clarinews@clarinet.com (REBECCA KOLBERG, UPI Science Writer) (02/09/90)
WASHINGTON (UPI) -- More than 18 months after signs of wrongdoing first surfaced in the generic drug industry, a trade group Thursday formed a panel to look into the scandal that has shaken confidence in such medicines. The Generic Pharmaceutical Industry Association said the experts are being asked to recommend ``whatever changes may be necessary to reassure the American people that generic drugs are properly tested and evaluated, and are safe and effective.'' The seven-member panel, which includes former Food and Drug Administration Commissioner Dr. Jere Goyan, will be given a free hand to conduct its investigation and should issue a report by the end of June, the association said. The industry group plans to pay the experts for their time and expenses. But one panel member, Dr. William Heller, executive director of the U.S. Pharmacopeial Convention Inc., said he is refusing pay. Since July 1988, the FDA and the generic drug industry have been confronting a scandal stemming from the bribery convictions of three FDA employees, and the revelations of widespread wrongdoing in the industry. In November, the FDA reported that its inspections of the nation's top 20 generic drug makers found signs of fraud or serious manufacturing flaws in at least seven companies. Some of the most serious wrongdoing uncovered so far involves instances in which companies tried to pass off brand-name drugs as their own to win FDA approval. Generic drugs are supposed to be chemically equivalent to brand-name drugs whose patents have expired. Generally cheaper than their brand-name counterparts, generic medicines accounted for nearly one-third of all prescriptions written in 1988 and had sales totaling $7 billion, the trade group said. At a news conference, panel members said they did not know if the generic drug scandal has prompted consumers to turn away from generics to brand-name drugs. Dee Fensterer, a spokeswoman for the industry group, said her organization has not seen a decline in sales among the generic drugs that remain on the market. But Fensterer conceded that some of the most widely used generic drugs -- including the No. 1 seller, Bolar Pharmaceutical's version of the high blood pressure drug Dyazide -- have been recalled amid allegations that companies lied to the FDA to win product approval. Lewis Engman, chairman of the panel and former chief of the Federal Trade Commission, said his inquiry will not compete with other investigations into the generic drug problem by federal procecutors, Congress, the FDA and the Health and Human Services Department. ``We are not a law enforcement agency, so we cannot get into law enforcement issues,'' said Engman, a lawyer who once headed the Pharmaceutical Manufacturers Association, which represents the brand-name drug industry. The panel will try to get ``a broader perspective'' on the extent of problems within both the generic industry and the FDA and will not try ``to pin the goods'' on specific companies or people, he said. One item to be considered is drawing up a code of conduct for generic drug makers, he said. The panel also includes: --Dr. Leslie Benet, chairman of the pharmacy department, University of California-San Francisco. --Dr. Ray Gifford Jr. of the Cleveland Clinic Foundation, who is a trustee of the American Medical Association. --Dr. Andrew Whelton of Johns Hopkins School of Medicine, who is president of the American Board of Clinical Pharmacology. --Lee White, a Washington lawyer and former chairman of the Federal Power Commission.