Generic Drugs

A hospital has suspended use of more than 150 generic drugs because of questions over the industry's attention to quality. Officials of the Hospital of St. Raphael said Monday that they would replace up to 80% of the generics the hospital uses with more expensive brand-name drugs as a precaution. The Food and Drug Administration is reviewing the 30 top-selling generic drugs because some makers are accused of faking test results or bribing FDA inspectors to win approval to market generics.

Re "What's in a drug's name?" Editorial, Aug. 9 It is hard to imagine why even a bureaucracy as relentlessly dense as the Food and Drug Administration would think it is encouraging competition by granting a monopoly on new generic drugs after the patent on the original medication has expired. It is a simple deal -- the generic manufacturer gets protection from competition from the FDA and then graciously accepts a fee from the original manufacturer not to produce the generic drug. The cure for this stupidity is not legions of federal investigators.

The Food and Drug Administration's inspections of a dozen generic drug makers found a range of manufacturing and record keeping irregularities at all but two of the companies, an FDA official told Congress today.

Walgreen Co.'s fiscal second-quarter earnings rose 25%, more than analysts estimated, on increased sales of more-profitable generic drugs. Net income climbed to $651.9 million, or 65 cents a share, from $523.5 million, or 51 cents, a year earlier, the company said. Analysts surveyed by Bloomberg had forecast profit of 61 cents at the largest U.S. drugstore chain. Sales at Deerfield, Ill.-based Walgreen rose 15% to $13.9 billion.

The Senate, desperate to do something about the increasingly burdensome cost of prescription drugs, overwhelmingly approved legislation Wednesday intended to get cheaper generic drugs to market more quickly. Moments after rejecting a final proposal to provide Medicare recipients with a prescription drug benefit, senators voted, 78 to 21, for a bill designed to hold down the costs of prescription drugs for everyone.

The Food and Drug Administration announced Wednesday that it is conducting comprehensive tests of the 30 most-prescribed generic drugs and their patented counterparts following allegations that pharmaceutical companies provided false test data.

One of the nation's largest groups of practicing physicians on Monday challenged the reliability of some generic drugs and condemned the spread of laws and policies that mandate their use as a means of holding down health-care costs.

The Senate, weighing legislation designed to cope with the rising costs of prescription medicine, signaled support Wednesday for the idea of forcing drug manufacturers to reduce their U.S. prices to what they charge overseas. In a pair of votes on amendments, the Senate decided 99 to 0 to require the secretary of Health and Human Services to certify that importation of generic drugs would pose no significant safety risk and would result in significant savings.

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.