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- 2026-04-17 19:19:01
- Company
- Punishment for rebate MD is on the rise
- by Jung, Hye-Jin Dec 19, 2019 06:35am
- A series of tougher penalties rulings against the medical personnel's illegal rebates have been issued. Once caught, the ruling to collect the full rebate collection has become the trend. Analysts say that the justice department increase the level of rebate punishment. Dailypharm's analysis of the major rulings on drug rebates on the 17th showed that in four recent cases, medical personnels were charged with the amount of rebates they received from pharmaceutical companies in addition to imprisonment or fines. Dr. A, who runs a hospital in Paju, Gyeonggi-do, was charged with receiving ₩15 million for prescribing medicines from a pharmaceutical company and was sentenced to a fine of ₩3 million by the Suwon District Court in September. The court ordered Dr. A to collect ₩100 million in addition to the fine. In October, similar rulings were followed in Suwon and Daegu. The Suwon District Court Seongnam branch decided on a year of imprisonment and a ₩150 million penalty for Dr. B, who operates an ophthalmologist in Ulsan. The additional ₩150 million is the rebate that Mr. B received twice from a pharmaceutical company. The Daegu District Court sentenced doctor C, who received a rebate, to pay a fine of ₩2 million and a penalty of ₩2.65 million. The penalty is also equal to the amount of rebate that Mr. C received from the related pharmaceuticals. Unlike other doctors, Dr. B was sentenced to one year in jail because he demanded more rebates from pharmaceutical companies on the condition that he would increase the size of the existing hospital and increase the volume of drug transactions. The court found that Mr. B was aggressively trying to get a rebate, and gave him to a severe sentence. In November, the Suwon District Court decided to pay a fine of ₩4 million by applying to Dr. D for violating medical law. Dr. D was not accompanied by a punishment, but the ruling said that “It is necessary, but it is clear that it did not collect from an abbreviated order, so the addition of collections in addition to previously sentenced sentences is not permitted in the interpretation of section 457, paragraph 2 of the Criminal Procedure Act”. the court revealed the reason for not being sentenced. In addition, the Seoul Central District Court ruling, which was made earlier, also shows a trend of strengthening the penalty. In June, the court sentenced Doctor E, who violated the Medical Law, two years probation for one year in prison and two years probation for eight months in jail for a representative of a wholesaler who violated pharmaceutical laws that provided rebates. Four of the five rebate-like judgments were received 100% collection. The other one, which did not order the collection, also revealed a valid basis for which the criminal law does not allow for collection. Article 88 (2) of the current Medical Law allows the collection of medical personnels who have received illegal rebates. Such trends in local jurisdictions show recent trends in penalties for drug rebates. Previously, even if rebates were caught, fines, probation, and imprisonment were mostly imposed, but as the recent rulings show, the government is collecting 100% of the rebates illegally received by medical personnel. The lawyer Jong-sik Woo of the law firm Gyuwon also made the same opinion that “Is it because of the light punishment that the judges are not eradicating the rebate?” Attorney Woo said, “A recent analysis shows that there is a clear trend to strengthen the penalty, recently the ruling on illegal rebates shows that the frequency of collecting 100% of the money received is almost the same”. “The legal basis for the surcharge was from the stage of a dual punishment system. The law was not changed, but the court is raising the surcharge level recently”. “It is analyzed that the Tribunal is moving towards the strengthening of collections to eradicate drug rebates.” he added.
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- 오츠카 The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug. According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia. As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application. Otsuka’s Samsca is protected by a patent on solid preparation and its manufacturing method of the medicine including bezoazepine, which is to be expired on June 20, 2028. In last May, Myung In Pharma evaded infringement of Samsca’s drug patent with Intellectual Property Trial and Appeal Board’s ruling. The company filed a defensive confirmation trial for the scope of a right, which then was affirmed. And in the same month, the company’s bioequivalence test protocol was cleared. Based on the clues, the industry is convinced Myung In Pharma has probably applied for the approval. The original Samsca is the first-and-only hyponatremia treatment approved by MFDS in September 2011. Hyponatremia is an electrolyte-associated adverse event commonly found in hospitalized patient, which can cause serious neurologic complications. Before Samsca was available, intravenous fluid with high concentration of sodium was given to the patients, but it did not treat the cause. Recently, Samsca was granted with reimbursement approval on indication for treating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). If Myung In Pharma snatches the first generic title in the market, it is expected to earn a significant commercial success with minimum competitors.
