[Congressional Record Volume 145, Number 16 (Thursday, January 28, 1999)]
[Senate]
[Pages S1089-S1093]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mr. Levin, and Mr. Moynihan):
  S. 324. A bill to amend the Controlled Substances Act with respect to 
registration requirements for practitioners who dispense narcotic drugs 
in schedule IV or V for maintenance treatment or detoxification 
treatment; to the Committee on the Judiciary.


                THE DRUG ADDICTION TREATMENT ACT OF 1999

 Mr. HATCH. Mr. President, I rise to introduce S. 324, the 
``Drug Addiction Treatment Act of 1999''--the DATA Act. The goal in 
this bill is simple but it is important: S. 324 attempts to help make 
drug treatment more available and more effective.
  In developing this legislation I have worked closely with 
Representative Thomas Bliley of Virginia, Chairman of the House 
Committee on Commerce who plans to introduce shortly the House 
counterpart of this bill. I am very pleased to report that in 
sponsoring this bi-partisan bill I am joined by two colleagues from 
across the aisle--Senator Levin from Michigan and Senator Moynihan from 
New York. Senators Levin and Moynihan and I have long shared an 
interest in speeding the development of anti-addiction medications.
  One of the most troublesome problems that our Nation faces today is 
drug abuse. The spectrum of deleterious by-products of drug abuse 
include rampant and often violent crime, breakdown in family life and 
other fundamental social structures, and the inability of addicted 
individuals to reach their full potential as contributing members of 
American society. For example, a 1997 report by the Utah State Division 
of Substance Abuse, ``Substance Abuse and Need for Treatment Among 
Juvenile Arrestees in Utah'' cites literature reporting that heroin-
using offenders committed 15 times more robberies, 20 times more 
burglaries, and 10 times more thefts than offenders who do not use 
drugs.
  In my own state of Utah--I am sorry to report--a 1997 survey by the 
State Division of Substance Abuse reported that 9.6% of Utahns--one in 
ten of our citizens--used illicit drugs in the past month. That is 
simply too high.
  Unfortunately, no state or city in our great Nation is immune from 
the dangers of illicit drugs. I want the children of Utah to grow up 
drug free so that they may realize their enormous potential. And I want 
to help my neighbors in Salt Lake and fellow citizens across Utah and 
throughout the country who are addicted to break the grip of this 
deadly epidemic.
  The wide variety of negative behaviors associated with drug abuse 
require policymakers to employ a wide variety of techniques to cut down 
both the supply of and demand for illegal drugs. We must do all we can 
do to stop the criminal behavior involved in supplying the contraband 
products as well as taking steps to stop all Americans from starting or 
continuing to use drugs.
  This legislation I am introducing today focuses on increasing the 
availability and effectiveness of drug treatment. The purpose of the 
Drug Addiction Treatment Act of 1999 is to allow qualified physicians, 
as determined by experts at the Department of Health and Human 
Services, to prescribe schedule IV and V anti-addiction medications in 
physicians' offices without an additional Drug Enforcement 
Administration (DEA) registration if certain conditions are met.
  These conditions include certification by participating physicians 
that: they are licensed under state law and have the training and 
experience to treat opium addicts; they have the capacity to refer 
patients to counseling and other ancillary services; and they will not 
treat more than 20 in an office setting unless the Secretary of Health 
and Human Services adjusts this number.
  The DATA provisions allow the Secretary, as appropriate, to add to 
these conditions and allow the Attorney General to terminate a 
physician's DEA registration if these conditions are violated. This 
program will continue after three years only if the Secretary and 
Attorney General determine that this new type of decentralized 
treatment should not continue based on a number of determinations. 
These determinations include whether the availability of drug treatment 
has significantly increased without adverse consequences to the public 
health and the extent to which covered drugs have been diverted or 
dispensed in violation of the law such as exceeding the initial 20-
patient per doctor limitation. This bill would allow the Secretary and 
Attorney General to discontinue the program earlier than three years 
if, upon consideration of the specified factors, they determine that 
early termination is advisable.
  Nothing in the waiver policy undertaken in the new bill is intended 
to change the rules pertaining to methadone clinics or other facilities 
or practitioners that conduct drug treatment services under the dual 
registration system imposed by current law.
  In drafting the waiver provisions of the bill, the co-sponsors have 
consulted with the Drug Enforcement Agency, the Food and Drug 
Administration, and the National Institute on Drug Abuse. As well, this 
initiative is consistent with the recent announcement of the Director 
of the Office of National Drug Control Policy, General Barry McCaffrey, 
of the Administration's intent to work to decentralize methadone 
treatment.

