Mineral Wells Index, Mineral Wells, TX

Local News

April 24, 2013

Local company claims FDA unfairly targets technology

(Continued)

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.

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