- Company
- New flu season to spark up another round of competition
- by Kim, Jin-Gu Dec 18, 2019 02:25pm
- KCDC public service announcement about preventing influenza by getting flu shot, properly washing hands, covering mouth when coughing and visiting healthcare institute when feeling unwell The flu season in Korea has just arrived for the year. Korea Centers for Disease Control and Prevention (KCDC) issued a flu warning on November 15. The season is to last until May next year. The new flu season is to start up even more fierce competition in the flu treatment market. The market leader, Tamiflu (oseltamivir) sales has been tumbling down since oseltamivir generics were launched. What’s worse, the flu treatment’s adverse reaction risk reported last season had its market position precarious. Now the gap between Tamiflu and the runner-up Hanmi Flu is in arm’s length. Prescription volumes of generics, on the other hand, are neck-and-neck, while the original’s performance is stagnating. Moreover, intravenously administered Permiflu jumped in to the already-heated competition strong with convenience of single-dosage. Now with the new flu season just penning, let us round up the highlights of the flu treatment market. ◆Tamiflu adverse reaction risk from last year, so what’s next this year? Last winter, Tamiflu was struck down with a concerning issue. In December last year, a middle school student fell from an apartment and was found dead in Busan, after taking Tamiflu. The student’s family suspected adverse reaction as she complained of hallucination after taking Tamiflu. And the media highlighted sporadic reporting of suicidal reaction from Tamiflu in Japan. The risk did not subside easily. As a result, the original and oseltamivir generics together generated prescription volume of 24.7 billion won in last flu season from November 2018 to May 2019. Compared to the 2017-2018 season generating 31.1 billion won, the last season’s sales dropped more than 20 percent. Besides, it was a big loss for the drugs considering the flu season struck hard last year. According to Health Insurance Review and Assessment Service (HIRA), 4.74 million patients visited hospitals for flu in the 2018-2019 season. The figure was at four-year high and it was 5.5 times more than 860,000 patients in the 2014-2015 season and 2.1 times more than 2.29 million patients in the 2017-2018 season. Tamiflu and generic prescription volume (source: UBIST) and flu patient size from last five season (source: HIRA) While the overall oseltamivir products had a drop in prescription volume, the original Tamiflu took the biggest blow. Its prescription volume plunged from 12.2 billion won to 7.7 billion won in a year. Hanmi Flu generating the second highest sales narrowed the gap with Tamiflu from 3.8 billion won to 1.7 billion won in the same period. The industry predicts the generic could actually surpass the original this season according to the trend. Top two market leaders Tamiflu and Hanmi Flu’s prescription volume in last five seasons (Unit: KRW 100 million) Source: UBIST ◆Peramiflu almost triples market share As a result of Tamiflu’s adverse reaction risk, GC Pharmaceutical’s Peramiflu (peramivir) took the opportunity. Compared to the previous season, the peramivir medicine’s market share more than doubled last season. The National Assembly Health and Welfare Committee reported 67,518 patients were prescribed with Peramiflu as of December last year. It was 4.4 times more than 15,481 patients in the season before. In the general flu treatment market including Tamiflu, Peramiflu’s share soared from 2.0 percent to 5.4 percent, about 2.7 times the rate. Some hospitals and clinics struggled to get a hold of Peramiflu stock, because a sudden spike in sales exceeded projected demand,. Apparently, pediatric institutes especially had difficulty in acquiring needed supply. Peramiflu also won expanded indication on pediatric patient under the age of two. And some sees that the word of mouth from young patients’ parents, concerned of the recent Tamiflu risk, have affected the shortage. ◆Hanmi Flu gulping up generic market share Since Roche introduced Tamiflu to Korea in 2000, its market share grew significantly in 2009 with the new influenza sweeping the nation. And the treatment dominated the