Laboratory Developed Tests

Thursday, July 11, 2013

After an awkward pause following a public FDA meeting in 2010, FDA has issued a new, if not necessarily final, word on the regulation of laboratory developed tests (LDTs).  

FDA has not been entirely silent on the matter. OIR has promised delivery of no fewer than three draft guidance documents addressing how FDA would regulate LDTs and has variously signaled use of a risk based approach, the likely need for classification panels, and the slow but steady phase in expected time (to be counted in years not months) for such a new program.  

No out of the ordinary pronouncements here. A category of high risk devices for immediate action is likely by necessity to be narrowly drawn, restricted to unarguably high risk devices.

But to date the proverbial check has been in the mail. Lack of public notice has not stopped intense lobbying.  To my eye the money has unfortunately been well spent. Regulatory scientists at OMB now appear to be second guessing the FDA in a manner that can only be described as reminiscent of the external help given to Plan B.  A curious addition to the Food and Drug Administration Safety and Innovation Act requires FDA to notify Congress at least 60 days prior to issuing a draft or final guidance on the regulation of LDTs. Rarely has an office at FDA been afforded such a unique opportunity for personal attention by Congress.  

On June 2, 2013 eyebrows were raised by comments made by FDA Commissioner Hamburg at a speech before the American Society of Clinical Oncology (ASCO). There was no mistake in the choice of venue: ASCO has been a sponsor of clinical practice guidelines since the early 90’s and is an advocate for evidence based medicine. Hamburg delivered a clear message: FDA is developing a risk-based framework that is intended to “make sure that the accuracy and clinical validity of high risk tests are established before they come to the market.” 

With this pronouncement  the check did seem to be in the mail although with either incredibly good fortune or simply a well planned and reserved counter attack, on June 4 the American Clinical Laboratory Association (ACLA)  fielded the latest in a growing list of citizen’s petitions to FDA on this subject. ACLA argues that LDTs are not devices and are not in commercial distribution.  While I am not a lawyer, as someone who knows a bit about FDA legal thinking, my personal view is that these notions are at best naïve and at worst delusional. To my eye LDTs do pass the duck test and look awfully much like medical devices (distinct only in the business model used for their creation). FDA’s broad use of the term inter-state commerce would belie the ACLA view of the LDT as an island unto itself.  

While the ACLA petition clearly adds to the cacophony of opinions on the subject, it is probably worth noting that FDA still has IOUs out on the last two petitions on this subject fielded by the Washington Legal Foundation in 2006 and Genentech in 2008. 

Providing a not so subtle hint as to where the hang up in policy might be, on June 6 Representative Louise Slaughter (D-NY) issued a letter to the Office of Management and Budget (OMB) urging the release of the FDAs draft guidance for LDTs. As Slaughter notes “the time has come for the Administration to address this regulatory gap and resolve the uncertainty hanging over this critical area of medicine by affirming FDA’s oversight of diagnostics.”  Wise words but one can only wonder what piqued Slaughter’s sudden interest in this issue.

The same request was made in a more public venue last weekend in an editorial in the New York Times entitled “The Gap in Medical Testing.” IVD issues seldom appear as lead pieces in the Times but this commentary puts this issue clearly in the limelight beginning with the warning “An alarming number of diagnostic medical tests have never been tested for safety and accuracy” and concluding with the modest proposal: “Regulation are long overdue; the draft guidelines should be quickly released for public comment.” Wise words but one can only wonder what piqued the Time’s sudden interest in this issue.

It is clear that the war over regulatory ownership of IVDs goes on. What happens next is anybody’s guess. One can only hope that in the end good science wins but as the lobbying continues nil admirari (be surprised by nothing!).

Tags: CDRH, LDTs, Politics

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