Suspicions of preferential tx for SK Bioscience & Celltrion

The head of the MFDS, domestic COVID-19 treatment and vaccine approval procedures "as the basis"

Special measures for misuse of narcotics are needed

The appearance of the parliamentary audit of the National Assembly

Suspicions have been raised during a parliamentary audit, led by opposition lawmakers, that the MFDS may have provided preferential treatment to the company for domestic COVID-19 drugs.

 

Kim Kang-rip, head of the MFDS, dismissed the suspicion, saying he approved it based on evidence.

 

Fentanyl Patch, a drug pain reliever, is being used by teenagers and requested to eradicate drug abuse.

 

There was also an opinion that a doctor who prescribed drug abuse needs to temporarily suspend his license.

 

It was found that opinions between the ruling party and the opposition party were divided on drugs to suspend pregnancy.

 

The MFDS plans to carefully examine the product.

 

Various issues such as COVID-19 treatment and vaccine screening were raised at the National Assembly Health and Welfare Committee's parliamentary audit held on the 8th.

 

Opposition lawmakers pointed out that SK Bioscience's approval of phase 3 clinical trials of the COVID-19 vaccine and Celltrion's conditional approval of Regkirona, an antibody treatment, had inflated K-Bio's performance.

 

"Isn't the government giving preferential treatment to domestic COVID-19 pharmaceutical companies?" Rep.

 

Lee Jong-sung of the People Power Party pointed out, "In the process of approving the phase 3 clinical trial of the SK Bio COVID vaccine, the MFDS did not comply with the 10% domestic regulations and approved the phase 3 clinical trial even though the phase 2 clinical trial was not completed." Rep.

 

Lee Jong-sung said, "It is very unusual to approve phase 3 before the results of phase 2 confirming the proper dosage and use of the SK vaccine are released."He said, "There is a reasonable suspicion that the MFDS was over-enthusiastic to make Moon Jae In government results rather than drug safety, or that Cheongwadae put pressure on K-Bio performance ahead of next year's election." He also claimed, "Celltrion's COVID-19 treatment Regkirona is suspected of giving preferential treatment to the MFDS even though the virus-negative conversion rate, which was the primary evaluation variable in clinical trials, failed to prove statistical significance."

Kim Kang-rip, head of the Ministry of Food and Drug Safety (left), and Seo Kyung-won, president of the National Institute of Food and Drug Safety Evaluation (right) (Photo = provided by the National Assembly Korea Special Press Association)

In response, Director Kim Kang-rip replied, "This is the result of expert advice that it will not be a problem at all if statistically significant patients are recruited to verify the validity of Koreans," adding, "We also confirmed more than five times the standard serum price in phase 2 and approved phase 3 with scientific judgment." Kang Ki-yoon, a member of the People Power Party, urged, "Samsung Biologics' GMP review of Moderna vaccine consignment production should be approved as soon as possible." Heo Jong-sik, a member of the Democratic Party of Korea, also said, "The Korean people can be vaccinated only with the production of COVID-19 vaccines at domestic production bases such as Samsung Biologics and SK Bioscience," adding, "This requires approval for use."

Ko Min-jung, a member of the Democratic Party of Korea (photo by the National Assembly Korea Special Press Association)

Samsung Biologics' GMP survey was conducted on September 25.

 

Director Kim said, "We have completed an on-site investigation of production facilities and requested Samsung Biologics to supplement the GMP review," and explained, "The review will be completed within this month." Mifegymiso, ruling party and opposition party are also divided.

 

Kang Ki-yoon, a member of the People Power Party (Photo provided by the National Assembly Korea Special Press Association)

Lee Sang-joon, CEO of Hyundai Pharmaceutical, was the only pharmaceutical company to be summoned as a witness during the parliamentary audit.

 

This is to inquire about The objective media Mifegymiso.

 

Mifegymiso is currently being reviewed by the MFDS.

 

However, the pros and cons are mixed over the Bridging Study for Koreans.

 

While civil society and women's organizations omit the Bridging Study and urge rapid approval, the obstetrics and gynecology society say it should be carefully introduced through the Bridging Study.

 

The arguments of women and opposition parties are also mixed.

 

In response, the head of the MFDS said, "We will review the submitted clinical data and refer to WHO guidelines and real data from 76 countries.

 

The Central Pharmaceutical Review Committee said it could review the Bridging Study exemption, but we will comprehensively consider safety such as how to take it."

Lee Sang-joon, CEO of Hyundai Pharmaceutical, who is sworn as a witness (photo = provided by the National Assembly

CEO Lee Sang-joon, who served as a witness, said, "Hyundai has the ability to proceed with Bridging Study." Asked by Rep.

 

Seo Jung-sook whether she predicts an increase in annual sales due to the introduction of Mifegymiso, CEO Lee replied, "The total number of abortions is reported in Korea, but it is difficult to predict Mifegymiso's market information, which can only be used within the first nine weeks."