DATE-RAPE DRUG CONTROL ACT OF 1999
(Senate - November 19, 1999)

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[Pages S14870-S14877]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   DATE-RAPE DRUG CONTROL ACT OF 1999

  Ms. COLLINS. Mr. President, I ask unanimous consent that the Senate 
proceed to the consideration of Calendar No. 416, S. 1561.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill to amend the Controlled Substance Act to add gamma 
     hydroxybutyric acid and ketamine to the schedules of control 
     substances, to provide for a national awareness campaign, and 
     for other purposes.

  There being no objection, the Senate proceeded to consider the bill 
which had been reported from the Committee on the Judiciary, with 
amendments as follows:
  [Matter proposed to be deleted is enclosed in black brackets; new 
matter is printed in italic.]

                                S. 1516

       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 ``Date-Rape Drug Control Act 
     of 1999''.]

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Hillory J. Farias and 
     Samantha Reid Date-Rape Drug Prohibition Act of 1999''.

     SEC. 2. FINDINGS.

       Congress finds as follows:
       (1) Gamma hydroxybutyric acid (also called G, Liquid X, 
     Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy, 
     Scoop) has become a significant and growing problem in law 
     enforcement. At least 20 States have scheduled such drug in 
     their drug laws and law enforcement officials have been 
     experiencing an increased presence of the drug in driving 
     under the influence, sexual assault, and overdose cases 
     especially at night clubs and parties.
       (2) A behavioral depressant and a hypnotic, gamma 
     hydroxybutyric acid (``GHB'') is being used in conjunction 
     with alcohol and other drugs with detrimental effects in an 
     increasing number of cases. It is difficult to isolate the 
     impact of such drug's ingestion since it is so typically 
     taken with an ever-changing array of other drugs and 
     especially alcohol which potentiates its impact.
       (3) GHB takes the same path as alcohol, processes via 
     alcohol dehydrogenase, and its symptoms at high levels of 
     intake and as impact builds are comparable to alcohol 
     ingestion/intoxication. Thus, aggression and violence can be 
     expected in some individuals who use such drug.
       (4) If taken for human consumption, common industrial 
     chemicals such as gamma butyrolactone and 1.4-butanediol are 
     swiftly converted by the body into GHB. Illicit use of these 
     and other GHB analogues and precursor chemicals is a 
     significant and growing law enforcement problem.
       (5) A human pharmaceutical formulation of gamma 
     hydroxybutyric acid is being developed as a treatment for 
     cataplexy, a serious and debilitating disease. Cataplexy, 
     which causes sudden and total loss of muscle control, affects 
     about 65 percent of the estimated 180,000 Americans with 
     narcolepsy, a sleep disorder. People with cataplexy often are 
     unable to work, drive a car, hold their children or live a 
     normal life.
       (6) Abuse of illicit GHB is an imminent hazard to public 
     safety that requires immediate regulatory action under the 
     Controlled Substances Act (21 U.S.C. 801 et seq.).

     [SEC. 3. ADDITION OF GAMMA HYDROXYBUTYRIC ACID AND KETAMINE 
                   TO SCHEDULES OF CONTROLLED SUBSTANCES; GAMMA 
                   BUTYROLACTONE AS ADDITIONAL LIST I CHEMICAL.

       [(a) Addition to Schedule I.--
       [(1) In general.--Section 202(c) of the Controlled 
     Substances Act (21 U.S.C. 812(c)) is amended by adding at the 
     end of schedule I the following:
       [``(d) Unless specifically excepted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation, which contains any quantity of the following 
     substance having a depressant effect on the central nervous 
     system, or which contains any of their salts, isomers, and 
     salts of isomers whenever the existence of such salts, 
     isomers, and salts of isomers is possible within the specific 
     chemical designation:
       [``(1) Gamma hydroxybutyric acid.''.
       [(2) Security of facilities.--For purposes of any 
     requirements that relate to the physical security of 
     registered manufacturers and registered distributors, gamma 
     hydroxybutyric acid and its salts, isomers, and salts of 
     isomers manufactured, distributed, or possessed in accordance 
     with an exemption approved under section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act shall be treated as a 
     controlled substance in schedule III under section 202(c) of 
     the Controlled Substances Act.
       [(b) Addition to Schedule III.--Schedule III under section 
     202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is 
     amended in (b)--
       [(1) by redesignating (4) through (10) as (6) through (12), 
     respectively; and
       [(2) by redesignating (3) as (4);
       [(3) by inserting after (2) the following:
       [``(3) Gamma hydroxybutyric acid and its salts, isomers, 
     and salts of isomers contained in a drug product for which an 
     application has been approved under section 505 of the 
     Federal Food, Drug, and Cosmetic Act.''; and
       [(4) by inserting after (4) (as so redesignated) the 
     following:
       [``(5) Ketamine and its salts, isomers, and salts of 
     isomers.''.
       [(c) Additional List I Chemical.--Section 102(34) of the 
     Controlled Substances Act (21 U.S.C. 802(34)) is amended--
       [(1) by redesignating subparagraph (X) as subparagraph (Y); 
     and
       [(2) by inserting after subparagraph (W) the following 
     subparagraph:
       [``(X) Gamma butyrolactone.''.
       [(d) Rule of Construction Regarding Controlled Substance 
     Analogues.--Section 102(32) of the Controlled Substances Act 
     (21 U.S.C. 802(32)) is amended--
       [(1) in subparagraph (A), by striking ``subparagraph (B)'' 
     and inserting ``subparagraph (C)'';
       [(2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       [(3) by inserting after subparagraph (A) the following new 
     subparagraph (B):
       [``(B) The designation of gamma butyrolactone or any other 
     chemical as a listed chemical pursuant to paragraph (34) or 
     (35) does not preclude a finding pursuant to subparagraph (A) 
     that the chemical is a controlled substance analogue.''.
       [(e) Penalties Regarding Schedule I.--
       [(1) In general.--Section 401(b)(1)(C) of the Controlled 
     Substances Act (21 U.S.C. 841(b)(1)(C)) is amended in the 
     first sentence by inserting after ``schedule I or II,'' the 
     following: ``gamma hydroxybutyric acid in schedule III,''.
       [(2) Conforming amendment.--Section 401(b)(1)(D) of the 
     Controlled Substances Act (21 U.S.C. 841(b)(1)(D)) is amended 
     by inserting ``(other than gamma hydroxybutyric acid)'' after 
     ``schedule III''.
       [(f) Distribution With Intent To Commit Crime of 
     Violence.--Section 401(b)(7)(A) of the Controlled Substances 
     Act (21 U.S.C. 841(b)(7)(A)) is amended by inserting ``or 
     controlled substance analogue'' after ``distributing a 
     controlled substance''.]

     SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND 
                   LISTING OF GAMMA BUTYROLACTONE AS LIST I 
                   CHEMICAL.

