FDA pulls generics labeling proposed rule
The Food and Drug Administration today announced it is withdrawing a 2013 proposed rule — the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.
If finalized, the rule would have allowed generic drug makers to independently, without prior FDA review and approval, update and promptly distribute new safety information in drug labels. Currently, only branded drug makers can do this.
“We’ve carefully considered all of the feedback we received from the various stakeholders — both in favor of and against the proposed rule. We’ve evaluated whether there are more effective and efficient ways of keeping generic drug labels up-to-date with the latest safety information, and helping to ensure that generic companies continue to engage in an appropriate level of post-market safety surveillance,” FDA commissioner Scott Gottlieb said.
Gottlieb also said that for a multisource drug — typically an older drug that is available as both a generic and brand medicine — generally several manufacturers will make a generic version. "The question posed by the proposed rule was whether each drug maker should be able to independently update its label. In our review of the issue, we uncovered several hurdles that, if the rule was implemented, could compromise public health."
Among the challenges the FDA identified is the ability of generic manufacturers to collect safety information to inform label changes. "We heard that generic drug companies don’t generally receive or possess all the data necessary to evaluate post marketing safety information to support these changes on their own," Gottlieb said.
Pointing out that another significant issue raised by the proposed rule is the potential for marked differences for some period of time between generic labels and the brand products, as well as amongst each of the generic labels, Gottlieb said, "This could potentially lead to patient and provider confusion. It runs contrary to the goals of the generic approval process, which requires generic medicines to have the same label as the reference listed drug."
Gottlieb said the agency also was concerned of the potential for additional or different warnings to temporarily appear in generic drug labeling compared with the brand drug, depending on the availability of information to various manufacturers and the timing of updates.
"Such differences, even if temporary, could undermine confidence in generic drugs and their therapeutic equivalence. We understand that the proposed rule may have also led to confusing, conflicting generic labels that were crowded with redundant safety information," Gottlieb said. "Individual generic manufacturers might have added additional and, at times superfluous, information to their individual labels to avoid the risk of liability for failure to warn."
The agency also based its decision on feedback that the proposed rule, if finalized, would have imposed significant burdens on the generic drug industry, and that it could have led to an increase in the cost of generic drugs or the market exit of certain products and manufacturers, exacerbating the risk of drug shortages and resulting in a less competitive marketplace.
Gottlieb emphasized the withdrawal of the 2013 proposed rule does not change the ongoing obligations under the FDA’s current regulations for all brand and generic drug manufacturers.
“These regulations already require drug manufacturers to take steps to update their product labels when new information becomes available that cause the label to become inaccurate, false or misleading. This responsibility isn’t only for brand drug manufacturers. It also applies to generic manufacturers. If a generic drug maker becomes aware of new safety information that’s not already on the drug label, they must also report it to the agency. This action, in turn, can result in safety changes that are directed by the FDA and would apply to all versions of the drug,” Gottlieb said.
Finally, the FDA has undertaken a new program to update the labels on certain generic cancer drugs with modern safety and efficacy information, and plans to take a more proactive role in identifying and facilitating updates to these older generic drugs.
If finalized, the rule would have allowed generic drug makers to independently, without prior FDA review and approval, update and promptly distribute new safety information in drug labels. Currently, only branded drug makers can do this.
“We’ve carefully considered all of the feedback we received from the various stakeholders — both in favor of and against the proposed rule. We’ve evaluated whether there are more effective and efficient ways of keeping generic drug labels up-to-date with the latest safety information, and helping to ensure that generic companies continue to engage in an appropriate level of post-market safety surveillance,” FDA commissioner Scott Gottlieb said.
Gottlieb also said that for a multisource drug — typically an older drug that is available as both a generic and brand medicine — generally several manufacturers will make a generic version. "The question posed by the proposed rule was whether each drug maker should be able to independently update its label. In our review of the issue, we uncovered several hurdles that, if the rule was implemented, could compromise public health."
Among the challenges the FDA identified is the ability of generic manufacturers to collect safety information to inform label changes. "We heard that generic drug companies don’t generally receive or possess all the data necessary to evaluate post marketing safety information to support these changes on their own," Gottlieb said.
Pointing out that another significant issue raised by the proposed rule is the potential for marked differences for some period of time between generic labels and the brand products, as well as amongst each of the generic labels, Gottlieb said, "This could potentially lead to patient and provider confusion. It runs contrary to the goals of the generic approval process, which requires generic medicines to have the same label as the reference listed drug."
Gottlieb said the agency also was concerned of the potential for additional or different warnings to temporarily appear in generic drug labeling compared with the brand drug, depending on the availability of information to various manufacturers and the timing of updates.
"Such differences, even if temporary, could undermine confidence in generic drugs and their therapeutic equivalence. We understand that the proposed rule may have also led to confusing, conflicting generic labels that were crowded with redundant safety information," Gottlieb said. "Individual generic manufacturers might have added additional and, at times superfluous, information to their individual labels to avoid the risk of liability for failure to warn."
The agency also based its decision on feedback that the proposed rule, if finalized, would have imposed significant burdens on the generic drug industry, and that it could have led to an increase in the cost of generic drugs or the market exit of certain products and manufacturers, exacerbating the risk of drug shortages and resulting in a less competitive marketplace.
Gottlieb emphasized the withdrawal of the 2013 proposed rule does not change the ongoing obligations under the FDA’s current regulations for all brand and generic drug manufacturers.
“These regulations already require drug manufacturers to take steps to update their product labels when new information becomes available that cause the label to become inaccurate, false or misleading. This responsibility isn’t only for brand drug manufacturers. It also applies to generic manufacturers. If a generic drug maker becomes aware of new safety information that’s not already on the drug label, they must also report it to the agency. This action, in turn, can result in safety changes that are directed by the FDA and would apply to all versions of the drug,” Gottlieb said.
Finally, the FDA has undertaken a new program to update the labels on certain generic cancer drugs with modern safety and efficacy information, and plans to take a more proactive role in identifying and facilitating updates to these older generic drugs.