FDA Hearings Invite Debate on Abuse-deterrent Pain Pills

November 4, 2014

by Amanda Conschafter, blog editor

Just weeks ago, the Food and Drug Administration approved a third opioid analgesic pain pill designed to frustrate attempts at abuse. The medication’s approval signals FDA’s increasing interest in abuse deterrent formulations, which elicited diverse opinions in last week’s public FDA hearings. The hearings invited insight from patient advocates, industry and government on the use – and usefulness – of abuse-deterrent technology for curbing rampant prescription drug abuse.

Abuse deterrent formulations take various forms, each specific to the type of abuse they’re designed to combat. Some formulations resist physical crushing, a characteristic designed to deter abusers who snort the medications. Other formulations resist dissolving in liquid, a property designed to impede abusers who would dissolve the pills in alcohol.

The FDA has eyed abuse-deterrent formulations for some time now as a means of abating the nation’s abuse epidemic. In January, the FDA issued draft guidance for industry on the issue. Last week’s hearings gave FDA the chance to improve the guidance with the benefit of broad input.

Participants at the hearing weighed in on several topics, including whether the FDA would favor abuse-deterrent forms at the exclusion of traditional pain pill forms. Manufacturers of generic medications expressed interest in the topic, which the FDA has said it will address case by case. Some argued that eliminating generics from the market in favor of brand-name abuse deterrent formulations could trigger a medication shortage, driving up prices for patients.

Participants overwhelmingly acknowledged the need for technology that combats the abuse epidemic. But several patient advocacy organizations also emphasized the needs of patients with legitimate pain. Their concerns are well founded; nearly 34 million Americans suffer from chronic pain, and the total annual cost of pain is estimated at more than $100 billion.

Thus, for regulators, industry and health care providers, the challenge remains addressing pain pill abuse while preserving access for the millions of Americans who need pain management therapies to maintain quality of life.

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