       (a) Emergency Scheduling of GHB.--
       (1) In general.--The Congress finds that the abuse of 
     illicit gamma hydroxybutyric acid is an imminent hazard to 
     the public safety. Accordingly, the Attorney General, 
     notwithstanding sections 201(a), 201(b), 201(c), and 202 of 
     the Controlled Substances Act, shall issue, not later than 60 
     days after the date of the enactment of this Act, a final 
     order that schedules such drug (together with its salts, 
     isomers, and salts of isomers) in the same schedule under 
     section 202(c) of the Controlled Substances Act as would 
     apply to a scheduling of a substance by the Attorney General 
     under section 201(h)(1) of such Act (relating to imminent 
     hazards to the public safety), except as follows:
       (A) For purposes of any requirements that relate to the 
     physical security of registered manufacturers and registered 
     distributors, the final order shall treat such drug, when the 
     drug is manufactured, distributed, or possessed in accordance 
     with an exemption under section 505(i) of the Federal Food, 
     Drug, and Cosmetic Act (whether the exemption involved is 
     authorized before, on, or after the date of the enactment of 
     this Act), as being in the same schedule as that recommended 
     by the Secretary of Health and Human Services for the drug 
     when the drug is the subject of an authorized investigational 
     new drug application (relating to such section 505(i)). The 
     recommendation referred to in the preceding sentence is 
     contained in the first paragraph of the letter transmitted on 
     May 19, 1999, by such Secretary (acting through the Assistant 
     Secretary for Health) to the Attorney

[[Page S14871]]

     General (acting through the Deputy Administrator of the Drug 
     Enforcement Administration), which letter was in response to 
     the letter transmitted by the Attorney General (acting 
     through such Deputy Administrator) on September 16, 1997. In 
     publishing the final order in the Federal Register, the 
     Attorney General shall publish a copy of the letter that was 
     transmitted by the Secretary of Health and Human Services.
       (B) In the case of gamma hydroxybutyric acid that is 
     contained in a drug product for which an application is 
     approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (whether the application involved is approved 
     before, on, or after the date of the enactment of this Act), 
     the final order shall schedule such drug in the same schedule 
     as that recommended by the Secretary of Health and Human 
     Services for authorized formulations of the drug. The 
     recommendation referred to in the preceding sentence is 
     contained in the last sentence of the fourth paragraph of the 
     letter referred to in subparagraph (A) with respect to May 
     19, 1999.
       (2) Failure to issue order.--If the final order is not 
     issued within the period specified in paragraph (1), gamma 
     hydroxybutyric acid (together with its salts, isomers, and 
     salts of isomers) is deemed to be scheduled under section 
     202(c) of the Controlled Substances Act in accordance with 
     the policies described in paragraph (1), as if the Attorney 
     General had issued a final order in accordance with such 
     paragraph.
       (b) Additional Penalties Relating to GHB.--
       (1) Controlled substances act.--
       (A) In general.--Section 401(b)(1)(C) of the Controlled 
     Substances Act (21 U.S.C. 841(b)(1)(C)) is amended in the 
     first sentence by inserting after ``schedule I or II,'' the 
     following: ``gamma hydroxybutyric acid (including when 
     scheduled as an approved drug product for purposes of section 
     3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-
     Rape Drug Prohibition Act of 1999),''.
       (B) Conforming amendment.--Section 401(b)(1)(D) of the 
     Controlled Substances Act (21 U.S.C. 841(b)(1)(D)) is amended 
     by striking ``, or 30'' and inserting ``(other than gamma 
     hydroxybutyric acid), or 30''.
       (2) Controlled substances import and export act.--
       (A) In general.--Section 1010(b)(3) of the Controlled 
     Substances Import and Export Act (21 U.S.C. 960(b)(3)) is 
     amended in the first sentence by inserting after ``I or II,'' 
     the following: ``gamma hydroxybutyric acid (including when 
     scheduled as an approved drug product for purposes of section 
     3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-
     Rape Drug Prohibition Act of 1999),''.
       (B) Conforming amendment.--Section 1010(b)(4) of the 
     Controlled Substances Import and Export Act (21 U.S.C. 
     960(b)(4)) is amended by striking ``flunitrazepam)'' and 
     inserting the following: ``flunitrazepam and except a 
     violation involving gamma hydroxybutyric acid)''.
       (c) Gamma Butyrolactone as Additional List I Chemical.--
     Section 102(34) of the Controlled Substances Act (21 U.S.C. 
     802(34)) is amended--
       (1) by redesignating subparagraph (X) as subparagraph (Y); 
     and
       (2) by inserting after subparagraph (W) the following 
     subparagraph:
       ``(X) Gamma butyrolactone.''.

     SEC. 4. AUTHORITY FOR ADDITIONAL REPORTING REQUIREMENTS FOR 
                   GAMMA HYDROXYBUTYRIC PRODUCTS IN SCHEDULE III.

       Section 307 of the Controlled Substances Act (21 U.S.C. 
     827) is amended by adding at the end the following:
       ``(h) In the case of a drug product containing gamma 
     hydroxybutyric acid for which an application has been 
     approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act, the Attorney General may, in addition to any 
     other requirements that apply under this section with respect 
     to such a drug product, establish any of the following as 
     reporting requirements:
       ``(1) That every person who is registered as a manufacturer 
     of bulk or dosage form, as a packager, repackager, labeler, 
     relabeler, or distributor shall report acquisition and 
     distribution transactions quarterly, not later than the 15th 
     day of the month succeeding the quarter for which the report 
     is submitted, and annually report end-of-year inventories.
       ``(2) That all annual inventory reports shall be filed no 
     later than January 15 of the year following that for which 
     the report is submitted and include data on the stocks of the 
     drug product, drug substance, bulk drug, and dosage forms on 
     hand as of the close of business December 31, indicating 
     whether materials reported are in storage or in process of 
     manufacturing.
       ``(3) That every person who is registered as a manufacturer 
     of bulk or dosage form shall report all manufacturing 
     transactions both inventory increases, including purchases, 
     transfers, and returns, and reductions from inventory, 
     including sales, transfers, theft, destruction, and seizure, 
     and shall provide data on material manufactured, manufactured 
     from other material, use in manufacturing other material, and 
     use in manufacturing dosage forms.
       ``(4) That all reports under this section must include the 
     registered person's registration number as well as the 
     registration numbers, names, and other identifying 
     information of vendors, suppliers, and customers, sufficient 
     to allow the Attorney General to track the receipt and 
     distribution of the drug.
       ``(5) That each dispensing practitioner shall maintain for 
     each prescription the name of the prescribing practitioner, 
     the prescribing practitioner's Federal and State registration 
     numbers, with the expiration dates of these registrations, 
     verification that the prescribing practitioner possesses the 
     appropriate registration to prescribe this controlled 
     substance, the patient's name and address, the name of the 
     patient's insurance provider and documentation by a medical 
     practitioner licensed and registered to prescribe the drug of 
     the patient's medical need for the drug. Such information 
     shall be available for inspection and copying by the Attorney 
     General.
       ``(6) That section 310(b)(3) (relating to mail order 
     reporting) applies with respect to gamma hydroxybutyric acid 
     to the same extent and in the same manner as such section 
     applies with respect to the chemicals and drug products 
     specified in subparagraph (A)(i) of such section.''.

     [SEC. 5. DEVELOPMENT OF FORENSIC FIELD TESTS FOR GAMMA 
                   HYDROXYBUTYRIC ACID.

       [The Attorney General shall make a grant for the 
     development of forensic field tests to assist law enforcement 
     officials in detecting the presence of gamma hydroxybutyric 
     acid and related substances.]

     SEC. 5. CONTROLLED SUBSTANCES ANALOGUES.

