[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
                            DATE RAPE DRUGS

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 11, 1999

                               __________

                            Serial No. 106-7

                               __________

            Printed for the use of the Committee on Commerce


                                


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                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff
                   James D. Barnette, General Counsel
      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

JOE BARTON, Texas                    RON KLINK, Pennsylvania
CHRISTOPHER COX, California          HENRY A. WAXMAN, California
RICHARD BURR, North Carolina         BART STUPAK, Michigan
  Vice Chairman                      GENE GREEN, Texas
BRIAN P. BILBRAY, California         KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee                   (Ex Officio)
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Adatsi, Felix, Toxicology Unit, Michigan State Police........    39
    Bane, Paul, Drug Enforcement Command, Maryland State Police..    38
    Dyer, Jo Ellen, Assistant Clinical Professor of Pharmacy, 
      University of California at San Francisco Bay Area Regional 
      Poison Control Center......................................    34
    Engel, Patti, Orphan Medical, Inc............................    88
    Faistenhammer, G. Mark, Detective, Grosse Ile Police 
      Department.................................................    26
    Jackson-Lee, Hon. Sheila, a Representative in Congress from 
      the State of Texas.........................................    13
    Maher, Patricia L., Civil Division, Department of Justice....    54
    Porrata, Trinka, D., designer drug consultant................    29
    Pruett, Candace, accompanied by Lugene Pruett, Commonwealth 
      of Virginia................................................    24
    Reuter, Nicholas, Associate Director, Domestic and 
      International Drug Control Office of Health Affairs, Food 
      and Drug Administration....................................    66
    Snyder, Denise, DC Rape Crisis Center........................    42
    Woodworth, Terrance W., Deputy Director, Office of Diversion 
      Control, Drug Enforcement Administration...................    58
    Zukin, Stephen, Director, Clinical and Services Research, 
      National Institute on Drug Abuse, National Institutes of 
      Health.....................................................    73
Material submitted for the record by:
    Meyers, Abbey S., President, National Organization for Rare 
      Disorders, prepared statement of...........................    99
    Plaisier, Melinda, Interim Associate Commissioner for 
      Legislative Affairs, Department of Health & Human Services, 
      letter dated April 27, 1999, enclosing response for the 
      record.....................................................   100

                                 (iii)


                            DATE RAPE DRUGS

                              ----------                              


                        THURSDAY, MARCH 11, 1999

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                                     Committee on Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:30 a.m. in 
room 2322, Rayburn House Office Building, Hon. Fred Upton 
(chairman) presiding.
    Members present: Representatives Upton, Burr, Whitfield, 
Bryant, Bliley (ex officio), Klink, Stupak, Green, McCarthy, 
Strickland, DeGette, and Dingell (ex officio).
    Staff present: Alan Slobodin, majority counsel; Chuck 
Clapton, majority counsel; Jason C. Foster, legislative clerk; 
and Chris Knauer, minority investigator.
    Mr. Upton. Welcome, everyone. Today this subcommittee will 
hear testimony and gather facts on a growing public health and 
safety problem, so-called date rape drugs.
    I want to particularly thank full committee Chairman Tom 
Bliley for supporting this hearing. I also want to recognize 
and thank our colleagues Sheila Jackson-Lee and Bart Stupak for 
their early leadership that they have shown on this issue, and 
our ranking member, Ron Klink, for his genuine concern that I 
know he shares about this growing problem.
    The reality of this problem hit me hard several weeks ago 
when I heard about what happened to two young women in my home 
State of Michigan. While they were at a party, their beverages 
were laced with GHB, probably without their knowledge. 
Tragically, 15-year-old Samantha Reid and her friend lapsed 
into a coma, and Samantha died.
    I am the father of an 11-year-old daughter, and I can only 
imagine what Samantha's family and friends have endured, and I 
want to join with Sheila Jackson-Lee and Bart Stupak for what I 
hope every member of this subcommittee today will do in 
committing themselves to doing whatever they can to prevent 
tragedies like this from occurring in the future, for I cannot 
imagine a worse nightmare for any parent.
    What are date rape drugs? Date rape drugs are a popular 
reference to lethal street drugs that people may use to get 
high or to incapacitate women and make them utterly vulnerable 
to sexual assault. These drugs can induce a deep, anesthetic-
type sleep.
    We know many drugs are used to facilitate rape, but the 
most commonly encountered drugs in drug-facilitated rapes are 
GHB, Ketamine, and Flunitrazepam. The victim blacks out, 
experiences amnesia, and by the time the victim wakes up and 
gets to the hospital, it may be too late to detect even the 
presence of the drug because the drug moves so rapidly through 
their system.
    I want to clarify that date rape drugs are in many cases a 
misnomer. They may be used by near strangers or others to 
incapacitate young women.
    A few years ago, Rohypnol, a prescription anesthetic drug 
sold in many foreign countries, was the leading date rape drug. 
Thanks to restrictions on its import, Federal controls and 
changes that the manufacturer made to it makes it less easy now 
to abuse it as a date rape drug. Rohypnol no longer is a big 
part of the problem. Now it is GHB, and to some extent 
Ketamine, which are the leading date rape drugs.
    What makes GHB a particularly fast-growing problem is the 
availability of its ingredients: hundreds of Internet sites. In 
fact, we have an example here, a demonstration. Maybe if we can 
just dim the lights? Darlene, can you just--thanks.
    Hundreds of Internet websites promoting GHB and others 
offer ingredient kits and recipes for making it and the 
difficulty in detecting this drug. Neither GHB nor Ketamine is 
under Federal control.
    The DEA has documented over 3,500 overdoses in law 
enforcement encounters with GHB and more than 32 GHB-related 
deaths since 1990. According to the Drug Abuse Warning Network, 
GHB-related hospital emergency department episodes increased 
from 20 in 1992 to 629 in 1996. Clearly the status quo is 
entirely unacceptable.
    In today's hearing, I want us to focus on what additional 
steps should and could be taken at the Federal and State levels 
to protect our vulnerable young people from the vile misuse of 
these substances.
    We have impressive witnesses to assist the subcommittee 
with its fact finding. We will hear first from Sheila Jackson-
Lee, our colleague from Texas, who has introduced legislation 
in response to the death of a 17-year-old girl in her district 
who died as a result of unintentionally drinking GHB, which was 
poured into her soft drink. I look forward to working with 
Congresswoman Sheila Jackson-Lee on this issue and others.
    We will then hear from a panel of witnesses offering 
various perspectives on the problem. Those perspectives will be 
those from victims, victim advocates, law enforcement and the 
medical community. We will hear from experts representing the 
Department of Justice, DEA, the Food and Drug Administration 
and the National Institute on Drug Abuse.
    Finally, we will hear from Orphan Medical, Inc., a company 
developing a GHB derivative drug in clinical trials for the 
terribly debilitating symptom of narcolepsy. They are concerned 
that if GHB was scheduled as a I or II drug, it would be 
impossible for them to continue their research.
    I appreciate the support of my colleague, Ron Klink, for 
holding this hearing, and I look forward to working with him 
and everyone else on this issue, and I will, in his stead as 
acting ranking member of the subcommittee, recognize Bart 
Stupak for an opening statement.
    [The prepared statement of Hon. Fred Upton follows:]
   Prepared Statement of Hon. Fred Upton, Chairman, Subcommittee on 
                      Oversight and Investigations
    Today, the Subcommittee will hear testimony and gather facts on a 
growing public health and safety problem: so-called ``date rape'' 
drugs. I want to thank full Committee Chairman Tom Bliley for 
supporting this hearing. I want to recognize and thank our colleagues 
Sheila Jackson-Lee and Bart Stupak for the early leadership they have 
shown on this issue and our ranking member, Ron Klink, for the concern 
I know he shares about this growing problem.
    The reality of this problem hit me hard when several weeks ago I 
read about what happened to two young women in my home state of 
Michigan. While they were at a party, their beverages were laced with 
GHB, probably without their knowledge. Fifteen-year-old Samantha Reid 
and her friend lapsed into comas, and Samantha died.
    I am the father of an eleven-year-old daughter, and I can only 
imagine what Samantha's family and friends have endured. I want to join 
with Sheila Jackson-Lee and Bart Stupak and what I hope will be every 
member of this Subcommittee today in committing ourselves to doing 
whatever is necessary to prevent tragedies like this from occurring in 
the future.
    What are ``date rape'' drugs? ``Date rape'' drugs are a popular 
reference to lethal street drugs that people may use to get high or to 
incapacitate women and make them utterly vulnerable to sexual assault. 
These drugs can induce a deep, anesthetic-type sleep. We know many 
drugs are used to facilitate rape, but the most commonly encountered 
drugs in drug-facilitated rapes are GHB (gamma hydroxy butyrate), 
ketamine (a veterinary drug), and flunitrazepam (trade name 
``Rohypnol''). The victim blacks out, experiences amnesia. By the time 
the victim wakes up and gets to the hospital, it may be too late to 
detect the presence of the drug because the drug moves so quickly 
through the bloodstream or urine. I want to clarify that ``date rape'' 
is in many cases a misnomer. They may be used by near strangers or 
strangers to incapacitate young women.
    A few years ago, Rohypnol, a prescription anesthetic drug sold in 
many foreign countries, was the leading ``date rape'' drug. Thanks to 
restrictions on its import, federal controls, and changes that the 
manufacturer made to make it less easy to abuse as a date rape drug, 
Rohypnol is no longer a big part of the problem. Now, GHB, and to some 
extent, ketamine, are the leading ``date rape'' drugs. What makes GHB a 
particularly fast-growing problem is the availability of its 
ingredients, the hundreds of internet web sites promoting GHB and 
offering ingredient kits and recipes for making it, and the difficulty 
in detecting the drug. Neither GHB nor ketamine is under federal 
controls. The Drug Enforcement Administration has documented over 3,500 
overdoses and law enforcement encounters with GHB and 32 GHB-related 
deaths since 1990. According to the Drug Abuse Warning Network, GHB-
related hospital emergency department episodes increased from 20 in 
1992 to 629 in 1996.
    Clearly, the status quo is entirely unacceptable. In today's 
hearing, I want us to focus on what additional steps should and could 
be taken at the federal and state levels to protect our vulnerable 
young people from the vile misuse of these substances.
    We have impressive witnesses to assist the Subcommittee with its 
fact finding. We will hear first from Congresswoman Sheila Jackson-Lee, 
who has introduced legislation in response to the death of a 17-year-
old girl in her district who died as a result of unintentionally 
drinking GHB which was poured into her soft drink. I look forward to 
working with Congresswoman Jackson-Lee on this issue.
    We will then hear from a panel of witnesses, offering various 
perspectives on this problem. Those perspectives will be those from 
victims, victim advocates, law enforcement, and the medical community.
    We will hear from experts representing the Department of Justice, 
the Drug Enforcement Administration, the Food and Drug Administration, 
and the National Institute on Drug Abuse.
    Finally, we will hear from Orphan Medical, Inc., a company 
developing a GHB-derived drug in clinical trials for a terribly 
debilitating symptom of narcolepsy. They are concerned that should GHB 
be made a schedule 1 or 2 drug, it will be impossible to continue their 
promising research.
    I appreciate the support of my colleague, Congressman Ron Klink, 
for holding this hearing. I looking forward to working with him and 
everyone else on this issue.

