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- 2026-04-27 19:16:07
- Opinion
- [Reporter’s view] We must prepare for the post impurity era
- by Kim, Jin-Gu May 27, 2020 06:04am
- The situation wasn't the worst. Unlike Ranitidine, not all Metformin sales have been stopped. It is expected that the confusion of patients and the potential damage of pharmaceutical companies will not be greater than in the case of the Valsartan·Ranitidine crisis. The MFDS decided to stop selling 31 of the 288 finished Metformin products in Korea on the 25th. The reason was the same as in the previous situation. N-nitrosodimethylamine (NDMA) was detected above the provisional management criteria. As a result, the case of impurities, starting from Valsartan and Ranitidine to Metformin, has been closed. At present, there are no other ingredients that raise concerns about impurities. However, it is not the end, it’s the beginning. Impurities have become a new disease and standard for drug safety management. The time has come for us to manage unexpected impurities in advance. It must be a contradictory situation. It is contradictory to anticipate and manage unexpected impurities in advance. However, this contradictory situation is the reality faced by the pharmaceutical bio industry. The paradigm of drug safety management has changed completely. The MFDS has been obliged to submit proof of safety for carcinogenic impurities, metal impurities, etc. when pharmaceutical companies apply for drug approval from September. It is only possible to preemptively check for harmful substances that can occur on its own and to prove safety. There are many problems that have not been solved. First, it is a standard for impurity management. Currently, NDMA·NDEA are all impurities that have been established as management standards. However, NDMA·NDEA are only some of the many impurities. The possibility of Nitrosamine-based impurities such as NMBA, DIPNA, and EIPNA cannot be excluded. If the range is extended to impurities other than Nitrosamines, theoretically, impurity problems close to infinity occur. These impurities should be cataloged, and separate control standards should be prepared for each impurity. The MFDS has announced that this work will be done in cooperation with regulatory authorities in each country. However, as COVID-19 suddenly became world-wide, it was postponed. The issue of responsibility derived from this is another problem. The regulatory authorities and the pharmaceutical industry may not be able to predict in advance, but the damage caused by the pharmaceutical industry should be more concerned. Discussions with the regulatory authorities and the pharmaceutical industry should begin to rationalize responsibility. At present, the Metformin situation is thought to be over. However, the new era of drug safety management has just begun. You can't have the same confusion every time. We look forward to setting new standards for the new era as soon as possible.
- Opinion
- [Reporter’s View]Raising the voice of rare disease patients
- by Eo, Yun-Ho May 20, 2020 06:11am
- Seems like rare diseases put patients in utmost pain, because of its ‘rarity.’ Rare disease treatments can hardly prove cost-effectiveness and predictability with limited patient size for the reimbursement listing approval. Regardless, the Korean government is aware of the struggle. The revised drug pricing system the Ministry of Health and Welfare (MOHW) unveiled is in process of legislative preannouncement until June 11. The key revision in the new drug pricing system is to expand eligibility in pharmacoeconomic evaluation (PE) exemption and RSA. The revision would stipulate the Korean government to sign risk sharing agreement (RSA) not only with first-in-class drugs, but also with follow-on drugs. And also the revision would expand subjects for PE exemption and coverage with phase III clinical evidence in development. Even the PE exemption, previously restricted to anticancer and rare disease treatments, would be applicable on National Essential Drugs, such as tuberculosis treatment, antibiotics and emergency antidotes. However, many of the public claim rare disease treatments would still face various obstacles before receiving RSA and PE exemption benefits. In Korea, rare disease is defined as a disease with patient size less than 20,000 with difficulties in diagnosis to survey accurate number of patients. The affected patients are desperate to get access to life-saving treatment as the diseases are difficult to diagnose and treat, but many of the diseases cannot even start a clinical study with barely sufficient number of patients. Pharmaceutical companies are hesitant to develop a novel drug for rare disease, as the limited number of patients means limited marketability, while the chances of successfully proving the cost-effectiveness of the drug through PE would be thin. Many countries around the world are introducing regulatory exceptions in legislation, special approval or reimbursement listing for better access to rare disease treatments. Korea has also provided regulatory exceptions like medically essential drug management, PE exemption system and RSA in reimbursement listing or drug pricing. Regardless, the limitations to treatment access still exist. In fact, data comparing listing rate by each drug type before and after implementing RSA and PE exemption systems for bettering the access to high-cost treatments showed a significant improvement in general drug (79.6 percent to 98.6 percent) and anticancer treatment (77.1 percent to 91.7 percent), but the improvement in rare disease treatment (71.1 percent to 71.4 percent) was rather unnoticeable. As a solution to the much needed access to rare disease treatment, some argue the PE exemption eligibility should be expanded for the rare disease treatment. They say the reimbursement review system should be flexible to exempt PE or adjust the number of PE sample patients similar to the special case reimbursement standard, when a drug has no other alternative option or has been approved with placebo-controlled study results. For instance, the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) or European Medicines Agency’s (EMA) Priority Medicine (PRIME) designation could be referred as a review standard. The PE exemption system aims to provide patients the access to rare disease and anticancer treatments unable to produce PE data, while protecting the initial purpose of positive listing system. So to serve its purpose, the Korean health authority should contemplate on the flexibility of the healthcare reimbursement listing procedure. Same goes for RSA. Compared to numerous anticancer treatments that received coverage through RSA, many of rare disease treatments have failed in passing the barrier to RSA due to lack of PE data. As far as quality-adjusted life-year (QALY) goes, the majority of rare diseases results in severe physical damage in patient’s body, lowers quality of life, and shortens life expectancy. And because of extremely small number of users, rare disease treatments are inevitably high-priced and show poor cost-effectiveness. The rare disease treatments can hardly prove cost-effectiveness, when applied with incremental cost-effectiveness ratio (ICER) thresholds on par with other general drugs. The regulation stipulates the health authorities to flexibly set ICER thresholds on rare disease treatments, but the drugs are challenged with PE barriers higher than that of anticancer treatments due to their practices so far. This is why many urge more adaptable ICER thresholds should be given to rare disease treatments for their PE. When the Rare Disease Management Act came in effect in 2015, the Korean government designated May 23 as the Rare Disease Day to raise awareness and understanding of patients fighting against rare diseases. Rare diseases have a handful of treatments for a handful of patients, which is why the voice to demand their healthcare benefit is so easily lost. Hopefully in the near future, the government and pharmaceutical companies would pay a closer attention to those patients, as much as they do for cancer patients.
- Opinion
- [Reporter’s View] COVID-19 and vaccine self-sufficiency
- by An, Kyung-Jin May 18, 2020 06:15am
- The U.S. and Europe have sparked a conflict over COVID-19 vaccine still in development. The tension arose when a multinational pharmaceutical company Sanofi announced its intention to prioritize the distribution of the vaccine to the U.S., in case the company successfully completes the development. During an interview with Bloomberg, Sanofi’s British CEO Paul Hudson who newly took over the office in last September said, “The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” so “the Americans will likely get Sanofi’s COVID-19 vaccine before the rest of the world.” Along with its competitor GlaxoSmithKline (GSK), the French-based multinational company has initiated COVID-19 vaccine co-development project. And apparently, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has provided USD 30 million (approximately 36.8 billion won) for the project Immediately after the news was released, the whole of Europe was shaken. Particularly, the reaction from France, where Sanofi’s headquarters and manufacturing plants are housed, was rough. The French government was infuriated by the pharmaceutical company’s public comment as the country and the EU have been often giving direct and indirect support for the company’s R&D programs. French Prime Minister Édouard Philippe reproached by twitting “A #COVID19 vaccine should be a global public good. And the equal access to the vaccine is not negotiable.” The European Commission official also published a statement insisting that “The vaccine against COVID-19 should be a global public good and its access needs to be equitable and universal.” The pharmaceutical industry experts are claiming the international cooperation has worsened as the EU intervened the U.S. and China’s race for the COVID-19 vaccine. Some are concerned that a war on exclusive pre-ordering of the vaccine in development may break out. Eventually, CEO Hudson took back his words, as his ‘America-first’ comment has inflicted a firestorm. When the vaccine is fully developed, he said all countries around the world would have an equal access to the vaccine. But the CEO also urged “the European countries should also assertively take risks on the vaccine development like the U.S.” He pointed out how the U.S. is taking a risk even before scientifically confirming the success of the vaccine development, whereas the European countries have not. The CEO also argued the risk should be shared among European countries and the U.S. Sanofi CEO’s comment also rings in a grave tone in Korea as well, where the country has not yet fully resolved the vaccine self-sufficiency issue. When Green Cross established the Hwasun vaccine plant in 2009, South Korea has become the 12th country in the world to locally