In a Federal Register Notice that published on February 27, 2014 (see here), the Drug Enforcement Agency (DEA) announced the proposed Rulemaking to place all hydrocodone-containing combination products into the more restrictive Schedule II category from Schedule III of the Controlled Substances Act. This process has been going on for several years and now looks like it will swiftly move towards becoming reality. This move has been hotly debated among consumer groups, healthcare providers, drug abuse experts and the like. FDA held a public advisory meeting in January 2013 to meet the requirement established by one of the provisions of Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). The Advisory Committee meeting was a compromise reached in FDASIA, as changing the schedule of these products was one thing that the Act’s sponsors had considered. The Committee that was charged with making a recommendation voted 19-10 in favor of the rescheduling effort.
Subsequent to the meeting, (to which the FDA received almost 800 comments), FDA and the Division of Health and Human Services (DHHS) provided their recommendation on rescheduling of Hydrocodone combination products (HCP) to the DEA. The DEA considered the following factors in reaching a final decision:
a) Individuals are using HCPs in amounts sufficient to create a hazard to their health, to the safety of other individuals, or to the community.
b) There is a significant diversion of HCPs from legitimate drug channels,according to forensic laboratory data as reported by the National Forensic Laboratory System.
c) Individuals are using HCPs on their own initiative rather than on the basis of medical advice.
d) HCPs are so related in their action to a drug or other substance already listed as having a potential for abuse to make it likely that they will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversion from legitimate channels, significant use contrary to or without medical advice, or that they have a substantial capability of creating hazards to the health of the user or to the safety of the community.
Based on the DEA’s evaluation of the information in totality they have determined that:
- HCPs have a high potential for abuse similar to that of Schedule II substances;
- HCPs have a currently accepted medical use in treatment in the United States. According to the HHS, several pharmaceutical products containing hydrocodone in combination with acetaminophen, aspirin, NSAIDS, and homatropine are approved by FDA for use as analgesics for pain relief and for the symptomatic relief of cough and upper respiratory symptoms associated with allergies and colds; and
- Abuse of HCPs 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 HCPs warrant control in schedule II of the CSA. 21 U.S.C. 812(b)(2).
Drug manufacturers should begin preparations for assuring they have all of the proper storage and administrative procedures in place in anticipation of a final ruling.
