Generic Drugs

Drug maker Barr Laboratories Inc. said profit more than doubled in its fiscal fourth quarter, boosted by strong sales of oral contraceptives and generic versions of medicines that recently lost patent protection. Net income climbed to $44.9 million, or 98 cents a share, well above the 85 cents analysts expected, from $19.7 million, or 44 cents, a year earlier. Revenue jumped 27% to $209.4 million.

A New York pharmaceutical giant temporarily shut down its generic drug subsidiary, the company said Wednesday, and a congressional source said the move stemmed from falsified data used to win drug approval. Carol Emerling, a spokesman for American Home Products Corp., confirmed that the company's Quantum Pharmics Ltd. plant in Amityville, N.Y., voluntarily halted production and distribution of generic drugs.

When two competing generic drugs come on the market, the average generic price can drop to half the cost of the comparable brand-name product, according to a U.S. government study released Tuesday. The study by the Food and Drug Administration found that savings weren't as significant when only one generic drug was on the market: the price of the generic drug is typically 6% less than the brand-name competition.

Drug distributor McKesson Corp. said its fiscal second-quarter profit rose 37% as generic drugs helped cut costs and the company sold more computer systems. A gain on income-tax expense boosted earnings. Net income for the quarter ended Sept. 30 rose to $229 million, or 75 cents a share, from $167 million, or 53 cents, a year earlier, San Francisco-based McKesson said. Revenue rose 5% to $22.4 billion. Profit beat analyst estimates.

Patents on a rainbow of branded drugs will expire in the next five years, promising a pot of profits for makers and marketers of generic drugs. The merger announced Monday between the generic-drug giant Ivax Corp. of Miami and the behemoth distributor Bergen Brunswig Corp. exemplifies steps being taken by companies throughout the industry to get ready to reap the rewards.

A pharmaceuticals executive was fined $150,000 and placed on 18 months of probation for bribing a Food and Drug Administration chemist in a generic drug scam. Ashok Patel, 49, of Upper Saddle River, N. J., was also sentenced Tuesday to a year of community service. The former senior vice president of Par Pharmaceuticals of Spring Valley, N.Y., pleaded guilty in July to paying a $500 gratuity to FDA chemist David Brancato to influence approval of Par generic drugs.

More than 18 months after signs of wrongdoing first surfaced in the generic drug industry, a trade group today formed a panel to look into the scandal that has shaken confidence in such medicines. The Generic Pharmaceutical Industry Assn. 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."

Federal officials are investigating Bolar Pharmaceutical Co. for possible fraud in connection with the approval of a generic version of the brand-name anti-depressant drug Mellaril. Knowledgeable officials said Thursday that both the Food and Drug Administration and the House Energy and Commerce oversight subcommittee are looking into charges that Bolar fraudulently submitted the brand-name drug instead of the generic version to a testing laboratory--the second such incident reported.

The Food and Drug Administration will take punitive action against two generic drug companies implicated in a bribery scandal and plans to inspect the plants of another 20 leading manufacturers, the agency announced Wednesday. The agency will seek to permanently remove from the market more than two dozen drugs made by Par Pharmaceuticals of Spring Valley, N.Y., and Vitarine Pharmaceuticals Inc., of Springfield, N.Y., the agency said.

The next time you need a prescription filled, there's a 40% chance of getting a generic drug instead of a brand-name medicine. And by the year 2000, the chances will increase to 50-50, according to forecasts from the Washington, D.C.-based Generic Pharmaceutical Industry Assn. What's fueling the boom? Cost savings of 50% or more, patent expirations on brand-name drugs and health insurers' emphasis on cost containment. But are generic medicines as good as the original brand-name version?