“Responding to America’s Prescription Drug Abuse Crisis”: Administration’s New Action Plan Includes Changes to the CSA

April 21, 2011

By John A. Gilbert, Jr. & Peter M. Jaensch

In a press conference at the National Press Club on April 19, 2011, the Administration presented its action plan (“Plan”) to address concerns about the increase in prescription drug abuse.  The Plan is entitled: “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.”  Representing the Administration were White House Director of National Drug Control Policy Gil Kerlikowske, FDA Commissioner Margaret A. Hamburg, Assistant Secretary for Health and Human Services Howard Koh, and DEA Administrator Michele M. Leonhart.  (In a separate post we discuss FDA's final Risk Evaluation and Mitigation Strategy the Agency will require for all extended-release opioid medications, which FDA announced when the Administration presented its Plan.)

The Plan focuses primarily on measures to combat the abuse of prescription opioid analgesics.  The Plan calls for coordinated efforts by federal and state authorities in four key areas: Education and Training; Tracking and Monitoring; Proper Medication Disposal; and Enforcement.  Among these would be changes to the federal Controlled Substances  Act (“CSA”) and possibly state controlled substances laws, requiring the support of Congress and state legislatures.

A principal feature of the Plan is a proposed new requirement that prescribers “be trained on responsible opioid prescribing practices” as a prerequisite to registration with the DEA. Given that a DEA registration is required for practitioners to prescribe controlled substances to their patients, practitioners would need to meet this requirement to be permitted to prescribe controlled drugs.   The Plan does not provide details concerning this proposed training, stating only that such “training would include assessing and addressing signs of abuse and/or dependence.”  Such action would require a legislative amendment to the CSA, as the Plan openly acknowledges.  In questioning at the announcement of the Plan, Administrator Leonhart appeared to anticipate Congressional cooperation would be forthcoming and not controversial.

The Plan also calls on those states that have not implemented Prescription Drug Monitoring Programs ("PDMPs") to do so.  Currently 35 states have such plans.  In addition, the Plan calls for efforts going beyond most currently existing state PDMPs by encouraging an exchange of information between state plans.  Such information-sharing would arguably permit state and federal authorities to prevent drug seekers from circumventing existing limits by doctor-shopping and filling prescriptions across state lines.

The Plan also anticipates DEA administrative actions around drug disposal and e-prescribing. In the short-term, such activities primarily involve increased frequency of events at which DEA and possibly other federal and state agencies will collect unused controlled substances from end-users for disposal.  The CSA contemplates a closed system of controlled drug distribution, thus the return of controlled substances by patients to a DEA registrant, such as a pharmacy, has been prohibited under DEA regulations, with limited exceptions.  In the long term, DEA has stated that this issue would be addressed through promulgation of new regulations on disposal of controlled substances dispensed to end-users.  The Plan further contemplates issuance by DEA of a long-awaited final rule on the e-prescribing of controlled substances.