A wake-up call for our drug authorities
Published: 02 Dec. 2024, 19:43
Updated: 02 Dec. 2024, 23:20
Lee Woong-ryeol, the honorary chairman of Kolon Group, was acquitted of the charge of using unauthorized ingredients in the osteoarthritis (OA) treatment therapy “TissueGene-C,” also known as “Invossa” in Korea. A Seoul district court ruled that Lee was not liable for an illegal ingredient mix-up during the developmental stage. Although the case requires higher court reviews, the first ruling calls for a revisit to the process of licensing, canceling and expelling drugs from the market.
The drug is a novel gene therapy to treat knee OA. Kolon developed it at a cost of more than 200 billion won ($143 million) since 1999. After clinical trials in Korea and the United States, the drug was initially permitted to sell at home in 2018. The trial in the United States was halted in 2019 after the Food and Drug Administration (FDA) found the developer used kidney-derived cells instead of cartilage-derived cells. The finding led to the cancellation of the permit in Korea and an investigation into intentional manipulation.
Authorities should be extra careful in evaluating the validity of a novel drug. They should suspend the drug’s sale to inquire on the cause and effect if they find the components of the drug different from the reported blueprint. But they must not jump to a conclusion of foul play and request policing before judging the fallacies and side effects. The U.S. FDA lifted the “clinical hold” on the phase 3 clinical trial of the drug in 2020 upon confirming safety after studying the supplementary data and documents from Kolon.
But our authorities kept the ban and disallowed supplementary development and research on its validity, causing massive losses of money and time for the maker to prove their case at the prosecution and court. The local drug agency is questioned for dumping the case onto the prosecution to avoid any accountability in the matter. In delivering the first ruling, the bench said more thoughts are needed for a judiciary intervention in the scientific field.
Legal challenges are just some of the plethora of setbacks for Korean drugmakers. The Ministry of Food and Drug Safety turns away a candidate if it cannot find similar foreign cases. It stays uncompromising no matter how many lab results scientists hand in to prove the validity and safety of new drug candidates. A revolutionary concept of mixing hair dying and shampoo was banned for the same reason a few years ago.
The pharmaceutical industry has unlimited potential for growth. The bonanzas of Wegovy and Covid-19 vaccines have showed the astronomical returns of novel drug development. But our drug authorities stick to the old and conservative manual ever since the disgrace over cloning scientist Hwang Woo-suk. The Kolon ruling should be a wake-up call for drug authorities.
The drug is a novel gene therapy to treat knee OA. Kolon developed it at a cost of more than 200 billion won ($143 million) since 1999. After clinical trials in Korea and the United States, the drug was initially permitted to sell at home in 2018. The trial in the United States was halted in 2019 after the Food and Drug Administration (FDA) found the developer used kidney-derived cells instead of cartilage-derived cells. The finding led to the cancellation of the permit in Korea and an investigation into intentional manipulation.
Authorities should be extra careful in evaluating the validity of a novel drug. They should suspend the drug’s sale to inquire on the cause and effect if they find the components of the drug different from the reported blueprint. But they must not jump to a conclusion of foul play and request policing before judging the fallacies and side effects. The U.S. FDA lifted the “clinical hold” on the phase 3 clinical trial of the drug in 2020 upon confirming safety after studying the supplementary data and documents from Kolon.
But our authorities kept the ban and disallowed supplementary development and research on its validity, causing massive losses of money and time for the maker to prove their case at the prosecution and court. The local drug agency is questioned for dumping the case onto the prosecution to avoid any accountability in the matter. In delivering the first ruling, the bench said more thoughts are needed for a judiciary intervention in the scientific field.
Legal challenges are just some of the plethora of setbacks for Korean drugmakers. The Ministry of Food and Drug Safety turns away a candidate if it cannot find similar foreign cases. It stays uncompromising no matter how many lab results scientists hand in to prove the validity and safety of new drug candidates. A revolutionary concept of mixing hair dying and shampoo was banned for the same reason a few years ago.
The pharmaceutical industry has unlimited potential for growth. The bonanzas of Wegovy and Covid-19 vaccines have showed the astronomical returns of novel drug development. But our drug authorities stick to the old and conservative manual ever since the disgrace over cloning scientist Hwang Woo-suk. The Kolon ruling should be a wake-up call for drug authorities.
with the Korea JoongAng Daily
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