Portions of New Opioid Label Requirements Apply to Generic Drugs

Certain requirements of the FDA’s new policy on opioid safety labels on long-acting and extended-release medications will not apply to generic manufacturers, according to the Centers for Drug Evaluation and Research.

Generic manufacturers will be exempt from postmarket study requirements on the medications specified by the new policy, Lisa Kubaska, PharmD, of the FDA’s Center for Drug Evaluation and Research (CDER), said in an e-mail to Pharmacy Times. The studies, which will be required of brand name manufacturers, would gauge risks associated with opioid use, including increased pain sensitivity, misuses, abuse, addiction, overdose, and death.

Manufacturers with an extended-release or long-acting opioid product on the market will need to revise the product labels to comply with the new labeling requirements, however.

The FDA announced the label changes in a September 10, 2013, press release.

The changes cover labeling revisions, including changes to prescribing information and boxed warnings, additional postmarket clinical study requirements, and modifications to extended-release and long-acting opioid analgesic risk evaluation and mitigation strategy (REMS) requirements.

The CDER notified brand name drug manufacturers and generic drug manufacturers for which the reference drug is not yet marketed of the new labeling requirements, Dr. Kubaska said.

Generic manufacturers that currently have an extended-release or long-acting opioid product on the market will be updated to conform to the labeling revisions of the reference product once the reference product’s labeling revisions are approved Dr. Kubaska added.

The labeling revisions include greater emphasis on long-acting and extended-release opioid use, risk of addiction and death, and updated warnings about opioid use in pregnant women.

For generic manufacturers, the label alterations also represent a slight change in previous procedures. Prior to July 2013, when the Supreme Court struck down another generic labeling liability lawsuit, generic manufacturers were not responsible for updating product labels to reflect safety information discovered after the generic came to market. The resulting differences between brand and generic labels meant generic manufacturers were not liable for adverse drug effects, despite being bioequivalent to a reference product.

The FDA stated its intent to allow generic manufacturers to update product safety labels following the Supreme Court ruling; however, it has not yet released any updates to its labeling rules. Under current practices, generic manufacturers can only update product labels if ordered to by the FDA, or if the manufacturers submit labeling changes to the agency directly and receive FDA approval of the changes.

The new opioid policy also changes long-acting and extended-release REMS materials, which generic and brand name manufacturers will be required to update.

“Among other things, the ER/ LA Opioid Analgesics REMS currently includes educational materials for prescribers to give to patients, helping prescribers to properly counsel patients on their responsibilities for using these medications safely,” Dr. Kubaska said. “Patients also receive an updated 1-page Medication Guide along with their prescription that contains consumer-friendly information with additional information on the safe use of these medications.”

The Generic Pharmaceutical Association (GPhA) opted against commenting on the labeling and REMS changes, noting that the changes pertain more heavily to brand name manufacturers than generic manufacturers, according to an e-mail from GPhA spokesman Steven Arnoff to Pharmacy Times.