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From the President’s Desk

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Contextualizing the VALID Act

September 2022—Like so many pathologists, I have been keeping a close eye on the VALID Act, which would create a new framework for FDA oversight of laboratory-developed tests (LDTs). As I write this, the VALID Act has been voted out of a Senate committee and now awaits further action by the full Senate.

I have heard from some pathologists and laboratorians who are concerned about this legislation and about the CAP position on it since the Senate HELP Committee released a draft on May 17, 2022. If you have not followed this bill and the issues of LDT oversight, allow me to offer some context.

Regulatory oversight of LDTs has been in active discussion since 2008 when the FDA intervened with a national reference laboratory that was selling a test that had been developed at a prestigious university to identify high-risk women who might have ovarian cancer. Patient advocacy groups had raised a concern because several women had undergone unnecessary prophylactic bilateral oophorectomy based on this LDT. In response, the FDA expressed concern about the public harm, and the reference laboratory pulled the test from the market.

Since then, patient advocacy groups have been calling for tougher safeguards on LDTs, demanding government oversight. In 2014, the FDA published a draft guidance for oversight of LDTs. In 2017, the Diagnostic Accuracy and Innovation Act was circulated. The CAP opposed this legislation, as it was overly complex and included extraneous provisions unrelated to LDTs.

Dr. Volk

For the past four years, Congress has been working on the VALID Act to address consumer group and laboratory industry concerns in an attempt to clarify the FDA’s role in regulating LDTs. This legislation is bipartisan and bicameral with significant congressional support.

A number of pathology and laboratory organizations are opposed to the VALID Act, objecting to any involvement of the FDA in the regulation of LDTs. This has been described as a CLIA-centric approach. The CAP has taken a different position in light of two important observations. First, the FDA has already made clear that it believes it has authority in regard to the safety of LDTs through the Federal Food, Drug, and Cosmetic Act. Second, the CAP advocacy team believes that VALID’s momentum, fueled by significant patient and consumer support, indicates a high likelihood of passage. Therefore, the CAP chose to work as a trusted stakeholder with Congress to advocate for important revisions in the bill.

The big difference between those in support of the VALID Act versus those opposing is the belief that Congress will reaffirm FDA’s jurisdiction. The CAP sees the FDA role as a political reality and thus has remained at the table lobbying for guardrails for FDA and flexibility for laboratories. As support for VALID has grown, some of the other laboratory groups responded with another bill (VITAL) that amplified their anti-FDA stance. This bill has a single congressional sponsor who is also one of the most virulent critics of the FDA.

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