Kang Yoon-hee has been working as a committee member of the Clinical Trial Task Force at the National Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety, over the past two years. She is a specialist in laboratory medicine and belongs to the clinical examination task force composed of doctors.
|Kang Yoon-hee, a committee member of the Clinical Trial Task Force at the Ministry of Food and Drug Safety’s National Institute of Food and Drug Safety Evaluation, holds a one-person protest in front of the National Assembly on Thursday. She called for expanding the expert workforce at the ministry, introducing DSUR and PSUR for strengthened safety management after the market release of drugs.
Kang held a one-person protest in front of the National Assembly building in Seoul from 10:45 a.m. Thursday. She called for beefing up medical human resources at the Food and Drug Safety Ministry, introducing DSUR (Developmental Safety Update Report) and PSUR (Periodic Safety Update Report) for strengthened safety management after the market release of drugs, and establishing a medicine (medical devices) safety management committee in assessing medical institutions.
Kang said that 15 doctors in the ministry assess protocols for clinical trials, but only 10 of them work five days a week because of maternity leave and other reasons. “The small number of personnel are examining not only all the clinical trial plans but major changes as well,” she added.
Kang raised the issue internally but was only told that she would have to wait until next year because the ministry does not have a sufficient budget. “I thought that it was a matter of patient safety. Why should we wait until next year?” she asked.
About 500 doctors work at the U.S. Food and Drug Administration to evaluate the safety and validity of medicines and medical equipment, according to Kang. China also strengthened its medical workforce to 700 doctors in the last three years, she said. “The Food and Drug Safety Ministry is reportedly recruiting doctors every year, but the reality is different from what is known,” she said.
“It has been about two to three years since we have come up with this clinical evaluation committee. The required workforce is 19 doctors but last year and this year there have been only 15. About 700 clinical tests are made every year in Korea, or about 1,000, if we include cases that need major revisions,” Kang said. “We have estimated how much manpower we would need, and concluded we need at least 49.”
She went on to say, “I think at least a half of that number should be recruited. I understand that the ministry has made a lot of efforts in terms of the employees’ salary and treatment. However, all I have heard from the ministry is that it does not have the budget for recruitment.”
She was negative with the idea of hiring outside experts, saying that it could cause conflicts of interests. “It will be difficult for outside experts to remain commercially neutral. It is only right to have a professional group within the ministry,” she said.
Kang emphasized that doctors should be involved throughout the drug approval process.
“Clinical trials and licensing are not separated in Korea. Phase 3 clinical trials conducted here are subject to permission. I think that doctors should be involved throughout the whole licensing process to examine the safety and validity of the process, separately from the evaluation work of the protocols,” she said. “Doctors are currently involved only in clinical trials, but I think they should be involved in the monitoring of drugs after their market release so that they can detect harms and resolve them in advance.”
Kang said that she decided to stage one-person protest because she is a doctor who worked at the Food and Drug Safety Ministry, and a doctor who discovered so many problems within it.
“I hope that the ministry will change at least a bit and improve. I have decided to resign. I made the decision and planned this one-person protest as a last resort,” she said.
“Why should the Food and Drug Safety Ministry struggle lacking in expertise?” Kang said. “I hope the ministry will change and receive more support from the state.”
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