CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through guidance documents as it previously did, the HHS legal opinion could benefit clinical labs and IVD companies. HHS seems to be using this memo as a way to assert its authority as the governing agency.
IN A SIGNIFICANT TWIST in the federal Food and Drug Administration’s years-long effort to regulate laboratory-developed tests (LDTs), the federal Department of Health and Human Services (HHS) has clarified the process FDA should follow to regulate LDTs.
This is an important development with major implications for any clinical laboratory that performs LDTs. The multi-year effort by the FDA to claim its authority to regulate LDTs by issuing guidance documents has been regularly disputed by many lab companies, national laboratories, and trade groups.
Regulation of LDTs
Since the early 1990s, the FDA has asserted its right to regulate these tests—an effort that many in the clinical laboratory industry oppose. But, in those almost 30 years, the agency did not finalize a plan to regulate LDTs. In 2014, it issued two draft guidance documents for its regulation of LDTs that were later withdrawn. Now the FDA’s ability to use guidance documents as the basis of regulating LDTs has been removed under a memo the HHS general counsel issued in June.
Press coverage of the issue made it appear that the FDA was feuding with HHS, but that’s incorrect, according to Roger D. Klein, MD, JD, a former adviser to the FDA and a Faculty Fellow at the Center for Law, Science, and Innovation at the Sandra Day O’Connor School of Law.
The HHS has the right to assert its authority over the FDA on this issue because FDA is an agency within the Department of Health and Human services and its commissioner derives his or her legal authority through the HHS secretary, Klein explained. (See “HHS ‘Stands Down’ FDA on Its Oversight of LDTs,” TDR, Aug. 24, 2020.)
“The FDA’s authority stems from the secretary of HHS. Therefore, FDA would need to issue new regulations through ‘notice and comment rulemaking’ in order to regulate LDTs,” said Klein in an interview with The Dark Report.
In a memo dated June 22, HHS General Counsel Robert Charrow explained that the department’s legal staff reviewed the FDA’s legal authorities and regulatory processes so that it could advise HHS, the FDA, and all policymakers on the issue. The legal team reviewed that authority, “especially in light of COVID-19,” the memo noted.
The FDA has come under fire during the coronavirus pandemic for requiring clinical laboratories to request emergency use authorizations for any LDT that labs would use to identify patients infected with the SARS-CoV-2 coronavirus causing the COVID-19 illness. (See “Regulators Acted Slowly as Labs Developed Tests for Coronavirus,” TDR, March 30, 2020.)
On Aug. 19, HHS issued a directive saying the FDA could not regulate LDTs without issuing new regulations under official rulemaking procedures. New reporting on that issue reveals that the August directive was based on Charrow’s legal review from June. (See, “FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says,” TDR, Aug. 24, 2020.)
Specifically, Charrow’s June 22 legal memo addressed three issues:
Whether LDTs are medical devices;
If LDTs are medical devices, under what circumstances the FDA has jurisdiction to regulate them; and
Whether the FDA can regulate LDTs without notice/comment rulemaking.
On the first two issues, the memo showed that LDTs are medical devices and that circumstances may exist in which the FDA has regulatory jurisdiction. On the last issue, the memo stated that the agency can regulate LDTs, but when doing so, it must use HHS’ notice-and-comment-rulemaking procedures as outlined in the Administrative Procedures Act, Klein explained. This last issue, therefore, forms the basis for HHS’ Aug. 19 announcement, he added.
In October 2014, the FDA issued draft guidance documents for clinical labs on LDTs. One of those documents was titled, “Framework for Regulatory Oversight of Laboratory-Developed Tests (LDTs).” That guidance was issued for comment only, but was highly controversial among clinical laboratories. (See “FDA Official Makes Case in Favor of LDT Guidance,” TDR, Dec. 28, 2015.)
“But now, if the FDA wants to regulate laboratory-developed tests, the agency will need to issue new regulations and it will need to do this through the notice-and-comment procedures,” Klein said. “The FDA can’t just issue guidance documents as it did in 2014.
“For many years, the FDA has been notorious for regulating through guidance documents,” he added. “But many in the legal and policy arenas have objected to the use of explanatory guidance documents to set forth what they argue are actually policy determinations. Fundamentally, that’s the issue—that even if the FDA has the authority to regulate LDTs, it cannot do so through guidance documents.
“What that means in practice is that the agency must take all the necessary steps required for notice and comment rulemaking,” he commented. “That’s a more difficult and more time-consuming process. This is an obstacle for the FDA, because now the agency would need to publish the rules in the Federal Register, after which the agency must respond to stakeholder comments.”
More Laborious Process
While that process is more laborious than issuing guidance documents, it is also less arbitrary and potentially even more equitable for clinical labs, in vitro diagnostics (IVD) manufacturers, physicians, patient groups, and the public, Klein observed.
With notice and comment rulemaking, those stakeholders would get a chance to explain why any proposed regulations would affect them before the regulations became final. For example, the proposed regulations could cause costs to rise or result in patient harm.
“Then, the FDA would need to review those comments and perhaps adjust the regulations accordingly or withdraw them if necessary,” Klein explained.
Contact Roger Klein, MD, JD, at email@example.com or 203-927-0257.