FDA user fees without VALID.
The Latest LDTs Reform False Alarm
For over a decade, the clear consensus has been that the FDA’s arbitrary policy of extending its authority over new medical devices to regulate LDTs has been effective only in keeping novel and needed tests from reaching the market, a point driven home with emphasis during the early days of the COVID-19 pandemic. But efforts to reform the system have repeatedly stalled and broken down. Initially driven by the lab industry, the FDA sought to usurp the reform process. In recent years, Congress took a more active role by proposing a series of reform bills, some preserving and others stripping the FDA of regulatory authority over LDTs.
VALID, short for Verifying Accurate Leading-edge IVCT Development, fell into the former camp, proposing a risk-based framework for in vitro clinical tests. The most recent version of the VALID Act, which was proposed earlier this year before clearing the House, would have required premarket review for high-risk tests while allowing lower-risk tests to reach the market after passing a far less stringent technological certification process. The new VALID Act would also grandfather in LDTs that are currently in clinical use.
While supported by the American Clinical Laboratory Association (ACLA), the new VALID has drawn opposition from academic and other labs that actually develop LDTs who think the bill is too financially onerous on smaller labs without the resources of the Abbotts, Quests, and Labcorps of the world.
The point is that these differences could have been addressed. However, the die was cast when VALID was made part of the bill that Congress had to pass by Sept. 30 to keep the FDA users fee program going. But the tactic of forcing quick passage seems to have failed. Instead of adopting an omnibus FDA bill, Congress has apparently decided to pass the bare minimum to a continuing resolution needed to avoid a government shutdown. As a result, VALID and the other policy rider baubles added to the user bill charm bracelet bill last spring will be set aside and debated separately. At least that’s how it appears.
But there are still two paths open:
- Rather than a “clean bill,” the user fees package may include at least some of the riders, potentially including VALID; or
- Congress will debate, mark up, and pass VALID on its own merits—a resolution that many labs have been calling for.