Prosecutors have reportedly found that Medytox fabricated data to win approval for its botulinum toxin (BTX) but could not indict the company because the statute of limitations expired.
Even though the Ministry of Food and Drug Safety plans to nullify the license of the botulinum toxin for the violation of the law in the manufacturing process, the punishment is too limited, critics said. Likewise, even if Medytox loses the permit for Meditoxin, it has no restriction to obtain approval for the product again with the same data one year later, they added.
The prosecution has charged Medytox CEO Chung Hyun-ho with violating the Pharmaceutical Affairs Act and the obstruction of justice. It said Chung had Medytox produce the BTX from unauthorized ingredients from 2012 to 2015 and faked titer test results dozens of times to get nods for exporting it.
According to the first whistleblower, the company committed such illegal acts before 2012 and even in 2006 when the company won the nod for Meditoxin.
Koo Young-shin, a lawyer who filed a public complaint with the Korean Anti-Corruption and Civil Rights Commission against Medytox on behalf of the informer, said Medytox made Meditoxin with test ingredient (10SBTA) at the stage of obtaining the license.
“This ingredient is ‘out of specification’ (OOS) solution, which could cause fatal harm to the human body,” Koo said.
Despite the risk, the company forged the materials regarding the manufacturing instructions and records to make it look as if the company had manufactured a finished product with BTA, the original solution for licensing, he said.
During investigations, the prosecution reportedly secured circumstantial evidence to reveal the company’s crime. However, the prosecution excluded such content from the indictment because the statute of limitations has expired. The statute of limitations on the obstruction of justice is seven years. Even if the company had violated a law before winning the license in 2006, the company could not be punished.
For such reason, the food and drug safety ministry punished the company for illegal manufacturing only, not for unfairly winning the permit. Even though the ministry’s punishment is not limited by the expiration of the statute of limitations, it could not punish the firm for unfairly obtaining the license because the content was excluded from the indictment.
The National Assembly recently revised the Pharmaceutical Affairs Act to enhance punishment on those who get approval for a drug with false or unfair acts, in light of the nullification of the license of Invossa-K that mislabeled a drug ingredient.
However, the revised law did not apply to the Medytox case.
As the government cannot punish illicit acts committed during the licensing stage, the company can seek approval again for the BTX one year later after getting the permit revoked. According to the Pharmaceutical Affairs Act, a company can file for a new drug approval one year after the revocation of the drug license. Even if the company seeks another nod, it has to submit new test results instead of the faked clinical or titer test results.
However, Medytox got punishment for the illegal manufacturing process only. This means that the company can submit the same data for the regulatory review without facing any restrictions.
“The prosecution has circumstantial evidence of illicit acts at the time of the approval, and the informer has related materials. Thus, the food and drug safety ministry should carry out an additional investigation and give additional punishment, regardless of the statute of limitations,” Koo said.
The ministry, however, said it was difficult to conduct a further investigation because the ministry had already filed a complaint against the firm with the prosecution and decided on the administrative order based on the prosecution’s indictment.
“It is true that the company can seek approval again with the same data one year later. If that is the case, however, we will request for the prosecution’s investigation materials to identify what was wrong in the data submitted for approval,” it added.
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