Regulatory Focus™ > News Articles > FDA Recommends Tighter Restrictions on Most Popular Prescription Drug Category in the US

FDA Recommends Tighter Restrictions on Most Popular Prescription Drug Category in the US

Posted 25 October 2013 | By Alexander Gaffney, RAC

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.

And in the middle, the US Food and Drug Administration (FDA), which until now has generally erred on the side of more liberal access to opioid medications. But on 24 October 2013, FDA announced it will recommend that the Drug Enforcement Administration (DEA) reschedule hydrocodone from a Schedule III medication to a Schedule II medication under the Controlled Substances Act (CSA).


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 harms.

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.

A Tough Decision

In a statement, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said the agency hadn't arrived at its decision lightly.

While giving a nod to the "millions of patients" for whom opioids are an essential tool to manage chronic pain, Woodcock explained that, "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."

"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," she continued.

And as a result, the agency said that it will soon submit a formal recommendation to DEA to reclassify hydrocodone combination products into Schedule II, beginning that agency's own deliberations on the matter. 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.

A String of New Restrictions

The decision marks but another chapter in FDA's long-running saga with opioids-one in which FDA increasingly seems to be placing more restrictions on their use.

The current decision comes out of a formal assessment process announced in 2009, when DEA petitioned FDA to determine if hydrocodone-containing products should be classified under Schedule II restrictions. That petition process resulted in a January 2013 meeting, where an advisory committee voted unanimously in favor of up-scheduling the drugs.

Other notable decisions have included FDA's July 2012 decision to launch class-wide Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid products, the release of a guidance document to "incentivize" abuse-deterrence studies for opioid products, and a September 2013 announcement that it would require safety labeling changes and postmarket studies for extended release and long-acting opioid analgesic products.

FDA Statement


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