Cassidy. Photo: Anna Moneymaker/Getty Images
Senate HELP Committee Ranking Member Bill Cassidy is taking the FDA to task for its new rule increasing oversight of laboratory-developed tests.
Why it matters: Overhauling this testing regulation was originally going to be legislative, through the VALID Act. But with that bill stalled, the FDA is going forward on its own — and provoking some controversy.
Between the lines: Cassidy argues the agency does not have the statutory authority to make this move on its own, and that it could harm innovation.
- "The FDA does not have the authority to unilaterally increase its regulatory jurisdiction," Cassidy said. "During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans."
- He called on Congress to take up the issue.
The other side: The FDA argues it's risky for patients to rely on in-vitro diagnostic tests that might not be fully accurate.
- The agency today said it would treat the tests as medical devices under the Food, Drug and Cosmetic Act and phase out its current approach of not always enforcing the requirements.
- "LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person's risk of cancer, or aid in diagnosing heart disease and Alzheimer's," FDA commissioner Robert Califf said.
- "The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work."
Our thought bubble: The FDA's action is a sign of the diminished prospects for the VALID Act.
- Former FDA commissioner Scott Gottlieb wrote on X that the rule "reflects the lost hope at FDA that Congress would pass the VALID Act, a more tailored approach to LDTs."
