U.S. FDA to propose allowing generic drugmakers to update drug labels

July 3 Wed Jul 3, 2013 7:27pm EDT

July 3 (Reuters) - The U.S. Food and Drug Administration plans to issue a proposed rule that would allow generic drug companies to update prescribing information for their products to reflect new safety information.

Currently, generic manufacturers, in contrast to branded drugmakers, are not allowed to update their drug labels even if they learn of a potential safety issue that is not included in the existing label.

The FDA's plan, described on the website of the Office of Management and Budget on Wednesday, would require all manufacturers of the same drug to carry consistent labeling revisions after the FDA had approved a revision by one company.

"Many potential hazards are not discovered until years after drugs have been on the market," said Dr. Sidney Wolfe, founder of Public Citizen's Health Research Group.

Wolfe's group about two years ago filed a citizen petition with the FDA asking that it to revise its labeling rules to establish labeling parity between generic and brand-name drug companies.

"The proposed rule is a classic example of harm reduction," he said. "When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

The proposed rule comes shortly after the U.S. Supreme Court ruled that generic drugmakers cannot be sued under state law for adverse reactions to their products. The court ruled that a state's law cannot run against federal laws on prescription medications whose design has been approved by the FDA.

A Supreme Court ruling in 2011 found that pharmaceutical companies that make branded drugs are liable for inadequacies in safety warnings on a drug's label, but not the makers of generic copies. Federal law requires generic drugs to have the same design and warning labels as their branded equivalents.

A couple walks along the rough surf during sunset at Oahu's North Shore, December 26, 2013. REUTERS/Kevin Lamarque

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