Over the past several years, the U.S. Food and Drug Administration (FDA) has been carefully
evaluating and weighing the appropriate use of opioid analgesic drug products. For the millions of
American patients experiencing an acute medical need or living with chronic pain, opioids, when
prescribed appropriately, can allow patients to manage their pain as well as significantly improve
their quality of life.
However, in recent years, the 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
By early December, FDA plans to submit our formal recommendation package to HHS to reclassify
hydrocodone combination products into Schedule II. The Agency anticipates that the National
Institute on Drug Abuse (NIDA) will concur with its recommendation. This will begin a process that
will lead to a final decision by the DEA on the appropriate scheduling of these products. Going
forward, FDA will continue working with professional organizations, consumer and patient groups,
and industry to ensure that prescriber and patient education tools are readily available so that
these products are properly prescribed and appropriately used by the patients who need them most.
In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and
Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone
combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II,
which would increase the controls on these products. Due to the unique history of this issue and
the tremendous amount of public interest, FDA is announcing the agency’s intent to recommend to HHS
that hydrocodone combination products should be reclassified to a different and more restrictive
schedule. This determination comes after a thorough and careful analysis of extensive scientific
literature, review of hundreds of public comments on the issue, and several public meetings, during
which the Agency received input from a wide range of stakeholders, including patients, health care
providers, outside experts, and other government entities.
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.