    Mr. Stupak. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    I was interested when I read the subject of this hearing in 
the briefing memo because it says, and I quote, ``The 
subcommittee will examine the problem of date rape drugs and 
considering whether the Federal Government is adequately 
responding to this serious problem.''
    Mr. Chairman, I agree the Federal Government is not 
responding to this problem in an adequate fashion, but I 
believe much of the blame falls on Congress. As my colleagues 
know, I have taken a special interest in law enforcement issues 
due to my background as a Michigan State police trooper. This 
interest has led me to chair both the Law Enforcement Caucus 
and the Democratic Crime Task Force.
    On May 21, 1997, I introduced H.R. 1699, the Families First 
Juvenile Offenders Control and Prevention Act of 1997. This 
bill was co-sponsored by Ms. Jackson-Lee, as well as a number 
of other members. The bill included a provision that would have 
scheduled GHB and Ketamine as Schedule III controlled 
substances.
    Then again on June 8, 1997, I introduced a provision on 
date rape drugs as a stand-alone bill because of the attention 
that this issue needed. Ms. Jackson-Lee introduced her own bill 
in May that would have also scheduled these drugs as Schedule 
I.
    Mr. Chairman, I know that you were not the chairman of this 
subcommittee last year, and if you had, many subcommittee 
priorities would have been different. But I feel compelled to 
point out that I believe that the legislation would not have 
languished in the committee since mid-1997, and I wish the 
majority would have done things differently to hasten its 
passage. In fact, I am told that the Judiciary Committee was 
willing to move Ms. Jackson-Lee's bill last year, but this 
committee refused to allow the bill to the floor.
    Mr. Chairman, I understand that you became aware of this 
issue because of the tragic death of a girl in the district of 
our colleague, John Dingell of Michigan. While we cannot be 
sure her tragic death could have been prevented, actions on 
these bills, my bill or Ms. Jackson-Lee's bill, may have 
prevented some of the tragedies that have occurred over the 
last 2 years.
    Yesterday I reintroduced the Date Rape Prevention Act of 
1999. We have worked with industries and others to move this 
bill along. This bill would require the Drug Enforcement Agency 
to schedule both GHB and Ketamine as Schedule III controlled 
substances.
    Second, it would increase the penalties for illegal 
possession and illegal import or export of these drugs to the 
Schedule I level, similar to the congressional treatment of 
Rohypnol.
    Third, it allows the tracking for GBL, the precursor 
chemical for GHB, to ensure that it is not being used to 
manufacture GHB. Congress has required similar tracking with 
Ephedrine, a bill that I introduced and was passed and signed 
into law in 1993, and that was with the drug Methcathadone or 
``Cat'' as we knew it back then. We have basically wiped that 
drug out.
    Finally, it would require the Attorney General to conduct a 
drug awareness campaign about the dangers of date rape drugs.
    Mr. Chairman, I look forward to working with you, and I 
urge you and the members on your side of the aisle to work with 
Representative Jackson-Lee and myself to pass our legislation 
quickly.
    After this hearing, I would ask that we circulate a letter 
among the members of the subcommittee to urge Chairman 
Bilirakis on the Health Subcommittee to mark up our legislation 
as quickly as possible.
    I want to thank my colleague, Ms. Jackson-Lee, and others 
for all their work on this issue. I look forward to working 
with her and you, Mr. Chairman, on quick action on my proposed 
legislation or any other legislation that would address this 
dangerous, growing problem. Let us not wait another 2 years.
    Thank you, Mr. Chairman.
    Mr. Upton. At this point I recognize the chairman of the 
full committee, Mr. Bliley.
    Chairman Bliley. I thank you, Mr. Chairman. I thank you for 
holding this hearing. I will put my statement in the record, 
but I would like to respond to the remarks of the gentleman 
from Michigan.
    Yes, we did oppose putting this on the omnibus bill because 
the ranking member of the full committee, the gentleman from 
Michigan, Mr. Dingell, contacted me about many proposals that 
were being suggested for the omnibus bill last fall that fell 
in the jurisdiction of this committee and urged me to oppose 
all of them.
    Therefore, I thought I was carrying out the wishes long 
held by this committee in the 19 years I have been on here, 14 
of them in the minority.
    Mr. Stupak. Would you care to----
    Chairman Bliley. I will not at this time. I will not. I 
listened with great dismay to the gentleman's remarks, and he 
can listen to mine. Thank you.
    We have traditionally refused. I wanted to bring the 
satellite bill up last week at full committee, but at the 
insistence of the ranking member, who insisted on regular 
order, we went through the subcommittee.
    We need to know more about this bill. We had had no 
hearings. Therefore, I felt that it was the right thing to do, 
and I am happy to be here today, and I will do what I can to 
encourage the chairman of the subcommittee to schedule hearings 
and bring the bill for mark-up as soon as possible.
    Thank you. I yield back the balance of my time.
    [The prepared statement of Hon. Tom Bliley follows:]
 Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
    Mr. Chairman, thank you for holding this hearing today to expose 
the growing national problem of the abuse of certain drugs to 
facilitate sexual assaults on unsuspecting victims. By holding this 
hearing, this Committee can hopefully bring greater public attention to 
this abuse, and educate potential victims of the dangers posed by 
substances that can be easily slipped into an unsuspecting person's 
drink which will leave that individual unconscious a short time later. 
The hearing will also focus on what the response of the Federal 
government has been to the emergence of these drugs as a serious public 
health concern, and what else can be done.
    GHB, flunitrazepam and ketamine are all powerful sedatives, which 
in certain dosages can induce unconsciousness or even death. In 
addition to the risk that is posed by the misuse of these drugs by 
sexual predators, misuse of these drugs for recreational abuse is also 
a growing danger. The numbers of emergency room admissions for 
overdoses, drunk driving accidents, and other injuries which are 
related to these drugs are all increasing. In addition, some of these 
drugs and their precursors can be obtained readily at local hardware 
stores, gyms, or over the Internet.
    I am particularly troubled by the difficulties that have been 
encountered in prosecuting the abuse of these drugs. Because of the 
unique characteristics associated with these drugs, including memory 
loss, and the rapid breakdown of the drug in the body which makes it 
especially difficult to detect, prosecutors have found it particularly 
difficult to obtain convictions for those who abuse these drugs. In 
response, many state and local law enforcement officials have lobbied 
to have these drugs listed as controlled substances under their state 
drug control laws.
    To date the Federal government has not scheduled either GHB or 
Ketamine. I look forward to hearing from the agency administrators who 
will testify about what actions have been taken to date, and when we 
can expect final actions to be taken on these drugs. Anecdotal evidence 
certainly indicates that this is a growing problem which is putting 
more of America's youth at risk every day. We will need to review the 
adequacy of the federal government's response to this problem, 
including their continuing efforts to assess the scope and severity of 
this particular issue. If this review indicates that the government's 
response has been insufficient, we should then consider what steps 
Congress should take to address this problem.
    I would like to welcome all of our panels here today to testify. I 
would especially like to welcome Candace Pruett, who is from Northern 
Virginia. Candace was the victim of a sexual assault when she was 
fifteen years old. Her attacker had given her a soda laced with 
Rohypnol, which rendered her unconscious for several hours and enabled 
him to assault her. She went through a very difficult trial where she 
had to recount these painful memories. I commend her courage in 
testifying about this troubling event before the Subcommittee today, 
which we all hope will help to educate other potential unsuspecting 
victims and prevent similar assaults in the future.

