Across the nation, dozens of lawsuits against manufacturers of generic drugs have been dismissed because of a decision by the Supreme Court a year ago that makes it all but impossible to sue them for failing to provide adequate warning of a drug's dangers.
Attorney Gary Leppla, who represented the family of a young woman who had an adverse reaction to a drug and died, says it's critical to know what your health insurance plan tells your pharmacist to do.
Proposed legislation in Congress would force generic drug-makers to update their warning labels when a new safety issue arises.
Leppla says you should ask your pharmacist if you're getting a generic.
"I think that consumers should be aware of this proposed legislation, which hopefully would level the playing field. We need to realize that 'big pharm' and insurance companies drive this train and the consumer has very little to say, that consumers need to gain information and network."
He says nearly 80 percent of all prescriptions in the U.S. are filled with generic drugs.
"So, it's got a tremendous impact, and the threshold question is, why should I be treated different as a consumer because I was required to have my prescription filled with a generic, as opposed to the original manufactured drug?"
Insurance companies say generic drugs save money and have the same active ingredients as the brand names. As the law stands now, generic manufacturers are not required to update their warning labels, even when they are aware of new safety issues associated with a drug's brand-name equivalent. Name-brand manufacturers however are required by the FDA to update their labels.
The Supreme Court decision referred to is Pliva v. Mensing. The legislation is S 2295 and HR 4384.
Tom Joseph
Its good if the generic drugs are to be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products. And the danger of its effect will slow down.
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