80 Percent of Prescriptions Exempt from Labeling Law
PHOTO: Gary Leppla, Attorney at Law
September 17, 2012
AUSTIN, Texas - Dozens of lawsuits against manufacturers of generic drugs have been dismissed because of a decision by the U.S. Supreme Court last year that makes it all but impossible to sue the medication makers for failing to provide adequate warnings about a drug's dangers. Nearly 80 percent of all prescriptions in the U.S. are filled with generic drugs.
Attorney Gary Leppla represented the family of a young woman who died from an adverse reaction to a prescription drug. He says it's critical that all consumers be given full information about their medications.
"It's got a tremendous impact. And the 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 originally-manufactured, drug?"
Under current law, generic manufacturers are not required to update warning labels, even when they are aware of new safety issues associated with the drug's brand-name equivalent. Name-brand manufacturers are however required by the FDA to update their labels to reflect new safety concerns.
National legislation proposed this spring in both the House and Senate would require makers of generics to update warning labels when new safety issues arise. But with no Republican sponsors or co-sponsors, the chances of passage this election year are only one or two percent, according to GovTrack.US, a nonpartisan legislative research group.
Leppla, meanwhile, suggests consumers do their own research, starting with asking pharmacists whether their prescriptions are generic or not.
"Consumers should be aware of this proposed legislation, which hopefully would level the playing field. When 'big pharm' and insurance companies drive this train and the consumer has very little to say, consumers need to gain information."
He says, while doctors may be aware of certain medication risks, it's the drug manufacturers and insurance companies that often dictate exactly how prescriptions are filled.
The Supreme Court decision referred to is Pliva v. Mensing. Relevant legislation is Senate Bill S.2295 and the House version is H.R.4384.