Debarment hearings

Executive Summary

Former My-K Labs president Kun Chae Bae is requesting a hearing on FDA's March 30 proposal to permanently debar him from participating in the drug approval process. Bae was sentenced in December 1990 to three months work release and a $25,000 fine for making illegal payments totaling $30,000 to former FDA generic drugs branch chief Charles Chang and for giving gifts to a buyer for a Defense Personnel Support Center. Former Vitarine VP for manufacturing John Bushlow is asking for a hearing on FDA's Feb. 5 proposal to permanently debar him. Bushlow was sentenced in February 1992 to four months in jail for failing to establish and keep drug manufacturing records with intent to mislead.