Many doctors work for the U.S. Food and Drug Administration (FDA), but that’s not the case for its South Korean equivalent, the Ministry of Food and Drug Safety (MFDS). Lee Won-sik, who became the director general of Pharmaceutical Safety Bureau in September 2016, is one of the rare doctors in MFDS.

Lee says his experience treating patients as a physician is very helpful in his work at MFDS. Since the establishment of MFDS, Lee was the first director general of the Pharmaceutical Safety Bureau to be appointed through open competition. As the first civilian to be appointed director general, Lee has received lots of attention. Not only was he recruited from outside the organization, but he is the first physician to hold the office.

Lee Won-shik, director general of the Pharmaceutical Safety Bureau, said his experience treating patients as a physician is very helpful in his work at the Ministry of Food and Drug Safety.

Lee graduated from Seoul National University College of Medicine, served as head of the family department at Hallym University Kangnam Sacred Heart Hospital, and was a senior researcher in the Korean MSD clinical research department. Before joining MFDS last year, he served as vice president of Pfizer Pharmaceutical Korea and has years of accumulated experience as a pharmaceutical doctor. So why did Lee move to MFDS from an executive position at a pharmaceutical company?

During a recent interview with The Korea Biomedical Review at his office in Osong, North Chungcheong Province, Lee said “It's busier now than when I was in a pharmaceutical company but I am enjoying it.”

“Before I take a new job, I always ask myself whether it will allow me to be of greater service to more people. When I worked at a university hospital, I could only help the patients who came to me. When I worked in a pharmaceutical company, I helped many more people with medicine -- though I never met them. By applying this same standard, I can impact an even greater population by working at MFDS.”

Soon after Lee’s MFDS appointment, Hanmi Pharmaceutical got in trouble for belatedly reporting deaths during clinical trials of Olita Olita (proper name Olmutinib), a lung cancer treatment. This incident occurred only 10 days after Lee was appointed. In addition to the undergoing the National Assembly’s audit process, he had to handle a crisis right out of the box.

“I hit the ground running, but that was expected of me as director general of the Pharmaceutical Safety Bureau. One thing that concerned me at the time was whether clinical trials would be stigmatized by the Hanmi incident, despite the fact it has provided drastic development over the past 20 years thanks to public and private research institutes.”

Doctors and pharmacists are supposed to make professional, informed decisions regarding a drug’s benefits and side effects on behalf of the patient. However, Lee was concerned that this incident might introduce a negative perception of the clinical trial process as a whole, thereby ceasing development of terminal lung cancer treatments.

South Korea’s clinical trial management standards are among the best in the world, as is demonstrated by Korea’s membership in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Seoul is internationally recognized as being No. 1 regarding clinical trials. However, due to social concern over clinical trials, MFDS remains strict about management.

“Clinical trial management standards are continuously improving and will continue to improve in the future. For instance, all adverse reactions detected during clinical trials will be reported electronically within a legally prescribed period. We also stood up a clinical trial improvement association to integrate the information. Digital systems will integrate relevant data into a single location. This will allow information about adverse side effects to be shared from early screening to final clinical trial approval.”

It has been six months since Lee started working as director general. Now that he is in the public sector, perhaps his perspective on MFDS has shifted compared to the one he had in the private sector.

“My point of view hasn’t changed, but I’m more aware that just changing one policy is a very involved process, which is something people on the outside don’t realize. Working with my colleagues at MFDS, I am always mindful of my duty to serve public interests. But I also need to work within the legal framework and a set budget, all while I listen, discuss, and negotiate with stakeholders. I came to realize that these additional efforts don’t necessarily translate into visible outcomes.”

“I am much busier at MFDS than I was when I worked for a pharmaceutical company. Various meetings and external schedules fill up my calendar, so I don’t have time to meet with acquaintances as before. I barely see my family members who live Seoul when I have meetings at Parliament. This busy schedule reminds me of the weighty duties that come with my position.”

Director General Lee has the background as a businessman and a physician, but he is the first physician to receive a major appointment at MFDS—an institution largely bereft of doctors. How has this experience as a doctor been helpful?

“People ask me all the time how I benefit from being a physician. As a doctor, I’m trained to represent my patients and make the best decisions on their behalf. The same was true when I worked for a pharmaceutical company, and it’s true now at MFDS. I often ask my colleagues how their policies will benefit the patient. My experience as a doctor was readily compatible with my mission here at MFDS. "

The term of a director general is three years. What are Lee’s intentions for this short yet extended period?

“My intention is to bring innovative and positive change to MFDS and the Pharmaceutical Safety Bureau, so they become transparent, communicating institutions. I am learning from colleagues and collaborating with them to cultivate better leaders than me. We are focusing on building capacities, curriculums, and approval screenings. Lastly, I hope to restore public confidence in drug safety policy.

lhs@docdocdoc.co.kr

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