market in the 2014-2015 season. In the 2015-2016, Hanmi Pharmaceutical modified the original’s saline substance to avoid patent infringement and launched Hanmi Flu. The incrementally modified drug generated 1.5 billion won from the first season’s prescription and had a perfect soft landing on to the flu treatment market. The prescription sales also hiked exponentially in the 2016-2017 season at 8.3 billion won. From the 2017-2018 season, Tamiflu’s patent was expired and generics flooded out to the market. About 50 pharmaceutical companies entered the oseltamivir generic market. The generics made a huge success from their first year. 31.1 billion won worth of generics were prescribed in their first flu season from 2017 to 2018. Tamiflu and oseltamivir generics’ prescription volume in 2018-2019 season (Source: UBIST) However, their sales plummeted to 24.7 billion won with the Tamiflu risk in the 2018-2019 season. But the upside was that the market share of generics in the overall flu treatment market surged from 60.9 percent to 68.8 percent. The generic’s share is expected to surpass 70 percent this season. Interestingly, the number one generic Hanmi Flu’s prescription volume has dropped from 8.4 billion won in 2017-2018 season with share of 26.9 percent to 6.0 billion won in 2018-2019 season with 24.3 percent market share. The decrease in Hanmi Flu’s market share was actually shared among other generic items including Fluone (Jeil Pharm), Seltaflu (Inist Bio), Tami-infle (Hutecs), Boryung Tami (Boryung Pharmaceutical), Tamipro (Arlico Pharm), Bisel Flu (Wooridul Pharmaceutical), Dongwha Flu N (Dongwha Pharm) and Tamiforce (Ilsung Pharmaceuticals). All of the said generics had growth in sales and market share. Meanwhile, Roche Korea is aiming for a turnaround with a new launch of Xofluza. However, the company would be unlikely to recover the fall this season as the new flu treatment launch would take a place in March next year at earliest.
- Company
- ‘Noltec’, domestic new drug sets a new record
- by Chon, Seung-Hyun Dec 18, 2019 06:25am
- Il Yang's anti-ulcer drug 'Noltec' is breaking a record every day. Continued upward trend after expanding indications, the company benefited from the reflection of impurities from competing drugs. According to UBIST, a drug research agency on the 17th, Noltech's outpatient prescriptions last month increased by 16.7% to ₩2.9 billion. By November, the cumulative prescription amount for this year was ₩28.2 billion, up 20.1% from last year's ₩23.5 billion. Noltec, released as a new domestic drug at the end of 2009, is a proton pump suppression (PPI) drug developed by Il Yang Pharmaceutical. Noltec's recent upswing is fueled by increased indications and the exit of competitive products. Initially, Nortec was licensed to treat only 'gastric ulcer' and 'duodenal ulcer'. But at the beginning of the launch, it did not stand out in the market. The reason for this is that they did not have indications for reflux esophagitis, which account for about 80% of the PPI drug market. Nortec's sales have risen vertically since winning the indication for reflux esophagitis in 2012. In 2014, the prescription amount exceeded ₩10 billion, and since then, H. pylori bactericidal indications have been added, showing rapid growth, and recorded prescription amount of ₩26.2 billion last year. Recently, the suspension of Ranitidine have been worked favorable factor. In September, the government suspended a sale of all anti-ulcer ranitidine products. In fact, it decided to exit the market because of its excess of carcinogen N-nitrosodimethylamine (NDMA). The discontinuation of ranitidine led to a significant increase in the use of H2 receptor antagonists and PPI-based drugs with similar treatment areas, and Noletec benefited. Recently, some of the Nizatidine-based products have been discontinued due to NDMA detection, and PPI-based drugs are becoming more popular. Nortec's prescription exceeded ₩3 billon for the first time in October, just after Ranitidine was discontinued. It increased 23.2% YoY and rose 20.1% MoM. Since the Ranitidine’s suspension of sale, prescriptions for October and November totaled ₩6 billion, up 20.3% YoY. If this is the case, Nortec is likely to surpass ₩30 billion in prescriptions for the first time since its launch.
