The FDA is working on revisions to its labeling regulations that could revoke the free pass the Supreme Court has handed generic drugmakers when it comes to state failure-to-warn claims.

The proposed changes would put generic drugmakers on par with brand drugmakers in the submission of changes-being-effected (CBE) labeling supplements. Once finalized, the rule would allow drugmakers to change their labels to reflect new safety information, regardless of whether a drug were approved under a new drug application (NDA), biologic license application (BLA) or abbreviated new drug application (ANDA).

The rule would revise and clarify the procedures for changing the labeling of an approved drug to "reflect certain types of newly acquired information in advance of FDA's review of such change," according to the U.S. Office of Management and Budget (OMB), which must review all significant proposed rules before they're published. (Rules are considered "significant" based on their economic, environmental or public health impact.)

While the details aren't available yet, OMB said the rule will describe how information regarding a CBE labeling supplement, for either a generic or reference drug, would be made public during the FDA's review of the labeling change. It also will address how other NDA/ANDA holders will be expected to change their labeling to conform to the action the FDA takes on a CBE labeling supplement.

Without the rule change, makers of generic drugs can't initiate labeling changes, as their labels must match that of the reference drug. That creates an "impossibility preemption" of state tort claims, the Supreme Court ruled in Pliva v. Mensing, because a generic drugmaker can't enhance its safety information in keeping with state law since federal law requires it to adhere to the FDA-approved labeling for the reference drug. (See BioWorld Today, April 23, 2012.)

The court reiterated the 2011 decision last month when it overturned a $21 million federal jury award in Mutual Pharmaceutical Co. Inc. v. Bartlett, saying the New Hampshire law, on which the award was based, imposed duties on manufacturers to ensure that their products are not "unreasonably dangerous." Those state-imposed duties, the court said, conflicted with FDA requirements. (See BioWorld Today, June 25, 2013.)

Since the makers of drugs approved under an NDA or BLA can initiate labeling changes when they become aware of safety issues, they don't face the state law vs. federal regulation conflict, so they can be held liable for state failure-to-warn claims. Thus, a patient who suffers a serious adverse event from a brand drug might have a cause of action against the drugmaker, but a patient suffering the same adverse event from a generic version of the drug would have no legal remedy.

The proposed "revisions will fill a regulatory gap that poses a risk to patient safety," said Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. He pointed out that current law keeps generic drug manufacturers from warning doctors and patients about newly discovered safety information.

The watchdog organization submitted a citizen petition nearly two years ago requesting that the FDA revise its labeling rules to address this "safety gap."

The U.S. government argued on behalf of preemption in an amicus brief filed earlier this year in Bartlett, but it signaled that the issue could soon be moot, noting that an FDA rule change was in the works that would allow generic drugmakers to change labeling in "appropriate circumstances."

"If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers," the solicitor general said in a footnote in the brief.

Such a change could have a sizable impact on generics, and possibly on biosimilars in the future, as it would open the makers of the cheaper, follow-on drugs to the litigation expenses and multimillion-dollar liability claims that brand drugmakers face.

Members of the Generic Pharmaceutical Association plan to work with the FDA on the issue, Ralph Neas, president and CEO of the trade group, told BioWorld Today.