USP CEO, Korean Minister of Food and Drug Safety Discuss Interventions to Secure Resilience of the Medical Supply Chain

The Republic of Korea, like the United States, faced several waves of COVID-19 in 2022 that ultimately impacted the medical supply chain throughout the country, according to the Honorable Dr. Oh Yu-Kyoung, Minister, Ministry of Food and Drug Safety (MFDS), Republic of Korea, during a fireside chat with US Pharmacopeia (USP) CEO Ronald T. Piervincenzi, PhD, as a part of the USP-FDA co-sponsored Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue at USP headquarters in Rockville, Maryland. Minister Yu-Kyoung explained further that MFDS implemented several strategies and policies to address that issue in Korea, which she noted may be beneficial to discuss at APEC due to similar challenges in the United States.

The fireside chat between Minister Yu-Kyoung and Piervincenzi took place on the heels of the first official state visit to the White House this year, hosted by President Biden, making the visit only the second during Biden’s presidency. Following the chat at APEC, Minister Yu-Kyoung said she was heading directly to the White House for an official state dinner.

“I'm very honored to be invited for this precious opportunity. [Also,] I just arrived 3 hours ago to Dulles Airport, so it's really a long journey after the 14-hour flight from Korea. So I’m a bit jetlagged, but very energized to be part of this important discussion,” Minister Yu-Kyoung said. “And I'd like to discuss more about the global supply chain and the regulatory convergence and the look forward.”

Minister Yu-Kyoung explained that MFDS, the regulatory body for food and drugs in Korea, covers many products, including pharmaceutical products, cosmetics and hygiene products, and food.

“If you go to a convenience store in Korea, maybe 80% of items in the convenience stores are actually controlled by MFDS,” Minister Yu-Kyoung said. Notably, this is a bit different from the scope of the FDA in the United States, which does not have the same oversight of cosmetics and most hygiene products.

Piervincenzi noted that the nature of the annual APEC dialogue is one that is focused on the sharing of best practices across nations. Given that, he went on to inquire after the type of activities taking place in Korea to improve supply chain resiliency for medical products.

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Minister Yu-Kyoung explained that the several waves of COVID-19 that hit Korea in 2022 caused difficulty in the supply chain of prescribed acetaminophen products in particular.

“Our ministry implemented several strategies or policies to address that issue, and maybe it is a bit informative for you to understand the Korean situation,” Minister Yu-Kyoung said. “The first policy to cope with the shortage of acetaminophen prescription products was to encourage medical doctors to prescribe alternative medicines with similar effects.”

Minister Yu-Kyoung explained that this campaign directed toward the efforts of medical doctors worked a bit, but it did not address the problem entirely. Following these results, MFDS pivoted to focus on the work of pharmaceutical manufacturers, and monitored the production and inventory of their acetaminophen prescription products at 2-week intervals.

“Based on the weekly production and inventory data, and the weekly new COVID-19 cases, we could estimate how much more we needed to produce to meet the demands,” Minister Yu-Kyoung said. “But after that, we recognized that there is another problem in the shortage of prescription acetaminophen product. Actually, the price of prescription acetaminophen product was pretty low, so many domestic Korean manufacturers were not interested as it was not lucrative.”

Minister Yu-Kyoung noted that the price of the prescription products in Korea are controlled by another ministry, the Ministry of Health and Welfare, which is outside the scope of the MFDS.

“We rushed it to the Ministry of Health and Welfare, and we discussed the issue of the low price,” Minister Yu-Kyoung said. “Then the Ministry of Health and Welfare increased the price of prescribed acetaminophen product up [by] 60% for the first time in 25 years. Then the [pharmaceutical] manufacturers were happy.”

The next step for MFDS was to designate the prescribed acetaminophen product as a public emergency product, which gave the federal government control over its production, according to Minister Yu-Kyoung.

“So, finally, because of the shortage of the prescribed acetaminophen product, I think the weekly monitoring and data-based prediction really worked out during the public emergency situation,” Minister Yu-Kyoung said.

Piervincenzi then noted that during the prior day’s discussion at APEC, international leaders were discussing the challenges around how, when the price of a drug gets too low, the drug can dip into shortage. He noted that the solution Minister Yu-Kyoung described is a very unique and targeted approach to an issue that has been broadly difficult to address internationally.

Responding further to the question about general policy, Minister Yu-Kyoung went on to explain that MFDS has 3 policies around the building and resilience of the medical product supply chain in Korea. The first policy of note is the discontinuation pre-reporting system, whereby the Korean manufacturer—upon deciding to discontinue production of a medical product—are required to report the discontinuation at least 60 days in advance.

“Upon receiving that kind of discontinuation report, my ministry is ready to work finding out some substitute products,” Minister Yu-Kyoung said. “The second policy is the communication with many stakeholders in Korea. In my ministry, we operate Korea Medical Products Monitoring Center and Korea Drug Product Monitoring Center. They work with stakeholders, such as Association of Medical Doctors, Association of Pharmacists, and Association of Pharmacy Manufacturers and Distributors.”

Minister Yu-Kyoung explained that the stakeholders then work together as a kind of committee or consortium that discusses fears of upcoming shortages, and then reports them to the monitoring center. This then allows the MFDS time to prepare.

“The third policy is that we are stockpiling some of the national essential drug products. If we designate [a product as a] national essential drug product, then the supply chain of the essential product depends heavily on [the government] overseeing production, so if the production is expected to be unstable because of some other issues, then both the government and the manufacturers stockpile the drug to maintain the stable drug supply chain,” Minister Yu-Kyoung said. “So, in the case of acetaminophen, we applied the policy step by step, but the general policy is to use the most relevant policy to each case.”

Reference

Piervincenzi RT, Yu-Kyoung O. Fireside chat on regulatory convergence with the Honorable Dr. Oh Yu-Kyoung, Minister, Ministry of Food and Drug Safety, Republic of Korea. Presented at: APEC Medical Product Supply Chain Dialogue in Rockville, Maryland; April 25, 2023.