       (a) Rule of Construction Regarding Controlled Substance 
     Analogues.--Section 102(32) of the Controlled Substances Act 
     (21 U.S.C. 802(32)) is amended--
       (1) in subparagraph (A), by striking ``subparagraph (B)'' 
     and inserting ``subparagraph (C)'';
       (2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       (3) by inserting after subparagraph (A) the following new 
     subparagraph (B):
       ``(B) The designation of gamma butyrolactone or any other 
     chemical as a listed chemical pursuant to paragraph (34) or 
     (35) does not preclude a finding pursuant to subparagraph (A) 
     of this paragraph that the chemical is a controlled substance 
     analogue.''.
       (b) Distribution With Intent To Commit Crime of Violence.--
     Section 401(b)(7)(A) of the Controlled Substances Act (21 
     U.S.C. 841(b)(7)(A)) is amended by inserting ``or controlled 
     substance analogue'' after ``distributing a controlled 
     substance''.

     SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS, 
                   FORENSIC FIELD TESTS, AND COORDINATION 
                   MECHANISM FOR INVESTIGATIONS AND PROSECUTIONS 
                   RELATING TO GAMMA HYDROXYBUTYRIC ACID, OTHER 
                   CONTROLLED SUBSTANCES, AND DESIGNER DRUGS.

       (a) In General.-- The Attorney General, in consultation 
     with the Administrator of the Drug Enforcement Administration 
     and the Director of the Federal Bureau of Investigation, 
     shall--
       (1) develop--
       (A) model protocols for the collection of toxicology 
     specimens and the taking of victim statements in connection 
     with investigations into and prosecutions related to possible 
     violations of the Controlled Substances Act or other Federal 
     or State laws that result in or contribute to rape, other 
     crimes of violence, or other crimes involving abuse of gamma 
     hydroxybutyric acid, other controlled substances, or so-
     called ``designer drugs''; and
       (B) model training materials for law enforcement personnel 
     involved in such investigations; and
       (2) make such protocols and training materials available to 
     Federal, State, and local personnel responsible for such 
     investigations.
       (b) Grant.--
       (1) In general.--The Attorney General shall make a grant, 
     in such amount and to such public or private person or entity 
     as the Attorney General considers appropriate, for the 
     development of forensic field tests to assist law enforcement 
     officials in detecting the presence of gamma hydroxybutyric 
     acid and related substances.
       (2) Authorization of appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this subsection.
       (c) Report.--Not later than 180 days after the date of the 
     enactment of this Act, the Attorney General shall submit to 
     the Committees on the Judiciary of the Senate and House of 
     Representatives a report on current mechanisms for 
     coordinating Federal, State, and local investigations into 
     and prosecutions related to possible violations of the 
     Controlled Substances Act or other Federal or State laws that 
     result in or contribute to rape, other crimes of violence, or 
     other crimes involving the abuse of gamma hydroxybutyric 
     acid, other controlled substances, or so-called ``designer 
     drugs''. The report shall also include recommendations for 
     the improvement of such mechanisms.

     [SEC. 6. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL 
                   AWARENESS CAMPAIGN.]

     SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL 
                   AWARENESS CAMPAIGN.

       (a) Annual Report.--The Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall periodically submit to Congress reports each of which 
     provides an estimate of the number of incidents of the abuse 
     of date-rape drugs (as defined in subsection (c)) that 
     occurred during the most recent one-year period for which 
     data are available. The first such report shall be submitted 
     not later than January 15, 2000, and subsequent reports shall 
     be submitted annually thereafter.
       (b) National Awareness Campaign.--
       (1) Development of plan; recommendations of advisory 
     committee.--
       (A) In general.--The Secretary, in consultation with the 
     Attorney General, shall

[[Page S14872]]

     develop a plan for carrying out a national campaign to 
     educate individuals described in subparagraph (B) on the 
     following:
       (i) The dangers of date-rape drugs.
       (ii) The applicability of the Controlled Substances Act to 
     such drugs, including penalties under such Act.
       (iii) Recognizing the symptoms that indicate an individual 
     may be a victim of such drugs, including symptoms with 
     respect to sexual assault.
       (iv) Appropriately responding when an individual has such 
     symptoms.
       (B) Intended population.--The individuals referred to in 
     subparagraph (A) are young adults, youths, law enforcement 
     personnel, educators, school nurses, counselors of rape 
     victims, and emergency room personnel in hospitals.
       (C) Advisory committee.--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary shall 
     establish an advisory committee to make recommendations to 
     the Secretary regarding the plan under subparagraph (A). The 
     committee shall be composed of individuals who collectively 
     possess expertise on the effects of date-rape drugs and on 
     detecting and controlling the drugs.
       (2) Implementation of plan.--Not later than 180 days after 
     the date on which the advisory committee under paragraph (1) 
     is established, the Secretary, in consultation with the 
     Attorney General, shall commence carrying out the national 
     campaign under such paragraph in accordance with the plan 
     developed under such paragraph. The campaign may be carried 
     out directly by the Secretary and through grants and 
     contracts.
       (3) Evaluation by general accounting office.--Not later 
     than two years after the date on which the national campaign 
     under paragraph (1) is commenced, the Comptroller General of 
     the United States shall submit to Congress an evaluation of 
     the effects with respect to date-rape drugs of the national 
     campaign.
       (c) Definition.--For purposes of this section, the term 
     ``date-rape drugs'' means gamma hydroxybutyric acid and its 
     salts, isomers, and salts of isomers and such other drugs or 
     substances as the Secretary, after consultation with the 
     Attorney General, determines to be appropriate.

     SEC. 8. SPECIAL UNIT IN DRUG ENFORCEMENT ADMINISTRATION FOR 
                   ASSESSMENT OF ABUSE AND TRAFFICKING OF GHB AND 
                   OTHER CONTROLLED SUBSTANCES AND DRUGS.

       (a) Establishment.--Not later than 60 days after the date 
     of the enactment of this Act, the Attorney General shall 
     establish within the Operations Division of the Drug 
     Enforcement Administration a special unit which shall assess 
     the abuse of and trafficking in gamma hydroxybutyric acid, 
     flunitrazepam, ketamine, other controlled substances, and 
     other so-called ``designer drugs'' whose use has been 
     associated with sexual assault.
       (b) Particular Duties.--In carrying out the assessment 
     under subsection (a), the special unit shall--
       (1) examine the threat posed by the substances and drugs 
     referred to in that subsection on a national basis and 
     regional basis; and
       (2) make recommendations to the Attorney General regarding 
     allocations and reallocations of resources in order to 
     address the threat.
       (c) Report on Recommendations.--
       (1) Requirement.--Not later than 180 days after the date of 
     the enactment of this Act, the Attorney General shall submit 
     to the Committees on the Judiciary of the Senate and House of 
     Representatives a report which shall--
       (A) set forth the recommendations of the special unit under 
     subsection (b)(2): and
       (B) specify the allocations and reallocations of resources 
     that the Attorney General proposes to make in response to the 
     recommendations.
       (2) Treatment of report.--Nothing in paragraph (1) may be 
     construed to prohibit the Attorney General or the 
     Administrator of the Drug Enforcement Administration from 
     making any reallocation of existing resources that the 
     Attorney General or the Administrator, as the case may be, 
     considers appropriate.

     SEC. 9. TECHNICAL AMENDMENT.

       Section 401 of the Controlled Substances Act (21 U.S.C. 
     841) is amended by redesignating subsections (d), (e), (f), 
     and (g) as subsections (c), (d), (e), and (f), respectively.
       Amend the title so as to read: ``An Act to amend the 
     Controlled Substances Act to direct the emergency scheduling 
     of gamma hydroxybutyric acid, to provide for a national 
     awareness campaign, and for other purposes.''.


