The FDA plans to issue final guidance next year on how it will enforce the regulation of laboratory developed tests, Center for Devices and Radiological Health Director Jeffrey Shuren told a House subcommittee last week during a hearing that focused on proposed legislation for diagnostic regulatory reform.
Rep. Marsha Blackburn (R-Tenn.) criticized the FDA for taking so long to release the final guidance. Shuren clarified that he does not actually have the authority to decide when to issue the document, and the agency hopes to finalize the guidance earlier in 2016, rather than later in the year.
News of the guidance's arrivalmay not be welcomed by a number of groups that promised to fight the agency on its proposals last year, including the American Clinical Laboratory Association.
The proposed guidance to regulate LDTs would be highly disruptive to laboratory services and compromise patient care, the group says in a statement issued last week.
The ACLA was among more than 50 organizations that wrote a November 2014 letter to the FDA asking the agency to withdraw the draft guidance because it conflicts with existing regulations and would impose substantial new requirements.
However, now several proposals from the lab community are acknowledging that LDTs must demonstrate they are analytically and clinically valid, that they should be subject to premarket review in moderate and high-risk tests, and that certain problems need to be reported to the government, Shuren said.
“None of those are currently enforced on them today. They all exist under an FDA framework,” he said.
LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, Peter Lurie, FDA’s associate commissioner for public health strategy and analysis, said in a statement. Yet, LDTs are still under a general policy of enforcement discretion, which means they rarely undergo FDA review to determine whether they are accurate, reliable and provide clinically meaningful results, he added.
The agency issued a report last week listing 20 case studies that shows how a lack of LDT oversight may cause significant harm to patients.
However, when questioned last week by Rep. Michael Burgess (R-Texas) during the hearing before the Energy and Commerce Committee’s subcommittee on health, Shuren said that there are more than 11,000 laboratory developed tests. Burgess pointed out that the rate of detecting problems is far less than one percent. In response, Shuren said, “There is no reporting system on LDTs. We are not monitoring for problems, and so you can’t say what the rate is, quite frankly.”
In response to a white paper the committee circulated last year, a number of labs and pathologists said the FDA should only have limited role in regulating a set of tests as medical devices, while the rest should be overseen by the Centers for Medicare & Medicaid Services through an updated Clinical Laboratory Improvement Amendments program.
A legislation discussion draft the committee circulated last month clarified FDA and CMS responsibilities on LDTs. FDA would regulate test development in risk-based manner. CMS would regulate lab operations. However, some alternative proposals would divide regulatory and oversight between the FDA and CMS, depending on the type of test.
Shuren told the House subcommittee that such a system would lead to inefficiencies, leading to inconsistent standards treating the same test differently depending upon who makes the test. “If we are going to assure that tests work, we need one unified system,” he said.
“On the other hand, CMS does not have scientific staff capable of determining whether a test is difficult to successfully carry out or likely to prove detrimental to a patient if carried out improperly. This expertise resides within the FDA, which assesses clinical validity in the context of premarket reviews,” said Patrick Conway, acting principal deputy administrator for the agency.
In a statement last week, AdvaMedDx said creating a new regulatory system at CMS dedicated solely to LDTs would duplicate resources and perpetuate disparate treatment of similar tests.
“FDA oversight of all diagnostic tests — under a risk-based framework — is crucial to ensuring patient safety, and FDA is the only agency with the current regulatory appropriate expertise and resources to provide effective oversight of this rapidly evolving area of healthcare,” said Andrew Fish, executive director of AdvaMedDx.