[Federal Register: May 15, 2003 (Volume 68, Number 94)]
[Proposed Rules]
[Page 26247]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my03-20]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-162W]
Schedules of Controlled Substances: Proposed Removal of
Fenfluramine From the Controlled Substances Act; Withdrawal of Proposed
Rule
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Withdrawal of proposed rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is withdrawing a
proposed rule that appeared in the Federal Register of May 6, 1997 (62
FR 24620) and is terminating the rulemaking. The proposed rule would
have removed fenfluramine from schedule IV of the Controlled Substances
Act. The drug's manufacturer has withdrawn its original petition that
requested decontrol. DEA has determined that fenfluramine should remain
in schedule IV due to the withdrawal of the petition, the removal of
products containing the drug from the United States marketplace, and
the public health and safety concerns expressed by the Department of
Health and Human Services that arose after publication of the proposed
rule.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION: In 1973, fenfluramine, its salts, isomers
and salts of isomers were placed into schedule IV of the Controlled
Substances Act (CSA), 21 CFR 1308.14(d). On March 18, 1991, Interneuron
Pharmaceuticals, Inc., the manufacturer of a fenfluramine product
(dexfenfluramine, brand name Redux), petitioned DEA to decontrol
fenfluramine. The fenfluramine product Redux, an anorectic indicated
for the management of exogenous obesity, was approved by the Food and
Drug Administration (FDA) of the Department of Health and Human
Services (DHHS) for marketing in the United States in 1996. After
receiving Interneuron's petition, and in accordance with the CSA
requirements at 21 U.S.C. 811(b), DEA reviewed available data about
fenfluramine. On June 3, 1996, the DHHS Assistant Secretary of Health
submitted a recommendation to DEA that the substance be decontrolled.
As a result of DEA's review and DHHS's recommendation, a notice of
proposed rulemaking titled ``Schedules of Controlled Substances:
Proposed Removal of Fenfluramine From the Controlled Substances Act''
was published on May 6, 1997 in the Federal Register (62 FR 24620).
This notice of proposed rulemaking was in direct response to
Interneuron's petition to decontrol fenfluramine. A sixty day comment
period was provided during which four comments were received, two in
favor of the proposed action and two against decontrol.
On July 8, 1997, two months after the proposed rulemaking was
published, FDA issued a public health advisory regarding the use of
fenfluramine, especially in conjunction with phentermine (commonly
known as ``fen-phen''), citing evidence of significant side effects
associated with fenfluramine. FDA announced a voluntary withdrawal by
the pharmaceutical manufacturers of fenfluramine (brand name Pondimin)
and dexfenfluramine (brand name Redux) from United States markets on
September 15, 1997. DHHS issued a final rule on March 8, 1999 listing
drug products that were withdrawn or removed from the market because
they were found to be unsafe or not effective, including fenfluramine
hydrochloride. (64 FR 10944). This regulation is codified at 21 CFR
216.24.
In a February 27, 2003 letter addressed to DEA's Acting
Administrator, John B. Brown III, Indevus Pharmaceuticals, Inc.,
formerly known as Interneuron Pharmaceuticals, Inc., wrote to withdraw
its petition to decontrol fenfluramine because the company no longer
markets fenfluramine products in the United States.
As a result of the recent withdrawal of the petition and the
earlier removal of the drug from the United States marketplace by FDA
due to health and safety concerns, DEA now has reason to reconsider its
proposed rulemaking. DEA no longer considers it appropriate to remove
fenfluramine from schedule IV. The health and safety concerns that
prompted the manufacturers' voluntary withdrawal of fenfluramine from
the marketplace and DHHS's subsequent codification of this withdrawal,
see 21 CFR 216.24, occurred after DEA's proposed rulemaking was
published. Based on these events, DEA has determined that
fenfluramine's current placement in schedule IV should not be altered.
Accordingly, DEA withdraws the proposed rule published in the Federal
Register on May 6, 1997 (62 FR 24620) and hereby terminates this
rulemaking.
Dated: May 2, 2003.
John B. Brown, III,
Acting Administrator.
[FR Doc. 03-12150 Filed 5-14-03; 8:45 am]
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