Removal of Ranbaxy Generic RxsIs Not Likely to Have The FDA’s decision last month to block imports of ments for the Ranbaxy products were found in less than more than 30 generic drug products from Indian manu- facturer Ranbaxy Laboratories Ltd. is not likely to cause Other large players also see little fallout from the Rx shortages or drive up generic drug prices, with the FDA’s move. Medco Health Solutions, Inc., which is one possible exception of a powerful acne drug, say health of the largest U.S. purchasers of generic drugs through plans and PBMs. Even though Ranbaxy is one of the larg- its massive mail-order operation, said that the Ranbaxy est foreign suppliers of generic drugs, other manufactur- import alert will not affect the PBM’s ability to meet the ers are stepping in to fill the void, they tell DBN.
Concerns over drug shortages and price hikes fol- “In fact, Medco only dispenses three of the prod- lowed the FDA’s Sept. 16 decision to slap an “import ucts on the alert list,” Keith Bradbury, Medco’s execu- alert” on dozens of Ranbaxy generic drugs after the man- tive director of drug information, tells DBN. These ufacturer failed to address repeated warnings regarding account for just 660 prescriptions of the more than “good manufacturing practices” at two facilities.
2 million that Medco dispenses each week, he adds. The import ban affects many widely taken generics, “There are alternate suppliers that can provide Medco including versions of cholesterol drugs Zocor (simvas- with its product needs during this interim period,” tatin) and Pravachol (pravastatin), the antibiotic Cipro (ciprofloxican), the epilepsy drug Neurontin (gabapentin) There is, however, one Ranbaxy product that and the acne treatment Accutane (isotretinoin). The ban could be see upward pricing pressure due to the im- does not include the antiviral ganciclovir, as Ranbaxy is port alert: the severe acne drug Accutane. Ranbaxy the sole U.S. supplier of the HIV drug, the FDA noted.
had 50% of the U.S. generic market for the product, The FDA said it has no evidence so far that Ranb- says Paul Bogorad, Ph.D., senior manager at phar-
axy has shipped any defective products. Nevertheless, a maceutical and biotech consulting firm Putnam PBM subsidiary of one large health plan decided to take action against the Ranbaxy products this summer after The drug requires a patient registry because of its it became clear the FDA had concerns about the firm’s safety risk profile, and it is one of the more expensive manufacturing processes. Prescription Solutions quaran- generic drugs to produce. “There are not a lot of play- tined the identified products in its mail-order pharmacy ers out there,” Bogorad tells DBN. “That’s a product
facility in July, says John Jones, senior vice president of which I’m sure companies are scrambling to replace.” government affairs and pharmacy policy at the PBM unit Kevin Gorman, managing partner at Putnam,
says that in the short term, drug payers will likely see generic Accutane’s price going up. But he also notes Generic Accutane Prices May Rise
that one of the hallmarks of the generic drug industry “When we look at something like that, the first thing is its ability to adapt rapidly to marketing opportuni- you have to ask is, is there something we can do about it ties. “Nature abhors a vacuum, so the other people if it’s a concern?” Jones tells DBN. In this case, Prescrip- who have supply will quickly bring additional capac- tion Solutions realized that many of the drugs on the ity on line,” he says. “I’d be surprised if this contin- FDA’s list could be replaced by other manufacturers, ues to be a disruption for more than a month to two Jones explains. “While it might have cost us a little bit more in drug costs, we felt we could basically quaran- But will the negative publicity surrounding Ranb- tine those products and replace them with competitors’ axy troubles play into the hands of skeptics who claim products and literally dispense practically none of them, generic drugs are not of the same quality as brands? except the one that they have a monopoly on.” Replace- Copyright 2008 by Atlantic Information Services, Inc. Reprinted with permission from Atlantic Information Services, Inc., 1100 17th Street, NW, Suite 300, Washington, D.C. 20036, 202-775-9008, www.AISHealth.com Jones points out that the FDA action relates only “The FDA, having been caught short, is effectively to the manufacturing process, and that it did not find shooting a target shot across the bow of Ranbaxy and any defects in the products themselves. “Because the the generic pharmaceutical industry in general, and plants are on foreign soil, the FDA has no direct regu- saying, ‘Hey, we’re going to take pre-emptive mea- latory control over them,” he says. “Its only leverage is sures when we think it’s appropriate rather than wait- ing for another Heparin disaster,’” Gorman says.
Gorman says the FDA’s move sends a strong mes-
Contact Jones through Theresa Shin at theresa.
sage, particularly as it follows the agency’s February [email protected], Bradbury through Ann Smith at 2008 recall of the blood thinner Heparin, which had [email protected], and Gorman and Bogorad at
been linked to several deaths due to allegedly tainted products originating in a Chinese plant.
For more information on Drug Benefit News, please visit www.AISHealth.com. Copyright 2008 by Atlantic Information Services, Inc. Reprinted with permission from Atlantic Information Services, Inc., 1100 17th Street, NW, Suite 300, Washington, D.C. 20036, 202-775-9008, www.AISHealth.com

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