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Revise Generic Drug Labeling, Petition Urges

Cheryl Clark, for HealthLeaders Media, August 30, 2011

"The Court concluded that 'it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,' " the petition said.

Zieve said that other similar cases which have not reached the Supreme Court involved the drug metoclopramide, the generic equivalent to Reglan, which is used to fight acid reflux but which provoked instances of tardive dyskinesia, involuntary movements in patients treated for long periods of time with a medication.

"Over the past few years there were a bunch of cases where the generic drug company argued, 'you can't sue us because we don't have the ability to change the label, so you can't sue us for a failure to warn,' " she said.

Jennifer Fuson, spokeswoman for the American Association for Justice, said many similar situations have occurred, but one that has been repeatedly documented involves propoxyphene, a generic substitute for Darvocet, but which caused arrhythmias and other heart problems. Both were recalled by the FDA in 2010.

Asked for comment, a spokesman for the Generic Pharmaceutical Association referred to a statement released after PLIVA v. Mensing.

"GPhA believes the High Court has appropriately recognized that current law leaves generic manufacturers with no alternative but to make certain that its products have labeling that is identical to the labeling of the reference brand product," said GPhA executive director Bob Billings.

"As the Supreme Court recognized in this decision, assessing liability based on label content that is beyond the control of the generic manufacturer places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use, but prevented by law from changing."

See Also:
Medicaid Skips Generic Drugs, Overspends by Millions
3 Words Could Increase Drug Costs By $1.2B Annually
Drug prices will fall sharply as patents expire

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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