The Drug Enforcement Administration (DEA) has released a proposed rule that adopts a recommendation by the US Food and Drug Administration (FDA) to reschedule combination hydrocodone products as Schedule II substances under the Controlled Substances Act (CSA).
In the US, access to opioid-based painkiller medications has long been the topic of a contentious debate. On one side have been patient advocates and some doctors, who say opioids should be easily available to facilitate the appropriate treatment of pain. On the other side have been many public health advocates and those in law enforcement, who say an epidemic of abuse has torn apart communities and killed tens of thousands of people.
In the midst of this debate has been FDA, which has historically erred on the side of more liberal access to opioid medications, believing that doctors should be able to make individual calls about the needs of their patients.
But on 24 October 2013, FDA announced it had recommended that DEA reschedule combination hydrocodone products from a Schedule III medication to a Schedule II medication under the CSA. That recommendation followed a process started by DEA in June 2012 asking FDA to evaluate the drug's broader benefits and risks.
The CSA is the statutory backbone under which drugs with the potential for abuse or misuse are regulated, and contains a progressive range of classifications. Schedule IV, for example, is intended for drugs with a low potential for abuse, minimal health effects associated with abuse, and a clear medical use.
Schedule III drugs have a moderate potential for abuse and the potential for dependency issues, but are still recognized for their medical use. Schedule I drugs are those without any recognized medical benefit, and generally have a higher potential for abuse and potential harm.
Schedule II, then, lies in between schedules I and III, and is characterized by a drug with a medical benefit, but also a high potential for abuse and dependency (either psychological or physical). Under the CSA, Schedule II drugs are subject to tighter prescribing controls, such as a ban on refills.
At the time, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said that agency had long deliberated about the best approach to regulate hydrocodone products under the CSA.
"In recent years, FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States," Woodcock said. "While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse."
As a result, FDA called for combination hydrocodone products to be reclassified as a Schedule II drug.
Non-combination hydrocodone products are already Schedule II drugs under the CSA, but the new policy would impact some popular drugs like Vicodin. More than 130 million prescriptions for hydrocodone were filled in 2011, according to IMS Institute for Health Informatics figures, making it the most popular prescription drug in the US.
In a 26 February 2014 Federal Register announcement, DEA said it had tentatively agreed with FDA's recommendation, and would move toward implementing that decision after the public has a chance to comment on the proposed change.
DEA's own analysis of the abuse potential of combination hydrocodone products found ample reasons to strengthen their scheduling under the CSA, including hospitalization rates, overdoses, deaths and rates of abuse. DEA also found that there are currently "significant" diversions of hydrocodone products from legitimate drug channels, and that many individuals are using the drugs "on their own initiative" instead of for medical reasons.
Ultimately, DEA based its scheduling decision on three factors:
- Hydrocodone combination products have a high potential for abuse similar to that of schedule II substances
- Hydrocodone combination products have a currently accepted medical use in treatment in the United States.
- Abuse of hydrocodone combination products may lead to severe psychological or physical dependence similar to that of schedule II substances.
"Based on these findings, the Administrator of the DEA concludes that hydrocodone products warrant control in schedule II of the CSA," DEA wrote.
The changes would require manufacturers, distributors, dispensers, importers and researchers to register with DEA. It would also institute stronger standards for security, labeling, packaging, record-keeping, prescribing and inventory tracking.
The public has 60 days in which to comment before DEA may finalize the proposed rule.
Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II