[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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