[[Page S1090]]

  In 1995, the Institute of Medicine of the National Academy of 
Sciences issued a report, ``Development of Medications for Opiate and 
Cocaine Addictions: Issues for the Government and Private Sector.'' The 
study called for ``(d)eveloping flexible, alternative means of 
controlling the dispensing of anti-addiction narcotic medications that 
would avoid the `methadone model' of individually approved treatment 
centers.''
  The Drug Addiction Treatment Act--DATA--is exactly the kind of policy 
initiative that experts have called for in America's multifaceted 
response to the drug abuse epidemic. I recognize that the DATA 
legislation is just one mechanism to attack this problem and I plan to 
work with my colleagues to devise additional strategies to reduce both 
the supply and demand for drugs. I urge all my colleagues to support S. 
324 because it promises to get more patients into treatment and back on 
the road to honest, productive lives.
  I ask unanimous consent that the text of S. 324 be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 324

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Drug Addiction Treatment Act 
     of 1999''.

     SEC. 2. AMENDMENT TO CONTROLLED SUBSTANCES ACT.

       Section 303(g) of the Controlled Substances Act (21 U.S.C. 
     823(g)) is amended--
       (1) in paragraph (2), by striking ``(A) security'' and 
     inserting ``(i) security'', and by striking ``(B) the 
     maintenance'' and inserting ``(ii) the maintenance'';
       (2) by redesignating paragraphs (1) through (3) as 
     subparagraphs (A) through (C), respectively;
       (3) by inserting ``(1)'' after ``(g)'';
       (4) by striking ``Practitioners who dispense'' and 
     inserting ``Except as provided in paragraph (2), 
     practitioners who dispense''; and
       (5) by adding at the end the following:
       ``(2)(A) Subject to subparagraphs (D) and (G), the 
     requirements of paragraph (1) are waived in the case of the 
     dispensing, by a practitioner, of narcotic drugs in schedule 
     IV or V or combinations of such drugs if the practitioner 
     meets the conditions specified in subparagraph (B) and the 
     narcotic drugs or combinations of such drugs meet the 
     conditions specified in subparagraph (C).
       ``(B) For purposes of subparagraph (A), the conditions 
     specified in this subparagraph with respect to a practitioner 
     are that, before dispensing narcotic drugs in schedule IV or 
     V, or combinations of such drugs, to patients for maintenance 
     or detoxification treatment, the practitioner submit to the 
     Secretary a notification of the intent of the practitioner to 
     begin dispensing the drugs or combinations for such purpose, 
     and that the notification contain the following 
     certifications by the practitioner:
       ``(i) The practitioner is a physician licensed under State 
     law, and the practitioner has, by training or experience, the 
     ability to treat and manage opiate-dependent patients.
       ``(ii) With respect to patients to whom the practitioner 
     will provide such drugs or combinations of drugs, the 
     practitioner has the capacity to refer the patients for 
     appropriate counseling and other appropriate ancillary 
     services.
       ``(iii) In any case in which the practitioner is not in a 
     group practice, the total number of such patients of the 
     practitioner at any one time will not exceed the applicable 
     number. For purposes of this clause, the applicable number is 
     20, except that the Secretary may by regulation change such 
     total number.
       ``(iv) In any case in which the practitioner is in a group 
     practice, the total number of such patients of the group 
     practice at any one time will not exceed the applicable 
     number. For purposes of this clause, the applicable number is 
     20, except that the Secretary may by regulation change such 
     total number, and the Secretary for such purposes may by 
     regulation establish different categories on the basis of the 
     number of practitioners in a group practice and establish for 
     the various categories different numerical limitations on the 
     number of such patients that the group practice may have.
       ``(C) For purposes of subparagraph (A), the conditions 
     specified in this subparagraph with respect to narcotic drugs 
     in schedule IV or V or combinations of such drugs are as 
     follows:
       ``(i) The drugs or combinations of drugs have, under the 
     Federal Food, Drug and Cosmetic Act or section 351 of the 
     Public Health Service Act, been approved for use in 
     maintenance or detoxification treatment.
       ``(ii) The drugs or combinations of drugs have not been the 
     subject of an adverse determination. For purposes of this 
     clause, an adverse determination is a determination published 
     in the Federal Register and made by the Secretary, after 
     consultation with the Attorney General, that the use of the 
     drugs or combinations of drugs for maintenance or 
     detoxification treatment requires additional standards 
     respecting the qualifications of practitioners to provide 
     such treatment, or requires standards respecting the 
     quantities of the drugs that may be provided for unsupervised 
     use.
       ``(D)(i) A waiver under subparagraph (A) with respect to a 
     practitioner is not in effect unless (in addition to 
     conditions under subparagraphs (B) and (C)) the following 
     conditions are met:
       ``(I) The notification under subparagraph (B) is in writing 
     and states the name of the practitioner.
       ``(II) The notification identifies the registration issued 
     for the practitioner pursuant to subsection (f).
       ``(III) If the practitioner is a member of a group 
     practice, the notification states the names of the other 
     practitioners in the practice and identifies the 
     registrations issued for the other practitioners pursuant to 
     subsection (f).
       ``(IV) A period of 30 days has elapsed after the date on 
     which the notification was submitted, and during such period 
     the practitioner does not receive from the Secretary a 
     written notice that one or more of the conditions specified 
     in subparagraph (B), subparagraph (C), or this subparagraph, 
     have not been met.
       ``(ii) The Secretary shall provide to the Attorney General 
     such information contained in notifications under 
     subparagraph (B) as the Attorney General may request.
       ``(E) If in violation of subparagraph (A) a practitioner 
     dispenses narcotic drugs in schedule IV or V or combinations 
     of such drugs for maintenance treatment or detoxification 
     treatment, the Attorney General may, for purposes of section 
     304(a)(4), consider the practitioner to have committed an act 
     that renders the registration of the practitioner pursuant to 
     subsection (f) to be inconsistent with the public interest.
       ``(F) In this paragraph, the term `group practice' has the 
     meaning given such term in section 1877(h)(4) of the Social 
     Security Act.
       ``(G)(i) This paragraph takes effect on the date of 
     enactment of the Drug Addiction Treatment Act of 1999, and 
     remains in effect thereafter except as provided in clause 
     (iii) (relating to a decision by the Secretary or the 
     Attorney General that this paragraph should not remain in 
     effect).
       ``(ii) For the purposes relating to clause (iii), the 
     Secretary and the Attorney General shall, during the 3-year 
     period beginning on the date of enactment of the Drug 
     Addiction Treatment Act of 1999, make determinations in 
     accordance with the following:
       ``(I)(aa) The Secretary shall--
       ``(aaa) make a determination of whether treatments provided 
     under waivers under subparagraph (A) have been effective 
     forms of maintenance treatment and detoxification treatment 
     in clinical settings;
       ``(bbb) make a determination regarding whether such waivers 
     have significantly increased (relative to the beginning of 
     such period) the availability of maintenance treatment and 
     detoxification treatment; and
       ``(ccc) make a determination regarding whether such waivers 
     have adverse consequences for the public health.
       ``(bb) In making determinations under this subclause, the 
     Secretary--
       ``(aa) may collect data from the practitioners for whom 
     waivers under subparagraph (A) are in effect;
       ``(bb) shall promulgate regulations (in accordance with 
     procedures for substantive rules under section 553 of title 
     5, United States Code) specifying the scope of the data that 
     will be required to be provided under this subclause and the 
     means through which the data will be collected; and
       ``(cc) shall, with respect to collecting such data, comply 
     with applicable provisions of chapter 6 of title 5, United 
     States Code (relating to a regulatory flexibility analysis) 
     and of chapter 8 of such title (relating to congressional 
     review of agency rulemaking).
       ``(II) The Attorney General shall--
       ``(aa) make a determination of the extent to which there 
     have been violations of the numerical limitations established 
     under subparagraph (B) for the number of individuals to whom 
     a practitioner may provide treatment;
       ``(bb) make a determination regarding whether waivers under 
     subparagraph (A) have increased (relative to the beginning of 
     such period) the extent to which narcotic drugs in schedule 
     IV or V or combinations of such drugs are being dispensed or 
     possessed in violation of this Act; and
       ``(cc) make a determination regarding whether such waivers 
     have adverse consequences for the public health.
       ``(iii) If, before the expiration of the period specified 
     in clause (ii), the Secretary or the Attorney General 
     publishes in the Federal Register a decision, made on the 
     basis of determinations under such clause, that this 
     paragraph should not remain in effect, this paragraph ceases 
     to be in effect 60 days after the date on which the decision 
     is so published. The Secretary shall, in making any such 
     decision, consult with the Attorney General, and shall, in 
     publishing the decision in the Federal Register, include any 
     comments received from the Attorney General for inclusion in 
     the publication. The Attorney General shall, in making any 
     such decision, consult with the Secretary, and shall, in 
     publishing the decision in the Federal Register, include any 
     comments received from the Secretary for inclusion in the 
     publication.
       ``(H) During the 3-year period beginning on the date of 
     enactment of the Drug Addiction

[[Page S1091]]

     Treatment Act of 1999, a State may not preclude a 
     practitioner from dispensing narcotic drugs in schedule IV or 
     V, or combinations of such drugs, to patients for 
     maintentance or detoxification treatment in accordance with 
     the Drug Addiction Treatment Act of 1999, unless, before the 
     expiration of that 3-year period, the State enacts a law 
     prohibiting a practitioner from dispensing such drugs or 
     combination of drugs.''.
       (e) Conforming Amendment.--Section 304 of the Controlled 
     Substances Act (21 U.S.C. 824) is amended--
       (1) in subsection (a), in the matter following paragraph 
     (5), by striking ``section 303(g)'' each place the term 
     appears and inserting ``section 303(g)(1)''; and
       (2) in subsection (d), by striking ``section 303(g)'' and 
     inserting ``section 303(g)(1)''.

 Mr. LEVIN. Mr. President, the need for additional anti-
addiction medications is a matter of great concern to me and an issue 
that I have been deeply involved with for a number of years. We must 
come up with new medications which block the craving of heroin. This is 
why I am very pleased to join with Senator Hatch and Senator Moynihan 
in introducing legislation that would establish the infrastructure to 
enable qualified physicians to prescribe schedule IV and V anti-
addiction medications in their offices without an additional DEA 
registration if certain conditions are met. This will allow for a 
promising new drug, buprenorphine, to be used in the treatment of 
opiate addiction in physicians offices, under a separate registration 
from the Attorney General. Specific conditions would have to be met. 
These conditions include: Certification by participating physicians 
that they are licensed under state law and have the training and 
experience to treat heroin addicts; and that they have the capacity to 
refer patients to counseling and other ancillary services.
  Mr. President, there are a number of reasons why this legislation is 
necessary. The Narcotic Addict Treatment Act of 1974, requires separate 
DEA registrations for physicians who want to use approved narcotics in 
drug abuse treatment and separate approvals of registrants by U.S. 
Department of Health and Human Services (HHS) and by state agencies. 
The result has been a treatment system consisting primarily of large 
methadone clinics located in big cities, and preventing physicians from 
treating patients in an office setting or in rural areas or small 
towns, thereby denying treatment to thousands in need of it. 
Additionally, experts say that many heroin addicts who want treatment 
are often deterred because of the stigma that is associated with such 
with such clinics.
  The intent of our legislation is to exclude medications like 
buprenorphine from burdensome regulatory requirements of the Narcotic 
Treatment Act, in order to carry drug abuse treatment beyond the 
methadone clinics and into physicians' offices. In so doing, the 
legislation includes protections against abuse. These protections 
include the following: Physicians may not treat more than 20 patients 
in an office setting unless the HHS Secretary adjusts this number; the 
HHS Secretary, as appropriate, may add to these conditions and allow 
the Attorney General to terminate a physician's DEA registration if 
these conditions are violated; and the program will continue after 
three years only if the HHS Secretary and Attorney General determine 
that this new type of decentralized treatment should continue based on 
a number of determinations.
  The National Institute on Drug Abuse [NIDA], under a Cooperative 
Research and Development Agreement with a pharmaceutical manufacturer, 
has helped to develop buprenorphine, which is expected to be approved 
by the Food and Drug Administration in the near future. The Congress, 
NIDA and the National Academy of Sciences Institute of Medicine (IOM) 
have long recognized the urgent need to develop new medications for 
drug addiction treatment. This is evident in the enactment of the Anti-
Drug Abuse Act of 1988, which established the Medications Development 
Division of the National Institute on Drug Abuse, and the enactment of 
legislation requiring HHS and IOM to cooperate in the development of 
anti-addiction medications.
  Recent data show that five out of six opiate addicts are currently 
not in treatment. This has contributed to a continuing public health 
crisis of significant proportions--the age of first heroin use is 
dropping; the number of heroin users is increasing; and the number of 
people becoming dependent on heroin is increasing. According to NIDA, 
the incidence of first-time use of herion in the 12-17 year old group 
has increased fourfold from the 1980s to 1995.
  These facts and sentiments were also expressed by experts in this 
field of critical importance to the Nation during a May 9, 1997 Drug 
Forum on Anti-addiction Research, which I convened along with Senator 
Moynihan and Senator Bob Kerrey. Forum participants, including 
distinguished experts such as Dr. Herbert Kleber and Dr. Donald Landry 
of Columbia University, Dr. Charles Schuster of Wayne State University 
and Dr. James Woods of the University of Michigan, made it crystal 
clear that time is of the essence--we must act expeditiously on new 
treatment discoveries. According to public health experts, the 
untreated population of opiate addicts (and other injection drug users) 
is the primary means for the spread of HIV, hepatitis B and C, and 
tuberculosis into the general population, not to mention the families 
of such addicted persons. Failure to block the craving for drugs along 
with failure to provide traditional treatment will most certainly 
continue the spiral of huge health care costs--costs that will largely 
be borne not by the addicts, not by insurance companies--but by the 
American taxpayer.
  Buprenorphine, currently in Schedule V of the Controlled Substances 
Act, has a unique property--it has a ceiling effect, it is well 
tolerated by opiate addicted persons, and has a very low value for 
diversion on the street. Clinical trials conducted in 12 hospitals 
around the United States proved the new medication to be an extremely 
effective treatment medication. According to NIDA, of the 100,000 
heroin addicts in France, between 40,000-50,000 addicts are being 
treated with buprenorphine without ill effects. Dr. Donald Wesson, 
Chairman of the American Society of Addiction Medicine {ASAM  
Medication Development Committee wrote: ``The availability of 
buprenorphine in physicians' offices adds a needed level of care and is 
one avenue to expand current opioid treatment capacity. ASAM strongly 
supports federal legislation to enable buprenorphine to be prescribed 
in physicians' offices for treatment of opioid dependence . . . We are 
very pleased to see that the bill makes provisions for physician 
training and qualification.''
  Mr. President, finally, there are a number of questions that I raised 
with NIDA regarding buprenorphine prior to the introduction of this 
legislation which I would like to share with my colleagues in the 
Senate. I would also like to share the informative memo on this subject 
which I received from The American Society of Addiction Medicine 
(ASAM). I ask unanimous consent that the October 5, 1998 reply from 
NIDA Director, Dr. Alan Leshner, and the October 8, 1998 memo from Dr. 
Donald R. Wesson of ASAM be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         Department of Health & Human Services, National Institute 
           on Drug Abuse,
                                   Rockville, MD, October 5, 1998.
     Hon. Carl Levin,
     U.S. Senate,
     Washington, DC.
       Dear Senator Levin: Thank you for your letter dated 
     September 17 requesting the views of the National Institute 
     on Drug Abuse (NIDA) regarding the use of buprenorphine and 
     buprenorphine/naloxone for the treatment of opiate 
     dependence. Your letter asked us to address three specific 
     questions. Our answers are provided below.
       Question No. 1. Is buprenorphine (alone and in combination) 
     a safe and effective treatment for drug addiction?
       While the ultimate decision concerning safety and efficacy 
     rests with the Food and Drug Administration (FDA), NIDA has 
     funded many studies that support the safety and efficacy of 
     buprenorphine and the buprenorphine/naloxone combination for 
     the treatment of opiate dependence. During the time NIDA has 
     studied this medication, we have been impressed with its 
     safety and efficacy as a treatment for opiate dependence. 
     Over the last 5 years, NIDA has worked with Reckitt & Colman 
     Pharmaceuticals, Inc., under a Cooperative Research and 
     Development Agreement in an attempt to bring buprenorphine 
     (which the FDA has designated as an orphan product), to a 
     marketable status in the United States. These studies have 
     been submitted by Reckitt & Colman to the FDA in support of a 
     New Drug Application for buprenorphine products in