- Company
- Chong Kun Dang in talks over approved Xofluza
- by Kim, Jin-Gu Dec 18, 2019 06:25am
- Xofluza (baloxavir), a follow-on drug for influenza patient treating Tamiflu (oseltamivir), has been recently approved the Korean health regulator, and is now in talks with Chong Kun Dang Pharmaceutical about the marketing deal in Korea. Korean Ministry of Food and Drug Safety (MFDS) has granted an approval on commercialization of Roche Korea’s Xofluza in 20 mg and 40 mg dose last month. The Korean industry predicts Chong Kun Dang would highly likely to grab the marketing rights of the flu treatment in Korea. According to a pharmaceutical industry insider on Dec. 16, Roche Korea and Chong Kun Dang are currently in negotiation over commercialization in Korea. Chong Kun Dang signed an exclusive distribution and sales deal on Tamiflu with Roche in 2012. The contract has been maintained to this day. With the long plausible relationship with the Korean company, the multinational company is positively having talks over Xofluza. The two companies had an official statement issued saying “Xofluza’s commercialization deal in Korea is ongoing at the moment. Nothing has been decided, yet”. When they agree on the final terms, the treatment is expected to be launched early next year at earliest, considering preparation time between the approval and actual launch date. Also taking in account of the insurance reimbursement review period, the treatment would join the competition in around next influenza season, either from winter of 2020 or spring of 2021. Xofluza, after its launch, would have to compete against GC Pharma’s Peramiflu, Hanmi Pharmceutical’s Hanmi Flu and other generics. In particular, Xofluza would compete against Peramiflu for the single-dose prescription. The two have contrasting advantages and disadvantages. Both of them are prescribed for a one-dose administration, but Xofluza is orally taken and Peramiflu is administered intravenously. However, Peramiflu has its indication approved for pediatric patients. Xofluza is currently only approved for adult and teenagers older than 12. Administration convenience and pricing are make-or-break factors the competition against generics like Hanmi Flu. Tamiflu and other generics are inconvenient for the patients as they have to be taken orally for five days. Meanwhile, Tamiflu generics in convenient suspension form are also their strength. Moreover, they have the upper hand with an indication for pediatric patients like Peramiflu.
- Product
- “Lipitor not sold out”, Pfizer clarifies rumors
- by Kim JiEun Dec 18, 2019 06:24am
- Rumors of cholesterol lowering treatment Lipitor tablet going out of stock have been spreading throughout major pharmacies, but its company clarified the rumor is false. Pfizer Upjohn Korea on Tuesday told Daily Pharm that the manufacturing of Lipitor 10 mg tablet (28BLP/ 90BLT) has no issue at the moment. The company’s statement was an answer to the recent Lipitor stock-out rumor spreading among pharmacies. Apparently, the talk of Lipitor going out of stock until next year was looming from pharmacists on social media channels and triggered some pharmacies to start hoarding the product. With a temporary spike in order volume, a certain distributor had to notify their salespeople to explain about the situation of pharmaceutical distributors and online shops having scarce stock of the drug to their designated pharmacies. The distributor informed their salespeople that “Lipitor has been sold out due to a baseless false rumor. It has affected all distributors in Korea. As temporary demand in other products has been increasing as well, please visit designated pharmacies to explain the situation”. The whole situation has caught the global company by surprise. The company has been ordinarily manufacturing and supplying the item, when the order has exponentially hiked because of the rumor. Pfizer Upjohn Korea official told, “As of afternoon of Dec. 16, Lipitor 10 mg supply is in a normal state. The company has confirmed Lipitor’s stock in some pharmacies have been sold out. To minimize inconvenience of doctor, pharmacist and patient, the company is in process of studying the origin of the rumor and resolving it”. The company also explained the drug is supplied based on market demand projection and it notifies the public when it predicts drug stock-out from plausible cause. “The company provides products considering a projection based on multiple years of collected market supply and demand data. Accordingly, supply amount is regularly monitored. When the company expects a setback in supply process, the company informs organizations of distributor and pharmacist to minimize turmoil in the market”, the official elaborated. “Pfizer Upjohn Korea would continue to strive for stable supply of drug”, the company official added.
