The Ministry of Health and Welfare recently concluded that the Korean Food and Drug Administration (KFDA) have taken belated measures to ban PPA-containing cold and cough medicines.

"The negligence of duty and lukewarm attitude of the KFDA officials in handling the case put the public health in serious danger," the ministry said in a report. "The KFDA failed to report the case to the ministry and consult with related agencies, without recognizing the importance of the case." The report, an outcome of the ministry's week-long investigation into the KFDA's handling of cold medications containing PPA, that is associated with hemorrhagic strokes, signified the KFDA had made serious mistakes and failed to fulfill its duty to protect public health.

On August 1, 2004, the KFDA banned production and sale of about 170 prescription and over-the-counter cold remedies containing PPA which were manufactured by 75 pharmaceutical firms.

On August 9, Shim Chang-koo, the KFDA Commissioner stepped down, took responsibility for the scandal surrounding a delayed ban on the PPA-containing medications.

"I decided to tender my resignation to take responsibility for the scandal," Shim told a news conference in his office in Seoul.

Shim's resignation is seen as the beginning of a shake-up of the KFDA and its monitoring system for drug safety. The ministry said it will install an independent committee comprising medical experts and consumer groups to strengthen monitoring of drugs and for research of the possible side effects of drugs on sale.

Despite the ministry's action, many questions still remain. Suspicions have emerged that the KFDA attempted to protect pharmaceutical firms and downplay the risk of the PPA-containing drugs.

Nine medical professors undertook research from March 2002 to June 25, 2004. Their research was financed by the pharmaceutical firms producing the PPA products. The KFDA was criticized for delaying the findings of the study, which concluded that PPA-containing drugs may be associated with strokes.

Yuhan Corp, Choongwae Pharma, Hanmi Pharm, Yungjin Pharm, Wyeth Korea and BMS Korea are some of the 75 manufacturers.

The KFDA has been under fire for downplaying the risk of the PPA-containing drugs. The drug agency did not mention the level of risk in its press release on July 31, although it was aware of the fact that use of the PPA increases the likelihood of hemorrhagic strokes among people over the age of 30, especially women.

Regulators last week found one of the nearly 170 banned medicines received a sales permit on July 20, days after the KFDA received the research results on June 15. Another 13 cold medicines containing PPA obtained sales permits after July 2001, after the government requested pharmaceutical firms to refrain from manufacturing PPA-containing drugs.

The Board of Audit and Inspection in Korea said that it will investigate the handling of the PPA drugs by the health ministry and the KFDA and the relationship between the KFDA and pharmaceutical firms involved.

Source: Korean newsmedia August 2004

[Editor's Note: In November 2000, the U.S. FDA took steps to remove PPA from all drug products and requested that all drug companies discontinue marketing products containing PPA following the release of the Yale study. Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826-32.]

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