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Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks

 
• By Kate Rawson

All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?

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• Source: Shutterstock

Proponents of the VALID Act hope that the US FDA’s controversial proposed rule on laboratory-developed tests will bring lawmakers from both parties back to the negotiating table to find a legislative solution for oversight of LDTs, members of the House Energy & Commerce Health Subcommittee said during a 21 March hearing.

Rep. Larry Bucshon (R-Ind.), a co-sponsor on VALID with Diana DeGette (D-Colo.), called the bill a “carefully developed, well-vetted piece of legislation,” although he acknowledged it “needs further work.”

Key Takeaways

  • FDA rule being rushed to finalization will pressure stakeholders to create a legislative solution to oversight of lab-developed tests.

  • Republican concerns about FDA review...

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