                           Amendment No. 2784

                  (Purpose: To modify the short title)

  Ms. COLLINS. Mr. President, I send an amendment to the desk and ask 
for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Maine [Ms. Collins], for Mrs. Hutchison, 
     proposes an amendment numbered 2784.

  Ms. COLLINS. Mr. President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       On page 1, beginning on line 4, strike ``Samantha Reid and 
     Hillory J. Farias'' and insert ``Hillory J. Farias and 
     Samantha Reid''.
       On page 6, line 21, strike ``Samantha Reid and Hillory J. 
     Farias'' and insert ``Hillory J. Farias and Samantha Reid''.
       On page 7, line 12, strike ``Samantha Reid and Hillory J. 
     Farias'' and insert ``Hillory J. Farias and Samantha Reid''.

  Ms. COLLINS. Mr. President, I ask unanimous consent that the 
amendment be agreed to, the committee amendment, as amended, be agreed 
to, and the bill be read the third time. I further ask unanimous 
consent that the Senate proceed to the consideration of the House 
companion bill, H.R. 2130, all after the enacting clause be stricken 
and the text of S. 1561, as amended, be inserted in lieu thereof. I 
further ask that the bill be read the third time and passed, the motion 
to reconsider be laid upon the table, the amendment to the title be 
agreed to, and that any statements relating to the bill be printed in 
the Record. Finally, I ask that S. 1561 be placed back on the calendar.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 2784) was agreed to.
  The committee amendments, as amended, were agreed to.
  The bill (H.R. 2130), as amended, was read the third time and passed.
  The title was amended so as to read:
  ``An Act to amend the Controlled Substances Act to direct the 
emergency scheduling of gamma hydroxybutyric acid, to provide for a 
national awareness campaign, and for other purposes.''
  Ms. COLLINS. Mr. President, I yield to the distinguished Senator from 
Michigan, Mr. Abraham, who has been a real leader on this bill, for any 
comments he might have.
  The PRESIDING OFFICER. The Senator from Michigan is recognized.
  Mr. ABRAHAM. Mr. President, I wanted to make a few comments about the 
legislation we are about to pass. Before I do so, I would like to thank 
a number of people for their help in this effort.
  First, I would like to thank my colleagues who cosponsored this 
legislation: Senators Feinstein, Lieberman, DeWine, Grassley, 
Coverdell, and Graham. Their support was crucial to moving forward with 
this bill and doing so in a timely fashion. Second, I would like to 
thank Senator Hatch, his Judiciary Chief Counsel Manus Cooney, his 
Deputy Chief Counsel Sharon Prost, his Chief of Staff Patricia Knight, 
and Bruce Artim and Pattie DeLoatche, all of whose commitment to seeing 
this effort through to fruition I appreciate both for the advice and 
guidance they provided and as the act of friendship I recognize it to 
be. Third, I would like to thank Senator Biden and his staff, 
especially Marcia Lee, whose assistance and cooperation in working out 
a final version of this bill acceptable to all involved, including the 
Administration, was indispensable. I would also like to thank my good 
friend Fred Upton, who first brought the serious problem that is the 
focus of this legislation to my attention, and Congressman Bliley and 
his able staff, especially John Manthei, who patiently tolerated and 
assisted with the vagaries of bicameral legislative drafting. Finally, 
I would like to thank my own staff, especially my Subcommittee General 
Counsel Chase Hutto, who worked tirelessly and creatively on this 
effort, and Lee Otis, my Subcommittee Chief Counsel.
  S. 1561, and its counterpart, H.R. 2130, are named for a young woman 
by the name of Samantha Reid. Samantha was born in the Henry Ford 
Hospital in Detroit on January 2, 1984. She grew up in Lincoln Park. 
She played trumpet in her elementary school band. She was a girl scout 
for eight years, with the help of her mother, Judi Clark, who was a 
troop leader. She was an ``all star'' 6th grade baseball player. She 
went on to attend Carlson High School in Gibraltar, where she played 
freshman basketball. Her favorite restaurant was McDonald's, and her 
favorite meal there was a Big Mac. She loved to go to Cedar Point 
Amusement Park, and got mad if she couldn't go at least twice a year. 
She earned her spending money by helping around the house with chores 
and babysitting, and indeed, on February 11, 1995, she earned an award 
for outstanding performance in completing babysitting training from the 
City of Lincoln Park. Her mother called her ``Hammy Sammy'' because of 
the way she always smiled in pictures. Her older brother Charles Reid, 
who is 18, remembers and misses her loud voice.

[[Page S14873]]

