High court splits Rezulin case 4-4 with Chief Justice opting out
WASHINGTON Supreme Court Chief Justice John Roberts decided to sit out the case of Warner-Lambert, a company now owned by Pfizer and Kent, according to the Associated Press. Roberts sat out due to financial holdings in the company and as a result of his uninvolvement, the case resulted in a tie 4-4 vote.
The result is the ruling falls back to the lower court level, which sided against the pharmaceutical company. In the original lawsuit, a number of Michigan residents alleged Rezulin, a drug to combat diabetes, harmed them. Federal regulators approved it despite risks to the liver and cardiovascular system.
In their suit, users of the drug are relying on a Michigan law to allege that the pharmaceutical company engaged in fraud by misleading federal regulators to get the drug approved. The Michigan law shields pharmaceutical companies from product liability lawsuits, unless they committed fraud.
At issue in the case is whether that fraud exception, which allows lawsuits to proceed, is preempted by federal regulation of the pharmaceutical industry. The 2nd U.S. Circuit Court of Appeals in New York ruled that the exception to the Michigan law was not preempted by federal regulations, enabling the Michigan plaintiffs to pursue the case.
Rx program more expensive than chain store prescriptions
DENVER Rx Outreach, a Colorado program aimed at helping low-income people afford drugs for chronic diseases, was found to be more expensive for purchasing drugs than regular chain-store pharmacies.
A 90-day supply from a choice of 110 generics costs about $20 each, and three-dozen other drugs sell for $30 and $40. In contrast, Kmart’s program for a choice of 300 generic medications for a 90-day supply retails for $15, while Costco sells their prescriptions for about $10.66 and Walgreens sells them for about $12.99.
The program, Colorado Cares Rx, was unveiled this month by the Department of Health Care Policy and financing in partnership with Rx Outreach. The program was started by the state to develop a low-cost drug program, but the sponsors are finding it harder to compete with chain store rivals, based on pricing.
Officials claim growing pains, however. Rep. Alice Madden, D-Boulder, said “This is just a first step. We have to do more.”
FDA approves Abilify for teens
TOKYO and PRINCETON, N.J. The Food and Drug Administration has approved the Otsuka Pharmaceuticals and Bristol-Myers Squibb drug application for Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients aged 10 to 17.
The approval is based on the results of a four-week study that compared Abilify to a placebo in treating pediatric patients with bipolar disorder I. Otsuka Pharmaceuticals sponsored the study.
“We are pleased that the FDA has approved Abilify to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder,” said Taro Iwamoto, Ph.D., chief executive officer, president and chief operating officer, Otsuka Pharmaceutical development and c commercialization. “The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”