BALTIMORE, DEC. 13 -- A former employee of Bolar Pharmaceutical Co. has pleaded guilty to her part in an alleged fraud scheme by Bolar to seek government approval of its generic version of the hypertension drug Dyazide by substituting the brand-name drug for the generic in tests.
Gloria H. Schetlick, 35, former regulatory affairs manager at Bolar in Copiague, N.Y., pleaded guilty in federal court here Wednesday to making false statements and obstruction of justice in the two-year investigation of Bolar and other manufacturers in the lucrative generic drug industry.
Schetlick, who was released on personal bond pending sentencing, faces up to 10 years in prison and $500,000 in fines. U.S. District Judge John R. Hargrove set sentencing for April 25.
Schetlick is the second former Bolar employee to plead guilty and reportedly is cooperating with prosecutors in the continuing probe. More charges are expected.
Investigators have said that several "senior Bolar officers" directed employees to falsify and cover up company records. Bolar is one of the largest U.S. generic drug makers.
Robert Shulman, former Bolar president, and Jack Rivers, former executive vice president, left Bolar in February after the firm came under criminal investigation by prosecutors here. A probe by the House Energy and Commerce subcommittee on oversight and investigations has been underway for two years.
Prosecutors accused Bolar executives of orchestrating a scheme to substitute Dyazide for Bolar's cheaper copycat version in tests for safety and effectiveness by the Food and Drug Administration in Rockville. When FDA inspectors became suspicious, prosecutors said, the executives ordered employees to lie, hide records and erase computer tapes. Bolar has said all employees involved in the alleged scheme have left the company.
Schetlick was accused of helping to create and alter a number of documents in the scheme.
Sales of Bolar's popular generic version of Dyazide totaled $142 million between August 1987 and last January, when it was withdrawn from the market. It is unknown if any of the 500,000 people who took the drug for high blood pressure were harmed.
Bolar's drug, called Triamterene/Hydrochlorothiazide, sold for about half the price of Dyazide, made by SmithKline Beecham.
Schetlick's guilty plea brings to 13 the number of drug firm employees, executives, consultants and FDA officials who have been convicted of charges ranging from fraud and racketeering to giving and accepting illegal gratuities. Three drug companies also have been convicted and fined.
Today, Kun Chae Bae, 56, multimillionaire former owner of My-K Laboratories in suburban Chicago, was sentenced to three months in a halfway house and fined $25,000 after pleading guilty to racketeering charges.
Bae was accused of paying $25,000 in 1986 and 1987 to a key FDA chemist to speed approval of new My-K drugs ahead of those of its competitors.