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FDA rule would allow generic drugmakers to update labels

Agency plans to issue new rule by September

The Food and Drug Administration (FDA) plans to issue a new rule that will allow generic drugmakers to make changes to their drugs’ labeling.

Federal law dictates that generic drug labels must be identical to their brand-name counterparts’ labels. Currently, generic manufacturers aren’t allowed to update their drug labels even if they learn of a potential safety issue that isn’t included on the existing label.

The FDA’s new rule, which the agency plans to issue by September, would make generic and brand-name drug companies equally responsible for drug safety. An FDA spokeswoman told the Wall Street Journal that it was too early to know precisely how the agency would word the new rule. 

The rule could vastly alter the drug litigation landscape. Generic manufacturers are currently shielded from liability when their drugs cause harm to patients. In the 2011 case Pliva v. Mensing, the Supreme Court ruled that federal labeling laws preempted plaintiffs’ liability suits against generic drugmakers.

Sen. Patrick Leahy, D-Vt., praised the proposed rule. “A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” he told the Journal. “I welcome this first step by the Food and Drug Administration to address this troubling inconsistency in the law.”

For more information, read the New York Times and Reuters.

For more InsideCounsel stories about pharmaceuticals, read:

Walgreens reaches $80 million settlement over painkillers

Government will allow morning after pill to be sold to all ages

FDA allows continued sale of generic Opana painkiller

FDA issues warning about shortened cancer drug name

Generic-drug makers sue brand-name companies for product samples

Panelists discuss whether pay-for-delay settlements violate antitrust laws

Drug maker's legal battle with the FDA delays generic competition


Ashley Post

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