James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “The Hazy Future of the VALID Act,” by Maya Goldman. (Read the full version – subscription required.)

Following is an excerpt:

The VALID Act is set to be reintroduced Wednesday — but its future is murky.

Why it matters: The bill is a priority for the diagnostic testing industry and for the FDA. But after it was cut twice from legislative packages last year and its main Senate champion retired, we’re watching to see if the policy can actually pass in the 118th Congress. …

The intrigue: VALID and diagnostic regulatory overhauls are not mentioned in the FDA’s 2024 budget document, which generally highlights an agency’s legislative agenda items for the fiscal year. …

  • As it waits for Congress to take action, the agency is moving forward with rulemaking on diagnostic testing regulation, an FDA official said this month.
  • But using the rulemaking process for this issue would open the FDA up to lawsuits, which could delay things and “cause a lot of havoc,” said James Boiani, a lawyer at Epstein Becker Green who specializes in FDA and clinical lab regulations.
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