By Kirell Lakhman

Writing about FDA's plan to regulate LDTs as medical devices over the past several months has caused a recurring image to appear in my mind: An FDA official, strapped to the Hoover Dam, plugging one leak as another nearby quietly spurts open. Then another, and another, until the official, barefoot and blistered, finds himself with few options left.

I'll spare you the psychoanalysis and say that market innovation, like water, will eventually find the path of least resistance, and no number of FDA digits will slow its pace. But this doesn't mean the agency's plan won't claim its share of losers.

This thought crossed my mind today after learning that OIVD Director Elizabeth Mansfield (at left) conceded that the FDA's wise policy of "enforcement discretion" over LDTs has over the years "become a loophole" for some test makers.

To be sure, Mansfield made her "loophole" remark as early as July in reference to certain IVD manufacturers, as my colleague Turna Ray has reported. Of course, Mansfield's remarks today, made to the lame-duck Secretary's Advisory Committee for Genetics, Health, and Society as part of an update to the FDA's LDT-oversight plan (the agency is still "trying to decide what [its] options are"), could also be applied to clinical labs that develop LDTs that could be rechristened as IVDs.

In her remarks, Mansfield said the FDA is currently drafting plans for how to regulate LDTs and is considering available options, according to my colleagues at GenomeWeb Daily News. These options, none of them new, include using a risk-based approach for overseeing the tests to creating a test registry to monitor them.

She told the Committee that CDRH, OIVD's home center, is now "putting together a framework document for oversight" and is drafting an operational plan while "trying to decide what our options are."

Mansfield's remarks brought to mind the evolutionary trait shared by most species in the private sector that enables them to legally sidestep regulations, and the clinical lab community is no different.

CDRH's decision to overturn enforcement discretion four months ago was the result of a sclerotic, underfunded, and understaffed agency chronically unable to keep pace with technological innovation and market penetration.

That same agency will be equally ill-prepared to monitor the market catfight stage-managed by lawyers, bureaucrats, and lobbyists whose results will be, you guessed it, more loopholes.

Regardless of the machinery the FDA eventually installs to help it regulate LDTs, the result could dramatically burden clinical labs with greater compliancy costs, and hurt patients, especially those in rural and other less-affluent regions. These will be the Loophole Losers.

The winners will be those clinical labs with the resources to auger new loopholes. In her remarks to SACGHS, Mansfield said the FDA has started down its LDT-IVD path because "business models arose that leveraged our practice of discretion to get to the market without FDA oversight. The business model is not really problematic; the lack of oversight is problematic."

But the business model could lead to a problematic situation for most clinical labs: 20 percent of all clinical labs in the US are small, private mom-and-pop operations, while 65 percent are located in physicians' offices and hospitals. The balance comprises the international and regional reference labs with the resources to absorb the added regulatory compliance costs, not to mention the post factum lobbying efforts that will accompany any new LDT regulatory framework.

And whether it likes it or not, the FDA will shoulder the former with unfunded mandates fit for Atlas: Today, clinical labs shell out between $100,000 and $300,000 to successfully market a single IVD, and most estimates show that around 40 percent of all existing LDTs are gene-based or are otherwise esoteric. These are the assays the FDA could classify as IVDs when it finally makes up its mind.

Two bright sparks appear in Mansfield's remarks. The first is that any regulatory plan the FDA is considering is currently "provisional," and that the agency wants to "look more broadly at all LDTs" — reiterating the foresight CDRH displayed four months ago when it originally announced its plan to deep-six enforcement discretion.

The second is that clinical labs can count on the FDA's phlegmatic decision-making process to bide them some time. "How many [LDTs] are there?" Mansfield asked SACGHS. "We don't know. What is being tested? What is at risk?" Ditto.

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