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By Lee Hyo-sik
Dermatologists are opposing a government move to nullify the permit issued to Medytox for the manufacture, sale and use of three dosage units of Meditoxin, the firm's flagship botulinum toxin product, according to their association Thursday.
The Korean Society for Aesthetic and Dermatologic Surgery (KSADS) has filed a petition with the Ministry of Food and Drug Safety, saying it is "too harsh" to cancel Medytox's license for 50-unit, 100-unit and 150-unit Meditoxin products.
On April 17, the ministry ordered a suspension of the production and use of the botulinum products and began the process of canceling the company's license. The decision was made after the prosecution disclosed the results of its investigation into Medytox's alleged use of an unapproved ingredient to produce the drug, and acquisition of export approval by fabricating efficacy test results.?
In response, Medytox asked Daejeon District Court to cancel the ministry's order, saying the Meditoxin products in question were manufactured from December 2012 to June 2015, and had all been used a long time ago.?
"We believe it is too severe a punishment to nullify the firm's license, which will be equivalent to kicking it out of the market entirely," the association said. "We are concerned that if canceled, this will create a significant backlash against dermatologists who have used Meditoxin for years, relying on its safety and efficacy."
The association said patients here have been able to receive effective and safe botulinum toxin treatments, thanks to Meditoxin, at 10 percent of the cost in the United States and Europe. Launched in 2006, Meditoxin became the first botulinum toxin product in Korea, and fourth in the world.?
"We, experts, are the ones who can detect safety problems associated with the use of Meditoxin, if there are any. But there have been none," it said. "The ministry's order to stop the use has made many patients worried about their treatments. We don't believe Meditoxin has caused any harm to our patients so it is too severe for the government to revote the permit. We want to continue to use the product."
After hearing from Medytox on the matter Friday, the ministry plans to decide whether to cancel the Meditoxin license.