procure flu vaccine. The locally made vaccine is viewed as the top contributor in overcoming the 2010 flu pandemic. Although it has been a decade since then, Korea’s self-sufficiency rate in vaccine has not improved much. Out of 19 National Immunization Program (NIP) vaccine types, only six types—hepatitis B virus, hemorrhagic fever with renal syndrome (HFRS), varicella, influenza, tetanus, diphtheria, and pertussis (Td), Haemophilus influenzae type b (Hib)—are locally produced without importing the vaccine strain. Other three vaccine types are locally produced with imported strain, and the rest of the nine types are imported as finished products. In case of a pandemic or biologic terrorism, Korea has to unavoidably rely on other countries for vaccine. When the country cannot even self-procure vaccines long demanded, it is skeptical if Korea would be able to promptly produce vaccine during a novel infectious disease outbreak. According to the World Health Organization’s (WHO) update, total eight cases of clinical studies in COVID-19 vaccine have started their global trial phase. Four of them are funded by Chinese government and corporations. Partnered with a biotechnology company Moderna, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), associated under the National Institute of Health (NIH), has started a clinical trial for a vaccine against COVID-19 from last month. The U.S. government body aims to report the immunological reaction in around coming July or August. In Korea, a number of pharmaceutical companies like SK Bioscience, GC Pharma and Genexine are seeking for a vaccine against COVID-19, but the progress is far behind compared to the U.S. or China. The country was able to put the limelight on its promising global level biotechnology as the world highly evaluated Korea’s ability to test the disease. To maintain the outstanding disease control capacity, the Korean government would need to invest and support the vaccine and treatment development, bottomlessly. Korea should let the latest pandemic be the reminder of the necessity of ‘vaccine self-sufficiency.’
- Opinion
- [Reporter's view] ‘Generic exclusivity' must be improved
- by Lee, Tak-Sun May 15, 2020 06:04am
- As the proposed regulation of the co-biological equivalence test was stopped by the Regulatory Reform Committee, The consigned generics business has revived. On the other hand, companies producing single generics that have claimed to regulate co-biological equivalence testing are concerned. They point out that there are many competitors in the market due to the activation of consigned generics, so there is no advantage of single-developed generics. Since the pharmaceutical industry was divided in half with respect to this regulation, it seems that everyone cannot be satisfied unless a new system is introduced. To this end, the generic exclusivity needs to be improved so that everyone can be satisfied. The generic exclusivity, which was introduced as the Korea-US FTA in 2013, has been collecting opinions from all over the recent improvement plan, but has not progressed. However, it is unlikely that any improvement measures that have been significantly changed . The biggest problem with the current generic exclusivity is that marketing exclusivity has no great benefit. The 9-month monopoly period is also a short period for generics to settle down, and there are many items that receive the generic exclusivity, so it is more than just satisfied with entering the market rather than being a monopoly. Some predicted that if the regulation is enforced, many companies will lose their generic exclusivity. However, with the withdrawal of co-regulation, the consignment system for entering the market is unlikely to be different. Through this regulation, it is predicted that the generic exclusivity will be acquired by a number of contractors with pharmaceutical companies that have successfully developed generics. As competition increases, marketing exclusivity becomes meaningless. In this regard, a plan should be devised so that generic exclusivity can be given only to companies that have overcome patents and developed generic drugs. In order to do that, even if the consignment company does not make a consignment production to the majority, it must create a structure that can benefit from the generic exclusivity to copyright. For example, it is necessary to find a way to extend the period of the right to copyright much more than 9 months a year, or to give preferential prices to the generics. If the ₩10 billion is secured during the period of generic exclusivity, there will be no other company to give profits to others. However, it is difficult for the generic to get ₩1 billion for 9 months. It is necessary to inform the medical institutions the generic exclusivity is the only generics that confronts the original through export preferential support, various tax benefits, and brand support. The MFDS has recently formed a public-private council aimed at strengthening international competitiveness of domestic generics to seek ways to support them. However, it is more difficult for generics that are not treated in the domestic market to have competitiveness overseas. Rather, it is better to grow it in the domestic market so that pharmaceutical companies can make global new drugs with that money. It is difficult to create a competitive generic with a system that cannot take advantage of generics as it is now. It seems that a more innovative support plan is needed.
