[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Proposed Rules]
[Page 56533-56534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se08-27]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-308W]
Technical Amendment to Listing in Schedule III of Approved Drug
Products Containing Tetrahydrocannabinols; Withdrawal of Proposed Rule
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
ACTION: Withdrawal of proposed rule.
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SUMMARY: DEA is withdrawing a proposed rule that was published in the
Federal Register on September 24, 2007 (72 FR 54226) and is terminating
the rulemaking. The proposed rule would have revised the DEA
regulations with respect to the listing in schedule III of a synthetic
isomer of tetrahydrocannabinols (THC) contained in a specific
formulation of a drug product approved by the U.S. Food and Drug
Administration (FDA). Specifically, the proposed rule would have
revised the DEA regulation so that it would also include generic drug
products approved by the FDA under section 505(j) of the Food, Drug,
and Cosmetic Act (FDCA) (21 U.S.C. 355) that cite the drug product
currently listed in schedule III as the reference listed drug. In view
of the comments DEA received in response to the proposed rule, DEA has
decided--in lieu of finalizing the proposed rule--to proceed with the
process set out in 21 U.S.C. 811 for transferring each such generic
drug individually to schedule III.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152; Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Under the Controlled Substances Act (CSA), the schedules of
controlled substances are published on an updated basis in the DEA
regulations. 21 U.S.C. 812(a), (c) and n.1. Currently, one of the
substances listed in schedule III is the following: ``Dronabinol
(synthetic) in sesame oil and encapsulated in a soft gelatin capsule in
a U.S. Food and Drug Administration [FDA] approved product.'' 21 CFR
1308.13(g)(1). This describes the drug product marketed under the brand
name Marinol. As explained in the Notice of Proposed Rulemaking (NPRM)
(72 FR 54226), it is possible that generic versions of Marinol could be
approved by the FDA yet not fit within the same schedule III listing as
Marinol. The proposed rule was intended to correct this situation so
that certain generic versions of Marinol that might be approved by the
FDA in the future would be in the same schedule as Marinol.
During the comment period, DEA received comments from nine entities
(firms, organizations, and one individual). Six of the nine commenters
expressed support for the proposed rule,\1\ two opposed it, and one
stated both that it was ``a good idea'' and ``not a good idea.'' \2\
One of the commenters that opposed the rule asserted that the rule was
not in conformity with the CSA. Specifically, this commenter asserted
that, to achieve the intended result of the rule (transferring to
schedule III any future FDA-approved generic versions of Marinol that
do not fit within the current wording of 21 CFR 1308.13(g)(1)), DEA
must engage in formal rescheduling action, following the procedures set
forth in 21 U.S.C. 811. Under these procedures, DEA requests from the
Department of Health and Human Services (HHS) a scientific and medical
evaluation and scheduling recommendation, with DEA and HHS being
required to consider the eight factors set forth in 21 U.S.C.
811(b).\3\ In addition, both of the commenters that objected to the
proposed rule asserted that the unique formulation of Marinol (that
which meets the current wording of 21 CFR 1308.13(g)(1)) prevents the
drug from having the ``high potential for abuse'' commensurate with
controlled substances in schedules I and II. Further, these commenters
asserted, generic versions of Marinol that might be approved by the FDA
in the future cannot be assumed to have the same potential for abuse as
Marinol if they were to differ from Marinol in their formulations or
routes of administration. Based on these considerations, one of the
objecting commenters asked that DEA withdraw the proposed rule or, in
the alternative, grant an administrative hearing to address the issues
raised in its objections.
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\1\ Three of the commenters that supported the rule also said,
in somewhat different ways, that the proposed rule should go
further--for example, by also transferring marijuana and/or its
derivatives out of schedule I or by granting a pending application
by a person seeking to become registered to manufacture marijuana.
\2\ This commenter suggested that all forms of THC should either
be in schedule I or schedule III, but that FDA-approved formulations
containing THC should not be listed separately from illicit forms of
the drug.
\3\ For a discussion of the formal rescheduling procedures under
the CSA, see Gettman v. DEA, 290 F.3d at 430, 432 (D.C. Cir. 2002).
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In the NPRM (in the preamble to the proposed rule), DEA addressed
the foregoing legal and factual issues raised by the objecting
commenters. Having considered the comments, DEA continues to believe
that the proposed rule is legally permissible within the structure of
the CSA, for the reasons set forth in the NPRM. In addition, having
obtained the input and concurrence of the FDA during the development of
the proposed rule, DEA believes that the proposed rule accurately
reflects the relevant legal considerations under the FDCA and further
that it is grounded in sound scientific considerations. It should also
be noted that two of the commenters that supported the rule agreed with
DEA regarding the core legal and factual issues raised by those
commenters that objected to the rule. Nonetheless, DEA must consider
what would likely be the practical realities of going forward with the
proposed rule at this time.
First, if DEA were to grant the objecting commenter's request for a
hearing, the administrative proceedings within the agency would likely
take at least two years to complete, taking into account the time to
conduct the hearing presided over by an administrative law judge (ALJ),
the issuance by the ALJ of a recommended decision, and the
[[Page 56534]]
issuance by the Deputy Administrator of a final order. Thereafter, if
DEA were to finalize the proposed rule, any person aggrieved by the
final rule would be permitted to seek review in the United States Court
of Appeals. It can never be automatically assumed that the Court of
Appeals will uphold a challenge to an agency rule. Thus, it is
conceivable that going forward toward finalizing the proposed rule at
this time could result in years of litigation followed by no final rule
that actually takes effect.
Given these considerations, DEA believes that the most sound
approach from this point forward is to withdraw the proposed rule and
proceed instead with a continuation of the formal rescheduling
procedures set forth in 21 U.S.C. 811 that are already underway for
each of the proposed generic versions of Marinol affected by the
proposed rule (those for which the sponsor has submitted to FDA an
abbreviated new drug application referencing Marinol but which fall
outside the current wording of 21 CFR 1308.13(g)(1)). For each such
product, where the proposed marketer has petitioned DEA to initiate
rulemaking proceedings to transfer the product into schedule III, DEA
has already--prior to the publication of the NPRM--forwarded the
petition to FDA for a scheduling evaluation in accordance with the
procedures set forth in 21 U.S.C. 811(b).
Thus, the net result of the withdrawal of this proposed rule is
that FDA and DEA will continue with the ongoing scheduling evaluations
and any resultant rescheduling proceedings for each of the individual
proposed generic versions of Marinol, rather than attempting to
reschedule all of them simultaneously through the issuance of this
proposed rule. DEA believes the former approach, as compared to the
latter, is most likely to result in such rescheduling becoming
effective in the shortest period of time.
Dated: September 18, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-22839 Filed 9-26-08; 8:45 am]
BILLING CODE 4410-09-P