How FDA’s Culture Beats the ‘Least Burdensome’ Law

Nearly two decades after its passage into law, “least burdensome” FDA regulation is still a hollow concept.

July 14, 2014

6 Min Read
How FDA’s Culture Beats the ‘Least Burdensome’ Law

Most medical device companies try hard to be good citizens and do their best to comply with FDA’s Byzantine regulations and policies. To varying degrees, they employ ex-FDA staff to help them do the right thing, and if they don’t outright employ them, they consult them.

Stay up to date on the goings-on at FDA by attending the MD&M Minneapolis conference October 29–30, 2014.

Many on the fringes, however, do neither.

But whether companies do or don’t seek out former FDA employees for help, there’s a universal enemy at the agency that they can do nothing to overcome: the FDA culture.

An object but obscure lesson in how much harm this seemingly unbeatable foe can cause surfaced briefly this past June in a Federal Register notice that, astonishly, withdrew a three-year-old proposed rule and proposed order to require the filing of a PMA for cranial electrotherapy stimulator (CES) devices—proposals CDRH has been pursuing relentlessly, on and off, for more than 20 years.

This document is simultaneously a remarkably opaque and unforeseen FDA capitulation to the legal reality that these devices have little to no risk and actually have been embraced by the U.S. military as boon in the treatment of post traumatic stress disorder, and a tacit admission that FDA’s culture obstructed a public health benefit.

Notwithstanding a clear congressional directive in the 1997 FDA Modernization Act—reinforced in subsequent legislation— that its reviews of medical devices must follow least burdensome requirements and procedures, CDRH repeatedly, for all those 20-plus years, imposed the opposite on the small cadre of manufacturers making CES devices.

Notable among these was Mineral Wells, TX-based Electromedical Products International Inc. (EPI), the 21-employee maker of the Alpha-Stim CES product for insomnia, depression, and anxiety. The company retained CDRH attorney Larry R. Pilot to battle the center’s “most burdensome” approach, established in 1978, to placing all such devises in Class III simply because “satisfactory effectiveness has not been demonstrated.”

That was a portal to regulatory burdensomeness wide enough to drive an army division through. According to a 1978 FDA classification: 

it is not possible to establish an adequate performance standard for this device because the characteristics of the electrical current necessary for effectiveness are not known. The panel believes that general controls will not provide sufficient control over these characteristics.

The classification went on to opine that the devices present “a potential unreasonable risk of illness or injury to the patient if the practitioner relies on the device, and it is ineffective in treating the patient’s illness.”

There followed an erratic regulatory follow-through, including decades of slumbering, until in 1993 CDRH proposed a rule requiring a PMA for the devices. Why did this take so long? Nobody has offered an explanation.

The rule was finalized in 1995 and revoked two years later after EPI sued the agency, causing it to briefly convert to full flexibility and admit in the Federal Register that it had “become aware of additional information relevant to the possible reclassification of the CES device from Class III to Class II or Class I.”

FDA then announced that it believed it was “more appropriate” to invoke the procedures under section 515(i) of the Food Drug & Cosmetic Act and issue an order requiring manufacturers of CES devices to submit information on their devices’ safety and effectiveness.

It took CDRH another 14 years to get serious about that. In April 2009 it published a 515(i) notice that applied to all of the 25 remaining devices, including EPI’s Alpha-Stim, that still held Class III preamendments status “as the first step in the process of final rule-making.” Letters went out giving their makers four months to respond.

The center then slumbered on the issue for another four years, until August 8, 2011, when it snapped back to its original 1978 position, proposing to require PMAs for the CES devices. That’s when EPI and two other CES manufacturers petitioned CDRH for Class II status.

In February 2012, CDRH took the matter to its Neurological Devices Panel (NDP). None of the members disclosed “qualified expert status” in CES devices, but they were provided with what EPI called a biased 83-page CDRH executive summary that argued for Class III status on the same vague grounds the center had used in 1993. As it customarily does, CDRH ambushed the company with this voluminous “data dump” in less than 48 hours before the meeting, depriving it of an effective response before the panel.

As intended by CDRH, the panel voted to keep CES in Class III because there was no showing of effectiveness. Neither, it failed to admit, was there any showing of risk beyond a few reports of skin irritation, headaches, and two cases of dizziness.
As in too many other episodes in this most dysfunctional of FDA centers over the years (e.g., Myo-Tronics, Utah Medical Products, TMJ Implants, Laerdal, et al), here appears another instance of CDRH serial malfeasance against a small company with a successful product that has somehow fallen from bureaucratic favor.

Fast-forward to June 12, 2014, and FDA’s one-page, smiley-faced complete reversal in the Federal Register, signed by assistant commissioner for policy Leslie Kux.

What happened? The notice doesn’t say, but it hints that instead of finding no evidence of effectiveness over 20 years of on-again, off-again searching, it finally found no evidence of risk sufficient to justify continuing to impose maximally burdensome requirements on this industry.

That discovery came more than 20 years later than it should have, and was doubtless brought about by the inevitable turnover in key decision-makers over such a long interval, and by the center’s latter-day tendency to put lawyers into key regulatory management positions. One of these lawyers must have recognized the festering CES mess CDRH had accumulated and, armed by the daunting fact that 300 public comments overwhelmingly favored down-classification in Class II, shoved the center out the nearest exit.

This poses the obvious question: Why does CDRH continually behave in such a way?

Pilot and an allied warrior in the trenches, ex-CDER engineer Leroy Hamilton—who, like Pilot, has the rare distinction of besting CDRH in combat (revising CDRH’s flawed device classification questionnaire last year)—blame the CDRH culture.

In their diagnosis, the culture has two dominant traits: a crudely expressed cover-your-butt syndrome and a reflexive command-and-control syndrome that compels it to retain power wherever it can, regardless of need.

In the view of both Pilot and Hamilton, these two syndromes are perversely encouraged by industry’s broad reluctance to push back when FDA demands become unreasonable.

The combined effect of these syndromes —not unique to CDRH but widely manifested across government in all agencies with police powers—almost always works to industry’s detriment, which in the case of the medical device industry, also means to the detriment of public health.

That might explain why, 17 years after its passage into law, “least burdensome” FDA regulation has been so hollow.

Stay up to date on the goings-on at FDA by attending the MD&M Minneapolis conference October 29–30, 2014.

—Jim Dickinson is MD+DI's contributing editor.


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