- Opinion
- [Reporter’s view] Yuhan's CEO Lee made a big decision
- by Lee, Seok-Jun May 13, 2020 05:54am
- Jung Hee Lee, Yuhan CEO, is due until March next year. This is due to the company's policy of having two consecutive terms in three years. It will end in March next year. since he started working in March 2015. Most CEOs make their performances within their tenure. This is because 'maximum performance since its founding' can be a 'decoration' for their career. However, CEO Jung Hee Lee does not care about performance. Last year's (0.84%) and the first quarter's (0.35%) operating margin were the lowest, but the technology fee, which is a positive factor in earnings, is divided as conservatively as possible. The recent business report confirms this trend. Yuhan extended the expiry date of LO’s upfront fee for three cases. This is different from the report of the third quarter of last year. LO’s upfront fee for Lazertinib (anti-cancer drugs) exported to Janssen ($30 million) has extended from 2020 to 2021. The upfront fee for non-alcoholic steatohepatitis treatment, (NASH) YH2574 ($38 million), licensed out to Beringer, was extended from 2020 to 2022. the upfront fee for NASH treatment, sold to Gilead was set to be until 2021. Previously, only the principle of split recognition was disclosed, and the end date was not disclosed. In short, Yuhan delayed the completion of unfront fee accounting until 2022. The intention is to secure a fixed profit by dividing the down payment by 2022. This is a big decision for CEO Lee. If all of the LO’s upfront fee were reflected within the term, better results were possible in terms of sales and operating profit. The LO’s upfront fee left by Lee can strengthen the next CEO. This is because fixed profits are the driving force for maintaining R&D continuity without compromising earnings. Yuhan has a tradition of competing for two vice presidents and choosing a president. Either Wook-je Jo, Vice President (Management Division) or Jong-hyun Park, Vice President (Pharmaceutical Business Division) is a strong candidate. For one of them, CEO Lee's management to prepare for the future can be a valuable asset.
- Opinion
- Time to stop the delay in drug patent conflict
- by May 08, 2020 06:33am
- Professor Kim Kwan Shik The world bombarded with COVID-19 related news has been disheartening. Even the new coined term ‘Corona Blue’ was trending. But on the lighter side, I came across some good news for myself, who mainly lectures and researches on patent law depicted in news articles. It was from a global pharmaceutical company, AbbVie announcing it would give up on the global patent rights to Kaletra, a potential COVID-19 treatment. In other words, anyone can make a copycat version (generic) of Kaletra. Anyone with a slightest interest in the industry would understand that giving up on a patent right means a tremendous commitment. Considering pharmaceutical companies are spending astronomical expense to protect and extend the pharmaceutical patent right as much as possible, the news actually sounded a little ironic. Global and Korean pharmaceutical companies use various tactics to prolong the market exclusivity period protected by the patent rights. One of the most popular strategies is ‘patent term extension.’ A patent’s term is valid until 20 years after the patent issue date, but in some cases it could be extended up to five years. As for pharmaceutical patent, a drug with listed patent cannot be commercialized immediately as it has to receive marketing approval from Ministry of Food and Drug Safety (MFDS) reviewed based on efficacy and safety data collected from clinical trial. Taking account of the time spent on the administrative procedure, the term can be extended up to five years. Many of Korean pharmaceutical companies tend to manufacture generics that copy original products with expired patent and sell them in inexpensive pricing. And by doing so, conflicts arise frequently due to the possibility of infringing patent rights. A famous case reported recently was on a drug sharing same effect with a patented original drug, but was using an incrementally modified substance uniquely approved by MFDS. The conflict fired up as the original drug company claimed the modified drug maker has infringed its patent right with extended term. In the end, the pharmaceutical industry was disconcerted by a staggering decision of the