FDA in No Hurry to Release Rule on Generic Rx Safety Labels

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By Bronwyn Mixter

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, also called prescribing information or package inserts, 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 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 generic drug industry has voiced objections to the rule saying it would create safety issues because a brand drug and each of its generic versions could have different and potentially conflicting safety information in their labels. But the consumer group Public Citizen has said the rule is needed so that new safety information can get into generic drug labels more quickly.

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.

Generic Industry Wants Rule Withdrawn

“As we have communicated to the Administration, the proposed labeling rule is in direct contravention to the sameness requirement in Hatch Waxman,” Allen Goldberg, vice president of communications for the Association for Accessible Medicines, formerly the Generic Pharmaceutical Association, told Bloomberg BNA in a July 31 email. The Hatch-Waxman Act, which governs the approval of generic drugs, requires brand and generic drug labels to be the same.

“Movement from immediate to long-term priority status for this ill-advised proposed regulation is a positive development but there is still work to be done. AAM will continue to advocate for the rule to be withdrawn permanently,” Goldberg said.

FDA Focus on Immediate Priorities

Jennifer Corbett Dooren, a spokeswoman for the FDA, told Bloomberg BNA in a July 31 email, “As part of the FDA’s effort to implement the Executive Orders that address regulatory reform and costs, and fulfill our public health responsibilities, the agency has focused on regulations that reflect its most immediate priorities” in the July 20 unified agenda.

“However, it is important to note that just because a previously identified regulation has been removed from the Unified Agenda, it does not mean the agency does not consider it a priority or will not continue to consider it moving forward,” Dooren said. “As the FDA updates the Unified Agenda to reflect the most immediate priorities, the agency will carefully consider the impact to public health and industry.”

Dooren said that some of the items not included in the July 20 unified agenda will appear on the next unified agenda released in the Fall.

Consumer Group Not Hopeful

Allison Zieve, director of the Public Citizen Litigation Group, told Bloomberg BNA in an email, “We assume that the FDA is not going to issue the rule.”

“After the Obama Administration essentially dropped it because of industry pressure, despite the FDA saying it was important for patient safety, we didn’t have much hope that this new Administration would issue the final rule,” Zieve said.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The proposed version of the rule is at http://src.bna.com/rfe.The rule in the regulatory agenda is at http://src.bna.com/rfn.

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