Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC office, was quoted in an article titled “FDA Defends Lab Test Oversight Before Critical Lawmakers.” (Read the full version - subscription required.)
Following is an excerpt:
Tuesday’s hearing featured a separate panel where additional skepticism of the FDA’s authority was voiced in prepared remarks by representatives of the American Clinical Laboratory Association and the Coalition for 21st Century Medicine, a trade group whose members sell LDTs.
ACLA President Alan Mertz, for example, said his group “strongly believes that the FDA cannot regulate LDTs.”
On the other side of the aisle, the Advanced Medical Technology Association, which lobbies for device makers, voiced continued enthusiasm for the FDA’s position. Representatives of the American Association for Cancer Research and the American Heart Association also lent their support.
Those latter endorsements may prove especially powerful, Epstein Becker Green attorney Bradley Merrill Thompson told Law360 on Tuesday.
“I was struck by what seems to be an emerging consensus among patient and provider groups that FDA’s historical approach of enforcement discretion [toward LDTs] represents a gap in regulatory oversight that needs to be filled,” Thompson said.
The FDA’s policy was detailed recently in a “framework” proposal and is expected to be formally issued soon as draft guidance, after which a lengthy period of public comment and outreach will begin.
