MFDS to independently investigate data manipulation

Director Kim Sang-bong “Vastly expanding investigational power on data manipulation”

Lawmaker Kang Byungwon “Meditoxin incident compares to Volkswagen scandal, company’s responsibility should be clarified”

Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau at MFDS (left) and Democratic Party Lawmaker Kang Byungwon

“This day in K-Bio is a hurdle we have to overcome to become the new drug developing country that tackles unmet medical needs.

 

But we have already started working on creating fertile grounds to leverage the Korean-made pharmaceuticals in the global market by utilizing this hurdle as an opportunity to tighten administrative investigational power.” On July 29, South Korea’s Ministry of Food and Drug Safety (MFDS) official declared relevant regulations would be tightened for the ministry to independently investigate data manipulation among approved and distributed pharmaceuticals without the help of prosecutors.

 

A discussion panel on strengthening business ethics in pharmaceutical industry was convened by Democratic Party Lawmaker Kang Byungwon, where Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau participated as a panel and presented the ministry’s plan to reinforce quality control in biopharmaceuticals.

 

MFDS means to assertively extend administrative power to prevent previous scandals like revoking marketing licenses of Kolon Life Science’ Invossa and Medytox’ Meditoxin due to their accusation of manipulating data for their biopharmaceutical approval review.

 

Director Kim addressed recent issues like Invossa and Meditoxin and said “ethics and morals in advanced biopharmaceuticals” are the crucial matters to contemplate on at the moment.

 

And he said Korea’s pharmaceutical industry of today stepped on to a phase of developing drugs to treat disease that has never been cured before.

 

The director urged, “The K-Bio is shooting for two key goals of growing the industry and curing diseases.

 

In the process, we have forgotten ethics and morals as if they were like oxygen,” and “unfortunate events like data manipulation and license revocation occurred.

 

We need to mark these events as a turning point.” Director Kim noted it was regrettable that MFDS’ investigation was unable to fully disclose the detailed causes of data manipulation incident, whereas the judicial authority did.

 

Accordingly, the director promised to considerably strengthen the ministry’s current administrative investigational power.

 

His vision is to improve the current macro approach of MFDS evaluation standards and system, to take micro approach to match the speed of advanced biopharmaceutical development, and to systematically enhance the competency of MFDS reviewers in charge.

 

The director elaborated, “The existing segmentalized but short and simple evaluation standards have been expanded to cover 109 items.

 

This would mark the beginning of enhancing administrative investigational power,” and “compared to synthetic pharmaceuticals, advanced biopharmaceutical needs frequent intervention of observer’s objective evaluation.

 

As the future of the industry like cell therapy and gene therapy require close attention, the precedent data manipulation cases cannot be treated as a simple incident.” Director Kim said, “The ministry goal is not to target the judicial authority, but to build a system for the ministry, as an administrative authority, to directly investigate data manipulation,” and “it would require securing general investigational capability, instead of relying on a few reviewers’ specialty.” The director also pin pointed, “The pharmaceutical companies may feel that the ministry is taking a medical evidence-based approach.

 

In the past, a company with archived record was able to dodge the penalty, but they would be penalized without photographed evidence from now on,” because “the ministry would consider it as data manipulation, if a company cannot retrospectively prove the evidence according to the disclosed approval standards agreed upon the industry.” This is the ministry’s effort to step away from the past of concentrating on enhancing the global credibility of the Korean-made drugs.

 

But now the ministry aims to create a ground to develop new drug for the unmet medical needs.

 

The ministry intends to take Invossa and Meditoxin incidents as an opportunity and ask the industry, government, academic societies and the people to play their roles in evolving the Korean pharmaceutical industry.

 

The director concluded, “Expanding the evaluation standards up to 109 items is only a beginning.

 

It would be fine-combed to eradicate any loophole of data manipulation.” He also stressed, “This is relevant to all bio and pharmaceutical industries, not just for specific company or incident.” Lawmaker Kang Byungwon, the organizer of the discussion panel, compared the Invossa and Meditoxin incidents to the Volkswagen’s scandal of cheating the pollution emission test and said he would fully support for the legislation of preventing unethical business practice.

 

Based on his experience of passing the bill to prevent Volkswagen incident and imposing reasonable fine on the responsible company, Lawmaker Kang aims to create an environment for the pharmaceutical industry to never repeat the data manipulation incidents again.

 

The lawmaker urged, “The Korean industries have been blindly advancing forward without looking back.

 

The process did not matter as long as the outcome was satisfying.

 

But such behavior cannot lead Korea to become a developed country, and achieving K-Bio is impossible.” He noted, “The consumers who purchased the imported automobiles did not realize how they were damaging their own body.

 

But the company knew exactly.

 

When the Korean pharmaceutical industry realizes the gravity of their responsibility, it would finally become a global pharmaceutical industry.”