    Mr. Upton. The Chairman yields back the balance of his 
time.
    The gentlelady from Colorado?
    Ms. DeGette. Thank you, Mr. Chairman. I would like to thank 
you for calling this hearing today also, and I would like to 
thank all of my colleagues who have introduced legislation to 
address this problem, specifically Congresswoman Jackson-Lee 
and my colleague, Mr. Stupak, from the committee.
    The problem of date rape drugs is real and must be 
addressed. The alarming incidence in reports of these drugs 
being slipped into the drinks of unsuspecting women in order to 
render them defenseless for sexual exploitation is disturbing.
    In Colorado, for example, my home State, a woman was raped 
in May of last year. Testing confirmed that someone had slipped 
GHB into her drink while in a bar. Two other women reported 
similar assaults within 2 months of that incident, and that is 
just in one State.
    GHB and similar substances are odorless, tasteless, 
colorless, and they induce serious impairments in functioning, 
such as drowsiness, dizziness, confusion and memory loss.
    Although they are not marketable in this country for 
prescription purposes, the common ingredients and recipes for 
making GHB are now available on the Internet, and reports 
indicate that these substances are widely available because of 
the Internet availability at fraternity parties, bars and other 
social gatherings.
    This is a complex issue that demands an intelligent 
response. When Congress passed the Drug Induced Rape Prevention 
and Punishment Act of 1996, Congress made a strong statement it 
wanted to find such a solution. With this law, Congress amended 
the Controlled Substances Act, imposing penalties for 
distributing these substances with the intent to commit a 
violent or sexual crime.
    We also directed the DEA to study the appropriateness of 
rescheduling Rohypnol as a Schedule I drug. After analysis and 
consultation with the Department of Health and Human Services, 
the DEA decided there was not sufficient rationale to 
reclassify Rohypnol as a Schedule I drug.
    Indeed, the company that produces that drug has made 
changes in the product to prevent it from being used as a drug 
for sexual assault. For example, the drug turns blue when it is 
put into a drink, and it has a salty taste so that people can 
tell it is being put into the drink.
    We applaud such steps to try to address the crisis, but it 
is pretty clear with the increase of these drugs being used 
that more needs to be done. That is why we are here today.
    There are other drugs that are misused to rape women; as I 
discussed, GHB, and Ketamine. Representative Jackson-Lee 
introduced a bill to reschedule these substances I believe 
under the Controlled Substances Act as Schedule I substances. 
The bill was referred to committee, but died, as Congressman 
Stupak said.
    I think it is time for this Congress to act. I think it is 
time for this Congress to act swiftly because with the Internet 
availability, more and more young women are becoming subject to 
date rape for this reason, and we need to do something to 
figure out how we can stop the illegal distribution of these 
drugs and we can stop these practices.
    With that, Mr. Chairman, I will yield the balance of my 
time to our acting Chairman, Mr. Stupak, who would like to 
follow up on his previous statement.
    Mr. Stupak. Thank you, and thank the gentlelady for 
yielding.
    I want to make it very clear. The Jackson-Lee bill was not, 
nor was it ever requested to be, part of the omnibus bill that 
we were working on in late October. It was a freestanding bill.
    We requested it to be a freestanding bill while we sat here 
for 2 weeks twiddling our thumbs while they put together the 
omnibus bill, and we had Judiciary to sign off. There was not a 
request to Mr. Dingell that this bill be part of the omnibus 
bill.
    We wanted to do a freestanding bill while we were here. As 
everyone on this side of the dais knows, we did plenty of bills 
in the 2 weeks while we were waiting for the omnibus bill.
    The point is there has been plenty of time to move our 
legislation. We get people to sign off, and it gets 
bottlenecked here. I want the bottleneck to stop, and I want to 
move forward so we can move this legislation.
    Ms. Jackson-Lee has worked with industry and others to get 
her bill in good shape. My bill was in good shape. We 
introduced it last night after we got the last of industry to 
sign off. We are ready to go. Let's move these bills forward.
    I would yield back to the gentlelady and thank her for the 
time.
    Ms. DeGette. And I will yield back the balance of my time, 
Mr. Chairman.
    Mr. Upton. The gentlelady's time has expired.
    Vice-Chairman of the committee, Mr. Burr, from North 
Carolina?
    Mr. Burr. Mr. Chairman, I thank you, and my colleague, Ms. 
Jackson-Lee, thank you for committing your time to come up. 
Hopefully we have gotten the name blame out of the way, and now 
we can all look forward to learning more about the problem, 
but, more importantly, more about the solution.
    I think it was in 1996 that Congress responded to an 
imminent problem of date rape. I appreciate my colleague from 
Colorado pointing out the fact that some companies have been 
responsive. Hoffman LaRoche did everything they could to help 
tighten controls over certain products.
    Congress also passed legislation at that time that I am 
convinced today, after reading back on it--I was here, but the 
intent was to eliminate this problem, and it did not. I think 
that is one of the reasons that hopefully this oversight 
hearing might be just the start of some additional hearings on 
what is the appropriate answer.
    I think one of the things that alarms me, and I hope that 
Mr. Stupak will be as vicious with his questions to the FDA, is 
that they made a recommendation for scheduling to FDA in 1997 
to set a scheduling change at that time for GHB. Unfortunately, 
I do not think that that has taken place yet, Mr. Chairman. If 
it did, it is only recently.
    We have a system that we thought would be responsive. 
Clearly there are areas of it that have been not effective or 
have broken down. I hope that through the efforts of some of 
our colleagues like Ms. Jackson-Lee and others who are 
passionate about this that in fact we can ensure all Americans 
that Congress has done everything within its power to make sure 
that this is not a problem and that the system does work.
    I thank the chairman for these hearings. I yield back.
    Mr. Upton. The gentleman from Pennsylvania, the ranking 
member of the subcommittee, Mr. Klink?
    Mr. Klink. I thank my friend, Mr. Upton, and I apologize. I 
had another meeting this morning, so I am delayed a little bit. 
I thank my friend, Mr. Stupak, for filling in. I know how 
important this issue is in his legislative office because he 
has seen the problems up in Michigan. I know he has been 
working very hard on this.
    I want to thank the chairman, Mr. Upton, for realizing that 
this was such an important issue and for conducting this 
hearing. It has been a pleasure to work with him on this. We 
think that something really should have been done earlier, but 
I am glad that the chairman has really taken the bull by the 
horns and moved forward on this, and we look forward to working 
with him.
    Can I ask you, my dear colleague, Ms. Jackson-Lee? In your 
opinion, what is more dangerous, the----
    Mr. Upton. Mr. Klink, we are doing opening statements.
    Mr. Klink. We are doing opening statements? I am sorry. You 
are going to have to really bear with me. I thought we were 
actually on questions.
    I was listening to the engaging way in which Mr. Burr was 
responding, and I thought that we were at a question time.
    Mr. Chairman, I, too, want to applaud you for having this 
hearing on date rape drugs. Sadly, the manufacture and use of 
GHB has recently become a problem for law enforcement 
authorities in my own State of Pennsylvania where authorities 
seized enough chemicals and packaging for thousands of doses of 
GHB, only to discover the drug is not illegal under Federal or 
Pennsylvania law.
    The sooner we take action to make these date rape drugs 
more difficult to obtain, the better, and I hope that this 
hearing will help us do that.
    There are two drugs under question for today's hearing: 
Ketamine and GHB. Both have been scheduled by a number of 
States, but have not been scheduled by the Federal Government. 
In that regard, today's hearing is more than about date rape 
drugs. It is also about what actions we in Congress should be 
taking to control these drugs.
    While I fully support the efforts of the Oversight and 
Investigations Subcommittee to look into this important matter, 
I wish that we could do it jointly with the Subcommittee on 
Health and Environment so we could mark up one of these bills 
that have been introduced so that we could schedule Ketamine or 
GHB as quickly as possible because I think they are very 
dangerous.
    The fact is that this issue is not entirely new. During the 
past Congress, no fewer than seven bills were submitted by 
Democrats to schedule Ketamine and/or GHB. In fact, two of 
those bills were referred to this committee. One, authored by 
my good friend Sheila Jackson-Lee, who is with us, and the 
other by my good friend Bart Stupak, was referred to the 
Commerce Committee almost 2 years ago. We did not take any 
action.
    I am glad that we have both of these people here today, and 
I look forward to working with both of them and with Chairman 
Upton on this issue. I cannot really blame any inactivity on my 
dear friend, Mr. Upton. He in fact is the reason that we are 
here today. He realized the importance of this. He was not at 
the helm of this subcommittee during the last Congress, nor 
were you in charge of determining, my friend, Mr. Chairman, 
what bills would be scheduled by the full committee.
    If anything, I have to applaud your willingness and your 
conviction to shed light on a matter in which a serious 
discussion by our committee is long overdue. Hopefully, this 
hearing will help us move closer to taking action on either Mr. 
Stupak's bill or Ms. Jackson-Lee's bill. In fact, maybe both of 
our colleagues will be able to work together to come up with a 
consensus bill. I would enjoy working with them on that effort 
if that is what they decide to do.
    I think we already realize that these drugs have been a 
problem and that there must be a Federal response. Whether they 
get scheduled as I, II, III, or IV is an issue that is worthy 
of debate. The important thing is that we do what we have to do 
to protect people from the misuse of these substances.
    For today's discussion, we must understand that the Federal 
scheduling of any drug is a slow process because it is a 
deliberative one. To make a recommendation to schedule a 
substance, the Food and Drug Administration must go through a 
multitude of investigational tests. The process is highly 
procedural. It requires significant data gathering and allows 
for the public input by those that might be affected by the 
decision.
    Mr. Chairman, we may not like how long it takes the FDA or 
NIDA or HHS or the DEA to do this, but that is what the law 
requires. While I look forward to hearing testimony from the 
FDA, so far we have seen no evidence suggesting that the FDA or 
our friends at HHS have been derelict in their effort to 
evaluate either GHB or Ketamine for the scheduling purposes.
    Some many wonder why many States have already scheduled 
these drugs when the FDA has not. The answer is a simple one. 
Like our colleagues, Mr. Stupak and Ms. Jackson-Lee, have 
attempted to do, most States that have scheduled these drugs 
have done so through legislative fiat. That, Mr. Chairman, is 
the debate that we need to have.
    I am not saying that either of these bills is perfect, but 
they are an excellent place for us to start. I am hopeful we 
can join together and commit ourselves to moving this debate 
forward.
    Mr. Chairman, I will conclude by saying that because Mr. 
Stupak is a former law enforcement official and has already 
been very active on this issue, I intend to turn the reins of 
this subcommittee ranking leadership over to him for today's 
hearing. I thank him in advance for his hard work.
    I also thank Ms. Jackson-Lee. She has shown extraordinary 
leadership on this matter, and we are privileged to have her 
here from the Judiciary Committee today.
    Finally, Mr. Chairman, again I thank you for your 
willingness to have this hearing. You have made a commitment to 
work with us together in this new Congress to solve serious 
policy matters, and I think that today's hearing, the way you 
have handled it, is a great start.
    This appears to be a reasonable starting point, and I look 
forward to something good coming out of today's hearing.
    [The prepared statement of Hon. Ron Klink follows:]
Prepared Statement of Hon. Ron Klink, a Representative in Congress from 
                       the State of Pennsylvania
    Thank you Mr. Chairman.
    Mr. Chairman, I want to applaud you for having this hearing on 
date-rape drugs. Sadly, the manufacture and use of GHB has recently 
become a problem for law enforcement authorities in my own State of 
Pennsylvania where authorities seized enough chemicals and packaging 
for thousands of doses of GHB only to discover that the drug is not 
illegal under Federal or Pennsylvania law. The sooner we take action to 
make these date-rape drugs more difficult to obtain the better, and I 
hope this hearing helps us do that.
    There are two drugs under question for today's hearing: ketamine, 
and GHB. Both have been Scheduled by a number of states, but have not 
yet been scheduled by the federal government. In that regard, today's 
hearing is about more than date-rape drugs. It is also about what 
actions Congress should take to control them.
    While I fully support the efforts of the Oversight and 
Investigations Subcommittee to look into this very important matter, I 
wish we were doing it jointly with the Subcommittee on Health and the 
Environment so that we could mark-up a bill to schedule ketamine and 
GHB as quickly as possible. The fact is that this issue in not entirely 
new. I would be remiss if I did not point out that during the past 
Congress alone, no fewer than seven bills were submitted by Democrats 
to schedule ketamine and/or GHB. In fact, two of those bills, were 
referred to this Committee. One, authored by my good friend Sheila 
Jackson-Lee and the other by my good friend, Bart Stupak, were referred 
to the Commerce Committee almost two years ago without any action being 
taken. I am glad to have them both here today and I look forward to 
hearing their testimony.
    Mr. Chairman, I don't blame the inactivity of the Committee on your 
leadership. You were not at the helm of the Oversight Subcommittee 
during the last Congress, nor were you in charge of determining what 
bills would or would not be scheduled by the full Committee. Rather, if 
anything, I applaud your willingness and conviction to shed light on a 
matter in which a serious discussion by our Committee is long overdue.
    Hopefully this hearing will help us move closer to taking action on 
either Mr. Stupak's or Ms. Jackson-Lee's bill. I think we already 
realize that these drugs have been a problem, and that there must be a 
Federal response. Whether they get scheduled as I, II, III, or IV, is 
an issue worthy of debate. The important thing it that we do what we 
have to do to protect people from the misuse of these substances.
    For today's discussion, we must understand that the Federal 
scheduling of any drug is a slow process because it is a deliberative 
one. To make a recommendation to schedule a substance, the Food and 
Drug Administration must go through a multitude of investigational 
tests. The process is highly procedural, it requires significant data 
gathering, and allows for public input by those that might be affected 
by the decision. Mr. Chairman, we may not like how long it takes the 
FDA, NIDA, HHS or the DEA to do this, but that's what the law requires. 
And while I look forward to hearing testimony from the FDA, so far, 
we've seen no evidence suggesting that FDA or our friends at HHS have 
been derelict in their efforts to evaluate either GHB or ketamine for 
scheduling purposes.
    Some may wonder how many states have already scheduled these drugs 
when the FDA has not. The answer is simple: like our colleagues Mr. 
Stupak, and Ms. Jackson-Lee have attempted to do, most of the states 
that have scheduled these drugs have done so through legislative fiat. 
That, Mr. Chairman, is the debate we need to have. I am not saying that 
either of these bills is perfect, but they are an excellent place to 
start, and I am hopeful that we can join together and commit ourselves 
to moving this debate forward.
    Mr. Chairman, let me conclude by saying that because Mr. Stupak is 
a former law enforcement official and has already been very active on 
this issue, I intend to turn the reins of ranking member over to his 
leadership for today's hearing. I thank him in advance for his hard 
work. I also thank Ms. Jackson-Lee. She too has shown extraordinary 
leadership on this matter and we are privileged to have her here today. 
Finally, Mr. Chairman, I want to again thank you for your willingness 
to have this hearing. You and I have made a commitment to work together 
in this new Congress to solve serious policy matters. This appears to 
be a reasonable starting point and I look forward to working with you 
to follow it to its conclusion.

