The whistleblowers who revealed Medytox’s alleged illegal manufacturing of a botulinum toxin and the company’s shareholders counterattacked the company’s statement released on Monday.
Koo Young-shin, a lawyer who filed a public complaint with the Korean Anti-Corruption and Civil Rights Commission against Medytox for using unauthorized material to manufacture the botulinum toxin on behalf of a former Medytox employee, said Tuesday the company’s statement could be misleading.
“The statement makes the situation look like as if a public hygiene hazard does not exist anymore, and as if the informer had some other purposes in reporting the case. It could damage the reputation of the informer,” Koo said in a statement.
Prosecutors said earlier that their investigations revealed the company had produced Meditoxin with an unauthorized ingredient and fabricated test results to obtain approval for shipments. The prosecution indicted Medytox CEO Jung Hyun-ho and the head of the Medytox’s plant. The Ministry of Food and Drug Safety suspended the making and selling of Meditoxin and took steps to nullify the product’s license.
However, Medytox on Monday filed an administrative suit against the food and drug safety ministry to stop the government from executing the administrative order, saying Meditoxin products manufactured in the past have already been consumed and do not pose a threat to the public health.
‘No present harms on public health’ vs. ‘Continuous titer forgery’
However, the company’s claim that “no public health risk exists” was not persuasive, Koo said.
According to the lawyer, three informers reported the Medytox case to the Korean Anti-Corruption and Civil Rights Commission, and more people testified the company’s alleged illegal acts.
Their testimonies show that Medytox manipulated the results of tests on Meditoxin’s safety from the initial stage of winning the license, he said. Also, the company continued to use illegal ingredients to make the product and fake test results. However, the company’s statement released on Monday sounded as if the company’s illicit acts existed only from December 2012 to June 2015, Koo said.
‘Medytox also faked data to win nod for Innotox’
Koo also took issues with Innotox, a liquid-type botulinum toxin. Medytox said amid the suspension of the sale of Meditoxin, the company would actively produce and sell Innotox to increase the revenue.
However, the company is expected to face a three-month suspension of manufacturing Innotox because of fabricating test results.
According to the tipoff, Medytox tempered with the 24-month stability test on Innotox when seeking approval in 2013. In the 24-month stability test conducted on Dec. 9, 2013, the titer of the standard product exceeded the allowable range (90 ~ 119) to 141. So, the company changed the result to 112 as if the stability test was normally performed, Koo said.
Also, Medytox continued to fake data when seeking changes in the approval condition to extend the license of Innotox.
In the 36-month stability test on Jan. 17, 2014, the titer of each batch exceeded the standard or approached the lower limit, so the company was arbitrarily manipulating the titer result to obtain the permit for changes in approval condition, Koo claimed.
‘Company deceived shareholders with misleading statement’
Shareholders of Medytox also criticized the company’s statement.
Eom Tae-seob, a lawyer at Oh Kims Law &Co., who is pursuing a suit against the company on behalf of shareholders, said the prosecution disclosed the remaining part of the statute of limitations (five years) on the company’s violation of the Pharmaceutical Affairs Act. Still, the statement looked like as if only the products made during the specific period were problematic.
“This case is unrelated to the risk of public health. Article 71 of the Pharmaceutical Affairs Act states that pharmaceutical products made and sold with unauthorized ingredients should be discarded to prevent the public health hazard,” Eom said.
As for Innotox, another botulinum toxin, the company said it would increase the sales of Innotox while the manufacturing of the product was expected to be suspended for three months, he noted.
“The company is still not providing accurate information for shareholders,” he added.
Shareholders initially believed the company’s recent public filing that it received approval for Innotox from the food and drug safety ministry, and released a statement that there would be no problem with recently-made products without mentioning about a false public disclosure issue, Eom said.
“Stockholders are furious that the company made a poor or false public disclosure even though such disclosure is crucial information for investors,” he said.
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