An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress.  It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog.  It’s not like such tests have been a product liability hotbed.  In fact, when searched for that term, we received zero results.

Section 587U of the proposed Act concerned preemption and, until recently, read:

“(a) In General.—No State, Tribal, or local government (or political subdivision thereof) may establish or continue in effect any requirement related to the development, manufacture, labeling, distribution, sale, or use of an in vitro clinical test that is different from, or in addition to, the requirements of this subchapter.

“(b) Exceptions.—Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—

“(1) to license laboratory personnel, health care practitioners, or health care facilities or to regulate any aspect of a health care practitioner-patient relationship; or

“(2) to enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws.

“(c) Clarification.—This section shall not be construed to shift liability to health care practitioners or other users.

That’s pretty standard preemption language for an FDCA amendment.   Indeed, the operative language – “different from, or in addition to” – is the same as the 1976 Medical Device Amendments, and thus has a well-defined scope.

Now, however, the proposed draft of the VALID Act has been amended in an ominous way effectively to nullify the FDA new powers by making them meaningless in civil litigation.  

Here’s the proposed as-amended language as we understand it:

“(a) In General.— Except as provided in subsection (b), no No State, Tribal, or local government (or political subdivision thereof) may establish or continue in effect any requirement related to the development, manufacture, labeling, distribution, sale, or use of an in vitro clinical test that —

(1) is different from, or in addition to, the requirements of any requirement applicable to an this subchapter of in vitro clinical test under this Act; or

(2) any requirement applicable to an respect to the analytical validity, clinical validity, or safety for individuals who come into contact with such an in vitro clinical test under this subchapter Act.

(b) Exceptions.—Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—

(1) to license laboratory personnel, health care practitioners, or health care facilities or to regulate any aspect of a health care practitioner-patient relationship; or

“(2) to enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws;

(3) to authorize laboratories to develop and perform an in vitro clinical test, pursuant to a law enacted by a State prior to January 1, 2022, as long as such law does not impose requirements that are different from any requirement applicable to an in vitro clinical test under this Act.

(c) Clarification.—This Nothing in this section shall not be construed to—

(1) modify any action for damages or the liability of any person under the law of any State; or

(2) shift liability to health care practitioners or other users.

Additions in italics; deletions in strike through.

As the draft VALID Act now reads, the to-be FDA-regulated manufacturers of in vitro chemical tests would be stripped by the revised “clarification” of any litigation benefit from the Act’s imposition of potentially onerous FDA oversight.   By this we mean, they are not only does the amendment eliminate outright preemption, such as exists under the Medical Device Amendments, but regulated test manufacturers would also be deprived of lesser “modifications,” such as whatever evidentiary effect state law would afford a manufacturer’s compliance with the FDA regulatory scheme.

This surprise act of legislative vandalism is indeed unfortunate.   There are undoubtedly good reasons for extending the FDA’s writ to these tests, but now congressional litigation allenablers have made this bill unnecessarily controversial by making the persons the VALID Act would regulate sitting ducks for litigation.