    Mr. Upton. Thank you.
    Mr. Whitfield from Kentucky?
    Mr. Whitfield. Mr. Chairman, thank you. I am particularly 
excited that you decided to have this Oversight hearing today 
on this important issue as we address the continuing problem of 
date rape drugs in general and the abuse of GHB and Ketamine in 
particular.
    The Controlled Substances Act requires the Drug Enforcement 
Agency to submit data to the Department of Health and Human 
Services and to request that HHS conduct a medical and 
scientific evaluation of the substance in question.
    GHB has no medical use, and the FDA has issued an advisory 
declaring GHB unsafe and illicit. The DEA finished its 
evaluation and submitted its report to HHS in 1997, and still 
HHS has not come up with its findings. HHS' findings as to 
scientific and medical matters are binding on DEA, so DEA 
cannot move unless HHS completes its responsibility, which it 
has not done.
    I hope that today's hearing will provide some answers as to 
why we are not taking advantage of the one aspect of the fight 
against drug use in our society that is within our control, the 
ability to schedule dangerous drugs.
    I would like to make one more comment. This administration, 
over the last 3 or 4 years, has been in the forefront of a 
well-coordinated campaign to protect children from tobacco use. 
We all recognize that tobacco use is damaging to children over 
the long term, but as I go around my district and my State and 
I talk to educators, as I talk to law enforcement people and 
others, the most direct, the most immediate threat to young 
people today is the proliferation of dangerous drugs, which are 
easily available and readily available around the country.
    I am delighted that we are focusing on some serious drug 
problems facing young people in America today, and I commend 
the chairman for having this hearing.
    Mr. Upton. Thank you.
    I would like to announce that all members of the 
subcommittee by unanimous consent will have an opportunity to 
insert their opening statements as part of the record.
    [Additional statement submitted for the record follows:]
    Prepared Statement of Hon. Henry A. Waxman, a Representative in 
                 Congress from the State of California
    Mr. Chairman, I am pleased this hearing has been called on a very 
important issue. Let me preface my remarks by welcoming Mr. Upton to 
the Chair. I look forward to cooperating with him on many issues in the 
future.
    ``Date rape'' or ``acquaintance rape'' is a new name for an old and 
terrible problem. More often than not, rapists are not strangers. Two 
thirds of all victims of rape and sexual assault know their 
assailants--their husbands or relatives, boyfriends or acquaintances. 
Most appalling, the use of drugs by rapists to incapacitate their 
victims may not only expedite a violent sexual assault, but also 
deprive the victim of her memory of the assault.
    In seeking an answer to this terrible problem, I want to associate 
myself with the remarks of my colleague from Pennsylvania. Almost two 
years ago, bills were introduced by our colleagues, Congresswoman 
Jackson-Lee and Congressman Stupak, to help solve this problem.
    Last year, the Judiciary Committee acted on Congresswoman Jackson-
Lee's bill. I think it is deeply regrettable that the Commerce 
Committee did not consider Congresswoman Jackson-Lee's bill. If the 
full Committee had acted as decisively as the Judiciary Committee last 
year, law enforcement would probably already have an effective Federal 
law at its disposal.
    Let me make a final point about the substances to be discussed 
today. The Food and Drug Administration will testify today. They may be 
criticized for not acting more quickly or decisively to restrict access 
to two of the substances being discussed today, GHB and its chemical 
precursor, GBL.
    I want my colleagues to understand that GHB and GBL are or were 
marketed as dietary supplements. Five years ago, this Congress placed 
very significant restrictions on the FDA and its ability to act against 
unsafe supplements. FDA does not approve supplements or supplement 
ingredients before they are marketed. FDA bears the burden in showing a 
supplement is unsafe. And FDA lacks the resources to effectively police 
the supplement marketplace.
    Before we throw stones at FDA, I caution my colleagues that we in 
Congress may live in a glass house. If anything, the problems with GHB 
and GBL suggest that the FDA needs more authority and more resources 
from Congress to evaluate dietary supplements and enforce the law 
against unsafe supplements. I would be happy to work with all of my 
colleagues on this problem in the future.
    I welcome Congresswoman Jackson-Lee and the rest of our witnesses. 
I look forward to their testimony.

    Mr. Upton. Ms. Jackson-Lee, before you begin I have some 
subcommittee business to do. You are aware that this 
subcommittee is an investigative subcommittee. As such, we have 
always had the long practice of taking testimony under oath. Do 
you have any objection to testifying under oath?
    Ms. Jackson-Lee. No, Mr. Chairman.
    Mr. Upton. We also advise you per se that you are allowed 
to be advised by counsel. Do you have any desire to be advised 
by counsel as well today?
    Ms. Jackson-Lee. Not as we begin. Maybe as we continue.
    Mr. Upton. We do not reimburse for that, by the way. In 
that case, would you please rise and raise your right hand?
    [Witness sworn.]
    You are recognized. Your statement will be made part of the 
record in its entirety, and you are recognized for 5 minutes.

   TESTIMONY OF HON. SHEILA JACKSON-LEE, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Ms. Jackson-Lee. Thank you very much, Mr. Chairman, and 
good morning to all of my colleagues.
    This morning I would say how do you spell relief? You spell 
it by the Subcommittee on Oversight and Investigations, chaired 
by Chairman Upton, and ranking member Klink, and with the 
leadership of Bart Stupak and the many, many talented members 
who are here this morning who have a great interest in this 
area.
    I am comforted by the expertise that you offer. I note 
particularly the leadership of Congresswoman DeGette on women's 
issues, and I am appreciative of both Chairman Bliley and 
ranking member Dingell coming together on this very important 
issue.
    This is the day that we should move forward, and I hope 
Chairman Bilirakis will move forward under your leadership in 
collaboration, Chairman Upton, on this very important point.
    Why am I here today? To save lives. To save young people 
and to commit to the promise that we have given to all young 
people to lead a healthy life.
    Let me acknowledge LPD retired police officer Trinka 
Porrata, who you will hear later on, who has dedicated her life 
to fighting against this unknown killer of which so many people 
have not been able to get a handle on.
    I would also like to acknowledge that I chair the 
Congressional Children's Caucus, and we have as a mission to 
promote children as a national interest.
    This morning's hearing is extremely important. I do want to 
acknowledge that Bart Stupak and myself have worked together on 
many issues. He has a bill to schedule GHB as Schedule III. I 
look forward to working with him.
    As you will note, I filed in January 1997 in the 105th 
Congress and now again on January 6, 1999, a G.H. bill named 
after Hillary J. Farais to schedule GHB as a Schedule I drug.
    I look forward, of course, to working with Mr. Stupak on 
his leadership to come together. Hopefully this is a party that 
will bring us all together to ultimately allow our young people 
to have parties that are safe. My bill, named after Hillary J. 
Farais, is a bill that would ask the Attorney General to 
schedule this at Schedule I and Ketamine at Schedule II.
    Particularly let me emphasize that my drug legislation also 
asks the Attorney General to establish programs throughout the 
United States and to disseminate materials to provide young 
people in high school and college with education about the use 
of controlled substances in the furtherance of rape and sexual 
assault and shall assist law enforcement personnel in the 
prevention of abuse of controlled substances for such purpose.
    Let me just tell you that I had my bill pulled off the 
Internet. I would hope that the only thing we can pull off the 
Internet would be legislation and other positive instructions 
to our young people, not the instructions on how to make GHB, 
which can be found, as you have so noted, on the Internet. We 
note that young people will make GHB in bathtubs for these rave 
parties that have been very popular around the country.
    As a legislator and a mother, I believe we must work to 
protect our loved ones from the insidious harm resulting from 
the misuse of potentially dangerous drugs. We must schedule 
this drug effectively to limit the abuse of GHB and to more 
efficiently prosecute those who use it for illicit purposes.
    I will move quickly, but I must tell you about Hillary J. 
Farais and this drug that killed a young woman, as I know many 
of you have experienced in your community. I have named it 
after her, H.R. 75, the Date Rape Prevention Drug Act, and I 
want to tell you about her story.
    Her death occurred in my home State in 1996 when Hillary J. 
Farais of La Porte, Texas, died as a result of unintentionally 
drinking GHB, which was poured into her soft drink at a teenage 
club on August 5, 1996. On the night she died, Hillary and two 
girlfriends went to a club where she consumed only soft drinks.
    Our immediate response to young people is were they on 
drugs? Were they drinking? We wish to sort of group them 
together. She was not a drinker. She was an athlete, a 
volleyball player, well loved and living with her grandmother.
    Soon afterwards, as I complete my remarks, I guess, she 
complained of feeling sick and having a severe headache. She 
went home to bed, and the next morning her grandmother was 
unable to wake Hillary. The grandmother contacted Hillary's 
uncle, Raul, and she was rushed to the hospital where she later 
died.
    Hillary, a 17-year-old high school senior, model student 
and varsity volleyball player, had died during the night as a 
result of the GHB slipped into her drink. As I said, she was 
not a drinker. She did not use drugs.
    This is a drug that attacks the central nervous system. It 
is detrimental, Mr. Chairman. It is one that has been called by 
the pharmaceutical offering with a medical use.
    Let me just conclude by saying that I worked extensively 
with DEA. We had the support of Chairman McCullum of the Crime 
Subcommittee. We worked with FDA. We started out this morning 
saying that we have relief so that I will not offer to finger 
point, but I will say that it is time that the Government 
agencies come up to the bar, if you will and work together.
    This is a deadly drug, and I would hope that we could move 
FDA expeditiously to work with those of us who have sought a 
compromise, and I would hope that if there is a compromise that 
we would ensure that the criminal penalties for the illicit use 
and selling and possession to do harm of GHB has a 20-year 
penalty. We must let America know we are serious not only about 
good health care, but as well in protecting our young people.
    I know the other witnesses will document for you, Mr. 
Chairman, the various incidents that have occurred in the use 
of this drug and rapes that may not have occurred or resulted 
in death. This is a tragedy. America must do something about 
it.
    I thank the chairman for his kindness and his indulgence 
and this committee for its leadership. Thank you very much, Mr. 
Chairman.
    [The prepared statement of Hon. Sheila Jackson-Lee 
follows:]
  Prepared Statement of Hon. Sheila Jackson-Lee, a Representative in 
                    Congress from the State of Texas
    Thank you Chairman Upton and Ranking Member Ron Klink for inviting 
me to testify this morning. I would also like to say that I look 
forward to working with Congressman Stupak who has a bill to schedule 
GHB in Schedule III. We must work together on this national problem. 
This legislation has great personal importance to me. As a legislator 
and a mother, I believe we must work to protect our loved ones from the 
insidious harm resulting from the misuse of potentially dangerous 
drugs. We must schedule this drug to effectively limit the abuse of GHB 
and to more efficiently prosecute those who use it for illicit 
purposes.
    H.R. 75, the Hillory J. Farias, Date Rape Prevention Drug Act 
amends Section 401 of the Controlled Substances Act. (21 U.S.C. 841) to 
make it a federal crime to possess, distribute or manufacture GHB, and 
adds up to 20 years imprisonment when the use of this drug causes 
serious bodily injury or death.
    This legislation is a direct result of a tragedy which occurred in 
my own home state of Texas in 1996, when Hillory J. Farias, of Laporte, 
Texas, died as a result of unintentionally drinking GHB (gamma 
hydroxybutryate) which was poured into her soft drink, on August 5, 
1996.
    On the night she died, Hillory and two girlfriends went to a club 
where they consumed only soft drinks. Soon afterwards, she complained 
of feeling sick and having a severe headache. She went home to bed, and 
the next morning, her grandmother was unable to wake Hillory. The 
grandmother contacted Hillory's uncle, Raul and she was rushed to the 
hospital where she later died.
    Hillory, a 17 year old high school senior, model student and 
varsity volleyball player had died during the night as a result of the 
GHB slipped into her drink. She was not a drinker and she did not abuse 
drugs.
    GHB is a central nervous system depressant that is abused for its 
ability to produce euphoric states. It also acts as a growth hormone 
releasing agent to stimulate muscle growth. Although GHB gained early 
favor with health enthusiasts as a safe and ``natural'' food supplement 
sold in health food stores in the late 1980's, the medical community 
soon became aware of overdoses and related problems caused by its 
abuse.
    In 1990, the FDA issued an advisory declaring GHB unsafe and 
illicit, except under FDA-approved, physician-supervised, study 
protocols. The FDA has not approved GHB for marketing, but it is 
currently under investigation for use in treating narcolepsy under the 
FDA's Orphan Drug program.
    Although the FDA has made it illegal to import, distribute and use 
GHB, the abuse of this drug has increased. As a drug of abuse, GHB is 
generally ingested orally after being mixed in a liquid. The onset of 
action is rapid, and unconsciousness can occur in as little as 15 
minutes. Profound coma can occur within 30 to 40 minutes after 
ingestion. GHB has also been used by drug abusers for its alleged 
hallucinogenic effects and by bodybuilders who abuse GHB for an 
anabolic agent or as a sleep aid.
    GHB is known to be responsible for as many as 19 deaths and 
innumerable rapes throughout this country. In seven of these cases, GHB 
was detected in the urine of the sexual assault victims.
    However, GHB's involvement in rape cases often goes unreported or 
unsubstantiated because little is known about how to detect the 
presence of the drug in victims rushed to hospitals and police 
stations. GHB has been widely used as a party drug and most 
horrifyingly, by those intending to drug and then rape their victims. 
In California in 1996, 2 men were eventually brought to trial and 
convicted of 43 counts of rape, attempted rape and conspiracy to commit 
rape. These men gave their dates drinks spiked with GHB and then 
brutally raped and sodomized them.
    During preparation for trial, prosecutors discovered nearly 2000 
photographs in one of the accused rapist's home. One of the police 
officers testified that some of the women looked obviously comatose in 
the pictures.
    Unfortunately, this terrible story is not an anomaly. Women who are 
drugged and raped using GHB, often do not remember the rape until much 
later, making the evidence scarce, and prosecution of these cases a 
legal nightmare.
    GHB has the greatest potential for abuse as a date-rape drug 
because it is more easily obtained than other drugs and can be 
manufactured by amateur ``basement chemists.'' Many of young people mix 
the drug with a home kit and with chemicals available at chemical 
supply and hardware stores. The recipe is readily available on the 
Internet.
    GHB comes in liquid form and is often slipped into drinks with eye 
droppers or bottle caps. Dizziness, confusion, overwhelming drowsiness, 
and unconsciousness are common. GHB is colorless and odorless, but may 
be detected by its slightly salty taste.
    During testimony last July, law enforcement officers, doctors and 
researchers agreed on the importance of scheduling GHB under the 
Controlled Substances Act. I would like to thank former Detective 
Trinka Poratta, of the Los Angeles Police Department; Detectives Mike 
Stevens and Toni Moreschi from Orlando, Florida; and Dr. Joy Carter 
from Houston, Texas for their help and encouragement in working to 
schedule GHB.
    This drug is currently controlled at the state level in 17 states, 
including Tennessee, Alaska and North Carolina which have scheduled it 
as a level 4 drug under the state controlled substances act.
    I believe we must do whatever we can to protect our young people 
from GHB when used improperly. I hope my colleagues will support my 
efforts in preventing date rape and lethal drug overdose. Thank you.

