Stew Lilker’s

Columbia County Observer

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pillsWhat You Might Not Know About Generic Drugs

TALLAHASSEE, FL - Across the country, 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 the firms for failing to provide adequate warning of a drug's dangers.

Attorney Gary Leppla represented the family of a young woman who had an adverse reaction to a drug and died. He says it's critical to know what your health-insurance plan tells your pharmacist to do.

• Wiki What is a generic drug
• FDA What are generic drugs?

"You have the drug manufacturers (and) insurance companies really dictating medical practice. Doctors have the opportunity to be aware of the risks of various medications, and yet what is used to fill a prescription is not necessarily dictated by the doctor. It happens after it leaves the doctor's desk."

Proposed federal legislation would require 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. When we realize that 'big pharm' and insurance companies drive this train and the consumer has very little to say, it means that consumers need to gain information and to 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 are required by the FDA to update their labels.

The Supreme Court decision referred to is Pliva v. Mensing. The legislation is S2295 and HR4384.  

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