A recent series of development over Medytox’s botulinum toxin is making it quite difficult to predict whether or not the government will revoke the BTX license, industry watchers said on Monday.
The company recently won a court’s ruling to stop the Minister of Food and Drug Safety Ministry’s Daejeon branch from proceeding with the ministry’s plan to suspend making and selling Meditoxin. The decision allows the company to continue to manufacture and market the BTX product until the government decides whether to nullify the drug license.
|Meditoxin, the botulinum toxin product by Medytox|
“To prevent the petitioner’s damages that could be irrecoverable as a result of the ministry’s order, we recognize an urgent need to stop the order,” Daejeon High Court said in a statement. The data submitted by the ministry is insufficient to prove that the suspension of the administrative order will cause significant harm to public health, the court added.
On Tuesday, the Daejeon District Court turned down Medytox’s appeal for suspending the government’s order to stop making and selling Meditoxin. The company appealed the decision to the high court, and the latter accepted the company’s claim, nullifying the earlier ruling by the lower court.
The latest court ruling coincided with a hearing on the ministry’s administrative order. When the court’s decision came out on Friday afternoon, the ministry’s Daejeon branch held the hearing to listen to the company’s stance regarding the administrative order. The hearing had been scheduled to take place on May 4, but a change in the moderator delayed it to Friday. On the day of the hearing, the company also won the court’s temporary lift of the sales ban.
The ministry said the court’s decision would not affect its decision whether to cancel the license of Meditoxin.
However, industry watchers said the court’s lift of the sales ban might affect the ministry’s plan. Plastic surgeons and patients also expressed conflicting opinions over the withdrawal of the Meditoxin permit.
On Wednesday, the Korean Society for Aesthetic and Dermatologic Surgery (KSDS) submitted a petition to the ministry, requesting leniency in the regulator’s move to nullify the BTX product permit.
In contrast, the Korea Alliance of Patients Organization (KAPO) released an opposing statement.
The patient group argued that the case of Medytox -- which allegedly used unauthorized ingredients and faked titer test results to manufacture and sell Meditoxin – was similar to that of Kolon Life Science that sold gene therapy Invossa-K despite an ingredient mislabeling error. KAPO called for the harsh punishment of Medytox and criticized plastic surgeons for supporting the company’s stance.
After reviewing materials and listing to the company’s arguments, the ministry is expected to make the final call within at least two weeks. In the case of Invossa, it took 15 days for the regulator to decide on the nullification of the drug license after a hearing.
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