  On January 17, 1999, Samantha died a few weeks after turning 15. She 
and two friends, none of them yet 16, were at a party given by a 25 
year-old man in Woodhaven, Michigan. Samantha Reid drank a Mountain 
Dew--a soft drink--and passed out within minutes. She vomited in her 
sleep, and she died. Her friend, Melanie Sindone, also 15, passed out 
as well. Melanie lapsed into a coma, but she has survived.
  These two girls had no reason to believe that they were drinking 
anything dangerous. But they were wrong. Their drinks had been laced 
with the drug GHB, commonly known as a ``date rape drug.'' Samantha was 
undoubtedly slipped it for the purpose that this name suggests, 
although she died before that purpose was accomplished.
  Mr. President, GHB and its analogues are becoming increasingly common 
in our nation. They are finding their way into nightclubs, onto 
campuses and into homes. They are being used by sexual predators 
against young--sometimes very young--women. Their unwitting victims may 
be raped, become violently ill, and even die.
  GHB is especially dangerous because it is relatively easy to produce. 
According to the DEA, the clandestine synthesis involves the use of two 
common, non-regulated chemicals: gamma-butyrolactone (GBL), the primary 
precursor chemical, and sodium hydroxide (lye). GBL is a solvent with a 
wide range of industrial uses. Tens of thousands of metric tons are 
produced annually and it is readily available from chemical supply 
companies. The synthesis is a simple one-pot method requiring no 
special chemical expertise. In addition, kits for making GHB containing 
GBL and sodium hydroxide are being sold on the Internet. GBL, once 
absorbed from the gastrointestinal tract after oral administration, is 
readily converted to GHB in the body and produces the same profile of 
physiological and behavioral effects as GHB. The combination of the 
ease with which GHB can be produced and widespread ignorance about 
GHB's dangers especially among our nation's youth has led the law 
enforcement community to view GHB as a serious and growing threat.
  The Controlled Substances Act provides an administrative mechanism 
for the Attorney General, in consultation with the Secretary of HHS, to 
place dangerous substances susceptible of abuse on a ``schedule'' of 
controlled substances, thereby restricting access to them and imposing 
criminal penalties for their illicit sale and manufacture. The Attorney 
General and the Secretary are in agreement that GHB should in fact be 
scheduled, but they are in disagreement over which schedule it should 
be placed on. This is because GHB is currently under investigational 
use as a means of treating narcolepsy and cataplexy, afflictions 
affecting about 70,000 Americans, and HHS has been understandably 
reluctant to agree that GHB belongs on Schedule I or II, which would 
carry the most serious penalties for illicit sale, because the security 
requirements that would accompany such scheduling would interfere with 
this medical research. On the other hand, the DEA has been 
understandably reluctant to agree to any lesser scheduling, because the 
result would be lower penalties for the unauthorized sale and 
distribution of this drug. Moreover, under the Controlled Substances 
Act, the fact that GHB is under investigation for possible medical use 
precludes the Attorney General from using her emergency authority to 
schedule it as an ``imminent hazard to the public safety.''
  The result has been an administrative deadlock that has resulted in a 
complete failure to schedule GHB at all. Hence legislative intervention 
is needed.
  This legislation has been drafted as a specific response to these 
various competing considerations, which the current scheduling 
categories are not all that well suited to handle in any event. 
Notwithstanding the current investigational medical use, the 
legislation determines that GHB is an imminent hazard to public safety. 
It therefore directs the Attorney General to place it on the schedule 
on which imminent hazards are ordinarily placed, which is Schedule I. 
It relaxes the physical security requirements that would ordinarily 
apply to Schedule I substances for the investigational medical uses of 
the drug, however, following the recommendation of the Secretary of HHS 
on what is appropriate in that area and thereby avoiding interfering 
with the ongoing research. It also makes clear that should this 
research pay off with a drug that the FDA approves because it concludes 
that it can responsibly be prescribed to treat narcolepsy, cataplexy, 
or other diseases, the FDA approved drug will be classified as a 
Schedule III drug, although the Attorney General can impose additional 
record keeping requirements to help assure that it is not diverted to 
improper uses. Finally, anyone involved in selling or distributing the 
diverted product will be subject to the same tough ``Schedule I'' 
penalties that apply to the sale or distribution of the illicit or 
unapproved drug.
  In practice, this means that while medical research will continue 
unhampered by the most cumbersome consequences of placing this drug in 
Schedule I, the harsh penalties provided for the sale, manufacture, and 
distribution of all Schedule I substances will apply to any and all 
illicit trafficking in GHB, whether the drug originated in a bathtub or 
a medical facility. This means that traffickers will be subject to a 20 
year statutory maximum for distributing this drug, and that if, as in 
the case of Samantha Reid, the drug is slipped to someone who dies, or 
if it is slipped to someone who is raped or suffers serious bodily 
injury, that 20 year maximum become a 20 year minimum.
  This legislation also addresses three other major problems society 
has had in responding to the threat posed by this drug. First, it would 
require the Attorney General to develop, and make available to Federal, 
State, and local authorities, model protocols for taking toxicology 
specimens and victim statements in connection with suspected crimes 
involving GHB and other controlled substances or so-called designer 
drugs. The Attorney General also would be required to provide training 
materials for law enforcement officials responsible for investigating 
these offenses. And finally, she would be directed to make a grant for 
the development of standardized tests that could be used in the field 
to test for the presence of these drugs.
  The reason for these requirements is that even many in law 
enforcement are unfamiliar with the operation of GHB. As a result, they 
may defer testing for it or taking victim statements on the mistaken 
assumption that the victim is drunk and will be more coherent later, 
whereas in fact this drug can be processed very quickly by the body and 
no longer be detectable at that time. Moreover, the victim's memory may 
be impaired by the substance and she may forget events that she would 
have remembered had her statement been taken more quickly. Hence the 
need for model protocols, training, and tests.
  Second, the legislation directs the Secretary of HHS to conduct a 
National Awareness Campaign about the dangers of GHB. Consciousness of 
the dangers of this drug is lagging far behind the threat the drug 
presents, and it is critical that we make it a national priority to 
remedy that problem.
  Finally, the legislation would direct the Attorney General to examine 
and recommend improvements to current mechanisms for coordinating 
federal, state and local investigations and prosecutions in this area. 
And it would establish a special unit within the DEA to assess the 
federal response to the abuse and trafficking of GHB, other controlled 
substances, and other designer drugs associated with sexual assault, 
recommended any reallocations of enforcement resources necessary to 
improve that response, and direct the Attorney General to make any such 
reallocations she believes are appropriate.
  It is time to act, Mr. President, to save young people, and young 
women in particular, from these deadly drugs and the predators who use 
them.
  I ask my colleagues to give their full support to this amendment.
  I also ask unanimous consent that a number of letters from families 
and victims of date-rape drugs be printed in the Record.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:


[[Page S14874]]


