Controversial Generic Labeling Rule Slated to Be Released in July 2016

The FDA has announced that it intends to make final a rule about generic labeling in July 2016. The controversial rule will allow generics manufacturers to independently update labeling with new safety information without prior FDA review—just as their branded counterparts have been able to do for many years.

The rule, “Supplemental Applications Proposing Specific Labeling Changes for Approved Drugs and Biological Products,” has received more than 23,000 comments since it was first introduced in November 2013. The introduction followed a Supreme Court decision in a high-profile case regarding liability claims and generic drug safety labels. The court determined that generic drug manufacturers could not be held responsible for failing to warn patients about postmarket safety changes because they must reproduce the originator’s product label exactly and cannot change labels without FDA approval.

Currently, the regulatory difference between abbreviated new drug application (ANDA) holders and NDA or biologics license application (BLA) holders is that a consumer can bring a product liability action for “failure to warn” against NDA or BLA holders, but generally not against an ANDA holder.

If finalized, the rule would allow a generic drug sponsor to immediately issue a labeling change for any safety-related change. The labeling-change application would have to include information about the basis for the change and available data to support to change— such as adverse data. According to the FDA, “The rule change may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements.”

The opposition to the rule has been very vocal. A 2014 study conducted by economic consulting firm Matrix Global Advisors and commissioned by the Generic Pharmaceutical Association examined the costs associated with the rule and the impact on private generic drug spending. The report results showed that changing drug-labeling permissions would add $4 billion to the nation’s annual health care costs, including $1.5 billion to government health programs and $2.5 billion to private health insurance.

Gordon Johnston, former deputy director of the FDA Office of Generic Drugs, said during a congressional briefing, “This proposal directly undermines the ‘sameness’ of generics and their brand counterparts—a fundamental scientific principle that is the very cornerstone of the successes of generic medicines in the last 30 years. The proposed rule paves the way for different versions of safety information for the same products, undermining the important principle of consistency. Disregarding decades of regulatory stability in this way will create unwarranted confusion, raises patient safety concerns, and threatens the system that created thousands of affordable options for consumers.”

Patient advocates, on the other hand, say timely access to updated safety information is critical. In a statement, Michael Carome, MD, director of the Public Citizen Health Research Group, called on the FDA to “resist pressure from the pharmaceutical industry and finalize a rule that will protect patients…The agency should move expeditiously to finalize the proposed rule.”

Beyond its effect on patients, the rule may also mean that pharmacists and other health providers could be exposed to state-law tort lawsuits and liable because of the particular brand name or generic drug they choose to dispense. The FDA has said it will continue accepting comments over the next few months. The announcement comes shortly after the FDA approved a rule that allows the agency to approve a generic application based on draft labeling.