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Wednesday, November 13, 2013

FDA Proposes Letting Generic-Drug Makers Change Labels

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The Food and Drug Administration proposed allowing generic drug companies to change drug labels after getting reports of bad reactions in patients, a step that could open the generic industry up to greater potential legal liability.
In 2011 and again this year, the Supreme Court issued rulings that shielded generic drug makers from consumer personal-injury lawsuits, even though the justices have allowed similar product-liability claims against makers of branded drugs.
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."
The Generic Pharmaceutical Association reacted cautiously, saying it is concerned that multiple labels on the same drug "could drive up costs…and should be approached very carefully."
Some of the leading makers of generic drugs include Hospira Inc., HSP +0.55%Hospira Inc.U.S.: NYSE$38.74 +0.21+0.55% Nov. 12, 2013 4:00 pm Volume (Delayed 15m) : 2.36MAFTER HOURS$38.58 -0.16-0.43% Nov. 12, 2013...
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