         Trinka D. Porrata, Designer Drugs--Teaching & Consulting,
                                    Pasadena, CA, October 3, 1999.
     Senator Spencer Abraham,
     329 Dirksen Senate Office Building,
     Washington, DC.
       Dear Senator Abraham: I'm writing in support of Senate Bill 
     1561. For four years, my life has revolved around a world of 
     drug abuse little known by law enforcement, medical 
     personnel, politicians and parents. I've watched MDMA explode 
     worldwide in the rave, college and club scenes. I've seen 
     flunitrazepam (Rohypnol, aka roofies) make its mark on sexual 
     assaults. I've seen LSD resurface. And, I've watched in 
     horror as the drug gamma hydroxy butyrate (GHB) has marched 
     coast to coast, plucking out young lives in its path, picking 
     up momentum as it goes. I consider it simply the most 
     dangerous drug I've encountered in 25 years as a police 
     officer. This is because of the overwhelming amount of 
     misinformation spread about GHB, the dramatic lack of real 
     scientific knowledge of it,the difficulty in testing for it 
     and recognizing it in the street, and how easily and 
     unpredictably it kills. GHB is indeed the Bad Child of the 
     Internet. And, it has forever change the face of sexual 
     assault investigations.
       Despite a world brimming with technology and communication 
     devices, knowledge of this drug has been based primarily on 
     information via the Internet that runs the gamut from 
     outdated to totally false. Any drug abuser or drug pusher can 
     go on the Internet and pump out volumes of lies and half 
     truths unabated. There are thousands of websites claiming GHB 
     to be the wonder drug that will cure anything you can think 
     of and instructing everyone NOT to call 911 for the victim of 
     a GHB overdose. Deadly advice indeed. Meanwhile, government, 
     law enforcement and the medical world have failed to make 
     significant gain in countering the flood of bad information, 
     identifying and making available accurate testing methods 
     for it and providing even the most basic education about 
     GHB. The ``system'' has truly failed the American public 
     on this drug. As a friend of Samantha Reid, the 15-year-
     old Michigan victim of GHB, so aptly put it, ``You tell us 
     every day about marijuana and other drugs. Why didn't you 
     tell us about GHB?'' Daily, I am asked by the families who 
     have lost loved ones to GHB--``I've never heard of this 
     drug. Why, why didn't we know about this drug?''
       Each day that GHB is not a federally controlled substance 
     is another day of failure by the ``system.'' No, controlling 
     a drug does not solve the problem, but it allows additional 
     resources to be plugged into the tasks of educating the 
     public, providing more standardized information to law 
     enforcement, and developing testing procedures. It would be a 
     giant step toward stopping the lies about GHB as a totally 
     safe, wonder drug.
       There isn't a meaningful data collection mechanism to 
     capture drug trends like this. Existing systems are 
     cumbersome, far behind in reporting statistics, and non-
     responsive to changing trends. In early 1997, the tally of 
     GHB-related deaths kept by the Drug Enforcement 
     Administration was seven. We knew that there was no way to 
     put a figure on the possible number of deaths related to GHB 
     where neither law enforcement nor the coroners knew to test 
     for it. During our hearings before the California 
     Legislature, Dennis Fraga showed up on the witness list. He 
     arrived with autopsy report in hand, showing that his 25-
     year-old son, Jeffery, had died from alcohol and GHB 
     ingestion. We realized that if we hadn't known about this 
     death, there were undoubtedly more where the coroner knew 
     that GHB was involved but hadn't known to report it to 
     anyone. Dr. Jim Tolliver, who was at that time tracking GHB 
     information for the DEA, began to make inquiries around the 
     country, and the death count rapidly jumped to 26. The death 
     toll continued to slowly increase, based on word of mouth, 
     followed by the DEA obtaining a copy of the autopsy to review 
     before including each death in the tally. Still, there was no 
     reporting mechanism, no blanket means of obtaining 
     information. Despite DEA polling its offices, where knowledge 
     of this drug was limited by DEA agents and local authorities, 
     it was obvious that not all cases were being spotted. I have 
     personally worked closely with Dr. Chris Sannerud, who is now 
     tracking GHB data for the DEA, and have referred numerous 
     leads about deaths to her for investigation.
       The count recently jumped to 49. I would like to point out 
     to you that of the 49, ten have been in 1999. Furthermore, 25 
     additional cases have come to light, all but one of them in 
     1999. These cases are now being reviewed. That would mean 
     more than 30 in 1999 to date. The victims get younger. More 
     of them involve GHB and its analogs only (no alcohol or other 
     drugs). I receive leads on GHB related death and rape cases 
     virtually daily. And, we have only scratched the surface at 
     this point. Law enforcement, legislators, doctors and parents 
     are still largely unfamiliar with GHB. Remember too, these 
     figures do not reflect the victims of impaired drivers under 
     the influence of GHB.
       Meanwhile, the drug company and the pro-drug abuse element 
     want to divert attention saying that it is the homebrew 
     aspect of GHB that is the problem and that it is only 
     dangerous with alcohol and other drugs. The homebrew aspect 
     occasionally adds an extra element of burns from high pH 
     levels. But that isn't the problem. It is GHB that impairs, 
     resulting in dangerous  users behind the wheel causing 
     accidents and deaths and resulting in victims unable to 
     protect themselves from sexual assault. Look beyond the 
     smoke and mirrors. The fact remains: 25-year-olds don't 
     die from a .17 blood alcohol; Jeffery Fraga died that 
     night BECAUSE he took GHB. Samantha Reid was drinking a 
     Mountain Dew the night she died. And 20-year olds don't 
     die from sleeping face down on a pillow . . . unless in 
     coma from GHB ingestion. Kyle Hagmann took it as a sleep 
     aid (after reading on the Internet that it is ``totally 
     safe''), not a recreational drug. It is GHB that kills.
       Not nearly enough is known about this drug from a medical 
     and scientific viewpoint. The literature is old and outdated. 
     New information is being learned daily and still not nearly 
     enough is known. The old literature says GHB is not 
     addictive. We know this to be untrue. In fact, withdrawal 
     from GHB addiction is life threatening. This is simply not a 
     market-ready product--any drug that is leaving 13-year olds 
     suffering pulmonary edema in our nation's hospitals and 
     alleys is not ready for market. One doctor with nine years of 
     GHB research walked away from it, saying a much safer, longer 
     acting product is needed. One doctor currently researching 
     GHB for narcolepsy first told me personally that it was eight 
     to ten years away for being ready and changed his story only 
     after claims were publicized that the supply would cease for 
     research if it became a Schedule I drug. There is simply no 
     reason to give concessions to future issues re this drug. Let 
     the research take its course and determine the future. Other 
     drugs have been developed in Schedule I. I personally do not 
     believe it will be GHB, but a safer, longer acting cousin 
     that is yet to be developed. Don't let them bypass proper 
     research and development!!!!!
       I have no doubt that if GHB is ever approved for 
     narcolepsy, the horror of abuse will only skyrocket as 
     doctors blatantly abuse the controversial, dangerous ``off 
     label use'' policy that would enable them to prescribe it for 
     anything, not just the combination of narcolepsy and 
     cataplexy of which it is being researched. There is simply no 
     mechanism in place that will prevent such abuse (there is 
     plenty of evidence of abuse of other drugs because of this 
     policy). And, I cannot imagine in my wildest dreams a company 
     saying, ``Oh excuse me, we are making too much money!!!!'' If 
     the Legislature is determined to deal with future issues, 
     then I adamantly urge that this drug be specifically excluded 
     from the ``off label use'' policy. Any use of GHB beyond 
     narcolepsy/cataplexy would require its own proper research 
     and development. If, as the drug company claims, their only 
     interest is for narcolepsy/cataplexy patients, then there is 
     simply no reason they would protest such a clause being 
     included.
       There is much work to be done on this drug in all arenas. 
     The dangers of GHB need to made crystal clear to America's 
     youth and parents. Law enforcement, prosecutors and medical 
     personnel are not uniformly prepared to handle cases 
     involving GHB. GHB has brought to the sexual assault 
     investigation a unbelievably challenge to overcome and an 
     added horror for rape victims that I cannot even begin to 
     address in this document. As a start, we need to standardize 
     all sexual assault medical kits nationwide to include urine 
     samples from victims and upgrade investigative and testing 
     procedures. Changes need to be made in the impaired driving 
     world as well. Aggressive federal/state prosecution is needed 
     against manufacturers and distributors of GHB and analogs.
       The GHB death toll speaks for itself. Legislation and 
     strong federal backing for education and enforcement is 
     clearly overdue and urgently needed.
           Sincerely,
                                                Trinka D. Porrata,
     Drug Consultant.
                                  ____

     To the members of the judiciary committee:
       On Jan. 17, 1999 I lost my only daughter, Samantha Reid, 
     when GHB and/or GBL was slipped into her Mountain Dew soft 
     drink. I knew nothing about GHB before this tragic event. I 
     took six months off of work and began educating myself on 
     GHB. The more I learn about this invisible predator the more 
     concerned for our nations safety I become.
       I have joined Spencer Abraham on campaigning to pass S. 
     1561. This bill is long overdue in our country and contains 
     many positive programs for awareness and will give law 
     enforcement the much needed tools necessary to prosecute GHB 
     cases. S. 1561 will allow for education targeting teens who 
     are now receiving false information on GHB. A nation wide 
     awareness campaign will give many young ladies the 
     information necessary to protect and ultimately save 
     themselves from GHB. Parents can be reached through public 
     service announcements giving them the opportunity to 
     communicate the dangers of GHB to their children.
       Samantha and I were not given the opportunity that S. 1561 
     has to offer.
       Lets not wait for one more senseless death before passing 
     this legislation. Not one more mother should have to water 
     the grass of a fresh grave, or place wind chimes on a tender, 
     young tree planted to shade the site of their daughter. 
     Pumpkins for Halloween should be carved at the kitchen table 
     together, not placed by a headstone.
       Our country is in desperate need of all the good this bill 
     has to offer.
           Respectfully,
                                                       Judi Clark,
                                               Rockwood, Michigan.

