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 "Knowledge Is Not Enough for Enforcement in FDA's Final Research-Use DX Guidance."
Following is an excerpt:
FDA final guidance signals plans to step up enforcement of companies that sell a test to labs for clinical diagnostic applications even though the test is labeled only for research. But the guidance, issued Nov. 25, removes language from a 2011 draft version that had troubled diagnostics firms because it appeared to put the onus on them to police the activities of their lab customers.
The guidance, titled "Distribution of In Vitro Diagnostic Products Labeled for Research-Use Only or Investigational-Use Only," tries to make clear that companies are at risk of enforcement if they take direct steps to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications. ...
"FDA retreated from this notion ?... that you have to police your customers, and figure out how they're using [a test], and stop selling to someone who is using it clinically," said Bradley Merrill Thompson.
"That was overreaching by the FDA, and they very appropriately eliminated that and replaced it with more examples of how a company might affirmatively mispromote, or promote too aggressively its product into clinical use," he said.
