Five senate Democrats called for the White House Office of Management and Budget to release a long-sequestered FDA draft guidance on laboratory-developed tests for public comment. In a letter to OMB acting director Brian Deese, they urged him to release the proposed regulation "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."
The FDA has traditionally opted not to regulate LDTs under its "enforcement discretion" doctrine, and instead left their validation to the states under the Clinical Laboratory Improvement Amendments, a standard that must be met by labs in order to receive Medicare or Medicaid payments. Since at least 2010 the agency has shifted its stance, and says it wants to regulate the tests due to their increasing complexity, but the draft guidance has been languishing in OMB for "several years," according to the letter.
"Many of these new diagnostic tools, widely developed and marketed as LDTs, are intended to help diagnose disease earlier, more effectively, less invasively, or in many cases, are the only pathology test available to diagnose a medical condition. These tests and their results are increasingly relied on by patients and medical to help predict the most appropriate course of treatment and care. These tests hold great promise to customize healthcare to be more efficient and targeted for an individual patient," the senators wrote.
They cited an April 2014 notice from the Centers for Disease Control and Prevention that said a common LDT to detect Lyme disease results in many false-positives and recommended using an FDA-approved diagnostics for the disease.
The current, two-tier regulatory system is inconsistent and confusing, the senators said. Manufacturers of LDTs and testing equipment must receive a PMA or 510(k) from the FDA to distribute their product, but "an independent laboratory can develop and use a LDT diagnostic test, for an infinite number of patients, without ever being subject to these same pre-market reviews," the letter points out. Instead, the lab must meet the CLIA rules, administered by the states and CMS, before disseminating the test's results.
The senators wrote that the delay violates a 1993 executive order issued by President Clinton which calls for OMB to review all regulatory policies within 90 days.
Support for FDA regulation of LDTs is far from unanimous on Capitol Hill. Rep. Michael Burgess (R-TX) introduced a bill in 2011 that would ban the FDA from regulating genetic diagnostic testing, according to the Patent Docs IP blog. However, the opposition to the draft guidance stems from someone who works for the White House, for OMB is an executive branch agency that helps agencies implement the commitments and priorities of the President.
- read the letter to OMB (PDF)