The Korea Food and Drug Administration (KFDA) Admits Mistake

Health and Welfare Minister Kim Geun-tae said on August 6 in regard to the current scandal of phenylpropanolamine(PPA)-containing cold medicine, “In order to prevent this from happening again, I will organize a drug safety policy review committee in the Ministry of Health and Welfare.”

Minister Kim attended the general conference of the Health and Welfare Committee in the National Assembly on that day and responded to a series of lawmakers’ remarks that the KFDA didn’t react properly to the current scandal in general. “[The new committee] will be developed to be a systematic arrangement to review the safety of drugs so that this won’t happen again.”

If the drug safety policy review committee is installed, the ministry’s supervision over KFDA, which is in charge of managing the drug safety, is predicted to be even tighter.

Shim Chang-gu, the commissioner of the KFDA, also attended the conference and revealed a plan of establishing a “drug information center,” which would manage the drug safety information.

Commissioner Shim apologized for the recent event. “There was not much efficiency in the current drug safety information collection and management system,” adding, “The new drug information center will gather safety information and manage it among KFDA, the Heath Insurance Review Agency, medical authorities, and consumers.”

One of the 166 cold medicines containing PPA was found to have received approval after the final commissioned report was submitted to the KFDA.

A Grand National Party’s assembly member, Jun Jae-hee, pressed, “On July 20, after the final report on PPA had been submitted and the KFDA summoned the pharmaceutical companies and notified them about it, the ‘C’ cold medicine from the ‘O’ pharmaceutical company was approved.”

According to Jun, 13 cold medicines have recently acquired new approvals in the last three years, among all 166 PPA-containing cold medicines. One in 2001, five in 2002, six in 2003, and this year, one medicine received approval from the KFDA.

Regarding this, the Commissioner admitted the mistake, “It is wrong to approve the medicine even after the report came out.”

Min-Hyuk Park mhpark@donga.com