[[Page S1092]]

     the treatment of opiate dependence. The major studies of 
     relevance have shown that buprenorphine is more effective 
     than a low dose of methadone (Johnson et al, J.A.M.A., 1992), 
     and that an orderly dose effect of buprenorphine on reduction 
     of opiate use occurred (Ling et al, Addiction, 1998). Most 
     recently, buprenorphine tablets (either buprenorphine alone 
     or the combination with naxolone) were shown in a large 
     clinical trial to be superior to placebo treatment in 
     reducing opiate use (Fudala et al, CPDD, 1998). Additional 
     clinical studies have shown that the addition of naxolone to 
     the buprenorphine tablet decreased the response to 
     buprenorphine when the combination is injected under 
     controlled conditions. This means that when persons attempt 
     to dissolve the tablets and inject them, they will either 
     experience withdrawal or a diminished buprenorphine effect. 
     These properties will make buprenorphine combined with 
     naxolone undesirable for diversion to illicit use, especially 
     when compared with other existing illegal and legal opiate 
     products.
       Pharmacologically, buprenorphine is related to morphine but 
     is a partial agonist (possesses both agonist and antagonist 
     properties). Partial agonists exhibit ceiling effects (i.e., 
     increasing the dose only has effects to a certain level). 
     Therefore, partial agonists usually have greater safety 
     profiles than full agonists (such as heroin or morphine and 
     certain analgesic products chemically related to morphine). 
     This means that buprenorphine is less likely to cause 
     respiratory depression, the major toxic effect of opiate 
     drugs, in comparison to full agonists such as morphine or 
     heroin. We believe this will translate into a greatly reduced 
     chance of accidental or intentional overdose. Another benefit 
     of buprenorphine is that the withdrawal syndrome seen upon 
     discontinuation with buprenorphine is, at worst, mild to 
     moderate and can often be managed without administration of 
     narcotics.
       Question No. 2. Do current regulations properly set forth 
     the rules for administration, delivery, and use of these 
     drugs?
       There are no current regulations which address the use of 
     buprenorphine or buprenorphine/naloxone for the treatment of 
     opiate dependence because these products are not yet approved 
     for this purpose by the FDA. The current regulations (21 CFR 
     291) for administration and delivery of narcotic medications 
     in the treatment of narcotic dependent persons were written 
     for the use of full agonist medications such as methadone 
     with demonstrated abuse potential and do not take into 
     account the unique pharmacological properties of these drugs. 
     Therefore, these regulations would need to be re-examined and 
     substantially rewritten in order to recognize the unique 
     possibilities posed by buprenorphine/naloxone. Among these 
     are the potential to administer buprenorphine and 
     buprenorphine/naloxone in settings and situations other than 
     the formal Narcotic Treatment Programs (NTPs) which have 
     existed to date under existing regulations. As you may be 
     aware, NTPs are the most highly regulated form of medicine 
     practiced in the U.S., as they are subject to Federal, State, 
     and local regulation. Under this regulatory burden, expansion 
     of this system has been static for many years. This has 
     resulted in a ``treatment gap'', which is defined as the 
     difference between the number of opiate dependent persons and 
     those in treatment. The gap currently is over 600,000 persons 
     and represents 75-80% of all addicts.
       It may be useful to note the status of the last new product 
     introduced to the opiate dependence treatment market 
     (levoacetyl methadol, tradename ORLAAM). ORLAAM was an orphan 
     product developed by NIDA and a U.S. small business in the 
     early 1990s for narcotic dependence. ORLAAM was approved by 
     the FDA as a treatment medication for opiate dependence in 
     July 1993. In the five years since its approval and 
     dispensing under the more restrictive rules relating to the 
     use of full agonist medications (21 CFR 291), ORLAAM has been 
     poorly utilized to increase treatment for narcotic 
     dependence. It is estimated that 2,000 of the estimated 
     120,000 patients in narcotic treatment programs are receiving 
     ORLAAM. The failure of ORLAAM to make an appreciable impact 
     under the more restrictive rules suggests that if 
     buprenorphine is to make an appreciable impact on the 
     ``treatment gap'' it must be delivered under different rules 
     and regulations.
       The issue then becomes why should buprenorphine products be 
     delivered differently from ORLAAM and methadone. First, 
     buprenorphine's different pharmacology should be kept in mind 
     when rules and regulations are promulgated. The regulatory 
     burden should be determined based on a review of the risks to 
     individuals and society of this medication being dispensed by 
     prescription and commensurate with its safety profile, as is 
     the case with evaluation of all controlled substances. It is 
     our understanding that the Drug Enforcement Administration 
     has recognized the difference between buprenorphine treatment 
     products and those currently subject to 21 CFR 291 and has 
     communicated these views to your staff. Second, there are 
     many narcotic addicts who refuse treatment under the current 
     system. In a recent NIDA funded study (NIDA/VA #1008), 
     approximately 50% of the subjects had never been in treatment 
     before. Of that group, fully half maintained that they did 
     not want treatment in the current narcotic treatment program 
     system. The opportunity to participate in a new treatment 
     regimen (buprenorphine) was a motivating factor. Fear of 
     stigmatization is a very real factor holding back narcotic 
     dependent individuals from entering treatment. Third, 
     narcotic addiction is spreading from urban to suburban areas. 
     The current system, which tends to be concentrated in urban 
     areas, is a poor fit for the suburban spread of narcotic 
     addiction. There are many communities whose zoning will not 
     permit the establishment of narcotic treatment facilities, 
     which has in part been responsible for the treatment gap 
     described above. While narcotic treatment capacity has been 
     static, there has been an increase in the amount of heroin of 
     high purity. The high purity of this heroin has made it 
     possible to nasally ingest (snort) or smoke heroin. This 
     change in the route of heroin administration removes a major 
     taboo, injection and its attendant use of needles, from 
     initiation and experimentation with heroin use. The result of 
     these new routes of administration is an increase in the 
     number of younger Americans experimenting with, and becoming 
     addicted to, heroin. The incidence of first-time use of 
     heroin in the 12 to 17 year old group has increased fourfold 
     from the 1980s to 1995. Treatment for adolescents should be 
     accessible, and graduated to the level of dependence 
     exhibited in the patient. Buprenorphine products will likely 
     be the initial medication(s) for most of the heroin-dependent 
     adolescents.
       Question No. 3: Should more physicians be permitted to 
     dispense these drugs under controlled circumstances?
       It is our contention that more treatment should be made 
     more widely available for the reasons stated above. The 
     safety and effectiveness profiles for buprenorphine and 
     buprenorphine/naloxone suggest they could be dispensed under 
     controlled circumstances that would be delineated in the 
     product labeling and associated rules and regulations. As 
     currently envisioned, buprenorphine and buprenorphine/
     naloxone would be prescription, Schedule V controlled 
     substances. The treatment of patients by physicians or group 
     practice would allow office-based treatment to augment the 
     current system, while placing an adequate level of control on 
     the dispensing of these medications. Given the increased need 
     for treatment, the relative safety and efficacy of the 
     treatment product, and the development of a regulatory scheme 
     satisfactory to the Department of Health and Human Services, 
     we believe that these goals could be accomplished in a timely 
     and effective manner.
       Thank you for the opportunity to respond to your questions. 
     Should you need additional information, please feel free to 
     contact me again.
           Sincerely,
                                            Alan I. Leshner, Ph.D,
     Director.
                                  ____


  Chairman, Medication Development Committee, The American Society of 
                  Addiction Medicine, October 8, 1998

                       (By Donald R. Wesson, M.D.)

