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[Reporter’s Notebook]MFDS incapable of reviewing new drugs?
  • By Lee Hye-seon
  • Published 2019.04.29 16:12
  • Updated 2019.04.29 16:16
  • comments 0

The most shocking news in the biotech industry in the first half was the mislabeling of osteoarthritis therapy Invossa-K by Kolon Life Science.

Physicians have used the treatment, trusting the data confirmed by the regulator after clinical trials. However, one of the drug ingredients has been mislabeled the whole time, appalling everyone – the drugmaker, the regulator, and patients.

More than a month has passed since the Invossa issue surfaced, but the health authorities have failed to clarify how the cell ingredient was replaced.

The Ministry of Food and Drug Safety (MFDS) said it would investigate the case until next month and decide whether to keep Invossa license. If it fails to identify the cause, it is also likely that the police could look into the case.

Unconvinced by the ministry’ response measures, critics questioned its ability to review new medicines. If it had accurately verified data during the Invossa approval process, the Invossa suspension would have never occurred in the first place, they said.

Apparently mindful of such criticism, the ministry said the data submitted by Kolon Life Science for Invossa approval showed that the main ingredient of the second fluid of Invossa was cartilage-derived cells. “There was no basis for us to judge that the ingredient was kidney-derived cells,” the ministry said in an interim result report, adding that a five-member expert panel confirmed it on cell and gene therapies.

Many others, however, do not trust the ministry’s capability for new drug assessment.
They argue that although the ministry quickly reviews new drugs already authorized by the U.S. Food and Drug Administration or European Medicines Agency, it cannot evaluate a locally-developed new drug. The revelation of the Invossa mislabeling started with a question raised during the FDA approval process for Invossa, they said.

Then, is the Korean ministry incapable of reviewing new medicines? I don’t think so.
The ministry has approved Celltrion’s Remsima, the world’s first biosimilar product. At the time of approval, the ministry reviewed the data submitted by Celltrion, requested additional data, and finally Okayed the drug’s sales.

The data that Celltrion submitted to the EMA for winning the European license was almost the same with the one that the company sent to the ministry. Remsima sales are growing quickly in Europe.

However, it is undeniable that the ministry had a loophole in the new drug approval review system. Thus, it should identify the cause of the ingredient mislabeling of Invossa and revamp the system to raise the credibility of the review.

The food and drug safety ministry needs a more careful and accurate evaluation of new drug candidates. The Invossa debacle showed that the quickest review might not be the best.

Of course, a lagging assessment procedure will become another problem. Even now, the pharmaceutical industry complains that it takes too much time from a new drug evaluation to a market release in Korea.

Biotech firms seeking to enter the global market claim that the government should raise review and approval fees to expand workforce for the review process.

A precondition for an accurate and fast assessment is hiring professionals dedicated to the review process.

The ministry’s evaluation team is comprised of experts, including its officials, and physicians. They review materials such as a plan for clinical trials. However, the size of the team is dwarfed by those in the U.S., Canada, and Europe. Some point out that the number of evaluation staffs in Korea is less than one-fifth of that in Canada.

The ministry said it was making every effort to improve the situation. In May, the ministry is to announce a comprehensive plan to enhance the expertise of the clinical trial advanced program team. The plan is expected to include concentrate workforce for the evaluation of locally-developed new drugs.

I sincerely hope that the food and drug safety ministry would learn the lessons from the Invossa suspension and prevent a similar mishap.


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