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.



