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 “FDA Lab Test Oversight Will Touch Off Industry Tug-Of-War.” (Read the full version – subscription required.)
Following is an excerpt:
The U.S. Food and Drug Administration on Thursday detailed plans to start regulating certain diagnostic laboratory tests, likely sparking a lobbying fight over the extent of oversight and whether manufacturers of diagnostic medical devices should get some of the same special treatment being extended to labs, experts say.
The agency’s long-anticipated announcement came in the form of a 69-page notification to Congress regarding upcoming draft guidance that will affect an estimated 2,000 labs, and battle lines were quickly drawn by lawyers, lawmakers and trade groups that offered competing views on the agency’s proposal.
“FDA [provides] quite a bit of flexibility in trying to help the labs avoid undue burden. That makes sense, but at the same time FDA has to be prepared to offer the same accommodations to other manufacturers,” said Bradley Merrill Thompson of Epstein Becker Green.
“I think it’s quite likely that this is going to be a very animated debate for months. There are so many strongly held points of view,” Thompson said. “We’re looking for ways to bring some structure to the next few months, so it isn’t just mudslinging.”