Generic Brands

Consumer products giant Procter & Gamble Co., responding to private-label competitors of its brand-name products, announced Thursday that it will close 30 plants and eliminate 13,000 jobs worldwide over the next three years. Edwin L. Artzt, chairman and chief executive, said the global cutbacks are the first on this scale for the 156-year-old company, famous for a broad range of items from Tide laundry detergent to Pampers disposable diapers.

The U.S. Supreme Court said it would decide whether pharmacy companies violate antitrust laws -- and drive up costs to consumers -- by agreeing to let brand-name drug makers pay rivals to delay selling lower-priced generics. In the last decade, several federal courts have upheld such agreements on the grounds that they are settlements of disputes over patents. The Federal Trade Commission, however, has been challenging the so-called pay-for-delay agreements as illegally stifling competition and preserving monopolies.

In carrying out its mission to ensure that generic drugs are "the same medicine" with "the same results" as the pioneer drugs they follow, the Food and Drug Administration rigidly applies a standard of what is called "bioequivalence." Measured in laboratories and in simple, small-scale human trials, a generic must deliver the same active ingredient to the bloodstream of patients in virtually the same amount at virtually the same rate as the pioneer drug.

The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar. Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?

Storming into a cramped Mobil gas station at the corner of Alvarado and Glendale avenues, Junko Anderberg of Echo Park pulls her dented green Chrysler into the first available spot and rushes to the cashier's booth for a pack of cigarettes. She is not looking for just any cigarette but what is possibly the best bargain in Los Angeles today: Private Stock brand at $1.05 a pack. She rips off the top of the plain white box and takes a super puff.

In the contentious debate over insuring Americans' health, the value of generic prescription drugs is a rare point of consensus. Patients, physicians, employers, politicians -- all hail generics as powerful treatment for a swelling healthcare tab. On average, these copycat medicines cost less than a third of the brand-name drugs they mimic. In turn, the competition they provide drives down the cost of those first-to-market drugs.

Procter & Gamble Co.'s decision to slash prices on its best-selling disposable diapers is yet another indication of how a tough economy is roughing up premium brands. Under pressure from generic and private-label diapers, Procter & Gamble announced Tuesday that it will lower prices on its Pampers and Luvs, the third price cut in 10 months. The move is significant for Procter & Gamble because Pampers account for 16% of its worldwide sales.

A former generic drug company executive was fined $250,000 and ordered to serve 60 days of an 18-month jail sentence after pleading guilty to bribing Food and Drug Administration officials, the U.S. attorney in Baltimore announced Thursday. Dilip P. Shah, 43, a founder and former president of Quad Pharmaceuticals Inc., also was ordered to devote 12 months of full-time community service to the American Cancer Society.

Watson Pharmaceuticals on Wednesday renewed its legal effort to launch a generic version of Bristol-Myers Squibb's popular anti-anxiety drug, BuSpar. In a suit filed in U.S. District Court for the District of Columbia, Corona-based Watson said that Bristol-Myers used illegal tactics to prevent it from selling a cheaper version of BuSpar, which had sales of more than $700 million in 2000. Bristol-Myers denied the allegations.

Biovail Corp. reached a settlement with four generic-drug makers that delays sales of cheaper copies of one form of its antidepressant Wellbutrin XL until next year. The deal resolves complaints against Anchen Pharmaceuticals, Impax Laboratories Inc., Teva Pharmaceutical Industries Ltd. and Watson Pharmaceuticals Inc., Mississauga, Canada-based Biovail said Monday. Biovail reported $302.2 million in Wellbutrin XL sales for the first nine months of 2006, or 42% of the company's product revenue.

Bristol-Myers Squibb Co. and Sanofi-Aventis won an appeals court ruling Friday that will help them block generic competition to the blood thinner Plavix, the world's No. 2 selling-drug, in the U.S. until 2011. Bristol-Myers and Sanofi said that as a result of the ruling by a three-judge panel of the U.S. Court of Appeals for the Federal Circuit in Washington, they will seek reimbursement from Canadian drug maker Apotex Inc.

One of the nation's largest drugstore chains ratcheted up a price war Thursday, offering deep discounts on generic prescriptions amid national concern about the spiraling cost of healthcare. Drugstore giant CVS Caremark Corp. announced it would sell 90-day supplies of more than 400 medications for $9.99 and offer discounts for cash-paying patients at its in-store medical clinics. The price war was unleashed by Wal-Mart Stores Inc., the country's largest retailer, a few years ago.

The government closed U.S. borders Tuesday to more than 30 generic drugs -- including popular antibiotics and cholesterol medicines -- made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Food and Drug Administration's move doesn't end U.S. sales by Ranbaxy Laboratories Ltd. Instead, it blocks imports of generic drugs -- including generic versions of the antibiotic Cipro and the cholesterol pill Zocor -- as well as pharmaceutical ingredients made at the suspect plants.

Medicare overpaid for drugs that had generic versions because of a time lag in computing prices from when the cheaper medicines became available, the U.S. Health and Human Services Department's inspector general said. Payments for cancer drug irinotecan, sold by Pfizer Inc. as Camptosar, remained at more than double the average manufacturer's sales price after the generic version was cleared for sale Feb. 20, said the report, released Tuesday. Medicare, the health insurance program for the elderly and disabled, would have saved $6.5 million in March had it factored the generic price into its rate.

A lawsuit settlement between AstraZeneca and India's Ranbaxy Laboratories will ensure that a cheap, copycat version of the best-selling heartburn drug Nexium won't hit the market until 2014. Nexium is the second-biggest prescription medicine globally, with sales of $5.2 billion in 2007. But its future has been under a cloud with the recent expiration of a stay blocking regulatory approval of a generic version. Under the deal, Ranbaxy can start selling a generic version of Nexium in May 2014.

A cheaper, generic version of GlaxoSmithKline's Wellbutrin XL antidepressant is just as safe and effective as the original drug, despite complaints from some patients, the Food and Drug Administration said. The FDA said it received 85 reports from patients who switched from Wellbutrin XL to a cheaper generic by Teva Pharmaceutical Industries and Impax Laboratories Inc., including 78 who said they slipped back into depression. Agency scientists reviewed versions of the two drugs and found the data did not show the problems stemmed from any differences between them.

Two generic drug companies already immersed in bribery charges have more pervasive problems than originally thought, and the companies likely will be investigated by the Justice Department's criminal division, two key members of Congress say in documents to be made public today. An admitted bribery payment to Food and Drug Administration employees "appears to be only the tip of the iceberg in a story . . . rife with problems," according to statements by Reps. John D. Dingell (D-Mich.

The Food and Drug Administration, escalating its campaign against generic drugs that it believes have been marketed improperly, announced Monday that it will withdraw approval of the last remaining generic equivalent of Dyazide, a leading blood pressure drug. The FDA said it could no longer be certain that Bolar Pharmaceutical's generic drug, one of the nation's best-selling generics, is precisely equivalent to Dyazide.

In carrying out its mission to ensure that generic drugs are "the same medicine" with "the same results" as the pioneer drugs they follow, the Food and Drug Administration rigidly applies a standard of what is called "bioequivalence." Measured in laboratories and in simple, small-scale human trials, a generic must deliver the same active ingredient to the bloodstream of patients in virtually the same amount at virtually the same rate as the pioneer drug.

In the contentious debate over insuring Americans' health, the value of generic prescription drugs is a rare point of consensus. Patients, physicians, employers, politicians -- all hail generics as powerful treatment for a swelling healthcare tab. On average, these copycat medicines cost less than a third of the brand-name drugs they mimic. In turn, the competition they provide drives down the cost of those first-to-market drugs.