The Ministry of Food and Drug Safety said it would conduct a comprehensive investigation on Medytox over several suspicions raised by a local broadcaster. However, industry watchers questioned the probe would yield meaningful results because the company had already scrapped related data.
|Medytox’ botulinum toxin Meditoxin
The public broadcaster KBS has recently reported that Medytox allegedly had a quality control problem and an illegal distribution of Meditoxin, its botulinum toxin.
KBS said the company supplied 114 bottles of Meditoxin samples for some hospitals before winning approval. After obtaining the nod, the company fabricated records to conceal contamination of production facilities in violation of Good Manufacturing Practice, according to the KBS report.
Besides, key decision-makers for approving Meditoxin included a clinical trial researcher, head of a toxicity testing institution, and the head of the food and drug safety ministry who were either a shareholder of Medytox or an affiliated person, KBS said.
The suspicion over a GMP breach has been circulating since May. Although the food and drug safety ministry made an urgent inspection on Medytox’ First Plant in Ochang, North Chungcheong Province, the ministry had already notified the inspection to the company and merely reviewed submitted records and documents.
The KBS reported quoted a ministry official as saying, “We cannot look into all of the company’s data just with suspicions, without any specific data from an informer.”
“We are analyzing the urgent inspection data, but the related division is probing ‘Invossa issue.’ We are understaffed to investigate the Medytox case,” the official added.
However, critics said the ministry has been negligent on the inspection of the Meditoxin manufacturing site. In response, the ministry said on Friday, “We collected products in distribution and tested them in 2014, 2016, and 2018, and all were qualified.” “We are investigating on the suspicion over Meditoxin injections. We also plan to check if the drug was manufactured under the latest safety management system.”
Observers said whether the ministry would be able to reveal the truth was questionable. The suspected wrongdoings are presumed to have occurred in early- and mid-2000s, and critical evidence has disappeared. The company reportedly scrapped GMP documents recorded at the time because the retention period has expired.
The ministry official also said, “We have the data summited by the company for regular inspections, but the data contains simple reports of results, not raw data or detailed information. With this data, it is difficult to judge whether Medytox violated GMP rules.”
He went on to say, “We received the report from a whistleblower, originally submitted to Anti-Corruption and Civil Rights Commission, in June, and we will discuss in which direction our investigation will go.”
The ministry’s investigation on the illegal supply of Meditoxin samples for hospitals is likely to gain momentum, as both the hospitals and the company admitted it.
Medytox, however, emphasized that it was “not an illegal distribution to make profits.”
“As we developed botulinum toxin as the first company in Korea, we wanted to have confirmation on the drug’s efficacy. Our employees volunteered to receive injections to confirm the effect themselves. We never aimed to earn profits through an illegal distribution,” a Medytox official said.
The food and drug safety ministry said it would consult with the Ministry of Health and Welfare to decide who will investigate the Meditoxin samples distributed before approval.
The food and drug safety ministry will also request the prosecution to look into the principal decision-makers of Meditoxin license.