[Asia Economy Reporter Cho Hyun-ui] The domestic botulinum toxin product 'Medytoxine' has taken its final step before the cancellation of its product approval. If the lawsuit between Medytox, the leading company in the domestic Botox market, and the Ministry of Food and Drug Safety (MFDS) intensifies, the domestic pharmaceutical and bio industries are expected to be embroiled in another controversy following the 'Kolon Invossa' incident.
On the afternoon of the 22nd, the MFDS held a hearing at the Daejeon Food and Drug Safety Office to hear the opinions of the manufacturer, Medytox, regarding the administrative disposition including the cancellation of Medytoxine's product approval.
Earlier, on the 17th of last month, the MFDS judged that Medytox violated the approval conditions and the allowable standards for the raw material in manufacturing and selling Medytoxine, constituting a violation of the Pharmaceutical Affairs Act, and initiated the procedure to cancel the product approval. The products in question are Medytoxine Injection 150 units, 100 units, and 50 units.
After a public interest report last year that the test certificates for Medytoxine Injection were fabricated, the prosecution conducted an investigation at the request of the MFDS. As a result of the investigation, the prosecution indicted Medytox for producing products with unauthorized raw materials and falsifying information, leading the MFDS to impose administrative sanctions.
The prosecution indicted CEO Jeong Hyun-ho without detention on charges of violating the Pharmaceutical Affairs Act and obstruction of official duties by deception, based on the view that Medytox fabricated Medytoxine test certificates and violated the allowable standards for raw materials.
Medytox believes that the MFDS's measures lack sufficient grounds. Considering that the MFDS's administrative procedures take a certain amount of time, it first provisionally suspended manufacturing and sales, but the products in question were produced between December 2012 and June 2015 and are no longer available. Medytox stated, "The MFDS order is premised on causing 'public health hazards,' but the products were already exhausted long ago and no longer exist," adding, "At this point, there can be no public health hazard."
Medytox actively presented its defense at the hearing. The Korean Society of Aesthetic Dermatology also sent a petition to the MFDS stating that "the cancellation of Medytoxine's product approval is harsh." However, the MFDS maintains that the possibility of reversing the cancellation decision is low. The court's statement on the same day, recognizing "an urgent need to suspend the effect of the disposition" in the appeal case filed by Medytox against the Daejeon Regional Food and Drug Safety Office's suspension order, is considered a separate matter from the cancellation of product approval.
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