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FDA Considering Review Of Generic Drug Label Policy


The FDA may revise its policy that prevents generic drug makers from quickly editing the information in safety labels. The move could come after calls from the watchdog group Public Citizen, which claims the policy creates a dangerous knowledge gap between drug makers and potential users.

In an official statement, Public Citizen's Sidney Wolfe says the revision could prove critical:

"When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety. The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

The FDA released a statement earlier this month noting that they would consider the revision. According to FDA estimates eight of every ten prescriptions in the US is a generic. The new rule would allow the label edits to be public while under FDA review.

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