Device Maker: CDRH Staff Conduct ‘A Serious Breach of Duty’

Last month, I told of small device maker Electromedical Products International (EPI)’s ongoing, 30-year battle to keep it sole product, the Apha-Stim cranial electrotherapy stimulator, out of Class III.

Since that column went to press, EPI has done what only a brave few in the industry have dared to do: publicly target specific, named CDRH employees with conduct in the matter that amounts “a serious breach of duty that is expected of federal government employees.”

The charge came in a heavily documented letter to FDA commissioner Margaret Hamburg that complained about the selection of and interactions with members of a 15-person advisory panel that in February recommended Class III status for such devices.

In it, EPI president Tracey B. Kirsch and vice president and general counsel Scott A. Elder asked Hamburg to grant their petition of last August seeking Alpha-Stim’s reclassification to Class II, under the same regulatory controls to which they say it has been successfully marketed for 31 years.

EPI isn’t the only company aggrieved by what went on at that meeting of the Neurological Devices Panel. Another CES manufacturer, Neuro-Fitness LLC, has petitioned Hamburg to revoke the panel’s recommendation. And a third, New York-based Fisher Wallace Laboratories, petitioned the agency to “(1) investigate possible noncompliance with applicable federal requirements, or misconduct, by CDRH in regard to the proposed reclassification of CES devices, (2) not to use any advice or recommendation provided by the Neurological Devices Panel … (3) refrain from issuing a final rule to require the filing of a premarket approval (‘PMA’) application or a notice of completion of a product development protocol (‘PDP’) for CES devices, and (4) either grant the reclassification petitions, thereby placing CES in class II …”

With 35 pages of attachments including summaries of safety and effectiveness studies of Alpha-Stim and a 20-point critique of the panel meeting’s organization and conduct, the EPI letter asks Hamburg to “eliminate the statutory application of Class III, premarket approval, to the Alpha-Stim CES device” because such devices “are neither life supporting/sustaining or of substantial importance in preventing impairment of human health.”

In its critique of the panel meeting proceedings, EPI says CDRH limited to 45 minutes the time each of the three CES makers could make their presentations — which sought different indications — while granting itself two hours and 15 minutes to present the Center’s case for Class III. This served only to “confuse the panel and further mask a legitimate review of CES for its current indications of use,” EPI’s letter says. “As CDRH’s lead reviewer, Timothy Marjenin, pointed out in an email to EPI dated January 20, 2012, ‘From a logistical standpoint, interacting with three separate petitioners is more labor intensive than working with one sponsor (like for a specific PMA); that in itself may make it difficult to be as collaborative as we might otherwise be.’”

Little to No Collaboration

Indeed, there turned out to be little to no collaboration, EPI’s letter tells Hamburg. The company had many procedural questions about the meeting, only a few of which were answered and it filed two Freedom of Information requests that still have not been answered. EPI wanted a discussion with CDRH before the meeting, but all it got was an 83-page executive summary and slides when those were publicly released 48 hours before the meeting — although CDRH had the benefit of EPI’s presentation and all supporting data two weeks before the meeting.

Under these CDRH-imposed circumstances, “there was no time or ability to respond to a vast number of errors and omissions in CDRH’s presentation. … More importantly, even if the petitioners had been given a chance to review FDA’s presentation, the panel meeting provided the petitioners with no opportunity to respond to assertions made by CDRH in its documents or in its presentation due to the structure of the panel meeting.”

Among numerous other criticisms, EPI alleged that CDRH’s “questions for panel” were changed from what it had distributed 48 hours before the meeting; CDRH’s executive summary and presentation “ignored almost all of the data that was presented by petitioners;” CDRH designated federal officer Avena Russell promised there would be no voting at the meeting since the panel consisted of only three “voting” members and 12 “nonvoting” consultants — but what occurred on the day “certainly seemed like voting;” and EPI alleged there was no panel member present who was listed as having any expertise or experience with CES.

It also alleged that the panel was used by CDRH “to get the desired result.” EPI criticized the conduct of CDRH Office of Device Evaluation director of ophthalmic, neurological and ENT devices Malvina Eydelman, who, it said, made the CDRH presentation, sat as a panel member, and interjected her opinion several times to “clear up statements” made by petitioners. “Petitioners were never afforded an opportunity to clear up any statements offered by CDRH or Dr. Eydelman, who was free to interject her views to the panel at any time without any ability for the petitioners to respond.”

EPI says its device is marketed over-the-counter everywhere else in the world.

There isn’t much of a track record of FDA commissioners actually doing anything about complaints like these. The last one who invited unhappy companies to use him as a last court of appeal — a power commissioners have but never in modern times use — was Lester Crawford, who resigned in disgrace.

What commissioners do with such cases is let the lower echelons deal with them, which is usually a formula for allowing the complained-about conduct to stand.