Higher court rules against MFDS' revocation of Medytox’s BTX license

The Daejeon High Court has ruled against the Ministry of Food and Drug Safety's (MFDS) decision to revoke the license for Meditoxin, a botulinum toxin (BTX) product manufactured by Medytox.

According to Medytox, the Daejeon High Court dismissed the MFDS' appeal in the case involving three Meditoxin products -- 50, 100, and 150 units, upholding the lower court's decision, canceling the MFDS' order to halt the manufacture and sale of Meditoxin due to the alleged use of unapproved raw materials.

"This case is significant as it underscores the court’s recognition of illegal administrative actions by the MFDS and the protection of the pharmaceutical company's rights,” Medytox’s legal representative Yoon and Yang LLC. said.

The case initially started when MFDS argued that Medytox violated pharmaceutical laws by using unapproved raw materials in the production of Meditoxin between 2012 and 2015 and falsifying documents to appear compliant with approved materials. As a result, the agency canceled the product licenses of the three Meditoxin products in 2020.

In response, Medytox filed a lawsuit seeking to overturn the MFDS's decision. A separate injunction allowed the company to continue selling Meditoxin while the case was being heard.

Medytox argued that while there had been changes in the manufacturing process, the raw materials themselves had not changed.

Also, while Medytox admitted to modifying production methods without authorization, they argued that these changes did not affect the safety or efficacy of the drug and claimed the MFDS’s decision was excessively harsh.

The MFDS, however, maintained that their actions were in accordance with pharmaceutical regulations, rejecting claims of abuse of authority.

However, in November of last year, the lower court ruled in favor of Medytox, leading the MFDS to appeal.