       Clinical experience within the context of narcotic 
     treatment clinics, drug abuse treatment clinics, and private 
     practice shows that opioid \1\ abusers are very diverse in 
     lifestyle, extent of involvement in the drug subculture, and 
     criminal activities. Clinical experience has also established 
     that many opioid abusers relapse to opioid use unless they 
     are maintained on medications with opioid properties.
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     \1\ Opioid is a broad term that covers drugs and medications 
     with morphine-like effects. Technically, opiate refers to 
     drugs or medications that are derived from the opium poppy 
     plant. The most common abused opiate is heroin; however, 
     synthetic medications with morphine-like effects, such a 
     fentanyl, are also abused. Opioid is the more inclusive term. 
     Opioid and opiate are often used interchangeably.
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       Opioid maintenance treatment, by blocking the effect of 
     illicit opioids and stabilizing patients' emotional states, 
     allows patients to receive outpatient treatment while making 
     the life-style changes needed to remain abstinent. Most 
     opioid abusers will relapse to illicit opioid abuse unless 
     they are also provided drug counseling, group therapy or 
     individual psychotherapy; however, all opioid abusers do not 
     require the same level of drug abuse treatment services. Some 
     need the highly-structured, behavior modification services 
     and maintenance with methadone or LAAM. Others require less 
     intensive drug abuse treatment and could be adequately 
     treated with a less potent opioid maintenance medication, 
     such as buprenorphine, provided within the context of 
     physicians' offices in conjunction with an appropriate level 
     of psychosocial services.
       Treatment of opioid addiction has for many years been 
     separated from mainstream medical practice. There is a body 
     of specialized knowledge concerning treatment of opioid 
     addiction that has evolved from clinical experience with 
     methadone maintenance and from non-narcotic treatment of 
     opioid addiction. Unlike most areas of medicine in which 
     physicians voluntarily confine their medical practice to 
     areas in which they have specialized training, treatment of 
     drug abusers is unusual in that many physicians may assume 
     competence that they may not, in fact, possess. At the 
     present time, many physicians who are not addiction 
     specialists do not understand addiction, particularly 
     narcotic addiction. Further, there are no generally accepted 
     practice guidelines for office-based narcotic addiction 
     treatment.
       The American Society on Addiction Medicine strongly 
     supports the position that physicians appropriately trained 
     and qualified in

[[Page S1093]]

     the treatment of opiate withdrawal and opiate dependence 
     should be permitted to prescribe buprenorphine in the normal 
     course of medical practice and in accordance with appropriate 
     medical practice guidelines, and that federal controlled 
     substance scheduling guidelines and other federal and state 
     regulations should permit buprenorphine to be made available 
     for physicians to prescribe to their patients in accordance 
     with documented clinical indications.\2\
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     \2\ Adopted by ASAM Board April 15, 1998.
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       The American Society of Addiction Medicine (ASAM) has a 
     certification examination in addiction medicine and the 
     American Board of Psychiatry and Neurology has a 
     certification examination in addiction psychiatry. The 
     American Society of Addiction Medicine, the American 
     Methadone Treatment Association and the American Academy of 
     Addiction Psychiatry have agreed to develop guidelines and 
     physician training for use of opioids in office-based 
     physician practices.
       It is highly desirable that physicians who plan to 
     prescribe opioids from their offices be certified by one of 
     the national organizations that offers training and 
     certification in addiction medicine or psychiatry.
       A problem with current federal regulation of opioid 
     treatment is that opioid maintenance is viewed as a treatment 
     of last resort and only possible within the context of 
     specially licensed clinics with methadone or LAAM. Because of 
     costs, or limited public sector treatment capacity, or 
     because they do not meet state and federal requirements for 
     maintenance with methadone or LAAM, many patients who need 
     opioid medication treatment cannot access methadone or LAAM 
     treatment. The availability of buprenorphine in physicians' 
     offices adds a needed level of care and is one avenue to 
     expand current opioid treatment capacity.
                                 ______