    Mr. Upton. Thank you very much. We appreciate--all of us--
your leadership on this issue.
    I know you spoke on the floor again yesterday or the day 
before with regard to this issue, and I just want to commit as 
chairman of this subcommittee, and as a Member of Congress 
representing my good State of Michigan, that we do want to see 
changes made.
    The purpose of this hearing is to identify some of those 
abuses, find out whether legislation is needed, whether FDA can 
act on its own. Those will be some of the tough questions that 
we will be asking later this morning.
    We just appreciate your testimony today, and with that I 
will yield for purposes of questioning to Mr. Stupak.
    Mr. Stupak. Just a quick question, and I am sure the 
sponsor of the legislation knows while FDA has been working 
with us, I am sure you understand there are two ways we can do 
this.
    We can either do it through the FDA and have them pass 
rules or regulations, or we can do it legislatively. Is there 
any preference you prefer?
    Ms. Jackson-Lee. Congressman, I would relish the 
opportunity for us to work together in the Congress and to move 
swiftly and to do this legislatively. I think in doing so, we 
would not in any way injure or damage the relationship between 
the Congress and the Executive.
    I think that the Congress is asked to deal with crises, and 
I think we now have a point where we can assess the GHB use and 
its proliferation as a crisis. I would welcome doing this 
through the legislative process.
    Mr. Stupak. In our conversations we have had on this issue, 
it was your hope and our belief and hope, much like I did in 
1993 when we did Ephedrine to wipe out the Cat problem, that we 
could introduce this legislation, move it legislatively and get 
it done within 6 months, as I did in 1993. I know that was your 
understanding.
    When we got it cleared through Judiciary Committee, it was 
your hope, was it not, that you wanted your bill to be passed 
as a freestanding bill in October in the waning days of the 
105th, or were you looking for it to be part of an omnibus 
bill?
    Ms. Jackson-Lee. I did file it as a freestanding bill, and 
as I worked through the process, Mr. Stupak, and got the 
support of Chairman McCullum and Chairman Hyde, I certainly 
wanted to collaborate with the appropriate jurisdictional 
committees, but I wanted it to be a freestanding bill.
    Mr. Stupak. Do you know of any reason why or have you had 
any objections from any pharmaceutical manufacturers, from 
anyone who would object to either your bill, my bill or any of 
these passing as a freestanding bill?
    Ms. Jackson-Lee. I would think with the intent of 
pharmaceuticals to do good that there would certainly seem no 
reason why they would not want to see this bill passed inasmuch 
as, and you are the experts, this would not preclude a 
medicinal use if it could be determined.
    We want to see if that is the case, but at this point I 
cannot imagine why there would be opposition, and I would hope 
there was not opposition.
    Mr. Stupak. You have worked on this--and especially with 
the tragic circumstances in your district, in your opinion, 
what is more dangerous, the use of GHB and its analogs as a 
tool to facilitate rape or the use of GHB as the party drug of 
choice for young people?
    Ms. Jackson-Lee. Well, you have me between a closed door 
and a brick wall. I would simply say that we know that the GHB 
in young people resulted in deaths. We know that the rape use 
of it has resulted in immobilization of the victim, who then 
cannot help law enforcement to even find the perpetrator.
    Death obviously will take the lead, but as a woman let me 
tell you that I have experienced or seen victims and heard 
stories from victims as we did our research, and it is an 
enormous tragedy on all counts.
    Forgive me for not trying to choose, but I think it is a 
tragedy. Maybe you were giving me the rhetorical question to 
say it is a dangerous drug that should be made criminal.
    May I just add my appreciation to my counsel, who did not 
have to sit here, but my staff person, Leon Buck, for the work 
that he and our staff did on this particular matter.
    Mr. Stupak. Leon does a good job, and I think he would 
agree with you that both are equally dangerous facets of GHB.
    Ms. Jackson-Lee. Absolutely.
    Mr. Stupak. Let me ask you one more. I understand that your 
bill, the Hillary J. Farais Date Rape Prevention Act, as it 
currently reads asks that GHB to be placed on Schedule I of the 
Controlled Substances Act.
    Are you open to other solutions that would provide law 
enforcement with additional tools for fighting the illicit use 
of this drug?
    Ms. Jackson-Lee. I think there is a great opportunity, Mr. 
Stupak, for us to work together, and, yes, I am.
    The only point that I would like to emphasize is the 
consideration of the criminal penalty of 20 years or some 
compromise thereof, but as well that we have an educational and 
prevention piece in it because I really want to have young 
people be aware themselves of the danger of the utilization of 
these kinds of drugs.
    Mr. Stupak. In fact, I believe both your bill and my bill 
ask the Attorney General to put forth some education process 
throughout the country as to the dangers of GHB and Ketamine--
--
    Ms. Jackson-Lee. Absolutely.
    Mr. Stupak. [continuing] and the precursor.
    If we place GHB on Schedule III, but if we put the 
penalties for Schedule I, which is I think $250,000 and 20 
years----
    Ms. Jackson-Lee. Yes.
    Mr. Stupak. [continuing] you have no objection with that?
    Ms. Jackson-Lee. We can work together, yes. Thank you.
    Mr. Stupak. Thank you, Mr. Chairman, and I would yield back 
my time.
    Mr. Upton. The gentleman from Virginia, Mr. Bliley?
    Mr. Bliley. I just have one question. My mind sometimes 
gets rusty. Did you not call me and ask me to allow your bill 
to be put on the omnibus bill at the end of the session?
    Ms. Jackson-Lee. I called and indicated that I had a 
freestanding bill and whatever the procedures might be to help 
get it in these last moments.
    My original request was a suspension bill, and staff 
instructed and staff was working on other aspects and so 
whatever they may have guided us to do, if it was possible, 
that may have been the case, but my bill was a freestanding 
bill that I asked to get on the suspension document at that 
time, Mr. Chairman.
    Mr. Bliley. Thank you.
    Mr. Upton. Mr. Klink, do you have questions?
    Mr. Klink. Yes, I sure do. Your testimony, I am intrigued 
by it, and I just have to laud you for moving forward with your 
bill.
    I have to tell you. As the father of an 11-year-old 
daughter, and not only your testimony, but I have read the 
testimony of the other witnesses we are about to hear. I am 
going to tell you something. We have to do something.
    Mr. Chairman, I thank you for holding this hearing. This 
action must be taken as immediate as we can take it. I just 
really think that the kind of protections that we have the 
ability to offer are certainly deserving by the young women of 
this country and by their parents that will need the peace of 
mind when they start to understand that these kinds of things 
are happening.
    I have to ask you, though. Are the punitive aspects of this 
bill, do you think, enough that will stop the misuse of GHB?
    Ms. Jackson-Lee. I think that if we utilize the 20 years' 
penalty that is associated with Schedule I and the fine that is 
associated that we will have a sufficient deterrent, along 
with, ranking member Klink, the idea of the preventative and 
educational aspects.
    That is extremely important, and so I want to be very sure 
that we have a combination, the criminal penalties that are 
strong enough and the educational aspects.
    Mr. Klink. We have to realize up front, though, that Orphan 
Drug is telling us there are legitimate uses for GHB; for 
example, the treatment of narcolepsy. Are you sensitive to that 
use, and how would you deal with that?
    Ms. Jackson-Lee. I am sensitive to the representation made 
by Orphan Drugs, and I am sensitive to those who suffer from 
that disease.
    I believe that we will be able to have provisions that 
would acknowledge the medicinal use of that drug and have this 
defined in illicit use, possession and selling or utilization 
of, and we separate it from the legal use of it.
    I mean, we have a variety of drugs that fall in that 
category that have medicinal purposes, and yet their illicit 
use have a penalty at that level.
    Mr. Klink. I do not want to speak for Orphan Drug, but I 
think it is counsel's understanding that they are willing to 
support Schedule III with very tough penalties, and I think 
there are some other things that we might want to be able to 
work some of this, I think.
    Are there any other steps that might be taken to combat the 
dangers of GHB?
    Ms. Jackson-Lee. Absolutely. We must wage a massive 
educational campaign because, as I said earlier, GHB by 
teenagers--and who wants to speak for teenagers?--is a fun 
drug, if you will, made in bathtubs, made for rave parties.
    I do not think the point has gotten out how devastating and 
deadly--just think of the examples. I think the chairman gave 
his example of the victims in his community. These youngsters 
have this drug the night before, and they are gone the next 
morning.
    There seems to be no way, because it attacks the central 
nervous system, of getting them in there and bringing them 
back, if you will, or using emergency medical devices because 
it has no odor, it has no telltale immediate signs, and so you 
cannot rush immediately to the hospital. They go home, and 
tragically the next morning or maybe hours later they have 
died.
    I think that is the tragedy of what we are here. It is 
extremely dangerous.
    Mr. Klink. Have you been contacted by others besides the 
Farais family who have had to deal with tragedies like this 
involving GHB?
    Ms. Jackson-Lee. In working with Officer Porrata, I know 
that there have been occasions in California. There have been 
incidents in Florida. Chairman McCullum is aware of them.
    So, yes, we are aware of incidents of death that have 
occurred because of the utilization of GHB and the 
immobilization of those rape victims I think as well.
    Mr. Klink. Again, when you read the stories that we are 
going to hear today, just reading the testimony I cannot 
imagine what it is going to be like to hear from these victims 
and the parents of these victims who have gone through this 
unbelievable experience.
    I will tell you, Congresswoman Jackson-Lee, as I said, as a 
father of a daughter that is about to enter that dating age, I 
am pleased to work with you, Mr. Stupak, Chairman Upton, and 
anyone else. We have to act very quickly. We cannot let this 
threat out there in the public another day than is necessary.
    I said in my opening statement and I realize our friends at 
the FDA have limits because they have to go through procedures. 
Congress has the ability to act, and I think with what Chairman 
Upton has scheduled here today, with your help and guidance and 
that of Congressman Stupak we can move very quickly and protect 
the children of this country and also give the parents some 
peace of mind that they deserve.
    Ms. Jackson-Lee. Thank you very much, Mr. Ranking Member.
    Mr. Upton. Mr. Whitfield, do you have any questions?
    Mr. Whitfield. Thank you, Mr. Chairman.
    Representative Lee, are you aware of any jurisdictions in 
the U.S. today where it would be illegal to possess GHB?
    Ms. Jackson-Lee. Pennsylvania and California. I am sorry. I 
had to be refreshed.
    Mr. Whitfield. Well, I did not have any idea, so I am glad 
you did.
    Ms. Jackson-Lee. We had all of this piled-up information. I 
wanted to be accurate.
    Mr. Whitfield. So in Pennsylvania and California, those are 
the only two States in which it is illegal to possess GHB?
    Ms. Jackson-Lee. That is why I think the congressmen and 
myself have recognized this as a national issue deserving of 
legislative attention.
    Mr. Whitfield. So the only other way that someone that used 
GHB illegally could be prosecuted criminally today would be if 
the victim died or suffered some sort of permanent injury or 
would be subject to a civil action? That would be the only----
    Ms. Jackson-Lee. That is correct, or in an instance in our 
State, in Texas, of course, there would be State criminal laws, 
of course, causing the death of another.
    Mr. Whitfield. Right.
    Ms. Jackson-Lee. As to how that would be determined, it 
could be manslaughter, et cetera, et cetera. You would be 
subject to that, but it would never end the dissemination and 
the making thereof of that drug and selling it for that 
purpose.
    Mr. Whitfield. So in 48 States, there is just nothing out 
there?
    Ms. Jackson-Lee. Nothing there, Congressman.
    Mr. Whitfield. You and Mr. Stupak had a conversation about 
Schedule I and Schedule III. Schedule I has a more severe 
criminal penalty, I guess you said up to 20 years.
    Ms. Jackson-Lee. Yes.
    Mr. Whitfield. Is that correct?
    Ms. Jackson-Lee. And $250,000 in fines, I believe.
    Mr. Whitfield. I do not want to speak for Mr. Stupak, but 
he seemed to be talking about Schedule III. What is the penalty 
on Schedule III?
    Ms. Jackson-Lee. Mr. Stupak?
    We are now working. As he gets his answer, I will say to 
you that I think in that instance that minimally at best, but 
we are working in collaboration with Mr. Stupak to see how we 
could combine the criminal penalties. That is the key for 
getting the message out that we are serious.
    I know that the criminal penalties for Schedule III did 
not, in my opinion, fit the level of the crime.
    Mr. Whitfield. Is there any difference?
    Mr. Stupak. If the gentleman would yield? While we may 
schedule it as Schedule III, we want the penalties as Schedule 
I.
    Mr. Whitfield. Okay.
    Mr. Stupak. We had done that with Hipynol, which was 
another one we did earlier, so we are following that same track 
because the criminal intent here is so heinous when you can put 
a person unconscious so they cannot help in the rape case, or 
just by the use of it, as in this case here, people die.
    While it may be scheduled under III because of the chemical 
make-up, we want the penalties to be criminal penalties under 
Schedule I, the maximum.
    Mr. Whitfield. You would prefer that it be scheduled as 
III, but have the penalties as I? Is that correct?
    Mr. Stupak. Correct. Correct.
    Mr. Whitfield. Is that----
    Mr. Stupak. Because of the legitimate uses involved in 
these drugs.
    Mr. Whitfield. Okay.
    Mr. Stupak. There are legitimate uses. It is when it is 
used illegally or concocted illegally that we have the problem.
    Mr. Whitfield. Okay. So, Representative Lee, you would not 
object to that in scheduling it as a III and penalty as a 
Schedule I?
    Ms. Jackson-Lee. No. I am very happy to work with 
Congressman Stupak on that collaboration.
    Mr. Whitfield. Now, are you aware of any funds that would 
be available at HHS or the Department of Justice or FDA or Drug 
Enforcement Agency that could be used to educate young people 
today about this problem?
    Ms. Jackson-Lee. When we first looked at this question, we 
looked to the Department of Justice, who indicated, or at least 
let me not represent their indication, but that there would be 
a revenue stream within the Justice Department for educational 
and preventative information disseminated that would already be 
included in their existing appropriations.
    Let me not conclude or at least foreclose the need for 
targeted funds for this legislation on the educational aspect.
    Mr. Whitfield. Are you aware which particular program the 
funds are already available at Justice for this purpose?
    Ms. Jackson-Lee. I think they would come, and let me not 
mis-speak, maybe under the community relations aspects, which 
is an outreach program which might be helpful.
    Mr. Whitfield. Okay. Now, I know you have been in the 
forefront on this issue.
    Thank you, Mr. Chairman.
    Mr. Upton. Ms. DeGette?
    Ms. DeGette. Chairman, I think Ms. Jackson-Lee has made a 
compelling case, and so I will let her off of at least my hot 
seat.
    Thank you. I have no questions.
    Mr. Upton. Okay. The gentlelady from Missouri?
    Ms. McCarthy. Thank you, Mr. Chairman, for calling this 
hearing.
    Thank you, Representative, for coming forward with 
testimony. I look forward to working with you toward successful 
completion of legislation.
    I am anxious to hear from the law enforcement panelists who 
will follow you so that I can better understand while we do 
change the schedule and the penalties how out in the States we 
will actually enforce this new law so that it is more than just 
merely a national intention and a Federal initiative, but 
within our local law enforcement agencies and within our State 
government we can make sure that your intentions are carried 
out.
    Thank you, Mr. Chairman.
    Mr. Upton. Thank you.
    The gentleman from Texas?
    Mr. Green. Thank you, Mr. Chairman, and I again will not 
belabor it because we have a long number of panelists.
    I would like to congratulate my colleague from Houston. It 
is my impression in Texas the State law is possession of GHB is 
a Class A misdemeanor. Is that correct?
    Ms. Jackson-Lee. It has that level. It is not a felony, 
which is what we are trying to do.
    Mr. Green. But selling it obviously is a State jail felony 
time.
    I agree that we need to do something on a national basis, 
and so, Mr. Chairman, with that I will yield back my time so we 
can go on, but congratulations.
    [The prepared statement of Hon. Gene Green follows:]
Prepared Statement of Gene Green, a Representative in Congress from the 
                             State of Texas
    Thank you, Mr. Chairman, for holding this hearing. We must never 
let down our guard in the fight against drug abuse.
    Mr. Chairman, we are here today to talk about drugs that are being 
horribly misused, these so-called ``date rape'' drugs. While none of 
these drugs should be easily available, I think that Congress needs to 
act to insure that our young people do not have access to these 
dangerous substances.
    In my hometown of Houston alone, there have been numerous cases of 
young people becoming ill or dying from the abuse of one of the most 
popular of these drugs, GHB.
    In late 1996, a young woman from the Houston area, Hillory Farias, 
died after someone laced her drink with a lethal quantity of GHB.
    GHB, which is an unapproved drug, is currently under investigation 
as a treatment for narcolepsy. A number of states have already 
scheduled this drug. Currently, the Federal Drug Administration (FDA) 
has GHB under consideration for scheduling and the Violence Against 
Women Act, which I am a cosponsor of, would make this a Schedule I 
drug.
    More recently, the FDA has acted to remove GBL, a chemical 
``cousin'' to GHB, from the shelves of gyms and health food stores, 
where it was being sold as a nutritional supplement.
    GBL is an organic solvent used in, among other things, paint 
thinner. However, it was easily transformed through simple chemical 
reactions to GHB.
    Mr. Chairman, the FDA has been reviewing scheduling these drugs. I 
would like to commend them for being proactive in addressing the 
dangers of these and other drugs.
    This Committee, though, has questions to answer. Where the FDA is 
deliberate, and rightfully so, we have the power to act quickly, 
swiftly and decisively on these issues.
    In our first panel, we will hear from Ms. Jackson-Lee, my colleague 
and friend from Houston. In 1997 and again this year, she has 
introduced legislation that would make GHB and other ``date rape'' 
drugs, like ketamine, schedule I or II drugs.
    Previously, her legislation, for whatever reason, died after being 
referred to the Commerce Committee. No action was taken on her bill. 
This is after the Judiciary Committee waived a full hearing for her 
bill, based on its bipartisan support.
    Also, my colleague and friend on this Committee, Mr. Stupak of 
Michigan, introduced similar legislation, which would have made these 
drugs schedule III drugs. His legislation, after being referred to the 
Commerce Committee, died without action at either the Subcommittee or 
full Committee level.
    Mr. Chairman, if these drugs are as dangerous as I think everyone 
here knows them to be, then why should we wait? Why has our Committee 
not scheduled these bills for hearings or markups? Why have we not 
moved these bills to be voted on by the House?
    We know that these drugs are powerful sedatives with dangerous side 
effects. Let's get together and put aside our differences to protect 
America's youth.
    We need to make it as difficult as possible for our children to get 
their hands on these drugs. Sitting around and doing nothing is 
irresponsible and dangerous to our children.

