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Nov. 18 — The FDA said it won’t be regulating laboratory-developed tests anytime soon, a decision that elicited praise from the lab industry and Republican lawmakers Nov. 18.
The FDA will wait until the next presidential administration to move forward with its plan to oversee such tests, the agency said in a statement. The agency was expected to issue final policies on the lab developed tests, known as LDTs, by the end of this year.
Lab test makers, such as Laboratory Corporation of America and Quest Diagnostics, stand to benefit from the delay. The Food and Drug Administration released two draft guidance documents in 2014 that explained how the agency planned to oversee laboratory developed tests, or those made by lab companies, in the same way as it regulates diagnostic kits manufactured by medical device companies. The LDTs are currently under the authority of another federal agency.
“We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right,” FDA press officer Tara Goodin said in a statement provided to Bloomberg BNA Nov. 18.
“We plan to outline our view of an appropriate risk-based approach in the near future,” the agency’s statement added.
The draft guidance documents described the FDA’s plans to take over oversight of LDTs from the Centers for Medicare & Medicaid Services, which was granted the authority to oversee the tests in the Clinical Laboratory Improvement Amendments.
Device companies, which make the in vitro diagnostic (IVD) kits, largely supported the FDA’s planned oversight of LDTs. They argue the CLIA standards for lab tests aren’t as stringent as the ones they must follow for IVDs and thus put device makers at a disadvantage.
The American Clinical Laboratory Association (ACLA), a lab industry group, heralded the announcement as a sign the FDA won’t issue the final LDT guidance documents. In a Nov. 18 statement, the ACLA said it “applauded today’s announcement by the Food and Drug Administration (FDA) that it will not release a final guidance to regulate laboratory developed tests and instead work with Congress and other stakeholders to determine the best solution to reform.”
In addition, the FDA’s move is a victory for innovation and patients, the ACLA’s president, Alan Mertz, said. The group has opposed the FDA’s plans to change how lab tests are regulated and, in 2014, hired prominent attorneys Paul Clement, a former solicitor general, and Laurence Tribe, a Harvard University law professor, to represent it on matters related to the draft guidance documents.
Waiting until President-elect Donald Trump and the next Congress take power paves the way for a transparent discussion on how LDTs should be regulated, Mertz said.
Another opponent of the FDA’s plans, Rep. Michael Burgess (R-Texas), also praised the delay and said it’s a victory for precision medicine, according to a Nov. 18 statement. Burgess is the chair of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade. Full Energy and Commerce Committee Chairman Fred Upton (R-Mich.) also praised the FDA’s move.
AdvaMedDx, a trade association for IVD makers, declined to comment on the FDA’s announcement. The device industry group had strongly supported the FDA’s LDT oversight plans.
Delaying a decision on the LDT documents reflects a cautious attitude toward making any big changes in policy during the change in administrations, attorney William Garvin told Bloomberg BNA Nov. 18. Garvin is a Washington-based life sciences attorney at Buchanan Ingersoll and Rooney PC.
Given the fact that people are uncertain about what the new administration is going to do with regards to certain FDA regulatory positions and priorities, the FDA is trying its best to hold off on taking positions that would need to get revised once Trump is in office, Garvin said.
The FDA didn’t provide a clear answer about its plans for the draft guidance documents. Goodin, in a separate e-mail to Bloomberg BNA, repeated the agency’s statement that it will wait until Trump and a new Congress are in power before making any changes to LDT oversight.
Garvin said, “I wouldn’t expect FDA to revise or remove these guidances anytime soon.”
“I think FDA will wait until they understand what the new administration will look like before they take any actions on the guidances,” Garvin said. In the interim, manufacturers are likely to take a variety of approaches when dealing with these guidance documents. Some will want to follow the draft documents and others will ignore them, he told Bloomberg BNA.
It’s fairly common for manufacturers to follow guidance documents that are in draft form.
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A 2014 draft guidance document, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf.
A separate 2014 draft guidance document, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs),” is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416684.pdf.
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