Supreme Court overruling the lower-instance Court’s conclusion that the patent was not infringed. Another pharmaceutical company has requested negative confirmation of the original’s patent scope to the Intellectual Property Trial and Appeal Board claiming that an item sold with effect and benefit, initially not acknowledged for the original’s patent that based the term extension, is not infringing the extended patent right of the original. However, the legal conflict has been on hold due to the COVID-19 pandemic. The order of strict social distancing has slowed down the court proceedings. Probably the pharmaceutical company pursuing the Court’s decision would be deeply frustrated as it needs to complete all procedures before the product launch. Recently lost in a series of term-extension related patent trials, pharmaceutical companies should not be hindered by the ‘delay in proceedings,’ when they have finally found an alternative strategy. This specific case and its follow-up trials would play a crucial role in the Korean pharmaceutical industry, as it could harmoniously arbitrate the conflict among pharmaceutical sovereignty, financial health of National Health Insurance, patients and stakeholders of the Korean pharmaceutical industry. Sources say the damage taken by pharmaceutical company from the pandemic is resulting in stagnating economic growth. The patent law was found to protect and promote invention and to contribute in industry advancement. The Intellectual Property Trial and Appeal Board and the Court should promptly make a reasonable decision, in accordance with the original objective of the patent law, for the pharmaceutical companies continuing to take challenges amid the difficult times to propel the flourishing industry in Korea.
- Opinion
- [Reporter’s View] What COVID-19 revealed in drug industry
- by Kim, Jin-Gu Apr 29, 2020 06:20am
- The humanity will ultimately overcome the COVID-19 pandemic. But the problem is what follows next. Scholars around the world talk about the Post-COVID-19. Each of them theorizes their own seemingly realistic ideas of “New Normal.” Among all of their hypotheses, ‘giving science back to the public’ speaks to the heart. At an online forum convened on Apr. 28 regarding the Post-COVID-19 and the new normal, Professor Park Sangook of Earth and Environmental Sciences Department at Seoul National University stated, “The science and technology should find their way back to the public in the future.” In fact, it was on the 100th day since the first reported case of COVID-19 in Korea. His diagnosis was unyieldingly honest. He said the science and technology in pharmaceutical and bio sector have advanced remarkably, but they are skewed to specific areas. It is as it is. Quoting his words, regardless of developed countries, global pharmaceutical giants or Korean pharmaceutical and bio industry, no one can deny the fact their R&D was fixated on “profitable sector.” Every one of them was into developing chronic disease treatment and “happy drugs.” The result is what we see today. According to Professor Park Sangook, the humanity is “in a dire situation, where we helplessly face a simple virus generated from the nature.” In their defense, the companies could claim their concentration on profitable business is obviously justifiable with their corporate nature. However, considering the pharmaceutical and bio industry put down their roots in public healthcare, they need to take a look back at themselves even shunning the ‘bare minimum.’ The government’s role is essential in turning the corporations around. To let the companies open their eyes on the public healthcare, the government should pay more attention and provide further support. Motivated by the pandemic, the Korean government seems to be making various promises to provide support for the pharmaceutical companies responding against the threat of the infectious disease. The government means to properly compensate the companies developing treatment and vaccines for the virus. These should not be empty promises for temporary purposes. Not just to spike their stock prices, but the government should show pharmaceutical companies that taking up a challenge for the public interest, despite the risk in failure and loss, would be compensated appropriately. Only when the government takes the right action, science and technology would find their way back to the public.
