FDA withdraws proposed rule on generic drug labeling

FDA on Thursday announced that it will not move forward with a proposed rule on generic drug label warnings.

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Background

Currently, generic drugmakers may not update their warnings unless ordered to do so by FDA. In contrast, brand-name drugmakers update their labels as health risks are discovered, with FDA approving changes later. Those changes ultimately lead to changes on generic labels.

The Supreme Court in 2011 ruled that generic drugmakers could not be sued for failing to make patients aware of their products risks, because the companies did not control what their labels said. As a result, FDA in 2013 issued a proposed rule to make the same update procedure that applies to brand-name drugs also apply to generic drugs.

Generic drugmakers opposed the proposed changes, arguing that they would increase burdens on the industry and, as a result, drive up generic drug prices. In 2014, FDA Commissioner Scott Gottlieb, who at the time was a resident fellow at the American Enterprise Institute, and colleagues told then-FDA Commissioner Margaret Hamburg that the proposed rule would make generic drugmakers vulnerable to litigation, which also could drive up prices.

FDA in 2016 announced that it would delay the proposed rule until 2017. In July 2017, FDA listed the proposed rule as a long-term priority.

FDA scraps proposed rule

FDA on Thursday said it has withdrawn the proposed rule, after considering comments and discussions concerning the proposed rule's possible effects, including the potential for price increases and differences between labels on brand-name drugs and their generic counterparts. "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 and Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, said.

However, Gottlieb and Woodcock acknowledged that some generic drug labels need updates. As such, the officials announced that FDA will launch a new program for updating the labels on certain generic cancer drugs. The officials also said FDA is working with Congress on the agency's potential need for new authority or resources to address outdated generic drug labels.

Reaction

The generic drug industry praised FDA for scrapping the proposed rule.

David Gaugh, SVP of science and regulatory affairs at the Association for Accessible Medicines, in a statement said the group "applauds … Gottlieb and the agency for prioritizing consumer access to safe, high-quality, affordable generic medicines by withdrawing its proposed labeling rule." He continued, "The agency correctly recognized the need for consistency and the potential for adverse consequences. The FDA's action further exemplifies its focus on the best interest of the public's health and provides patients with the utmost confidence in their health care choices."

Pharmaceutical Research and Manufacturers of America also expressed support for the move. "We continue to believe the best public health solution for patients and prescribers is for the FDA to require the agency's expeditious prior-approval of all safety-related changes to labeling to protect patient health—regardless of whether the changes are submitted by a brand or generic manufacturer," the group said.

But the consumer advocacy group Public Citizen criticized FDA for withdrawing the proposed rule. Michael Carome, director of Public Citizen's Health Research Group, said the reasons FDA cited for scrapping the proposal are "fallacious." He said, "We already have, today, labeling for the same medicine across generic drug makers that has variations, or variation between the brand name and generic drug makers. We already have a world in which there are inconsistencies. That doesn't mean that we shouldn't be giving generic drug manufacturers the ability to update labels with new warnings, new safety information."

Carome said the move highlights why Public Citizen opposed Gottlieb's nomination for FDA commissioner. "We thought he was too closely aligned with industry's interests and was going to make decisions that aligned with industry, and this is an example of that," Carome said (Wang, Inside Health Policy, 12/13 [subscription required]; Burton, Wall Street Journal, 12/13; Siddons, CQ Health, 12/13 [subscription required]).

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