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[News Focus] Kolon, regulator rapped for not doing enough to quell concerns of patients
  • By Jeong Sae-im
  • Published 2019.05.22 11:59
  • Updated 2019.05.22 11:59
  • comments 0

More than 50 days have passed since the Ministry of Food and Drug Safety (MFDS) suspended the sales of Invossa-K, an osteoarthritis gene therapy, due to the mislabeling of a cell ingredient.

However, the ministry, the drug manufacturer Kolon Life Science and its subsidiary Kolon TissueGene have failed to address the issue and ease fears of patients treated with the injection quickly, critics said.

Free Medical Service Movement, an activist group, demands Food and Drug Safety Minister Lee Eui-kyung resign, during a news conference in front of the Seoul Central District Prosecutors’ Office on Tuesday.

A legislator, activists, Invossa-treated patients, and minority shareholders of Kolon filed a complaint against the MFDS and Kolon with the prosecution. They demanded Food and Drug Safety Minister Lee Eui-kyung step down and the prosecution raid Kolon for an intense probe.

Critics said the MFDS lost its credibility as an investigator because it did not review Invossa thoroughly enough before approving.

On Sunday, the ministry sent a delegation for an inspection of Kolon TissueGene in the U.S. to identify how its ingredient was mislabeled. The inspectors are visiting Kolon TissueGene, cell line manufacturer Wuxi Apptec, and Thermo Fisher Scientific where cell bank is situated, this week.

Activists argued that the prosecution should investigate the ministry not only because it is suspected of giving favor to Kolon for Invossa approval but also because it has failed to complete the probe into Kolon over the past 50 days.

Rep. Youn So-ha of the minor opposition Justice Party, who is a member of the National Assembly’s Health and Welfare Committee, People’s Solidarity for Participatory Democracy, and Center for Health and Social Change, and Association of Physicians for Humanism held a news conference at the National Assembly on Tuesday.

“As soon as the food and drug safety ministry knew that the drug had a problem, it should have collected the drugs from the market and analyzed them. However, it has never done so. It only checked the master cell bank and the cell bank in Chungju factory,” they said in a statement. “The ministry could have finished its investigation within two or three days. We can no longer trust the ministry and wait while doing nothing.”

Another activist group and Invossa-injected patients demanded Minister Lee resign, accusing the ministry of intentionally delaying the probe and responding to the issue too slowly.

“Free Medical Service Movement” held a news conference in front of the Seoul Central District Prosecutors’ Office to urge Lee’s resignation on Tuesday.

“Food and Drug Safety Minister Lee Eui-kyung put the Invossa suspension on hold from March 22 to March 29, which was immediately after Lee’s appointment. The delays made an additional 27 patients receive Invossa injections. She is suspected of unfairly giving favor to Kolon to pass a bill to support advanced regenerative medicine,” the group said.

It also claimed that Lee did not immediately verify Invossa products and delayed the verification until late May, without any apology about the ministry’s poor management of Invossa license.

“The minister is poorly addressing this issue by passing the time. To normalize the function of the MFDS, Lee should step down immediately,” it said.

Kolon Life Science and Kolon TissueGene, which have repeatedly been saying they did not know about the mislabeling, faced charges by minority shareholders.

More than 100 minority shareholders filed a complaint with the Seoul Central District Prosecutors' Office against former Kolon Group Chairman Lee Woong-yeul and former and incumbent executives at Kolon on charges of “obstructing business by hierarchy.”

Kolon Life Science is soon to be probed by the prosecution, as Citizens United for Consumer Sovereignty (CUCS) filed a complaint with the prosecution against the firm for violating the Pharmaceutical Affairs Act on May 7.

Rep. Youn of the Justice Party suggested the National Assembly hold a parliamentary hearing to disclose the full story of the Invossa case.

He called for an investigation by the Assembly’s Health and Welfare Committee into all suspicions involving stock price rigging and the government’s making of legislation using a lawmaker’s name.

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