    Ms. Jackson-Lee. Thank you very much, Mr. Green.
    Mr. Upton. The gentleman from Tennessee, Mr. Bryant?
    Mr. Bryant. I thank the chairman, and I would say that it 
is disappointing having to be here to hear this testimony and 
the fact that this is a subject that we do need to act on and 
probably should have acted some time ago.
    I know all sides on this issue--it is certainly not a 
partisan one--agree that this is a serious problem, and we have 
attempted to address portions of this previously, but there is 
I guess a continuing problem that we are going to hear more 
about today. I look forward to doing that.
    I simply want to close my remarks by thanking my colleague 
from Texas for the outstanding work that she is doing in this, 
and also I would add a compliment to her staff. Having lived 
next door to them for 4 years now, going on our fifth year, we 
have a great relationship.
    Ms. Jackson-Lee. Thank you.
    Mr. Bryant. Again, I appreciate very much your efforts, as 
well as your office. Thank you.
    Ms. Jackson-Lee. Thank you very much. Thank you for your 
help.
    Mr. Upton. The gentleman from Ohio, Mr. Strickland? Do you 
have questions for----
    Mr. Strickland. No opening statement. Thank you.
    Mr. Upton. Do you have questions? Your opening statement, 
if you want, will be----
    Mr. Strickland. No questions.
    Mr. Upton. Okay. Ms. Jackson-Lee, thank you for coming. We 
appreciated your testimony and your answers.
    Ms. Jackson-Lee. Thank you very much, Mr. Chairman.
    Mr. Upton. We look forward to working with you.
    Ms. Jackson-Lee. Mr. Chairman, let me thank you for this 
hearing.
    My legal mind wants to just conclude by simply saying that 
this bill, we hope, will go forward as a freestanding bill as I 
wanted in the last Congress, and any questions to suggest its 
inclusion in omnibus, let me make sure that we clarify and say 
that if we were advised by staff to do anything that might have 
added it to that at that point that might have been the action, 
but it did not occur so I want to be very clear that we did not 
have it in that legislation, and we hope that we will move 
forward in a freestanding bill this session. I want to clarify.
    Mr. Upton. Thank you. Thank you.
    Ms. Jackson-Lee. Thank you very much.
    Mr. Upton. Okay. We are ready for Panel 2.
    You are excused.
    Ms. Jackson-Lee. Thank you.
    Mr. Upton. The next panel will be Dr. Felix Adatsi from 
Michigan State Police; Ms. Jo Ellen Dyer, Assistant Clinical 
Professor of Pharmacy at the University of California-San 
Francisco; Lieutenant Paul Bane from the Drug Enforcement 
Command from the Maryland State Police; Ms. Denise Snyder from 
the Rape Crisis Center here in Washington, D.C.; Ms. Trinka 
Porrata from Pasadena, California; and Sergeant Mark 
Faistenhammer from the Grosse Ile Police Department.
    We are hoping that Mrs. Lugene Pruett and her daughter, 
Candace, from Virginia will be here as well.
    Male Voice. They are here.
    Mr. Upton. They are here. Okay. Good. Terrific.
    If all of the witnesses would take an appropriate seat at 
the table? If you were here at the beginning, you heard me tell 
Ms. Jackson-Lee that the common practice in this subcommittee 
historically has been to take your testimony under oath. Do any 
of you have an objection to that?
    [No response.]
    Mr. Upton. We also have the practice if you would like to 
have counsel, which you need to let us know about in advance. 
Anyone have a problem not having counsel?
    [No response.]
    Mr. Upton. Okay. If you would stand with me and raise your 
right hand?
    [Witnesses sworn.]
    Mr. Upton. All right. Ms. Pruett, we will start with you.
    By the way, for all the witnesses I had the luxury of 
looking through some of your testimony last night because you 
complied with our committee rules. Your testimony will be made 
entirely a part of the record.
    We would like you to limit your remarks to 5 minutes. I 
know for some of you you will either have to read very, very 
fast, or you will have to summarize it in quite a fashion.
    We appreciate your testimony, but we would like to stick to 
the 5 minute rule.
    Ms. Pruett, thank you for coming.

