Devices

Lobbying Killed VALID Act: ProPublica

Intense lobbying on behalf of laboratory-developed test (LDT) makers, professional associations, and academic medical centers led Congress to reject the inclusion of the VALID (Verifying Accurate Leading-edge IVCT Development) Act in the omnibus spending bill that was approved at the end of 2022, according to a ProPublica analysis. “Congress was on the cusp of creating a pathway for FDA to scrutinize these tests, as it does for many other commercial tests,” the report says. “For much of 2022 the VALID Act seemed on track for passage, and then, in the final weeks of the year, legislators backed away.”

ProPublica says opponents argued that VALID would have created burdensome regulations for LDTs, stunting essential innovation and flexibility while limiting patient access to healthcare. “Several people involved in bill negotiations told ProPublica that concern over how it would affect academic labs is what killed it,” the report says.

The report says Association of American Medical Colleges senior director for science policy and regulatory counsel Heather Pierce said that many academic medical centers make and use a number of LDTs and they typically don’t have the infrastructure or staff to handle the type of FDA oversight set out by VALID. Pierce also said FDA review would add time to the process of developing tests for patients with urgent needs.

The makers of prenatal screening tests also lobbied against the bill, the report says.

ProPublica says some proponents of the legislation fear it is unlikely to get traction again any time soon, leaving FDA with a decision on whether to move forward with rulemaking. FDA commissioner Robert Califf told a 10/2022 trade conference that having clear legislation is preferable to the agency acting on its own, but added that FDA can’t stand by if Congress fails to act.

Some VALID opponents have said that regulation is needed but that it should be through the Centers for Medicare and Medicaid Services’ review of lab operations rather than through FDA.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome