[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Proposed Rules]
[Page 26247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12150]


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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 The drug's manufacturer has withdrawn its original petition that 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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