FDA Outlines Standards for Abuse-Resistant Generic Opioids

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By Nathaniel Weixel

March 24 — The FDA is encouraging generic drug manufacturers to make abuse-deterrent opioid medications, and a new draft guidance from the agency aims to ensure those generics are just as effective as the brand-name drugs.

The guidance, issued March 24, outlines recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand-name product, with respect to all potential routes of abuse. The agency said it is seeking comments until May 24 (FDA-2016-D-0785).

According to the Food and Drug Administration, abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding. They don't prevent abuse of the highly addictive drugs, the FDA said. “Because opioid drug products must be able to deliver the opioid to the patient, there may always be some abuse of these products,” the agency said in the guidance.

The draft guidance is part of the agency's larger reassessment of its regulation of opioid medications, and comes just days after the agency said it would require a black box warning on packages of the most common opioid medications .

The agency said it would change the way it regulates prescription opioid medications after the nomination of FDA Commissioner Robert Califf was held up in the Senate. Senators were highly critical of his role in what they said has been an underwhelming agency response to the prescription opioid epidemic . On Feb. 24, the Senate voted 89-4 to confirm Califf.

Evolving Technology

Other efforts the agency said it will undertake include convening an advisory committee to review new opioids without abuse-deterrent properties, and an updated risk management strategy for all types of the medications.

Opioids are a class of powerful narcotic pain medicines that are used to treat moderate to severe pain that may not respond well to other pain medicines. Generic drugs have an expedited approval process that only requires them to be “therapeutically equivalent” to brand-name drugs on the market, without clinical testing.

“We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy,” Califf said in a March 24 statement.

Given the lower cost, on average, of generic products, encouraging access to generic forms of abuse-deterrent opioids “is an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain,” the FDA said.

Generic Industry's Views

In a statement provided to Bloomberg BNA, the Generic Pharmaceutical Association said it shares the FDA's “goal of addressing prescription opioid abuse, and using a science-based approach to take on this complex problem. At the same time, we recognize the importance of balancing patient access to medicine with efforts to minimize abuse.”

The industry group said the new guidance, along with the draft guidance on abuse-deterrent formulations made available in January 2013, “represents a beginning for generic manufacturers seeking to create these formulations.” GPhA said it looks forward to providing additional feedback through the comment process.

GPhA added that the FDA’s determination of whether a generic prescription opioid receives the “abuse-deterrent formulation” labeling shouldn't be based on whether the generic has an identical abuse-deterrent formulation technology. “GPhA believes that we should encourage innovation by drugmakers in developing abuse-deterrent formulation of prescription opioids, and that requiring a specific type of technology—rather than having the determination be based on scientific results—would discourage that innovation.”

Attorney's Perspective

Attorney David Rosen told Bloomberg BNA that there is a relatively small number of drugs with existing abuse-deterrent formulations.

Rosen, with Foley & Lardner in Washington, also noted that although the draft guidance doesn’t mention patent protections, such intellectual property concerns could arise because branded companies have patented their abuse-deterrent formulations. This means that generic companies would have to try to work around such formulations, and may have to ask the courts to determine if the patents are unenforceable, invalid or not infringed by the generic company’s formulation.

Rosen noted that, coupled with recent FDA actions and the Centers for Disease Control and Prevention’s recent guide on opioid prescribing, the newest action shows the government’s “heightened focus” on opioids and their correct use. The cooperation of prescribers, dispensers and patients is needed to ensure the drugs are taken responsibly, Rosen said, adding that opioids have an important place in pain relief treatment.

To contact the reporter on this story: Nathaniel Weixel in Washington at nweixel@bna.com

To contact the editor responsible for this story: Janey Cohen at jcohen@bna.com

For More Information

The draft guidance is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf.

A notice about the guidance, set for publication March 25 in the Federal Register, is at http://src.bna.com/dAa.