Following months of debate about the proper role of the FDA in coronovirus test authorization, another move occurred Wednesday.
See article in Politico here. Early coverage at Genomeweb here. Modern Healthcare here. Washington Examiner here. CIDRAP here. The Hill here. Leading a brief notice, HealthDay has a good headline: "White House Blocks FDA's Power to Regulate Labs," here.
Detailed story at WaPo here. Detailed article from Covington law firm, open access, here. Deeper dive story at Genomeweb, by Adam Bonislawski, here. Therein, noted attorney Jeff Gibbs notes there may still be a gray area between IVDs, LDTs, and a third category, what are now RUO kits that are self-validated by CLIA labs. The guidance may play out in ways that alter the implicit ground rules around RUO kits.
Update: One week review and deep dive analysis August 28 at Genomeweb; subscription; here.
The August 20 guidance seems to be based on a June 22, 2020 17-page legal memo, here.
See the actual HHS announcement here - "Rescission of Guidances...concerning Premarket Review of LDTs."
The core HHS message is here:
As part of HHS's ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19, the department has determined that the Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.
Those seeking approval or clearance of, or an emergency use authorization ("EUA") for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so.
In the Politico story, including headline, this HHS position is billed as related to COVID, but it appears to my eye to apply to any type of LDT test. That said, the broadly worded guidance appears at HHS.gov under the category COVID, then testing, then LDT, and then this guidance.
Doesn't Override Other COVID Law
Other points of COVID lawmaking in the past months, such as insurance coverage and payment, may directly state they apply to tests that are cleared, approved, or under FDA EUA. Where those rules inclusive of FDA test review have been directly legislated, they still apply (HHS mentions this). See for example CARES Act S. 3201. Also, some aspects of ADLT law and the CMS NCD for NGS tests give coverage or pricing privileges due to FDA approval.
There's years of legal debate on how much FDA can do via "guidances" versus "notice and comment rulemaking." See many papers over the years by, among others, law professor Lars Noah (one prime example here.)
Yale Law Journal on COVID, Law, FDA
See also an open access article in Yale Law Journal about FDA's role in handling COVID, by Evans and Clayton, which is in fact largely an article about guidance based policy-making (here).
HHS Follows WSJ?
Whether coincidence or not, the HHS announcement comes just two days after a highly critical article about COVID testing, CDC, and FDA, by Armour et al. in WSJ on August 18. The August article refreshes an investigation with initial reports by the same team back to mid-April.
FDA and PGx
Another back story would be the 2019, 2020 attack by FDA on LDTs for pharmacogenetic tests (e.g. subscription story at Genomeweb here).
Footnote: CMS and FDA versus the "Burden" and "Time" of Rulemaking
I've often heard FDA staff say, "We can't do notice and comment rulemaking, it takes five years." But CMS puts out tons of notice and comment rulemaking every year - 500 pages of inpatient rules, physician rules, Medicare Advantage rules, etc - and turns them around with a 60 day comment cycle then 30-60 days of finalization. Medicare does this through N&C rulemaking across hundreds of topics, or policy points, annually.
The HHS position seems to be that FDA doesn't have authority regulate LDTs involuntarily without rulemaking, but FDA does have authority to regulate LDTs (e.g. issue PMAs) if asked to do so. I think this is an unusual position - that FDA can regulate an item or class of by law, but, only if asked voluntarily.