White House marshals multi-agency effort to combat opioid drug abuse

Pharmaceutical CommercePharmaceutical Commerce - March/April 2011

Program will seek new legislation while coordinating manufacturing, healthcare-provider and enforcement resources

A new White House initiative will again take on the problem of prescription drug abuse, primarily focused on long-acting and extended-release forms of opioids. The effort coordinates a literal alphabet soup of federal agencies: FDA, DEA, CDC, DOD, NIDA (National Institute of Drug Abuse), ONDP (Office of National Drug Control Policy) and SAMSHA (Substance Abuse and Mental Health Services Administration). State Prescription Drug Monitoring Programs (PDMPs) will also be engaged.

The call to action, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” highlights well-known facts about prescription drug abuse: it is the second-highest abused-drug problem (behind marijuana) and a leading cause of death, especially among young people. At the same time, opioid pain relievers have increased dramatically in recent years; one medical study cited in Epidemic notes that average opioid use in the US has grown from 74 to 369 mg per capita between 1997 and 2007—a 402% increase.

The new plan calls for increased education among prescribers and patients (including FDA-originated oversight of REMS—risk evaluation and mitigation strategies); development of a Model Pain Clinic Regulation Law for states to counter the rise of “pill mills;” and increased law enforcement activity. Manufacturers will also be engaged to continue the testing and development of abuse-resistant opioid drug formulations. DEA will develop administrative rules to enhance the effectiveness of medication disposal rules, and will call on PhRMA and others to assist. (Unused prescription drugs often find their way to abusers.)

Opioid REMS have been a frustrating project for FDA; after announcing plans for “class wide” REMS for opioids, FDA’s proposed voluntary prescriber education program was shot down by its own review panel last summer. Meanwhile, although 43 states have PDMPs, they are active in only 35, and earlier this year Florida, widely regarded as the epicenter of pill mills, tabled its own PDMP program legislation. Drugmakers have had mixed results in gaining FDA approval of abuse-resistant formulations.

The renewed federal effort could certainly unify the multitude of efforts by state and federal government to confront prescription drug abuse. But footnote 20, the last words of the Epidemic report, sound a federal-debt-crisis caution: "Accomplishment of the plan and its goals is dependent on the availability of resources.”

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