- Company
- Oraxol by Hanmi apply US license
- by An, Kyung-Jin Dec 18, 2019 06:24am
- The commercialization of the anti-cancer drug 'Oraxol', a technology exported by Hanmi, is imminent. Hanmi's US partner Athenex unveiled its Phase III clinical results for patients with metastatic breast cancer and announced its intention to approve the FDA in early next year. Some assessments suggest that some indicators, such as gastrointestinal adverse events, do not meet expectations. ◆Athenex, confirmation of anticancer effect of Phase III clinical trial for oral Paclitaxel Athenex unveiled the results of its Phase III clinical study at the San Antonio Breast Cancer Symposium (SABCS 2019) held in Texas, USA on 13th (local time). This study compares the efficacy and safety of randomly assigned metastatic breast cancer patients enrolled in 45 Latin American clinical trials into Oraxol group or Paclitaxel IV group. Oral test drug 205 mg / m² three times a week, and the control group received 175 mg / m² of Paclitaxel intravenous injection every three weeks, and then confirmed the tumor response through imaging tests. The conference announcement was similar to the topline results that Athenex released in August. According to the Intention to Analyze (ITT), which included those who discontinued or changed the treatment during the clinical trial, the objective response rate (ORR) of the Oraxol group was 35.8% (95 of 265) better tumor suppression effect (P = 0.001) than 23.4% (32 of 137) of the IV group. The median response time was higher in the Oraxol group (27.9 months) than in the Paclitaxel intravenous group (16.9 months), overall survival (median) was also significantly different (P = 0.035) at 27.9 months and 16.9 months respectively. However, the progression-free survival period (median value) was 9.3 months in the group taking Oraxol, which did not show a statistically significant difference from the IV group (8.3 months) (P = 0.077). Oraxol, Phase III Clinical Results (Source: Athenex) 'Oraxol' is a synthetic drug that Hanmi exported to Athenex in the US in 2011. Hanmi Pharmaceutical turned its Paclitaxel injection into oral by applying its own developed ORASCOVERY platform technology. By blocking the membrane transport protein P-glycoprotein (P-gp) that interferes with the oral absorption of anticancer drugs, it is a mechanism to improve the absorption rate has been pointed out as a disadvantage of oral drugs. The Paclitaxel injection, which is the most commonly used for breast cancer treatment, is changed to oral drug, thereby increasing convenience and increasing marketability. It is also meaningful that Hanmi’s ORASCOVERY platform technology has entered commercialization on track. ◆Investment industry, "Effective goal met, but adverse reaction is key" However, the investment industry is disappointing with the results of the Phase III clinical trials. Although the primary efficacy endpoints were met, the safety profile was ambiguous. Shortly after the conference, Athenex shares fell 17 percent. According to the report, the incidence of alopecia and severe neuropathy adverse events was 17% in the Oraxol group, which was lower than 57% in the intravenous group. Severe neuropathy symptoms were also improved in the Oraxol group at 1% and 8%. Toxicity profile was similar. On the other hand, neutropenia, infection, and gastrointestinal adverse events were higher in the Oraxol group. Athenex Based on this three-phase clinical data, Athenex expresses its intention to commercialize the Oraxol in earnest, and the marketability of the Oraxol is expected to be tested. Atenex executives said during the third quarter of last month's results that they are preparing a pre-meeting to submit a new drug application (NDA) for the US Food and Drug Administration (FDA) in the first quarter of next year. He also said he is also considering expanding the range of Oraxol’s use to other carcinomas, including advanced gastric cancer, using anti-PD-1 antibodies such as Keytruda. In addition to Paclitaxel, the company aims to develop oral formulations of various anticancer drugs such as Irinotecan and Eribulin using ORASCOVERY Platform technology. Athenex executives held the conference call related to the announcement of SABCS 2019. He stressed “Oraxol has achieved meaningful results in phase III clinical trials, and this is the first case of Paclitaxel that has been converted to oral to demonstrate anti-cancer effects, and Oraxol is expected to be an important treatment option for breast cancer patients”.
