Mineral Wells Index, Mineral Wells, TX

Local News

April 24, 2013

Local company claims FDA unfairly targets technology

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.

Text Only
Local News
Featured Ads
Mineral Wells Index


Front page
Seasonal Content
AP Video
Raw: More Than 100,000 Gather for Easter Sunday Raw: Greeks Celebrate Easter With "Rocket War" Police Question Captain, Crew on Ferry Disaster Raw: Orthodox Christians Observe Easter Rite Ceremony Marks 19th Anniversary of OKC Bombing Raw: Four French Journalists Freed From Syria Raw: Massive 7.2 Earthquake Rocks Mexico Captain of Sunken SKorean Ferry Arrested Raw: Fire Destroys 3 N.J. Beachfront Homes Raw: Pope Presides Over Good Friday Mass Raw: Space X Launches to Space Station Superheroes Descend on Capitol Mall Man Charged in Kansas City Highway Shootings Obama Awards Navy Football Trophy Anti-semitic Leaflets Posted in Eastern Ukraine Raw: Magnitude-7.2 Earthquake Shakes Mexico City Ceremony at MIT Remembers One of Boston's Finest Raw: Students Hurt in Colo. School Bus Crash Deadly Avalanche Sweeps Slopes of Mount Everest
Hyperlocal Search
Premier Guide
Find a business

Walking Fingers
Maps, Menus, Store hours, Coupons, and more...
Premier Guide
Stocks
Parade
Magazine

Click HERE to read all your Parade favorites including Hollywood Wire, Celebrity interviews and photo galleries, Food recipes and cooking tips, Games and lots more.
Must Read