FDA Proposed Rule on Lab-Developed Tests
Without any progress from Capitol Hill on a legislative solution to reign in laboratory-developed tests (LDTs), FDA is now plowing ahead under a proposed rule to increase its scrutiny of such tests that have grown in use and complexity over many years. “Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate,” said CDRH director Jeff Shuren in announcing the proposal.
FDA describes laboratory-developed tests as in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory that meets certain laboratory requirements. The proposed rule intends to put LDTs on equal footing with other traditional tests made in manufacturing facilities. The agency says its proposal “seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.”
FDA is also proposing a policy under which it intends to provide greater oversight of LDTs through a phaseout of its enforcement discretion policy applied to such devices. It notes that times have changed since the LDT enforcement discretion was created when the agency implemented the Medical Device Amendments of 1976 (MDA). “Enforcement discretion for LDTs developed as a matter of general practice,” the proposed rule says. “However, the risks associated with LDTs are much greater today than they were at the time of enactment of the MDA.” It says today’s LDTs are used more widely, by a more diverse population, “with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions. In this regard, today’s LDTs are similar to other IVDs that have not been under this general enforcement discretion approach.”
Last year, FDA commissioner Robert Califf said (see earlier story) his preference would be for Congress to pass legislation on the regulation of laboratory-developed tests. Asked how he would respond if Congress fails to act, Califf said, “That’s a tough question. You know, it’s not something we want to do because having a clear law passed leads to the best situation. The other option besides the law is federal rulemaking, which is always an option for FDA, but it is a very lengthy and contentious process. It would be much better for the lawmakers to come to an agreement. But we also can’t stand by.”
FDA has long maintained that it needs to regulate certain LDTs and even issued a guidance outlining a risk-based approach as the Obama presidency drew to a close. The guidance was withdrawn during the Trump years and FDA instead issued a white paper explaining why regulating the tests is important.
Earlier this year, the Center for Science in the Public Interest and 15 other public interest organizations urged FDA to regulate LDTs. A 5/30 letter said the agency has the authority to regulate LDTs but has chosen not to use it because early tests were fairly simple and used on a small number of patients. “However, the availability and complexity of these tests have grown over time and many have been found to be inaccurate,” the letter said.
Meanwhile, House Energy and Commerce Committee chair Cathy McMorris Rodgers (R-WA) cautioned that the agency proposed rule goes well beyond legislative proposals entertained on Capitol Hill, and will stifle diagnostic innovation. “By adding new costly regulations, patients could lose access to diagnostics that identify potentially fatal conditions,” she said. “Any LDT policy should go through the legislative process with deliberative consideration by the committees of jurisdiction. In order to strike the appropriate balance between adequate protections of public health and facilitating innovation, the FDA should rescind this rule and allow Congress — the people’s voice — to consider the matter.”