- Policy
- The MFDS plans to collect & test Metformin
- by Lee, Tak-Sun Dec 18, 2019 06:24am
- The Ministry of Food and Drug Safety (the Minister, Eui-Kyung Lee) has decided to collect and inspect commercial distribution items to investigate impurities on Metformin. As a result, the MFDS is preparing a test method with a goal within the year and is conducting a raw material system investigation for the preliminary safety management. The MFDS said it is conducting an impurity investigation on Metformin on the 16th. Prior to this, the Singapore Health Sciences Agency (HSA) announced that it detected and recovered trace amounts of 'N-nitrosodimethylamine (NDMA)' in three out of 46 Metformin-containing products. NDMA is a Group 2A human carcinogen suspected by the World Health Organization (WHO) International Cancer Institute (IARC). The MFDS confirmed that the same products as those recovered in Singapore were not imported in Korea. However, raw materials from the same manufactory used in the medicine are said to have come from Korea. However, even if the raw material of the same manufactory lot may be different because there is not necessarily the risk of problems. First, the MFDS is conducting a systematic investigation of the source (import source) of the use of Metformin-containing medicines in advance of safety management. It also plans to establish a test method for NDMA in metformin within the year. After the test method is established, Metformin raw materials and drug products will be collected and tested as soon as possible. An official from the MFDS said, "We will start collecting products this month and carry out inspections from January next year". Investigations are expected to be conducted first with products that are the same manufacturer as the raw material for products recovered in Singapore. It will be considered whether to expand the survey. This is because the test subjects are so large that Metformin is allowed in 640 items in Korea. An official from the MFDS said, “We will carry out test tests promptly, and we are working closely with regulatory agencies such as the European EMA, the US FDA, and the Japanese PMDA to exchange related information such as the cause of occurrence”. In addition, the MFDS and the Korean Diabetes Association, Metformin is a diabetic drug, and continuous medication is very important for the treatment of diseases. Patients taking Metformin-containing medicines were advised not to stop taking it without consulting their doctor or pharmacist. In the future, if there is a test result exceeding the acceptance criteria, it will immediately notify the health professionals and the public, including medical and pharmacists.
- Company
- Korean companies now having long year-end holiday
- by Lee, Seok-Jun Dec 17, 2019 12:33pm
- The Korean pharmaceutical industry is starting to adopt the long year-end holiday season to wrap up the year around Christmas and to start fresh from the New Year. Boryung Pharmaceutical and other Korean companies are having a long holiday for the first time this year. Multinational pharmaceutical companies are starting their long holiday season soon like they have been for years. Apparently, AbbVie is to have is the longest 18-day holiday season. Daily Pharm surveyed year-end holiday schedules of 40 pharmaceutical companies in Korea, including top 20 Korean companies, 18 global companies, and two pharmaceutical industry organizations—Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) and Korean Research-based Pharmaceutical Industry Association (KRPIA). Nine out of 20 companies are leaving for the holiday from Dec. 26 to 31. Including public holiday on the Christmas day and the New Year’s day, they are closed for total eight days. The list of companies include GC Pharma, Hanmi Pharmaceutical, Dong-A ST, JW Pharmaceutical, Ildong Pharmaceutical, Boryung Pharmaceutical, Huons, Dongwha Pharmaceutical, and Samjin Pharm. Boryung Pharmaceutical is having their first long-term year-end leave. Five companies including Kwangdong Pharmaceutical, Daewoong Pharmaceutical, Jeil Pharm, Celltrion and Handok’s year-end schedule is to use employee’s individual annual leave. The companies are highly recommending the employees to use the rest of their annual leave. Yuhan is the first to close the office from Dec. 16 to 20. Including the weekends, the companies are on holiday for nine days. But it opens again from Dec. 23 to prep for the next year’s start. Chong Kun Dang Pharmaceutical and Daewon Pharmaceutical have set Dec. 30 and 31 as designated annual leave day. Whereas Ilyang Pharmaceutical and Dongkook Pharmaceutical have designated Dec. 23 and 24 as annual leave day. They took an advantage of weekends and holidays to take a longer holiday. An industry insider commented, “A long year-end holiday season has been a typical system only for multinational companies even until recently, but nowadays Korean companies have implemented the similar system to have refreshing holiday season. Most of them use employee’s annual leave days, but employees can fully enjoy a long holiday with an official corporate holiday season”. Multinational pharmaceutical companies’ long year-end holiday season is not so different from previous years. Among the surveyed multinational companies, AbbVie is having the longest year-end closing. The 18-day leave is to stretch from Dec. 19 to Jan. 5 next year. AbbVie has decided to grant special vacation day on Dec. 30 and 31, and use employee’s annual leaves on other days. The office usually closes on Jan. 2 as it is AbbVie’s foundation day. Pfizer is to close the office from Dec. 17 to the end-of-the-year. Including the New Year’s day, they will be closed for 16 days. AstraZeneca, Boehringer Ingel Heim, Roche, Takeda, Daiichi Sankyo, Sanofi and Amgen are closing around Christmas. Other companies are to use employee’s annual leave for the year-end holiday season.
