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Members of Congress Urge Obama Administration to Release FDA Draft Guidance on LDT Regulation

NEW YORK (GenomeWeb News) – Nine Democratic members of Congress are urging the Obama Administration to release a US Food and Drug Administration draft guidance on the regulation of laboratory-developed tests.

In a letter to Sylvia Mathews Burwell, the director of the Office of Management and Budget, the legislators said, "We have reached a critical point in the development of advanced diagnostics at which it has become essential that FDA move this guidance forward to ensure appropriate and efficient oversight of safe and effective diagnostics."

The letter points to the "widespread development and use" of molecular diagnostic tests by laboratories without FDA oversight, which could put patients at safety risks without FDA's assurance that the tests are effective.

"The time has come for the Administration to address this regulatory gap and resolve the uncertainty hanging over this critical area of medicine by affirming FDA's oversight of diagnostics," the letter said. "The promise that advanced diagnostics hold for patients is tremendous, but, at the same time, the increasingly pivotal role of these diagnostics in patient care makes it imperative that their safety and effectiveness is assured by the FDA prior to use."

The letter was signed by Representatives Louise Slaughter (D-NY); Ami Bera (D-Calif.); John Delaney (D-Md.); Rosa DeLauro (D-Conn.); Steve Israel (D-NY); Barbara Lee (D-Calif.); Carolyn Maloney (D-NY); Jan Schakowsky (D-Ill.); and Debbie Wasserman Schultz (D-Fla.).

The letter is the latest development in a long-fermenting issue that pits FDA against LDT developers. FDA released a draft guidance two years ago that recommended LDT developers receive FDA approval for tests that are used to determine whether a patient should receive a drug.

LDTs have traditionally been regulated under the Centers for Medicare and Medicaid Services' Clinical Laboratory Improvement Amendments, and diagnostic and drug developers involved in LDTs have complained that further FDA regulation on top of CLIA requirements would create an unlevel playing field and drive up costs.

In June, FDA Commissioner Margaret Hamburg signaled that FDA may once again have its sights set on the regulation of LDTs, as Pharmacogenomics Reporter reported at the time.

At the American Society of Clinical Oncology's annual meeting, Hamburg told attendees that even as advanced diagnostics now "are the cornerstone" of personalized medicine, "unfortunately … not all complex diagnostics used in cancer diagnosis and treatment have been developed to perform at the same demonstrated standards."

At the same time, though, the American Clinical Laboratory Association called for FDA to keep its hands off LDTs, and in a Citizen's Petition it said that the agency lacks the legal authority to regulate such tests.