FDA’s Generic Drug Labeling Rule Delayed Again


The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety any time soon.

Under the rule, generic drug manufacturers would be able to independently update product labeling with newly acquired safety information before the Food and Drug Administration’s review of the change, in the same way brand drug manufacturers do. Generic manufacturers also would be required to inform the brand name manufacturer about the change under the rule, which was proposed (RIN:0910-AG94) in 2013.

Currently, FDA regulations do not permit generic drug manufacturers to update product labeling unless they are mimicking a change already made by a brand-name drug manufacturer or the FDA orders them to do so. If the rule were to go into effect, it could open the generic drug industry up to more lawsuits. Currently, generic companies can’t be sued for defects in warning labels because they can’t independently change their own labels.

The rule didn’t make it onto the Office of Management and Budget’s unified regulatory agenda released July 20. The unified agenda generally lists regulatory activities that are planned to take place within the next 12 months. The rule has been delayed several times, and the FDA had previously said it planned to issue the rule in April.

The generic drug industry wants to rule to be permanently withdrawn.

Allen Goldberg, vice president of communications for the Association for Accessible Medicines, told me the proposed version of the rule goes against the sameness requirement in the Hatch-Waxman Act and his group will continue to push for the rule to be withdrawn. The Hatch-Waxman Act, which governs the approval of generic drugs, requires brand and generic drug labels to be the same.

But the FDA is still planning to issue the final rule at some point. Jennifer Corbett Dooren, a spokeswoman for the FDA, told me that just because the rule was removed from the unified agenda, doesn’t mean the agency won’t consider it moving forward. She said the unified agenda just reflects the agency’s most immediate priorities.

Read my full article here.

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