- Policy
- Why did MFDS release its Metformin self-investigation plan?
- by Lee, Tak-Sun Dec 17, 2019 07:20am
- The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore. It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the recovery of three Metformin items. The MFDS has said through media coverage that it is investigating the domestic inflow of raw materials used in Singapore's products in question, but the MFDS kept silent about collection and inspection plans for domestic distribution items. Let’s learn about the background of MFDS' silence and the release of Metformin's own investigation through a press release. Public opinion has changed, ordered from the Diabetes Association The MFDS released a press release on the 16th, is currently preparing a test method for Metformin formulations, and is conducting a systematic survey on domestic distribution items to identify the source of raw materials. In addition, as soon as the test method was prepared, the MFDS added that they plans to collect and inspect domestic distribution items. In fact, the MFDS has not said that they will not directly conduct an investigation into Metformin's impurities. Nor did they instruct the vendor to do the test autonomously. However, as part of the follow-up measures of Ranitidine and Nizatidine, the press release and public hearings revealed that companies should directly investigate raw materials and finished products that are likely to cause impurities. Some companies have conducted their own tests. Some expressed suspicion that the MFDS was not actively involved in collection and inspection, as opposed to when NDMA problems were raised in Valsartan or Ranitidine. Indeed, the Korean Diabetes Association, which consists of domestic diabetic doctors on the 13th, said, "There is no official announcement whether the raw materials of the company in question were imported to Korea". The Society stressed that the MFDS should address the public's concerns through direct investigations. The Diabetes Society's point was enough to raise suspicion that the MFDS remained a mere spectator. An official from the industry said, “If the MFDS conducted a survey of domestic distribution items based on Singapore collection only when the impurity risks of Metformin preparations were not verified, it would have increased public anxiety, however, on the contrary, it seems to have disclosed its own research plan immediately after pointing out that it should actively take the measures to resolve the public unrest”. Raw material check… increased need for recovery investigation Although it did not appear in the press release distributed on the 16th, it is confirmed that the drug substance imported from Singapore is met with the same drug substance as the Metformin preparation recovered in Singapore. Earlier, the MFDS said that there was no inflow of finished products in Korea, and that it was checking whether the drug substance was imported. The fact that the MFDS conducted a systematic investigation to identify drug substance manufacturers for Metformin ingredients and finished drugs in Korea was influenced by the inflow of ingredients from the same factories as those of Singapore. Therefore, the necessity of checking the raw materials through the systematic investigation, collecting them directly, and increasing the need for self-investigation was increased. However, an official of the MFDS said, “Even if the raw materials are the same, there is no risk because the production lot (process) may be different”. also added “there is no intention to select the raw materials in question because the systematic survey is to investigate the source of all distribution items”. However, it is highly likely that the target of the first collection, inspection planned by MFDS will be the same raw material manufacturer as the recalled product in Singapore. If the risk is identified, the collection and inspection can be extended, otherwise the case can be closed. The MFDS also recognizes the limitation of recovery and investigation of all items. Metformin is a multi-frequency prescription drug that is used as the first-line drug for type 2 diabetes treatment, and this is because 640 domestic licensed items are available. The MFDS expects to investigate domestic distribution items as early as January next year. As such, collection of some distribution items is highly likely to begin this month. The MFDS' full-fledged investigation does not increase the risk of Metformin. The MFDS said in a press release on the 16th. that, among other things, patients taking Metformin-containing medicines should not stop taking it without consulting their MDs or pharmacists.
