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Who Is Now Responsible for Discovering and Warning About Adverse Effects of Generic Drugs?

Aaron S. Kesselheim, MD, JD, MPH1; Michael D. Green, JD2; Jerry Avorn, MD1
[+] Author Affiliations
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
2Wake Forest University School of Law, Winston-Salem, North Carolina
JAMA. 2013;310(10):1023-1024. doi:10.1001/jama.2013.228349.
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When a patient in the United States fills a prescription, the likelihood that a generic drug will be dispensed is overwhelming—and increasing. Generic drugs account for more than 80% of prescriptions, but only 20% of total drug spending, because of their lower cost. The move to generics is estimated to have saved more than a trillion dollars in the last decade.1

Although generic drugs are bioequivalent to their brand-name counterparts, important legal distinctions between the 2 categories have resulted from 3 Supreme Court decisions. The first, Wyeth v Levine, arose after a woman developed gangrene in her forearm caused by intra-arterial injection of Wyeth’s antiemetic Phenergan (promethazine); the patient was awarded $6.7 million in damages based on her claim that the drug’s label did not sufficiently warn about its risks. In 2009, the Court upheld the award, noting that brand-name manufacturers are primarily responsible for providing accurate safety warnings for the drugs they produce.2 The decision makes sense because premarket testing does not reveal the full range of a drug’s adverse effects, postmarket surveillance by the US Food and Drug Administration (FDA) is insufficient, and state tort liability incentivizes manufacturers to continue monitoring the safety of their products.

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