[Federal Register Volume 59, Number 24 (Friday, February 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2470]


[[Page Unknown]]

[Federal Register: February 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0317]

 

Albuquerque Substance Abuse Clinic; Denial of Hearing and 
Revocation of Approval of a Narcotic Addiction Treatment Program; Final 
Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking approval of 
an ``Application for Approval of Use of Methadone in a Treatment 
Program'' (Form FDA-2632) held by Albuquerque Substance Abuse Clinic, 
Inc. (ASAC). The sponsor has failed to demonstrate the ability to 
correct and prevent violations of FDA's methadone regulation. Also, FDA 
is denying ASAC's request for hearing because they failed to submit 
information showing that there is a genuine issue of fact to justify a 
hearing.

EFFECTIVE DATE: February 4, 1994.

FOR FURTHER INFORMATION CONTACT: Gerald R. Hajarian, Center for Drug 
Evaluation and Research (HFD-342), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1029.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 23, 
1993 (58 FR 49519), FDA published a notice of opportunity for a hearing 
(NOOH) proposing to revoke approval of ASAC's Form FDA-2632 because of 
recurring, egregious violations of FDA's methadone regulation in 
Sec. 291.505 (21 CFR 291.505). The September 23, 1993, NOOH: (1) Set 
forth in detail the specific violations found in three FDA inspections 
conducted between April 2, 1991, and September 11, 1992; (2) described 
FDA's two unsuccessful efforts to arrange an informal conference to 
allow ASAC the opportunity to explain why the program's approval should 
not be revoked; and (3) offered ASAC the opportunity for a hearing on 
the proposal to revoke approval.
    By letter dated October 19, 1993, ASAC submitted a written notice 
of appearance and request for a hearing, but they failed to submit the 
information and analyses to demonstrate that there is a genuine issue 
of fact to justify a hearing.
    FDA's Associate Commissioner for Regulatory Affairs has reviewed 
ASAC's notice of appearance and request for a hearing, as well as the 
data on file with the Dockets Management Branch (HFA-305), Food and 
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 
submitted by the Center for Drug Evaluation and Research in support of 
the NOOH, and concludes that ASAC has failed to raise a genuine and 
substantial issue of fact requiring a hearing under Sec. 314.200 (21 
CFR 314.200), and that summary judgment should be entered against ASAC. 
The reasons for this decision are set forth in section II of this 
document.

I. Legislative and Regulatory Background

    Under the Controlled Substances Act (Pub. L. 91-513) (21 U.S.C. 801 
et seq.), methadone is classified as a schedule II controlled substance 
(21 U.S.C. 812(c)). A schedule II classification means that methadone 
is regarded to have a currently accepted medical use, but it has a high 
potential for abuse that may lead to severe psychological or physical 
dependence (21 U.S.C. 812(b)).
    Methadone is a synthetic narcotic analgesic and has been approved 
by FDA for: (1) Relief of severe pain, (2) detoxification treatment of 
narcotic addiction, and (3) temporary maintenance treatment of narcotic 
addiction. As discussed in this section, the use of methadone for 
maintenance treatment of narcotic addiction is permitted to be used 
only by approved methadone programs, i.e., programs found to be in 
accord with the conditions for distribution and use of methadone set 
forth in Sec. 291.505. The reason for this restriction is methadone's 
potential for abuse and diversion from legitimate commerce into the 
illegal marketplace.
    The current action revoking approval of a methadone program's Form 
FDA-2632 is the first such action FDA has taken in more than 20 years 
of regulating methadone programs. The following discussion is intended 
to provide the legislative and regulatory history underlying this 
action, so that the serious nature of ASAC's violations, and FDA's 
response to them, are clearly understood.
    The current system by which FDA regulates and monitors the use of 
methadone in the treatment of addiction began in 1970 with passage of 
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (the 
CDAPCA) (Pub. L. 91-513) (21 U.S.C. 801 et seq.). Prior to the CDAPCA, 
FDA's control over methadone was based exclusively on FDA's regulation 
of new drugs, including the investigational use of new drugs, under 
section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 355).
    The CDAPCA directs the Secretary of Health and Human Services to 
determine the appropriate methods of professional practice in the 
medical treatment of the narcotic addiction of various classes of 
narcotic addicts (42 U.S.C. 257a). The Secretary's authority to 
determine the safety and effectiveness of drugs or to approve new drugs 
to be used in the treatment of narcotic addicts is delegated to the 
Commissioner of Food and Drugs (Sec. 5.10(a)(8) (21 CFR 5.10(a)(8))). 
Practitioners who wish to prescribe or dispense controlled drugs, 
including methadone, are required under the CDAPCA to register annually 
with the Drug Enforcement Administration (DEA).
    In the Federal Register of April 2, 1971 (36 FR 6075), FDA 
published guidelines for investigating the use of methadone in 
maintenance treatment. The purpose of these guidelines was to assure 
the availability of valid data on the use of methadone in maintenance 
treatment and to protect the community from the hazards of diversion 
and abuse of methadone.
    It was FDA's position that restricting the use of methadone in 
maintenance treatment only under investigational new drug application 
(IND) protocols was not warranted and that methadone should be 
available to all addicts who consent to use it in approved treatment 
programs. On the other hand, FDA was aware that, despite the 
distribution restriction of the IND protocols then in effect, the use 
of methadone outside IND protocols was substantial. FDA was concerned 
that the usual form of new drug application (NDA) approval would lead 
to even greater diversion or misuse of the drug, because it would 
permit relatively unrestricted distribution and allow all physicians 
wide discretion in prescribing the drug. Therefore, FDA exercised its 
authority under both the IND and NDA control mechanisms, as well as the 
authority granted under the CDAPCA, to ensure that the required 
information for assessing the safety and efficacy of methadone would be 
obtained, and close control would be maintained over the distribution, 
administration, and dispensing of the drug.
    In 1972, FDA issued its methadone regulations under the new drug 
provisions of section 505 of the act and the CDAPCA. These regulations 
set forth medical standards in the treatment of narcotic addiction in 
accord with the CDAPCA and provided for a closed system of methadone 
distribution.
    In the early 1970's, diversion of methadone from legitimate 
commerce into the illegal marketplace became a serious problem. The 
authority of DEA to impose and enforce standards relating to the 
security and diversion of narcotic drugs used in the treatment of 
narcotic addiction was strengthened in 1974 when Congress enacted the 
Narcotic Addict Treatment Act of 1974 (the NATA) (Pub. L. 93-281) (21 
U.S.C. note). The NATA ensured that only bona fide narcotic addicts 
were admitted to maintenance or detoxification treatment, that they 
received quality care, and that illicit diversion was limited.
    Under the NATA, those practitioners who dispense narcotic drugs in 
the treatment of narcotic-dependent persons must obtain an annual 
registration with DEA. This registration is distinct from the general 
registration requirement, previously mentioned, under the CDAPCA to 
prescribe or dispense controlled drugs. To be registered, these 
practitioners must comply with the requirements established by DEA for 
secure drug storage, recordkeeping, and unsupervised use; and these 
practitioners must be found qualified under the treatment standards 
established by FDA's methadone regulation to engage in such treatment 
(21 U.S.C. 823(g)).
    In the Federal Register of September 19, 1980 (45 FR 62694), FDA 
and the National Institute of Drug Abuse jointly issued a final rule 
amending FDA's methadone regulation to make it consistent with the 
requirements of the NATA and the implementing regulations issued by 
DEA. Changes included requirements for physiologic dependence of 
patients, physician staffing, and urine testing in methadone 
maintenance programs, more flexibility in clinical standards, 
clarification of patient care responsibilities by indicating the 
minimum standards for the appropriate methods of professional practice 
in the medical treatment of narcotic addicts, and recommendations 
regarding sound medical practice in the safe and effective treatment of 
narcotic addicts with methadone.

II. ASAC's Hearing Request and FDA's Finding

    ASAC, 117 Quincy St. NE., Albuquerque, NM 87124, is a substance 
abuse treatment clinic; one of its primary functions is the dispensing 
of methadone hydrochloride in the treatment of narcotic addiction 
(heroin or other morphine-like drugs).
    The NOOH proposing to revoke approval of ASAC's Form FDA-2632 set 
forth in detail a long list of serious violations of FDA's methadone 
regulation. These violations have continued to recur over an extended 
period of time. ASAC has shown an inability to function in accord with 
the methadone regulation.
    The fact that ASAC was unable to bring itself in compliance with 
the methadone regulation after multiple inspections is clear evidence 
that the management of ASAC is not suited to run a narcotic treatment 
center using methadone. Moreover, since publication of the NOOH, FDA 
has become aware that ASAC no longer has a medical director. A narcotic 
treatment center using methadone treatment cannot legally function 
without a medical director. (See, inter alia, Sec. 291.505(c) and 
(d)(4)(ii).)
    ASAC's entire hearing request consists of the following statement, 
dated October 19, 1993:
     This letter is being sent to request a hearing for [ASAC] that 
we may show why our approval for a narcotic treatment program should 
not be revoked.
     We are gathering together all information and data showing just 
cause for us to remain open. We are in hopes this data will 
demonstrate our ability to correct and prevent violations.
    The information will follow within the next thirty days.
    We are sincerely hoping you will accept and allow our request 
for the hearing.
    ASAC did not submit any additional information, and the request 
itself is nothing more than a notice of appearance. As stated in the 
NOOH, a hearing request must set forth specific facts showing that 
there is a genuine issue of fact that requires a hearing. ASAC has 
failed even to attempt to submit such information.
    Therefore, for the reasons stated in the September 23, 1993, NOOH, 
and the reasons discussed in this final order, the Associate 
Commissioner for Regulatory Affairs hereby enters summary judgment 
against ASAC and revokes approval of ASAC's ``Application for Approval 
of Use of Methadone in a Treatment Program'' (Form FDA-2632), effective 
February 4, 1994. DEA and the New Mexico State authority are notified, 
concurrently with the issuance of this notice, that the Associate 
Commissioner has determined that ASAC is not qualified to engage in the 
treatment with respect to which registration under section 303 of the 
Controlled Substances Act (21 U.S.C. 823) was previously granted. This 
notice is issued under authority delegated to the Commissioner of Food 
and Drugs (Sec. 5.10 (a)(9)) and redelegated to the Associate 
Commissioner for Regulatory Affairs (21 CFR 5.20).

    Dated: January 24, 1994.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-2470 Filed 2-3-94; 8:45 am]
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