Mineral Wells Index
By CHRIS AGEE
Officials at one local company are again speaking out against what they feel are unfair regulatory practices.
Daniel Kirsch, founding president of Electromedical Products International Inc., said this is the eighth time in the company's history the U.S. Food and Drug Administration has targeted the company's product.
"The FDA wants us to go through a pre-market approval process," he explained, which would treat the company's Alpha-Stim product – which has been used for 32 years to treat anxiety, insomnia, depression and pain – "like a new device."
He said such compliance would be unfeasible given Alpha-Stim's long record of use.
"It's not even possible for us to meet their criteria," he said.
Kirsch explained the latest complication is similar in nature to a number of previous situations.
"In 2011 and again this month, they did the exact same thing they did in the '90s," he said, noting his company makes every effort to comply with federal regulations as they exist and the FDA responds by ordering him to return to the drawing board and begin the approval process again.
"This is onerous work," he said. "All my top executives worked day and night."
Additionally, he wants Alpha-Stim downgraded to a less-regulated device in light of its safe use by millions of clients.
After complying with FDA demands two years ago, he said the process concluded with a panel meeting ostensibly designed to foster expert testimony.
"There were no experts," Kirsch alleged, calling the entire process a "kangaroo court."
He said they used questionable research, including a French study he said involved a product different than Alpha-Stim.
"They kept telling the panel it has the potential to cause seizures," he said, explaining his side of the discussion was limited to 45 minutes in the morning and he was unable to respond to any allegations by government witnesses.
In the end, he said, one witness was forced to admit "seizures happened prior to the use of electrical stimulation," Kirsch added, which he said means the device could have had no role in causing the adverse medical event.
Kirsch also complained about the dismissal of decades worth of research during the hearing.
"We pride ourselves on having more research than any other therapeutic device," he said, alleging the agency discriminately imposed restrictions on hearing such evidence.
While the FDA's 2011 attempt to impose additional regulations on the product ultimately failed, Kirsch said it was a long and difficult ordeal which is currently repeating itself.
"Rather than complete the process, they just decided to do it over again," he said.
As one of the few devices cleared to treat insomnia and depression, Kirsch and EMD Vice President Scott Elder speculate the FDA is trying to use increased regulation to undo a designation made four decades ago.
Elder noted times have changed in the industry.
"We live in a world where pharmaceutical drugs have a lot of power with the FDA," he said.
Despite the perceived federal backlash, Kirsch said sales of his product remain strong, particularly among veterans.
"Business is booming," he said. "If it wasn't for [the ongoing regulatory issue], we'd be a model company in America."
For more information about Alpha-Stim and its continued interaction with the FDA, visit alpha-stim.com.