  Mr. ABRAHAM. Mr. President, I would like to close by reading one of

[[Page S14875]]

those letters, the letter I received from Judi Clark, Samantha Reid's 
mother, that, better than anything I can say, makes the case as to why 
this legislation is needed now. She wrote this letter to the members of 
the Senate Judiciary Committee.
  It is as follows:

     To the Members of the Senate Judiciary Committee:
       On January 17, 1999, I lost my only daughter, Samantha 
     Reid, when GHB and/or GBL was slipped into her Mountain Dew 
     soft drink. I knew nothing about GHB before this tragic 
     event. I took six months off of work and began educating 
     myself on GHB. The more I learned about this invisible 
     predator the more concerned for our nations safety I become.
       I have joined Spencer Abraham on campaigning to pass S. 
     1561. This bill is long overdue in our country and contains 
     many positive programs for awareness, and will give law 
     enforcement the much needed tools necessary to prosecute GHB 
     cases. S. 1561 will allow for education targeting teens who 
     are now receiving false information on GHB. A nationwide 
     awareness campaign will give many young ladies the 
     information necessary to protect and ultimately save 
     themselves from GHB. Parents can be reached through public 
     service announcements giving them the opportunity to 
     communicate the dangers of GHB to their children.
       Samantha and I were not given the opportunity that S. 1561 
     has to offer. Lets not wait for one more senseless death 
     before passing this legislation. Not one more mother should 
     have to water the grass of a fresh grave, or place wind 
     chimes on a tender young tree planted to shade the site of 
     their daughter. Pumpkins for Halloween should be carved at 
     the kitchen table together, not placed by a headstone.
       Our country is in desperate need of all the good this bill 
     has to offer.
           Respectfully,
                                                       Judi Clark,
                                               Rockwood, Michigan.

  Mr. President, I would say in closing that I am happy we have finally 
taken the action which Judi Clark and other parents across this country 
have been asking us to take, to make sure that other children will be 
made aware of the dangers of GHB. Hopefully the predators who use drugs 
such as this will be treated in the fashion they deserve, which is to 
be prosecuted effectively and put behind bars where they belong.
  No one else should have to go through what this family has suffered.
  I am very determined to not only see this legislation pass, but also 
to work closely with the Department of Justice, the Drug Enforcement 
Agency, and State and local law enforcement agencies, to make sure this 
is just the first step in what will ultimately be a successful campaign 
to rid this Nation of the illicit use of this drug, and to make sure 
the children of our country are no longer the victims of predators who 
use it for criminal purposes.
  I yield the floor.
  The PRESIDING OFFICER. The Chair recognizes the Senator from Maine.
  Ms. COLLINS. Mr. President, I commend the Senator from Michigan for 
his leadership and his eloquent statement.
  Mr. HATCH. Mr. President, Today, the Senate adopted a significant 
measure against date rape and other heinous crimes associated with 
abusing certain types of drugs. I want to make a few comments on this 
bill, S. 1561, which addresses the abuse of the dangerous drug GHB 
which has been used to commit date rape and other crimes.
  As Chairman of the Senate Judiciary Committee, I am proud that it was 
a member of our Committee, Senator Spencer Abraham, who introduced and 
has played the key leadership role in Senate passage of S. 1561, The 
Samantha Reid and Hillory J. Farias Date Rape Prohibition Act of 
1999.'' I am also proud that other members of the Judiciary Committee, 
Senators DeWine, Feinstein, and Grassley have joined Senator Abraham in 
co-sponsoring this legislation.
  It is only through the hard work and insistence of Senator Abraham 
that this bill will pass the Senate today. I also want to commend his 
able staff, especially Lee Otis and Chase Hutto, who have spent 
considerable time and effort in improving this legislation. Their 
efforts were in the best tradition of staff of the United States 
Senate.
  I also want to thank my friend on the other side of the aisle, 
Senator Biden, who has long been in the forefront of controlled 
substances and other drug abuse issues. I must also recognize the 
efforts of Ms. Marcia Lee of his staff for her diligence and creativity 
in developing this language.
  I must also recognize the efforts of Chairmen Thomas Bliley and Fred 
Upton for their work in developing and sheparding the House companion 
to S. 1561, H.R. 2310, through that body. In this regard, I must 
mention the efforts of John Manthei of the House Commerce Committee as 
well as Ms. Jane Williams of Rep. Upton's staff. Both of them deserve 
recognition for their dedication to passing this bill.
  S. 1561 is concerned with the proper regulation of gamma hydrobutyric 
acid, the chemical known on the street as GHB which has both hateful 
and hopeful uses. On one hand, many families across America have 
suffered due to abuse of this agent which has been used to lull 
unsuspecting women into a date-rape situation and has even resulted in 
death through overdose. On the other hand, GHB holds unprecedented 
promise to those one-quarter million Americans suffering from extreme 
sleep disorders such as cataplexy and narcolepsy.
  Cataplexy is a debilitating condition suffered by some 70,000 
Americans that results in an inability of the muscles to function. 
Narcolepsy, which attacks 170,000 Americans, causes a person suddenly 
and unpredictably to fall asleep. Neither of these terrible diseases 
have an effective treatment today. As author of the 1984 Orphan Drug 
Act which creates incentives for private sector drug firms to 
investigate treatments for rare diseases, I am particularly sensitive 
to the needs of families suffering from low-prevalence conditions. We 
need to do everything we can to get academic researchers and the 
pharmaceutical industry to find cures for the hundreds of currently 
untreatable rare diseases.
  The problem for policymakers, both in the Congress and at the DEA, is 
how to encourage the use of the medically promising uses of GHB while 
discouraging and outlawing the illicit uses such as date rape.
  While there are no known cases of diversion of this drug from the on-
going and highly promising clinical trials of GHB as a treatment for 
cataplexy and narcolepsy, the problem of GHB abuse demands our 
attention.
  According to DEA, hospital and law enforcement officials have 
reported about 5,500 cases of GHB abuse, including 49 deaths. Aggregate 
statistics, as alarming as they may be, cannot convey the absolute 
upheaval that GHB abuse can cause for an individual and a family.
  Senator Abraham has told me the story about the untimely death of a 
bright and vivacious 15-year-old young woman from Michigan, Samantha 
Reid. She went to a small gathering of friends, was given a drink from 
a soft drink bottle laced with GHB, and died. Samantha did nothing 
wrong. Her mother, Judi Clark, did nothing wrong. Unfortunately, this 
tragedy has struck this family.
  Four young men have been charged under Michigan law for involuntary 
manslaughter and poisoning. But, given the prevalence and, as the Reid 
case highlights, the potential severity of GHB abuse, it seems clear--
and both public health and law enforcement officials agree on this--
that this chemical warrants regulation under the Controlled Substances 
Act. That's exactly what S. 1561 and its House companion accomplish.
  Some may raise a question about whether the federal Controlled 
Substances Act failed to operate in a fashion that could have prevented 
deaths or sexual assaults through abuse of GHB.
  Although there have been reports of substantial GHB abuse for several 
years now, I do not know why the Attorney General and Secretary of 
Health and Human Services have been unable to resolve the matters that 
have precluded this drug from being scheduled through the normal 
procedures under the Controlled Substances Act. I don't know why it 
took until September of 1997 for the DEA to request FDA to analyze the 
medical and scientific matters relating to GHB. I don't know why it 
took until May 19, 1999 to get a response to this request. I don't know 
why DEA has not acted in the last six months to bring this matter to a 
conclusion through administrative means. It should not take an act of 
Congress to schedule a dangerous drug under the Controlled Substances 
Act.

