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 in the Bloomberg BNA Health Care Daily Report, in “Lab Test Oversight Plan Scaled Back Under Revised FDA Proposal,” by Jeannie Baumann. (Read the full version – subscription required.)
Following is an excerpt:
Thompson said the prospective plan indicates the agency “is not being imperialistic” but “seems quite willing to work with many other stakeholders,” including the CMS and third parties.
“Embedded in the proposal is a plea for greater transparency,” he said. “Right now we don’t know what we don’t know. Indeed, because the information is not aggregated across labs, no one knows what we don’t know. So FDA very intelligently prioritizes collecting information to get a better sense of whether there’s any problem here.”