FDA Proposes Change In Generic Drug Makers' Labels

The change would allow generic manufacturers to put new safety information on the labels without having to get FDA permission.

The New York Times: Label Updates May Be Allowed For Generics
The Food and Drug Administration proposed a rule on Friday that would permit generic drug makers to update their labels if they received information about potential safety problems. The move puts the companies on equal footing with brand-name manufacturers, but it also opens the door to lawsuits against them for the first time since the Supreme Court barred such cases two years ago. Until now, only brand-name drug makers had the ability to independently update their labels if important new information surfaced about one of their drugs (Thomas, 11/8).

The Wall Street Journal: FDA Proposes Letting Generic-Drug Makers Change Labels
The step Friday by the FDA means that generic companies—which sell about 84% of the prescription drugs by volume in the U.S.—would have the same ability to change their labels as brand companies. The FDA would review any proposed changes, as it already does with changes to branded-drug labels. "Our effort is to keep all the labels the same, and to level the playing field," said Janet Woodcock, director of the FDA's center for drug evaluation and research. The proposal, she said, "would change current procedures, where only the brand companies can unilaterally put certain safety information in the label" (Burton and Kendall, 11/8).

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