  TESTIMONY OF CANDACE PRUETT, ACCOMPANIED BY LUGENE PRUETT, 
  COMMONWEALTH OF VIRGINIA; G. MARK FAISTENHAMMER, DETECTIVE, 
GROSSE ILE POLICE DEPARTMENT; TRINKA D. PORRATA, DESIGNER DRUG 
  CONSULTANT; JO ELLEN DYER, ASSISTANT CLINICAL PROFESSOR OF 
 PHARMACY, UNIVERSITY OF CALIFORNIA AT SAN FRANCISCO BAY AREA 
  REGIONAL POISON CONTROL CENTER; PAUL BANE, DRUG ENFORCEMENT 
COMMAND, MARYLAND STATE POLICE; FELIX ADATSI, TOXICOLOGY UNIT, 
MICHIGAN STATE POLICE; AND DENISE SNYDER, DC RAPE CRISIS CENTER

    Ms. Pruett. Thank you, Mr. Chairman and members of the 
committee.
    Mr. Upton. If you would not mind, all the witnesses, 
putting the mike fairly close to you? That would be terrific. 
Thank you.
    Ms. Pruett. Thank you for inviting me to appear before you 
today. My name is Candace Pruett, and I am an 18-year- old 
senior in high school.
    Three years ago, I was raped after someone gave me a soft 
drink laced with Rohypnol, which left me unconscious for 
several hours. I am appearing here today to warn other 
potential victims about the dangers of date rape drugs and how 
they can be misused. I hope that by telling my story I can help 
prevent other unsuspecting victims from being assaulted like I 
was.
    One of the most difficult things I had to cope with after I 
was raped was not knowing what happened to me that night. One 
of the symptoms associated with the so-called date rape drugs 
is that you remember very little, if anything, after being 
given the drug.
    Afterwards, I did not know what happened to me. I did not 
know what I had been given, that I had been given a drug or 
that I had gone into a coma and could have died. I did not 
remember being raped, nor did I even know who raped me. The 
only things that I knew were that something was very wrong, and 
I wanted to go home. I do know these questions should never 
have to be faced by any 15-year-old girl.
    Luckily, my parents had notified the police, who found me 
the next morning. I was taken to a hospital where they were 
able to perform a test which revealed that I had been given 
Rohypnol.
    Additional tests indicated that I had been raped by a 19-
year-old man while I was unconscious. The police were able to 
apprehend this person and later bring him to trial, but it was 
not until he made two separate attempts, one fleeing the State 
and one fleeing the country, to avoid his prosecution.
    The most frustrating part of the trial was that I could not 
remember what he had done to me. I wanted to be able to tell 
the Judge and jury what happened that night, but I could not 
because of the drug that was given to me.
    The forensic evidence, including the tests the police had 
given me, showed that I had been given Rohypnol and that 
someone had raped me. The drug, unfortunately, had robbed me of 
my memories and what happened that night. What he did to me 
also robbed me of my childhood. Going through the trial took 
away my innocence and forced me to become a grown up.
    I hope that by appearing today, I can let other people know 
about the danger that exists because of the sick people who use 
these drugs to assault unsuspecting victims. I also want to 
reassure other girls who may have been drugged and assaulted to 
immediately get help.
    An entire network of people, including counselors, police 
and prosecutors helped me during the trial. By seeking such 
assistance, other victims can get the help they need and 
hopefully work to put their rapists in jail.
    I want to thank the chairman for giving me the chance to 
tell my story today and hope that the committee can find some 
way to prevent what happened to me from ever happening again.
    Thank you.
    [The prepared statement of Candace Pruett follows:]
                  Prepared Statement of Candace Pruett
    Mr. Chairman and Members of the Committee, thank you for inviting 
me to appear before you today. My name is Candace Pruett and I am an 
eighteen year old high school senior. Three years ago, I was raped 
after someone gave me a soft drink laced with Rohypnol, which left me 
unconscious for several hours. I am appearing here today to warn other 
potential victims about the dangers of date rape drugs and how they can 
be misused. I hope that by telling my story, I can help prevent other 
unsuspecting victims from being assaulted like I was.
    One of the most difficult things I had to cope with after I was 
raped was my not knowing what had happened to me that night. One of the 
symptoms associated with the so-called date rape drugs is that you 
remember very little if anything after being given the drug. I did not 
know that I had been given a drug, or that I could have gone into a 
coma and died. I did not remember being raped, nor did I even know who 
raped me. The only things that I knew were that something was very 
wrong and that I wanted to go home. I do know that these questions 
should never have to be faced by any fifteen year old girl.
    Luckily, my parents had notified the police, who found me the next 
morning. I was then taken to a hospital where they were then able to 
perform a test which revealed that I had been given Rohypnol. 
Additional tests indicated that I had been raped by a nineteen year old 
man while I was unconscious. The police were able to apprehend this 
person, and later bring him to trial, but not until after he made two 
separate attempts to flee the state to avoid prosecution, once getting 
as far as London, England before being brought back to stand trial.
    The most frustrating part of the trial was that I could not 
remember what he had done to me. I wanted to be able to tell the judge 
and jury what happened that night, but I could not because of the drug 
that I had been given. The forensic evidence, including the tests that 
the police gave me, showed that I had been given Rohypnol, and that 
someone had raped me. One of the scariest things about date rape drugs 
is that they are absorbed very quickly by your body. If a test for the 
drug is not performed right away, it may only detect very small traces 
of the drug or it may not even show up at all. Another problem is that 
not all laboratories even know how to test for date rape drugs. Before 
I went to the hospital that morning, my mother had called several labs, 
but could not find any labs who were willing or knew how to test for 
date rape drugs.
    The drug I was given unfortunately had robbed me of my memories of 
what happened that night. What my attacker did to me also robbed me of 
my childhood. Going through that trial took away my innocence and 
forced me to become a grown-up.
    I hope that by appearing today, I can let other people know about 
the danger that exists because of the sick people who use these drugs 
to assault unsuspecting victims. I also want to reassure other girls 
who may have been drugged and assaulted to immediately get help. An 
entire network of people, including counselors, police and prosecutors 
helped me during the trial. By seeking such assistance, other victims 
can get the help they need and hopefully work to put their rapists in 
jail.
    I want to thank the chairman for giving me the chance to tell my 
story today and hope that he and the Committee can find some way to 
prevent what happened to me from ever happening again.

    Mr. Upton. Thank you very much.
    Sergeant Faistenhammer?

