Medytox Files Administrative Lawsuit Against MFDS's Order to Suspend Manufacturing and Sales of 'Medytoxine' (Update)

[Asia Economy Reporter Cho Hyun-ui] Medytox, a domestic manufacturer of 'botulinum toxin' known as Botox, has filed an administrative lawsuit against the Ministry of Food and Drug Safety's order to suspend the manufacturing and sales of its products.

On the 20th, Medytox stated in a press release, "We filed a 'request for suspension of execution' and a lawsuit to 'cancel the order' regarding the MFDS order at the Daejeon District Court at 9 p.m. the previous day."

Earlier, on the 17th, the MFDS announced that it had initiated administrative measures to temporarily suspend the manufacturing, sales, and use of Medytox's product 'Medytoxine Injection' and to revoke its product approval. The products subject to the planned revocation of approval are three items: Medytoxine Injection 150 units, 100 units, and 50 units.

Medytox stated, "Since its initial launch in 2006 until 2019, a total of 16.9 million vials (based on 100 units) of Medytoxine Injection were produced, and to date, there have been no reports of serious adverse events confirmed to be causally related to the product."

This MFDS action follows a report by a former Medytox employee and current Daewoong Pharmaceutical employee, Mr. A, to the Anti-Corruption and Civil Rights Commission, alleging that the company produced products using unauthorized raw materials from December 2012 to June 2015. The MFDS requested an investigation by the prosecution, which indicted Medytox CEO Jung Hyun-ho without detention.

While acknowledging the change in raw materials, Medytox opposed the MFDS's measures. The company said, "The legal basis for the MFDS's disposition is Article 71 of the Pharmaceutical Affairs Act, which presupposes that the manufactured and sold pharmaceuticals currently pose a 'public health hazard.' The relevant product production period is from December 2012 to June 2015."

Medytox argued that currently distributed products were manufactured after the raw material change and thus pose no issues. The company stated, "Medytoxine Injection produced during that period has long been exhausted and no longer exists," and "At present, there can be no public health hazard."

Furthermore, "Currently distributed Medytoxine Injection products were manufactured after April 2017," and "Medytox not only passed the MFDS's distribution product recall inspections conducted in 2016 and 2018 but also showed no safety or efficacy issues in multiple special pharmaceutical surveillance and random distribution product inspections conducted by the MFDS in 2019 within the product expiration period," the company added.

Medytox has temporarily suspended the manufacturing and sales of the problematic products in accordance with the MFDS order. The company said, "We plan to increase sales through the full-scale production and business activation of next-generation botulinum toxin formulations 'Innotox Injection' and 'Coretox Injection,'" and "We will do our best to prevent recurrence through more thorough internal verification and strengthened monitoring."

Meanwhile, Medytox referred to the ongoing U.S. International Trade Commission (ITC) lawsuit against Daewoong Pharmaceutical, stating, "This MFDS order concerns issues in the production process of Medytoxine Injection that occurred long ago," and "The domestic and international civil and criminal lawsuits and ITC litigation regarding the theft of Medytox strains and manufacturing technology against Daewoong Pharmaceutical are separate from this matter." It added, "Starting with the ITC's preliminary determination on June 5, the substantive truth will be revealed one after another."