By Jim Dickinson
A stalled Obama administration regulation on laboratory-developed tests (LDTs) is long overdue and should be released quickly for public comment, the New York Times editorial board said in a July opinion piece. Today’s regulatory approach by FDA is outdated and allows sophisticated tests that are developed by a clinical laboratory for use at its own facilities to be sold without a premarket review, the opinion piece said. “Experts are unsure about how well these so-called laboratory-developed tests, or LDTs, perform in identifying diseases,” it added.
“The FDA,” the piece continued, “has always had the authority to regulate laboratory-developed tests but chose not to do so when tests were used locally. Now that commercial testing companies with laboratories scattered around the country have become major players, the agency has prepared a draft guidance document on how the tests developed by clinical laboratories should be regulated.
“The document is stalled somewhere within the administration, possibly at the Office of Management and Budget, a frequent graveyard for regulatory initiatives.
“The Cancer Leadership Council, an advocacy group, warned the OMB last November that ‘cancer patients have in recent years suffered harm from LDTs that did not provide the accurate and meaningful information that was promised.’ Regulations are long overdue; the draft guidelines should be quickly released for public comment.”
Another example, perhaps, of political interference in FDA’s work?