- Opinion
- [Reporter’s view] Pharmacist's role to meet post COVID-19
- by Kim, Min-Gun Apr 29, 2020 04:59am
- COVID-19 is changing our lives and culture itself with more powerful infectious power than any other epidemic. Telecommuting and video conferencing, represented by social distance, began in earnest, and online shopping malls are booming. It is a daily routine of non-facing contact. Hong Nam-ki, Deputy Prime Minister and Minister of Economy and Finance also pointed to non-face-to-face meetings such as teleconference and video conferencing for economic policy since COVID-19 outbreak. In order to prevent the spread of infection in medical institutions, the government even allowed non-face-to-face treatment for people with chronic diseases and the elderly. The U.S. FDA also issued a deregulation guideline that lowered the barrier to entry into telemedicine during the COVID-19 epidemic in March. This is to activate telemedicine to prevent infection between face-to-face contacts. Non-face-to-face treatment is an issue directly related to the delivery of prescription medicines. The Korean Pharmaceutical Association is concerned about this. The government reassured that there was no expansion of telemedicine beyond the current law, saying that non-face-to-face care is needed to protect medical institutions and patients from COVID-19, a highly contagious infection. However, it is a sign that non-face-to-face counseling, such as telemedicine, will become necessary in the future in response to infectious diseases. However, the current social distance is accompanied by economic losses. There are also a lot of people who are tired of restraining outside activities. Accordingly, the government is considering the future health care system. There will be active discussions regarding non-face-to-face contact policies. The government is preparing to switch to a non-face-to-face, life-prevention system. It becomes social distance campaign in life. The most important countermeasures against the epidemic have been proved that quarantine measures through rapid inspection and confirmation, and that essential quarantine supplies should be supplied in a timely manner. This means that the diagnosis and prevention of infectious diseases is not the only role of medical institutions. Through the 5-day rotation mask distribution system, it was recognized that the pharmacy's role in the daily life prevention system is important. As the interest in the role of the pharmacist's skill that has been overlooked has been refocused, the pharmacist society should not be left behind by the post-COVID-19 era that will change in the future rather than clinging to telemedicine issues. The role of the pharmacist's function in the era of infectious diseases and the future are even more important. Masks, hand sanitizers, and disinfectants can also be bought at marts, but an expert who can explain the exact range of use and how to do it can be done by a pharmacist at the pharmacy. The role of the pharmacist in the daily life prevention system is inevitable. The pharmacist should conduct specialized training to cope with infectious diseases, and the trained pharmacist should be more professional in the prevention of life. In addition, specialized pharmacists in the prevention of infectious diseases should be fostered in accordance with the legislation of the specialized pharmacist system. If the pharmacist's skill is specialized, the opinion that pharmacists should be included in the health care providers will be more supported. In this case, expansion of the pharmacist's competency may also be considered. It can be considered that if the patient's care and prescription are stopped in response to an infectious disease that occurs simultaneously in a specific local medical institution, it is considered to be in accordance with the exhibition situation. If patient care and prescriptions are stopped in response to infectious diseases that occur simultaneously in certain local medical institutions, it will be like wartime situation. Before separation of prescribing and dispensing drugs, the pharmacy directly diagnosed the patient and took the role of prescribing and dispensing. In order to prevent the collapse of the health care system in the epidemic area, Measures for prescribing medicines temporarily by local pharmacies may be considered. Systematic protection measures should be prepared, such as storing personal protective equipment (PPE) for each pharmacist society and distributing it to member pharmacies when an epidemic occurs.
- Opinion
- [FOCUS]We expect the MFDS to act wisely on impurity measures
- by Chon, Seung-Hyun Apr 22, 2020 06:02am
- At the end of September last year, when the MFDS decided to stop selling all products of the anti-ulcer drug “Ranitidine,” the pharmaceutical industry reacted strongly. The MFDS decided to withdraw because Ranitidine has unstable properties and is always exposed to the risk of carcinogenic substance 'N-nitrosodimethylamine (NDMA)'. The pharmaceutical industry complained strongly about tough measures in Korea, saying that we have not yet concluded whether or not the drug is harmful, and it is reasonable for NDMA to recover only the products in question that have been overdetected. At the time, in the United States and the EU, only the manufacturing number of products exceeding NDMA was recovered. Nevertheless, the MFDS was confident of the measures, saying that it has tested NDMA the most in the world. The Food and Drug Administration (FDA) decided to withdraw the Ranitidine product in the market on the 1st, about six months after that. The FDA concluded that the market withdrawal was justified for the reason that the impurities contained in some Ranitidine formulations could be detected over time to be acceptable. This is what gave the MFDS the decision made six months ago. Although the US