FDA Impedes Company with Medical Device Mostly Used By Recovering Veterans

Mineral Wells, TX – Last week, a publication in the Federal Register brought a glimmer of hope to a company that has been fighting for proper recognition and classification from the United States Food and Drug Administration for the last 33 years.

Electromedical Products International, Inc. or EPI, was founded by Dr. Daniel L. Kirsch in 1981. The premise of EPI revolved around the Alpha-Stim, a Cranial Electrotherapy Stimulation (CES) Device. It was originally cleared by the US FDA to treat the conditions of anxiety, insomnia, and depression. However, EPI ran into problems with the FDA, when it came to classifying their device.

While the Alpha-Stim is sold over the counter in Europe and Canada, the FDA in the United States has limited it to only being available to patients, by or on the order of a licensed healthcare practitioner. Also, whereas the Alpha-Stim is classified as a Class II device, according to the regulatory authorities in Europe and Canada, it is classified it as a Class III device in the United States. The main difference is that at Class II, the Alpha-Stim is subject to special controls, while at Class III, it is subject to the Pre-Market Approval Process.

According to EPI’s President, Tracey B. Kirsch, “Arbitrary actions by FDA were first experienced by EPI in 1990 for its 510(k) submission for CES indications. This statutorily mandated 90-day review process took 22 months, and more than once during this lengthy process FDA would request more valid scientific evidence to support the application on the 89th day of review, thereby restarting the FDA’s 90-day clock.”

It wasn’t until May 12, 1992, that EPI received its substantial equivalence letter from the FDA. “Years of hard work and substantiation had finally been completed, or so we thought,” said Mrs. Kirsch.

In 1993, the FDA issued a proposed rule to reclassify CES devices, which was finalized in 1995. EPI complied, and submitted a Pre-Market Approval, or PMA, in November of 1995, for its Alpha-Stim CES technology. EPI received a refuse to file letter in the following month, in which the FDA claimed that EPI’s PMA did not contain the required information, therefore the application could not be filed and EPI would have to cease distribution of its CES technology.

In 1996, EPI filed suit against the FDA in Federal District Court, and in 1997 there was a Federal Register notice published which revoked the FDA 1995 regulation requiring PMA’s for CES devices. This allowed commercial distribution through 510(k) clearances. According to Mrs. Kirsch, “There was no reason given for this revocation.”

EPI was allowed to market and distribute its CES products in relative peace from 1998 until 2009, when FDA requested CES manufacturers again provide their research to FDA so that a proper final classification could be made,” said Mrs. Kirsch.

In 2012, representatives from EPI were called before with the Neurological Devices Panel of the Medical Devices Advisory Committee to the FDA. The FDA wanted to keep CES devices in Class III, but EPI presented their safety and effectiveness data in an attempt to reclassify the Alpha-Stim to a Class II device.

The FDA published a Proposed Rule in 2011, and then, after ignoring EPI’s compliance, they published a similar mandate in 2013, this time a “Proposed Order.” EPI responded with over 300 letters, filled with practitioner and patient testimonials. Sixteen of those letters were written by Dr. Kirsch, himself.

The subject matter in Dr. Kirsch’s letters ranged from wanting to know why the FDA was supporting studies that turned anonymous individuals into experts on the Alpha-Stim, to accusing the FDA of discarding 360 of the 392 studies on Cranial Electrotherapy Stimulation that were presented to the Neurological Devices Panel.

Dr. Kirsch wrote that the FDA had left the Neurological Device Panel with “no useful data upon which to make their recommendation as to effectiveness of CES in the treatment of anxiety, insomnia and depression.” He went on to write, “We ask that FDA review all of the valid scientific evidence and present it to the Neurological Devices Panel in a fair and unbiased manner so that the Petitions for Reclassification submitted on behalf of CES devices can be adequately considered.”

In the same Proposed Order where the FDA demanded that all Cranial Electrotherapy Stimulation devices be classified as Class III devices, it also suggested reclassifying sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, from Class III into Class II.

One of the largest things setting the two devices apart were the side-effects. While sorbent hemoperfusion devices had side effects such as blood loss, platelet loss, and Leukopenia, CES devices had a much smaller list, which included side effects such as headaches and skin irritation.

We feel it is appropriate to highlight the standards FDA has imposed on CES manufacturers in FDA’s review of their petitions to reclassify CES as a Class II device and compare that with the standards imposed by FDA in its review of sorbent hemoperfusion devices,” explained Dr. Kirsch. “A review of the standards imposed for each device shows a clearly arbitrary and inconsistent process of review which FDA is implementing in its determination of a device’s classification.”

In regards to the Cranial Electrotherapy Stimulation Devices made by EPI, Dr. Suresh Kotagal, a member of the Neurological Devices Panel in 2012, said, “I just have a very simple comment, that the device is safe. There is really no convincing evidence of any potential adverse effects.”

The long, continuous battle has taken a toll on Dr. Kirsch. He told Benswann.com, “Every day for over 20 years when I woke up in the morning I worried what the FDA may do to us. Indeed they did a lot. I often thought I lived in a nightmare version of the movie Groundhog Day.

The recent publication in the Federal Register showed that the FDA was finally taking steps to accept the multiple reclassification petitions submitted by EPI to put CES devices into their proper category. Dr. Kirsch sees this as great news, which will lead to removing uncertainty from EPI’s future. “Now while they still will regulate us with a harsh hand, they can not just make our 33 year history go away ever again and force us to start over,” said Dr. Kirsch.

Currently, the largest customer of the Alpha-Stim is the United States Government. The US Department of Defense and Veterans Affairs Medical Centers accounts for over 60% of EPI’s sales, using the CES Devices primarily for treatment of depression, anxiety, insomnia, and Post-Traumatic Stress Disorder. “More than half our business is with the same government that has lied and ignored their own rules to try to run us out of business,” acknowledged Dr. Kirsch.

Army Reserve Psychology Consultant, Dr. Kathy Platoni, testified, “In my experience, without exception, there is no more powerful form of therapeutic intervention, either as an adjunct or a stand alone treatment than Alpha-Stim CES.”

Dr. Kirsch tells Benswann.com that he looks forward to the majority of EPI’s profits no longer going to staying in business, but rather to more productive uses such as helping our Service Members come all the way home. “The FDA finally doing the right thing means more Service Members and Veterans will regain their optimism for life and more insurance companies will pay for Alpha-Stim,” said Dr. Kirsch.

Dr. Kirsch believes that the spreading of Alpha-Stim technology will lead to America becoming a safer place, due to the fact that the Alpha-Stim is a safe alternative to using anti-depressant drugs, which, according to the International Coalition For Drug Awareness, not only have horrendous side effects, but are also the main cause of all the school, church and mall shootings we have seen since there drugs became popular.

Perhaps Alpha-Stim can now achieve my personal goal to make America a safer, kinder and happier place for all freedom-loving people,” said Dr. Kirsch.