Illustration: Eniola Odetunde/Axios
A long-awaited move by the Food and Drug Administration to put regulation of lab-developed tests under its control hasn't dampened congressional interest in writing a regulatory framework for the tests into law, by reviving the VALID Act.
Why it matters: Legislation offers more legal certainty than a proposed rule that could quickly be ensnared in legal challenges by academic medical centers and laboratory industry groups that oppose the effort.
- But the VALID Act was dropped from two legislative packages last year and faces uncertain prospects this session.
Details: The FDA's proposed rule would treat in-vitro diagnostic tests that have long escaped strict agency scrutiny as medical devices under the Food, Drug and Cosmetic Act and end the agency's discretionary enforcement approach over five years.
- Use of the tests has expanded in recent years, to help diagnose cancer and other diseases and identify if patients are candidates for targeted therapies.
- The FDA said that the rule is needed since laboratory developed tests "may not provide accurate test results," leading patients to either seek unnecessary care or to delay or forego treatment altogether.
- FDA commissioner Robert Califf has repeatedly asked Congress to give his agency the needed power rather than relying on the rulemaking process.
Flashback: The framework for what would become the VALID Act was first released by a bipartisan group of lawmakers in 2018, and the bill was introduced in 2020 by Sens. Michael Bennet and Richard Burr and Reps. Larry Bucshon and Diana DeGette. Burr has since retired.
- The measure was included in the Senate's 2022 FDA user fee reauthorization package, but never made it into the House's version.
- VALID later was dropped from the end-of-year omnibus amid opposition from academic medical centers, saying it would impose burdensome regulations.
- This year's House version of VALID was introduced in March and would give the FDA explicit authority to regulate laboratory developed tests as well as create a new product category for tests to be reviewed under, via an electronic system.
What they're saying: Members of Congress are still insisting that legislation is needed so lawmakers can have more say in shaping the regulatory framework.
- "I think there's a lot of positive things in the VALID Act that are not going to be in this rule at the end of the day but you know, we also want to get through the comment period and see how they might adjust it," Bucshon told Axios on Monday night.
- He said he's talking to the House Energy and Commerce Committee staff about having a hearing on VALID but hadn't yet asked Chair Cathy McMorris Rodgers for one.
McMorris Rodgers said in a statement on Friday that, "this rule goes well beyond any of the proposed LDT legislation and will stifle innovation of diagnostics."
- "The FDA should rescind this rule and allow Congress — the people's voice — to consider the matter," she added.
- DeGette told Axios in a statement on Friday that she was still "reviewing the details of this proposed rule, but this appears to be a step in the right direction — and long overdue."
- "I'm going to continue pushing to pass the VALID Act to ensure that we are balancing patient safety and fostering innovation at the same time," she said.
Of note: Bennet still hasn't found a Republican co-sponsor to take up Burr's role.
The other side: The American Clinical Laboratory Association, one of the laboratory industry groups, said in a statement it opposes the FDA's proposed rule and want to continue working with Congress on "diagnostic-specific legislation."
Our take: Even with a few lawmakers pushing for it, the VALID Act doesn't appear to have enough juice behind it in this Congress, especially with the ongoing fights over federal spending and multitude of other health matters that have to be settled.