  I do know that part of the unjustifiable delay in the scheduling of 
GHB

[[Page S14876]]

stemmed from the fact that there is a difference of opinion between DEA 
and FDA about how to schedule this drug. But that answer is not good 
enough. It is simply inadequate to tell a mother of a child like 
Samantha Reid, a promising young woman with her whole life ahead of 
her, that the system ``just takes time'' because two bureaucracies 
disagreed about how something so serious should be handled.
  This situation points out that a significant breakdown in the system 
has occurred with respect to the scheduling of GHB. It behooves the 
Congress to deliberate more over ways to make the key agencies, DEA and 
FDA, be more responsive in the future, rather than be forced to do 
their jobs for them. The lesson of GHB should not be to teach the 
agencies to wait for Congressional action whenever the bureaucracy 
cannot act.
  Let me just say that as a general matter I do not favor legislative 
scheduling or rescheduling. By statute, the responsibility for 
scheduling is delegated to the experts at DOJ and HHS. The world is 
turned upside down when DOJ informs Congress, as if did on May 3, 1999, 
that: ``DOJ believes that it is appropriate for Congress to schedule 
GHB at this time.''
  By any measure, a fair reading of the Controlled Substances Act 
places the primary responsibility for regulating dangerous drugs upon 
law enforcement and public health experts at the appropriate federal 
agencies. I do have a concern about Congress legislating on the safety 
and efficacy of individual drug products, especially before clinical 
testing or introduction into commerce commences. Nor should we allow 
the Congress to be placed in the position of making technical, 
scientific and law enforcement judgment whenever an individual drug 
product with an actual or potential legitimate medicinal use is 
determined by experts to warrant the application of the CSA.
  I am firmly behind efforts to stop so-called ``date rapes,''; this is 
a despicable crime and the Federal Government should take action to 
make sure it does not occur. While I wholeheartedly applaud the efforts 
of the House to strike a blow against abuse of GHB, I am concerned 
about Congress getting directly involved in the scheduling process as 
the House mandated in adopting H.R. 2130. In this regard, it was my 
strong sense that rather than for Congress to legislatively schedule 
GHB, it would have more impact to amend the statute and direct DEA to 
implement the Surgeon General's recommendations that were issued back 
on May 19, 1999.
  I will not take the time today to consider the full implications of a 
policy of legislative rescheduling. I do plan in the future to re-
examine the scheduling provisions of the Controlled Substances Act.
  At this point, let me elaborate further on some of the issues I have 
raised.
  Subsections (b) and (c) of section 201 of the Controlled Substances 
Act identify eight criteria that must be taken into account in 
scheduling a drug. With respect to scheduling a drug, these factors 
are:

       (1) Its actual or relative potential for abuse.
       (2) Scientific evidence of its pharmacological effect, if 
     known.
       (3) The state of current scientific knowledge regarding the 
     drug or other substance.
       (4) Its history and current pattern of abuse.
       (5) The scope, duration, and significance of abuse.
       (6) What, if any, risk there is to the public health.
       (7) Its psychic or physiological dependence liability.
       (8) Whether the substance is an immediate precursor of a 
     substance already controlled under this title.

  The statute proscribes that.

       The recommendations of the Secretary (of Health and Human 
     Services) to the Attorney General shall be binding on the 
     Attorney General as to such scientific and medical matters, 
     and if the Secretary recommends that a drug or other 
     substance not be controlled, the Attorney General shall not 
     control the drug or other substances.

  This is the section of the law which appears not to have functioned 
optimally in the case of GHB. We can, and should, do better in 
anticipating and combating the next GHB.
  To a large degree, the legislation we adopt today implements the May 
19, 1999 HHS recommendations and the accompanying ``Eight Factor 
Analysis Report'' that take into account both the illicit abuse of GHB 
as well as the highly promising legitimate uses of this substance. 
While I believe that the language worked out by Senators Abraham and 
Biden, Chairman Bliley, Chairman McCollum, and the DEA, is preferable 
to the earlier versions of the bill, I remain troubled by some aspects 
of how the current statute has worked and may work in the future.

  First, I am troubled that if we place promising pharmaceutical 
candidates such as GHB into Schedule I of the Controlled Substance Act 
we undermine its integrity of the CSA and will discourage the 
legitimate, potential life-saving uses of such compounds. According to 
the statute, one of the three requirements of schedule I is that there 
is ``no accepted medical use'' in the United States. But the May 19, 
1999 HHS recommendation has already found that the cataplexy product 
has cleared this hurdle:

       . . . the abuse potential of GHB, when used under an 
     authorized research protocol, is consistent with substances 
     typically controlled under Schedule IV . . . An authorized 
     formulation of GHB is far enough along in the development 
     process to meet the standard under Schedule II of a drug or 
     substance having a ``currently accepted medical use with 
     severe restrictions.'' Under these circumstances, HHS 
     recommends placing authorized formulations of GHB in Schedule 
     III.

  On October 12, 1999 DOJ sent a letter that disregards the May 19th 
HHS schedule III recommendation. DOJ first states ``. . . the DEA 
strongly supports the control of GHB in Schedule I of the CSA'' and 
then asserts: ``The data collected to date would support control of the 
GHB product in Schedule II.''
  Second, in addition to giving no apparent deference to HHS on matters 
supposedly binding on DOJ under section 201(b) of the CSA, DOJ almost 
seems to be interpreting the statute as requiring full FDA approval 
before the ``currently accepted medical use'' language of the CSA can 
be satisfied. Such an outcome is neither compelled by the statute, nor 
does it reflect sound public health policy as it acts to discourage 
drug development and patient access to promising drugs in clinical 
trials.
  I hasten to point out that I have advocated stiffening the penalties 
for abuse of date-rape drugs such as GHB. In 1997 I successfully led 
the charge to enact a law that imposed schedule I-level penalties for 
another date rape drug, flunitrazepam. This product was marketed for 
legitimate medical purposes overseas and did not meet the Schedule I 
requirement that ``there is lack of accepted safety for use of the drug 
or other substance under medical supervision.'' Therefore, the Congress 
passed, and the President signed, my legislation to increase the 
penalties for this drug. But we stopped short of scheduling the 
pharmaceutical into Schedule I, recognizing that the product does have 
accepted medical uses. It was my hope that this could be the model for 
GHB legislation as well.
  I want to work constructively with my colleagues in Congress to 
achieve our common goals of taking immediate action against GHB, 
preserving the integrity of the CSA, and sending a strong message to 
those agencies charged with implementing the CSA that they must work 
together in a cooperative and expeditious way to protect the American 
public.
  While I think the bill we adopt today might have been written 
differently, I agree with my colleagues that our foremost goal must be 
to take quick and decisive action with respect to the criminalization 
of GHB used for non-medical purposes. Senator Abraham's bill is a good 
bill and he deserves a lot of credit for putting this improved 
legislative package together.
  Let me also note that the bill we have just passed includes language 
I drafted requiring DEA to create a Special Unit to assess the abuse 
and trafficking of GHB and other date rape drugs, and will identify the 
threat posed by date rape drugs on a national and regional basis. I am 
pleased to be the sponsor of S. 1947, the bill that creates this 
Special Unit. S. 1947 has been incorporated in the final language that 
we adopt today. I can assure all my colleagues that this is one Senator 
that will closely review the Attorney General's report on the 
allocation and reallocation of resources to combat date rape and other 
crimes related to designer drugs.
  We can and should look further into the problems associated with the

[[Page S14877]]

scheduling of drugs under CSA and whether we need to change the 
relevant laws. But today we honor the memory of Hillory Farias and 
Samantha Reid by taking an act that will hopefully reduce the risk of 
GHB abuse being visited upon unsuspecting women.

                          ____________________