Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted by Fast Company in “Due to This Obscure Loophole, Some Medical Test Avoid Oversight,” by Christina Farr.
Following is an excerpt:
The agency has made it clear that it wants to regulate LDTs and protect patients. So why aren't LDT's regulated?
"Politics," says Bradley Merrill Thompson, an attorney with the firm Epstein, Becker & Green who specializes in FDA law. "The lab industry has long been vocally complaining to any who will listen, and brandishing its political sword in the form of lobbying and threatened litigation."
Indeed, resistance has been fierce for decades. A handful of Republican lawmakers spoke out against regulation of LDTs at the Energy and Commerce's Subcommittee on Health in November, citing the lack of patient complaints. "My office isn't being overrun by calls from doctors and patients saying that there are some terrible LDTs out in the marketplace," said Congressman Joe Barton (R-TX).
