Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled “Combination Product Group Calls For New FDA Policy on Two Kinds of Tests.”
Following is an excerpt:
The Food and Drug Administration needs to take action and make a decision on whether it has the authority to regulate laboratory developed tests (LDTs) as medical devices, a group representing manufacturers of combination products said in a recent letter to the agency.
The Combination Products Coalition (CPC) May 15 told the FDA it needs to make a decision about regulating LDTs and in-vitro diagnostics (IVDs). According to the letter, the FDA’s approach to lab-developed tests and the FDA’s approach to IVDs can’t both be correct. Either the federal government is dramatically overregulating IVDs, or underregulating lab-developed tests, or both, the group said.
The group called on the FDA to create a single regulatory system for both IVDs and LDTs. ?…
Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C. in Washington and general counsel to the CPC, told Bloomberg BNA May 19 the group decided to act because it appeared that all IVD/LDT-related efforts at the FDA “have ground to a halt.”
Thompson said, “We’ve been waiting and waiting for a [final] guidance on companion diagnostics. Our understanding is that it’s being held up” at the White House Office of Management and Budget because of unresolved concerns about LDT regulation. The CPC letter calls on the guidance to be released, and for other agencies to “step aside” if they are holding up its release.
Sending a letter “was the best approach we could think of. It’s pure and simple frustration. I don’t see how this gets resolved without FDA being more bold” about making a decision, Thompson said. ?…
Thompson said nothing can be done about the regulations without Congress getting involved, but as a minimum first step, he said the agency needs to act, and come out with a policy.
“Then we can have a discussion with Congress, get everyone talking,” Thompson said. “I want to have a debate. I’m convinced that once the debate starts, we will get somewhere. It all starts with FDA. FDA can’t walk around wringing its hands. Doing nothing can’t be good for patients. There’s no way the current system puts patients first.”