action cannot be a barometer for judging the right or wrong of our government's decision, as a result, the MFDS was acknowledged that it took six months ahead of the US to proactively take scientific action. It should be praised enough. The complaints that the MFDS' follow-up to Ranitidine was overly impatient remained too hasty. In recent years, the pharmaceutical industry is paying great attention to the follow-up of NDMA for the diabetes treatment drug “Metformin”. In December of last year, the Singapore Health Sciences Authority (HSA) retrieved three products for the reason that NDMA exceeding the daily allowance was detected as a result of investigating 46 items of Metformin preparations on the market. In Canada, Metformin preparations from three pharmaceutical companies have voluntarily recovered due to NDMA detection for a month since February. In the United States and the EU, there is still an ongoing defense against Metformin's NDMA risk. The U.S. Food and Drug Administration (FDA) released a survey of 10 Metformin products in circulation in the U.S. in February, suggesting that NDMA was detected in two products, but no recall was recommended. However, a US private research firm, Valisure, proposed to the FDA earlier last month, announcing an analysis that NDMA exceeding the daily allowance was detected in some products of the drug 'Metformin' in circulation in the U.S. for diabetes. The European Medicines Agency (EMA) released its findings in an official statement on the 3rd of last month as soon as possible, and announced that imformation investigation results for Metformin are imminent, saying that patients with type II diabetes should continue taking Metformin until further announcement. It has been around four months since the Metformin NDMA risk in Singapore has risen, but the MFDS has never released an official position. Last year, the MFDS announced the results of an interim check that NDMA was not detected in domestic distribution products within three days after receiving the information about the detection of residual NDMA in the United States. Compared to this, the Metformin case doesn't seem to be quick. The MFDS received data on the use of Metformin in December last year from pharmaceutical companies. Metformin's NDMA test method was also released on January 15th. Earlier this year, we conducted a collection test for Metformin drug substance, and recently visited pharmaceutical companies to collect finished medicines. This is the point that the announcement of the Metformin inspection is imminent. Of course, it is expected that the MFDS will have great concerns. Metformin is the first and most widely used drug for people with type II diabetes, so it is a burden to take drastic measures like Valsartan and Ranitidine. Any follow-up can lead to extreme confusion among medical staff and patients. However, follow-up measures that apply different standards for different drugs can reduce trust in the government. However, if the collection inspection is over, follow-up should not be delayed. We look forward to wise follow-up by the MFDS based on scientific evidence. Transparency in the policy-making process can be supported by the people.
- Opinion
- [Reporter’s eye] Measures about NDMA should be careful
- by Lee, Tak-Sun Apr 16, 2020 06:34am
- Measures are imminent when the MFDS begins testing by collecting finished products of Metformin, which are used as diabetes treatments. In last December, an excess of NDMA (N-nitrosodimethylamine), a carcinogen, was detected in Metformin preparations in Singapore. Since then, the MFDS has been conducting extensive investigations. After collecting and inspecting about 900 raw materials, it is believed that the investigation process is being expanded to the finished product and the process of selecting products with excess impurities is in progress. Although the results of the investigation are still unknown, some people have analyzed that NDMA was detected in the raw material and then expanded the investigation to finished products using the raw material. The MFDS only states that it is currently considering various aspects of the investigation direction and measures. Regardless of the results of the investigation, measures against Metformin preparations should be determined more carefully than existing NDMA-detected products. This is because Metformin is used as a primary treatment for type II diabetes treatments. Diabetes patients who are being treated for the first time are starting with Metformin. And. Metformin with other drugs, a combination of metformin and other ingredients is also on the market. There is also a survey that the size of the outpatient prescription market for drugs containing Metformin alone reaches ￦473.2 billion (Source: UBIST). Therefore, as in the case of Ranitidine, if Metformin is banned and recovered, there is no alternative drug, and the lack of alternative medications will create a great disruption for the market, medical staff and patients. Therefore, measures to minimize the impact should be prepared. The products of concern should be selected rather than a quick investigation. If there are medicines of concern for risk, the first priority is to protect the safety of the people through prompt action. The MFDS will have a lot of worries in many ways. There are conflicting results abroad. The U.S. FDA announced in mid-February that it did not recommend recovery because Metformin's NDMA issue was not serious, while some products are being recovered in Singapore and Canada. In the United States, a private research institute, Valisure, also suggested that FDA recover the product, saying that some Metformin products had excessive NDMA. It is best that NDMA does not exceed daily allowances in Metformin products, but if there are products detected in excess, measures should be taken to minimize the gaps in patient care.
