June 23rd, 2011
04:30 PM ET
The Supreme Court ruled Thursday that generic drug companies do not share the same level of responsibility as their brand name counterparts in terms of updating warning labels when significant new risks of taking the products are presented.
It's a decision that Judge Sonia Sotomayor says leads to unfathomable and "absurd consequences" for patients.
The plaintiff in the case, Gladys Mensing, started taking the generic version of an acid reflux medication in 2000, and by 2005 she had developed involuntary muscle movements in her hands and feet and her speech became slurred. She sued the generic drug's manufacturer, claiming the label provided insufficient information about the risks of tardive dyskinesia, the neurological condition she developed.
Studies had shown the drug posed a health risk, but the brand name had not updated the label, and as a result, neither had the generic manufacturers. In 2009 the FDA issued a mandatory black box warning on the brand name drug, noting that the “benefit is thought to outweigh the risk of developing tardive dyskinesia,” when the medication is used for longer than 12 weeks. The labeling on the generic version also changed then.
The Supreme Court ruled that if the generic manufacturers had independently changed their labels, they would have violated the federal requirements that their labels be the same as the corresponding brand-name. Generic manufacturers say reinventing “the costly research and testing FDA required to approve the brand drug” would harm their goal of “making prescription drugs available to as many people as possible at the lowest possible cost.”
According to the American Association for Justice 70% of all prescriptions are filled with generic versions, accounting for about 2.6 billion prescriptions every year. It is calling the Supreme Court's decision a “disastrous outcome for patient safety.”
Judge Sotomayor also expressed concern. In her dissent she states, "If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue."
So what should you do if you’re worried about the safety of your drugs? Experts say there are a few things you can do each time you receive a new prescription.
The National Institute of Health has website called DailyMed where consumers can look up their drug by class and brand name, and find up-to-date information about labeling, package inserts and more.
Dr. Douglas Bremner, a professor of psychiatry and behavioral sciences at Emory University, encourages patients to chat with other patients about their experiences. He recommends checking out Medications.com and Askapatient.com, and read about the experiences others have had with the medication you have been prescribed.
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