The cancellation of the license for gene therapy drug Invossa should offer painful, but precious lessons to the country, especially the biopharmaceutical industry and the government that regulates the increasingly sophisticated sector.
Most of all, the revocation of the license for what had been hailed as a pioneer in the Korean biotech industry should serve as a grim reminder that ethics and honesty should be the unchallenged principles in the development of new drugs.
Obsession with being the supplier of the “first,” “only” and “new” drugs is also something those in the industry should guard against.
Invossa, developed by Kolon Life Science and the drugmaker’s US biopharma unit Kolon TissueGene to treat knee osteoarthritis, had been hailed as the nation’s first gene therapy drug.
As it turned out, Kolon was more bent on becoming the first supplier of such a drug and making money than ensuring its safety and effectiveness.
It is simply dumbfounding that Kolon officials filed false documents to get government approval for the new drug. The Ministry of Food and Drug Safety, which investigated the case for about 50 days, has every reason to revoke its license and ask the prosecution to launch a criminal investigation.
According to the ministry, Kolon said Invossa was made of cartilage when it applied for a government license two years ago. But what it actually used came from kidney, and the company was aware of the false labeling. More outrageous is that Kolon Life Science was informed of the fact by the US affiliate after it submitted the application documents but did not report it to the ministry.
This reminds us of the disgraceful fall in 2004 of cloning expert Hwang Woo-suk, whose stem cell research projects, which had been touted as a breakthrough achievement, turned out to be fake.
One big problem is that unlike the Hwang case, which involved a research project, the Invossa mishap is battering many in the real world, from patients who took the drug to shareholders of the Kolon companies and other biotech and pharmaceutical firms as a whole. It is also hurting the nation’s reputation as a country that seeks to develop the nation’s biotech industry to world levels.
Government officials said a total of 438 hospitals and clinics in the country have given 3,707 shots of the drug to knee osteoarthritis patients. One can imagine how they would feel, having spent 7 million won ($5,880) per shot in the hope that it could treat their illness.
Officials said they have not yet found any notable negative side effects from the drug. But it is too early to rule out risks from the falsely labeled drug, and they ought to keep their promise to monitor those who got the Invossa injection for up to 15 years.
It is important to make sure the Invossa case does not damage domestic and international confidence in the Korean bio-health industry.
One essential effort should be upgrading the expertise and safety management system of the Food and Drug Safety Ministry.
It needs to take swift follow-up actions to improve its system to oversee the bio and pharmaceutical industries, especially the development of new drugs.
Last week, President Moon Jae-in unveiled a “national vision” for the development of the bio-health industry as a new growth engine. He said the government will earmark 4 trillion won to achieve the goal of making Korean drugs and medical equipment take 6 percent of the global market on the strength of $50 billion worth of exports by 2030.
It sounds pretty good. But all such ambitious plans and blueprints will be meaningless if the government and the biomedicine industry fail to ensure the safety of drugs. Drug safety can never be compromised.