Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "The LDT Letter Battle."
Following is an excerpt:
Earlier this month, five democratic U.S. Senators sent a letter to the Office of Management and Budget (OMB) regarding the regulation of laboratory-developed tests (LDT). In this letter, Senators Edward J. Markey (D-MA), Richard Blumenthal (D-CT), Elizabeth Warren (D-MA), Sherrod Brown (D-OH), and Dick Durbin (D-IL) called on the Obama administration to release a draft guidance that FDA submitted several years ago to ensure appropriate oversight of LDTs.
"The LDT topic is long overdue for discussion, but unfortunately no real meaningful discussion will take place until OMB releases the FDA draft. Nothing is gained by OMB sitting on it," said Bradley M. Thompson, JD, an attorney at Epstein Becker Green (Washington, DC). "It's time for OMB to let its hostage go, and for the rest of us to roll up our sleeves and figure out a sensible, uniform, risk-based approach to ensuring the safety and effectiveness of all laboratory diagnostics."
Thompson added that while he is looking forward to see the LDT topic discussed, he gave the following summary of his main concerns: The two systems for IVDs and LDTs cannot both be right. One risk-based system for everyone is needed, whether that is a CLIA system, FDA system, or something in between.
