Plastic surgeons and dermatologists have asked the regulator to reconsider its decision to revoke the license of Meditoxin, a botulinum toxin product made by Medytox allegedly using unauthorized ingredients.
Last Friday, the Korean Society for Aesthetic and Dermatologic Surgery (KSDS) submitted a petition to Minister of Food and Drug Safety Lee Eui-kyung, requesting leniency in the regulator move to nullify the permit of Meditoxin.
The group said in the letter that Meditoxin led the growth of the domestic BTX market and contributed to patients’ easier access to BTX products.
“Meditoxin has significantly contributed to improving patient accessibility by reducing the BTX production cost by half. The popular use of the product delayed the need for invasive procedures,” the group said. “Although many other BTX goods came out in the market, Meditoxin has made the most significant contribution to the broader use of BTX, which had been limitedly used with the high cost in the past.
|Meditoxin, a botulinum toxin product by Medytox (Credit: Medytox)|
The group claimed that Meditoxin has no safety issues. BTX has its pharmacological mechanism, and its action appears topically in the injected muscles, so side effects are clearly shown depending on the application site, the petition said. If some uneasy feelings occur, specialists can easily detect them because patients actively report them, it said.
Despite the safety of Meditoxin, the food and drug safety ministry’s decision to suspend it raised concerns among patients, the society noted.
“After the ministry’s order to suspend its use, patients worried that if their treatment had any problem or if they needed to check any other side effect,” it said. “Although the ministry said Meditoxin had no safety concern, the sales suspension alone can make patients worry about its safety, and even physicians who have been using Meditoxin for almost 15 years are concerned.”
If Medytox had violated the law regarding the manufacturing and managing of the drug, it would be reasonable to reveal the wrongdoings, punish it accordingly, and seek measures to prevent a similar mishap, the doctors said.
From the viewpoint of medical professionals, however, it was difficult to say that Meditoxin harmed patients, they claimed.
“A revocation of the license, which would be equal to kicking the drug out of the market, is too harsh,” the group concluded.
It was unusual that a group of doctors requested the regulator’s leniency for a particular treatment. Earlier, the food and drug safety ministry said it would revoke the Meditoxin’s license because Medytoxin made Meditoxin with unauthorized ingredients and fabricated titer test results between 2012 and 2015, violating the Pharmaceutical Affairs Act.
The ministry plans to hold a hearing on Friday and make the final decision.
Industry watchers are paying attention to whether the KSDS’ letter would affect the decision.
In response, an official at the food and drug safety ministry said the government could consider the petition in its review to decide on Meditoxin.
However, the government had announced the plan to nullify the permit because the company’s alleged fabrication of test results was a serious issue, he added.