Today
the U. S. Drug Enforcement Administration (DEA) published in the Federal
Register a Notice of Proposed Rulemaking (NPRM) to move hydrocodone combination
products (HCPs) from Schedule III to Schedule II, as recommended by the
Assistant Secretary for Health of the U.S. Department of Health and Human
Services (HHS) and as supported by the DEA’s own evaluation of relevant
data. This NPRM proposes to impose the
regulatory controls and sanctions applicable to Schedule II substances on those
who handle or propose to handle HCPs.
The public is invited to review the proposed rule, which is posted on
the DEA’s website at
http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0227.htm
The
Controlled Substances Act (CSA) places substances with accepted medical uses
into one of four schedules, with the most potentially harmful and abusable
medications being placed in Schedule II, and medications with progressively
less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled
substances with no currently accepted medical use and lack of accepted safety
for use.) HCPs are drugs that contain
both hydrocodone, which by itself is a Schedule II drug, and specified amounts
of other substances, such as acetaminophen or aspirin.
When
Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it
had placed hydrocodone itself in Schedule II.
The analysis by HHS and the DEA shows HCPs have a high potential for
abuse and abuse may lead to severe psychological or physical dependence. The many findings by the DEA and HHS and the
data that support these findings are presented in detail in the NPRM and
supporting materials on the website.
Data and surveys from multiple federal and non-federal agencies show the
extent of abuse of HCPs. For example,
Monitoring the Future surveys of 8th, 10th, and 12th graders from 2002 to 2011
found that twice as many high school seniors used Vicodin®, an HCP,
nonmedically as used OxyContin®, a Schedule II substance, which is more tightly
controlled.
All
substances placed under the control of the CSA since it was passed by Congress
in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its
implementing regulations, found in Title 21 of the Code of Federal
Regulations. Scheduling or rescheduling
of a substance can be initiated by the DEA, by the HHS Assistant Secretary of
Health, or on the petition of any interested party. (Detailed information on the scheduling and
rescheduling process can be found in the first chapter of Drugs of Abuse [link]
on the DEA’s website.)
The
rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a
scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, the U. S. Food and Drug
Administration held a public Advisory Committee meeting on the matter, and the
committee voted to recommend rescheduling HCPs from Schedule III to Schedule II
by a vote of 19 to 10. Consistent with
the outcome of that vote, in December of 2013 HHS sent such a recommendation to
the DEA. With the receipt of that
recommendation, the DEA initiates the formal rulemaking process by publishing a
notice and soliciting public comments, as we are doing today.
After
reviewing today’s NPRM, members of the public are invited to submit comments or
request a hearing through www.regulations.gov (follow the instructions at that
site). Electronic comments must be
submitted, or written comments postmarked, by 11:59 p.m. Eastern Time on April
27. Requests for hearings must be
submitted by March 31. Additional
instructions about this may be found in the NPRM.
Once
the public comment period has closed and the DEA has considered all comments,
the DEA will publish a Final Rule in the Federal Register.