Whistle-blower rejects Medytox’s safety claimsA lawyer representing a whistle-blower who has alleged illegal manufacturing practices by Medytox on Tuesday said her client disagrees with the drug manufacturer’s claims that any past issues would have only applied to botulinum toxin products that expired or were used years ago.
Through Koo Young-shin, an attorney at Jehyun Attorneys at Law, the whistle-blower alleged in a statement Tuesday that Medytox used an unauthorized ingredient in manufacturing Meditoxin way earlier than the company claims.
The whistle-blower’s identity has not been publicly released. Koo also said Monday that two other whistle-blowers have come forward in relation to the case.
“Medytox claims that [potential] legal violations only pertain to vials of Meditoxin manufactured from December 2012 to June 2015,” the attorney said in the statement. “But Medytox rigged safety test results and unfairly earned sales approval, and the company kept this problem to continue using the unauthorized ingredient and fabricate the safety and efficacy levels.”
Last week, prosecutors filed a criminal complaint against the company’s CEO, and the Ministry of Food and Drug Safety moved to revoke the company’s license to manufacture Meditoxin and pull the product from the shelves, based on allegations that Medytox had used an unapproved ingredient in the manufacturing process.
In a statement Monday, Medytox had disputed the allegations and claimed that the accusations only covered the earlier period, meaning any products still in circulation are safe and effective.
The law firm disputed that statement, and Koo argued on behalf of the whistle-blowers that the ministry has previously ordered Medytox to destroy some volume of Meditoxin that was found to have been sold with rigged test results.
Koo added that violations which allegedly occurred while the company was earning approval to sell the toxin can’t be investigated, because they fall outside the ministry’s time limits for launching an investigation.
Launched domestically in 2006, Meditoxin was the first approved botulinum toxin product in Korea and has been reportedly sold in 60 countries.
The ministry ordered Medytox in October to discard three product lines of its botulinum toxins made at the company’s factory in Osong, North Chungcheong, after results from the ministry’s August inspection determined the toxins were not effective or safe enough. The law firm added that the ministry had done the same thing in 2017 after uncovering rigged test results.
Koo also alleged that Medytox manufactured Meditoxin in 2006 in a contaminated environment by bringing in an unauthorized ingredient. The attorney also demanded Medytox clarify what happened to the original ingredient that Medytox put on paper for winning approval from the Korean drug authority.
BY KO JUN-TAE [firstname.lastname@example.org]