Production of 5 drugs suspended
By Kim Jae-won
The government decided Thursday to file a criminal complaint with the prosecution against the head of Janssen Korea for manufacturing and selling dangerous medicine.
The Ministry of Food and Drug Safety (MFDS) also told the Korean branch of the drug and pharmaceutical unit of Johnson & Johnson to suspend production of five types of medicine for up to five months.
The ministry said its punitive measure is heavier than usual because of the firm's multiple violations. It remains to be seen whether consumer advocates take legal action against the firm. No complications from using the medicine have been reported.
Under the Pharmaceutical Affairs Law, CEO Kim Oak-yeon may face three years behind bars.
"Despite being aware of the anomalies in March, it was a month before Janssen Korea notified us. During that period, the company sold about 38,000 bottles of Children's Tylenol Suspension 100ml and 500ml, though they potentially could cause liver damage," Lee Dong-hee, the ministry's director, said in a news conference.
This was clearly against of a regulation that obligates pharmaceutical companies to immediately report any safety problems to the ministry.
Lee said the company also manufactured 0.6 percent of its Tylenol products using hand-operations, a violation of pertinent regulations.
The five medicines subject to the ban in question are fever reliever Children's Tylenol Suspension, anti-dandruff medicine Nizoral, prescription painkiller Ultracet, stomach and bowel medicine Pariet 10mg, and attention deficit hyperactivity disorder medicine Concerta OROS 18mg.
The decision came a month after the ministry ordered the company to recall all of the Children's Tylenol Suspension on the market.
Lee said the ministry ordered the suspension of the production of Nizoral for four months and the other three drugs for one month, because the firm did not abide by production rules in its factory in Hwaseong, Gyeonggi Province.
Industry officials say Janssen Korea should have been more careful in managing its safety problems, especially given that the products are consumed by children aged between four months and 12 years old.
Janssen Korea CEO Kim said, in a statement, "We apologize for causing concern regarding the recall of Children's Tylenol Suspension. We will cooperate with the authorities and make every effort to regain the trust of consumers, patients, medical experts and the government."
Janssen Korea is a mid-sized pharmaceutical company and posted a 2.6 billion won net profit last year, according to data from the Financial Supervisory Service.
정부는 한국얀센 대표가 위험한 의약품을 제조하고 판매한 혐의에 대해 형사고발을 하기로 결정했다고 목요일 말했다.
식품의약품안전처는 또한 한국얀센의 다섯 가지 제품에 대해 최대 5개월간 제조업무 정지를 명령했다. 한국얀센은 미국에 본사를 둔 거대 제약회사이자 존슨앤존슨의 제약부문 자회사인 얀센의 한국지사이다.
식약처는 한국얀센이 다수의 규정을 위반했기 때문에 통상적인 수준보다 무거운 징계를 받았다고 말했다. 소비자들이 이 회사에 대해 소송을 제기할지에 대해서는 아직 결정된 바 없다.
약사법에 따르면, 한국얀센 김옥연 CEO는 최대 3년의 징역형을 받을 수 있다.
“한국얀센은 3월에 제품에 문제가 있음을 발견했음에도 불구하고, 한 달이나 지나서 우리에게 보고했다. 이 기간 동안 얀센은 이 제품에 아세타미노펜이 과다하게 함유돼있을 가능성을 알고 있음에도 불구하고, 약 38,000병의 어린이타이레놀현탄액을 계속 판매했다,”고 식약처 이동희 과장이 기자회견에서 말했다.