A group of five Senate Democrats wants the White House to release a draft Food and Drug Administration (FDA) guidance that describes how the agency will regulate laboratory-developed tests (LDTs). Signed by Sens. Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Richard J. Durbin (D-Ill.), the letter said the White House Office of Management and Budget (OMB) has delayed the FDA’s draft guidance on LDTs. “The FDA has developed what the agency has referred to as ‘risk based’ draft guidance on how the agency will exercise its authority over LDTs, while recognizing the unique circumstances of the laboratory community,” the letter said. “For years this draft guidance has languished at OMB causing continued unpredictability and uncertainty for industry, clinicians, patients, and the general public.” Potential changes to the regulation of LDTs by the FDA have pitted groups representing device and combination product manufacturers against clinical laboratories. A citizen petition filed June 4, 2013, by the American Clinical Laboratory Association (ACLA) questioned the FDA’s authority to regulate LDTs as medical devices (NIR, June 10, 2013, p. 1). Expressing a different view, on May 15, the Combination Products Coalition sent a letter to the FDA to […]
A group of five Senate Democrats wants the White House to release a draft Food and Drug Administration (FDA) guidance that describes how the agency will regulate laboratory-developed tests (LDTs).
Signed by Sens. Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Richard J. Durbin (D-Ill.), the letter said the White House Office of Management and Budget (OMB) has delayed the FDA’s draft guidance on LDTs.
“The FDA has developed what the agency has referred to as ‘risk based’ draft guidance on how the agency will exercise its authority over LDTs, while recognizing the unique circumstances of the laboratory community,” the letter said. “For years this draft guidance has languished at OMB causing continued unpredictability and uncertainty for industry, clinicians, patients, and the general public.”
Potential changes to the regulation of LDTs by the FDA have pitted groups representing device and combination product manufacturers against clinical laboratories.
A citizen petition filed June 4, 2013, by the American Clinical Laboratory Association (ACLA) questioned the FDA’s authority to regulate LDTs as medical devices (NIR, June 10, 2013, p. 1).
Expressing a different view, on May 15, the Combination Products Coalition sent a letter to the FDA to request that the agency decide whether it possesses the authority to regulate all LDTs as medical devices (NIR, June 5, 2014, p. 1). The coalition said at the time that the current system doesn’t offer balance, because it treats two indistinguishable products—LDTs and in vitro diagnostics (IVDs)—completely differently, “and imposes a number of extra requirements on IVDs beyond those for LDTs.”
Reactions Highlight Industry Divisions
The senators’ letter drew support from the Advanced Medical Technology Association (AdvaMed), a devices industry group. Andrew Fish, the executive director of AdvaMedDx, said the group “thanks Sens. Markey, Blumenthal, Warren, Brown and Durbin for their leadership on this important issue. AdvaMed along with 24 patient groups have urged FDA to release its guidance on LDTs to clarify the regulatory requirements of these tests. The Senate letter follows a similar request from members of the U.S. House last year. We have long maintained that for the safety of public health all diagnostic tests should be held to the same regulatory requirement regardless of location of manufacture.”
In a July 2 statement, Alan Mertz, president of the ACLA said that regulation of LDTs by the FDA “would be duplicative, contrary to the public health, stifling innovation and negatively impacting patient access to this critical category of diagnostic laboratory service.” He added that, ACLA maintains the FDA does not have the authority to regulate laboratory developed tests. LDTs are laboratory services, not devices as defined by the Federal Food, Drug, and Cosmetic Act.
Takeaway: The clinical laboratory industry and the medical device industry remain divided on whether the FDA should regulate lab-developed tests. A group of senators is seeking to shake draft guidance on LDTs loose from the OMB.
