PHARMACY

Supreme Court to decide on Warner-Lambert case

BY Drew Buono

WASHINGTON The Supreme Court said this week that it will decide on a case that involves whether federal regulation of pharmaceuticals preempts state law.

The case involves the drug Rezulin, a diabetes drug. A group of Michigan plaintiffs in April 2000 sued Warner-Lambert, a unit of Pfizer. The Food and Drug Administration removed the drug from the market in March 2000, after it was linked to nearly 400 deaths and hundreds of cases of liver failure.

A federal district court dismissed the suit after it was cited that Michigan law shields FDA approved pharmaceuticals from liability lawsuits. The 2nd U.S. Circuit Court of Appeals, based in New York, reinstated the suit disagreeing that the Michigan law involved an exception of fraud against the FDA.

The case will likely be decided before the court adjourns in June.

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A new clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a place

BY Drew Buono

BASEL, Switzerland New clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a placebo, according to Novartis.

Galvus was approved last year by the Food and Drug Administration. The drug is a member of a new class of diabetes medicines called DPP-4 inhibitors, which also includes the drug Januvia, made by Merck.

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FDA bill currently in consideration to regulate prescription drug advertising

BY Drew Buono

WASHINGTON A new user fee program for Direct-To-Consumer broadcast ads will soon be put into law as part of a Food and Drug Administration bill working its way through Congress.

As a result, sponsors will soon have to tell the FDA how many of these ads it expects to submit for pre-view during the fiscal year 2008. Otherwise, you can be charged 50 percent for late penalty fees or lose your payment if you underestimate the number of ads you’ll run.

The FDA will be given power to determine what is acceptable and what is not, so it will be the job of the sponsors to conform to the FDA’s requirements to avoid those extra fees. The ads could be priced anywhere from $62,500 to $83,000, depending on how much money the FDA will need to keep the program going.

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