               TESTIMONY OF G. MARK FAISTENHAMMER

    Mr. Faistenhammer. Good morning. I am a Detective/Sergeant 
with the Grosse Ile Police Department assigned to a Michigan 
State Police managed drug unit known as DRANO.
    DRANO is a consortium which is made up of 19 member 
communities, and we police south of Detroit, Michigan. The unit 
is administered and managed by the Michigan State Police. My 
role there is an assistant crew leader and an investigator of 
controlled substance distribution in the metro Detroit area.
    During the past 2 years, the unit itself has noted an 
increase in the illegal distribution of GHB and GBL, a 
component of GHB. We often refer to it out on the street as 
scoop. Unit members are aware and have assisted in several 
investigations in the area 19 member departments, one of them 
being Brownstown Police Department, where they have had in the 
last year and a half 13 complaints of persons being scooped out 
of bars; that is, given GHB without their knowledge in the bar, 
someone pouring it in their drink, either by rescue runs or 
complaints the following morning.
    One of the people involved was a 15-year-old who was given 
GHB without her knowledge in May, 1997. Sex acts were done to 
her in an unconscious state, and the offender has been 
successfully prosecuted in Michigan and is in jail currently.
    The Riverview Police Department, another member of our 
consortium, has reported three confirmed suspicious deaths from 
GHB. The persons involved were body builders. Laying on the 
floor next to them were bottles of clear liquid. At the time, 
neither the officers involved in the case nor did the Wayne 
County Prosecutor's Office know to even look at GHB as the 
culprit. Although it is not the listed cause of death, 
information that the DRANO unit has been able to develop makes 
it more than just the suspected culprit in the cases.
    Cases that officers have investigated have been hampered by 
the fact that the body actually produces GHB; that in our 
bodies GHB is contained in there at all times. Additionally, it 
has been reported that GHB dissipates from the body within 24 
hours, making it tough to find on autopsy.
    At the same time, the DRANO unit has numerous cases that 
are open, but one of which currently has 12 suspects that just 
in our 19 member community has been mixing and distributing GHB 
in the area bars.
    Investigations from Woodhaven Police Department, as well as 
Gibraltar and Southgate Police Department, all describe deaths, 
people being scooped out of bars. Again, I refer to scoop as 
the act of placing it without your knowledge.
    The Michigan State Police DRANO unit, through 
investigations, believes that GHB is a drug of abuse that we 
need your assistance on. We have been finding it in our gyms. 
Body builders utilize scoop as a fat-burning process, as well 
as a method for getting high without the calories of alcohol.
    We also find it inside the dancers at many area bars who 
use it because they in turn can get high. They will place one 
capful of this clear liquid, and they report that it equals 
approximately 12 beers.
    Users report that they become extremely addictive to the 
drug. We have arrested people who we have had a great deal of 
problems in incarceration in that they have had to be woken up 
and actually needed to take GHB four or 5 hours into their 
sleep. They report to being addicted to GHB 24 hours a day.
    The biggest problem for us at the Michigan State Police is 
that there are no test kits available. Since it is not an 
illegal drug, companies are not pursuing the test kit. When we 
run into it on the street, we cannot develop probable cause. 
There is no immediate way to test for GHB in the containers 
that we are running into.
    When I say just GHB, I also mean GBL. In addition, officers 
have been buying large quantities of GBL. We have learned that 
GBL is manufactured by the body into GHB. GBL is a component in 
making GHB, so what has been occurring with us is that we have 
a group of attorneys in the metro Detroit downriver area who 
have been advising their clients to not sell GHB, but to 
distribute GBL and a person's body will make it for you, so the 
analog statute is very important. We fell a bit short in 
Michigan State law on that.
    As a member of the Grosse Ile Police Department, we have 
been working in conjunction with the Wayne County Prosecutor's 
Office in the investigation of the death of a girl who came to 
Grosse Ile in the middle of the night and with her friends was 
also scooped out. This girl recently died in January of this 
year.
    [The prepared statement Sergeant G. Mark Faistenhammer 
follows:]
Prepared Statement of G. Mark Faistenhammer, Detective Sergeant, Grosse 
  Ile Police Department, Michigan State Police, S.E.C.I.D. DRANO Unit
    I am a D/Sgt. from the Grosse Ile Police Dept., assigned to the 
Michigan State Police, Downriver Area Narcotics Organization (DRANO). 
DRANO is a consortium made up of 19 member communities, which is 
located south of Detroit, MI. The unit is administered and managed by 
the Michigan State Police. My role at DRANO is that of Assistant Crew 
Leader and an investigator of controlled substance use and distribution 
in the metro Detroit area. During the past two years the DRANO unit has 
noted an increase in illegal use and distribution of GHB which is 
BUTYROLACTONE (GBL) plus SODIUM HYDROXIDE equals GHB, with the street 
name of ``scoop''. Unit members are aware and have assisted in 
investigations with several members of other departments to include the 
Brownstown Twp. Police Dept. who, through investigations, have at least 
13 ``scooped'' victims in the past one and a half years. ``Scooped'' is 
what is referred to as the placing of GHB in someone's drink without 
their knowledge. Example: If you were at a bar and someone did place 
GHB in your drink, people on the street refer to you as being 
``scooped''. One of Brownstown Twp. cases involved a 15 year old girl 
who was given GHB without her knowledge and therefore was ``scooped'' 
in May 1997, and sex acts were done to her in an unconscious state. The 
offender has been prosecuted and is currently in jail.
    The Riverview Police Dept., an additional member of the downriver 
community, reports at least 3 confirmed suspicious deaths where GHB is 
the suspected culprit. The persons involved were body builders, and 
lying on the floor next to them was a bottle with a clear liquid 
inside. At that time, neither officers knew about GHB nor did the Wayne 
County Medical Examiner. The cases were not noted GHB deaths, however 
information received by DRANO officers makes GHB more than the 
suspected culprit.
    Cases that this officer has investigated have been hampered by the 
fact that the body produces GHB, not only after death, but contains 
some GHB in it at all times. Additionally, it is reported that GHB will 
dissipate from the body within 24 hours, making it impossible to find 
during an autopsy. At this time, in just one of the DRANO units open 
cases, there are at least 12 suspects that are responsible for the 
transportation, mixing and distribution of GHB into our area. 
Investigators from the Woodhaven Police Dept., another downriver 
community, reports five unexplained deaths. In the past year at least 
two juveniles have been ``scooped'' in Woodhaven and admitted to the 
hospital for an overdose. Gibraltar Police Dept. and Southgate Police 
Dept. also reports incidents of ``scoop'' in their area.
    The Michigan State Police DRANO Unit, through their investigations, 
have learned that GHB is a drug of abuse, which has been on an increase 
in the area gyms. Body builders utilize ``scoop'' to assist them in 
their fat burning process, as well as a method of getting high without 
adding the calories of alcohol. Body builders seem to equate one pop 
bottle cap full of GHB equaling the high of approximately 12 beers. 
DRANO officers have located GHB mostly in pop bottles, however numerous 
water bottles and containers have been discovered. This same formula 
has been utilized by dancers in adult bars. The dancers abuse GHB 
because it gives them the alcohol high without the calories. This 
officer has been involved in investigations where persons utilizing the 
GHB have been severely addicted to the drug. Users report that they 
will take GHB, go to sleep at night, and approximately four to five 
hours later wake up with a severe need to utilize GHB again and remain 
on the drug throughout the day and night (24 hours a day). In spite of 
the fact that these abusers have been in drug rehabilitation, they 
continue to come out and go right back to utilizing GHB.
    One of the biggest problems for the Michigan State Police DRANO 
Unit has been the fact that there are no test kits available and that 
the Michigan State Police lab is having problems with the analysis of 
GHB. Most any material the lab would use to break down and test the GHB 
also manufacturers it. In addition, officers on the street brought in 
numerous bottles and containers from inside vehicles, which have a 
possible odor of being GHB; but have no method of testing the liquid on 
the street. Therefore, we have established a great need to develop a 
field test kit. DRANO officers have also run into a major problem in 
that GHB components are legal. An example would be GBL, which is one of 
the major components needed to make GHB. It has been learned that if 
GBL, is consumed by itself the body will then produce GHB and the same 
high will be accomplished. Officers have seized multiple gallons of GBL 
and cases cannot be brought against the culprits because it is not GHB, 
but in fact GBL. DRANO officers are finding abuse of GHB and GBL in 
various locations such as the local bars, adult dancing bars, gyms, 
high schools, therefore by persons from all walks of life. Information 
from confidential sources, as well as defendants themselves, have 
stated that lawyers are advising persons engaged in sales of GHB to 
only deal in GBL, a GHB component. The attorneys are advising their 
clients that there is no federal law prohibiting GBL and that state law 
in the State of Michigan does not cover GBL only GHB. Officers in the 
DRANO unit have several cases where only GBL has been acquired from the 
suspects. I have been a party to an investigation assisting the Grosse 
Ile Police Dept. in an incident where juvenile girls were ``scooped'' 
or possibly given GBL without their knowledge. The suspects in this 
particular case admit that they deliberately gave the girls GBL, 
knowing that their bodies would convert it into GHB and did so without 
the knowledge or consent of the girls. Both of the juvenile girls given 
the drug were admitted to the hospital in an unconscious state. The 
outcome was one of the girls was eventually pronounced dead at the 
hospital and the second recovered from a severe overdose. The Grosse 
Ile Police Dept., working with the Wayne County Prosecutor's Office and 
the Michigan State Police, should be acquiring warrants within a couple 
of days but word from the prosecutor's office is that it will be a 
death by poisoning charge as opposed to a charge involving GHB or GBL.
    In the prospective of officers investigating these types of cases 
at the MSP DRANO unit, the inadequate laws, as well as the nature of 
GHB interacting with the body, makes them difficult if not impossible 
to prove. Our crime labs are having a difficult time analyzing GHB, the 
fact being if you take GBL and place it in the body, the body itself 
will manufacture GHB and the person will get high anyway. The fact that 
there are no test kits available for officers on the street who may 
encounter GHB or GBL, and that the drug dissipates in the body, blood, 
or urine samples within 24 hours whether the subject is alive or 
deceased, makes the investigator's task to be more than just 
cumbersome. Officers can only rely on assistance from the FDA as 
opposed to being able to call the Drug Enforcement Administration, FBI, 
or United States Customs and get the assistance needed from agencies 
set up to deal with illicit drugs.

    Mr. Upton. Thank you.
    Folks here in the room know the buzzer has sounded, which 
means we have a vote in progress. Mr. Burr has gone over to 
vote. He will relieve me soon, but we will continue with the 
testimony since the witnesses have started.
    Ms. Porrata, you are recognized for 5 minutes.

                 TESTIMONY OF TRINKA D. PORRATA

    Ms. Porrata. Thank you. I have waited a long time to be 
here for this day. I normally teach an 8-hour class, so I will 
try to condense it.
    I brought these because I want you to see just how easy it 
is to hide GHB. This is all that a rapist needs to commit a 
rape with GHB; nothing more than a little eyedropper full. The 
guy who just got 77 years in California for rape with GHB 
started his career with just an eyedropper in his pocket.
    We see it now in little Bianca bottles, food coloring and 
vanilla bottles. They are nice, flat bottles. They fit in a 
man's pocket nice and easy when he goes to the club. A 
videotape of suspects in Hawaii were using food coloring 
bottles for that purpose.
    Any container that will hold a liquid. It seems like an 
empty container. No. He just drank the GHB out of it. Mouth 
wash bottles, water bottles. I commend the officers who found 
this one. It was a woman's hair spray bottle, purse size, full 
of GHB, taken into a club, and we have seen it in kids' 
bubbles.
    There is not any container that is not fair game. It is a 
clear liquid. It can be colored to look like the mouth wash or 
the Gatorade bottle that it is in. It does not matter. It is 
just that easy to hide, and law enforcement is missing it.
    You have absolutely no clue how big this problem is. The 
rape statistics are minute compared to what really is going on. 
For every rape victim out there, there are hundreds of 
overdoses that were caused by voluntary ingestion. There are 
dozens and dozens of kids deeply, deeply addicted to this drug. 
It is much more harder to get off of than heroin.
    I get e-mails from kids who say I shook heroin on my own. I 
shook cocaine on my own. I shook nicotine. Why can't I get off 
of GHB? It is that hard for them to get away from.
    It is hard to believe that if your kid is running around, 
if you have a 15-year-old son, a 25-year-old son. A 30 year 
veteran of the Los Angeles Police Department, his son walked 
around the house sipping from a water bottle. He thought it was 
kind of odd that he sipped from it. You normally drink from a 
water bottle. His son had a deep, deep, serious addiction to 
GHB right in front of him, and he knew nothing about it until 
he read my training bulletin.
    The scope of this problem is humongous. If you really look 
at it, it is far bigger than rape. Rape is a serious issue, but 
we are missing the boat. This is a serious drunk driving issue. 
We have had at least a couple of deaths from it. You have to 
understand that for every death that occurs, there are more 
that just were not caught by the coroner. For every drunk 
driving case, there are hundreds more that were not caught.
    In California, a young man made it two and a half times 
through the criminal justice system without GHB surfacing. He 
was convicted for drunk driving with actually a very low blood 
alcohol, but his aggression was so intense that he did get 
convicted. They thought it was alcohol only.
    The second time he had a very low BA, and he got through as 
a reckless driver because again a very low BA, a negative for 
any other drugs in the standard drug screen, and yet the third 
time when he killed somebody he got through the prelim as a 
drunk driver only, alcohol only, but the word GHB came up 
during the investigation, and we were able to get it tested and 
determine that he was a chronic GHB user. We had testimony to 
that effect. He pled guilty. He is doing 14 years in 
California.
    There are hundreds more cases like that out there, but the 
officers did not notice the water bottle on the car seat or the 
mouth wash bottle on the floor of the car. They would have no 
way of knowing. The training is totally inadequate. Every 
single place that I teach--every single place--within 2 weeks 
they are arresting people for GHB.
    I want to stress the biggest problem I have had in doing 
the legislation in California and other States is the total 
misunderstanding and confusion. This drug has no approved 
medical use. There is no approved medical use for GHB.
    Your action, if you put this in Schedule III, does not make 
this drug available as a prescription drug. Orphan Medical 
would like to get their foot in the door by you doing that, but 
by making it Schedule III you are not approving this drug. The 
FDA still has to do that.
    The failure of the Federal Government to take action on 
this drug has caused additional confusion in the States. The 
States, too, when they look at this drug go whoa. We have this 
drug company here telling us it is like a good drug, and they 
have these people that want to come and take this drug.
    That is not what determines what schedule you put it in. I 
am personally bothered as an officer who just retired and as a 
citizen that the drug scheduling concept is now being violated 
based on what the drug companies want.
    Rohypnol. There is no approved medical use for Rohypnol, 
yet it is in Schedule IV. I plead with you to put these drugs 
where they belong. These are unapproved drugs. There is no 
medical use. If and when there is ever a medical approval, then 
you can move them down.
    [The prepared statement of Trinka D. Porrata follows:]
   Prepared Statement of Trinka D. Porrata, Designer Drug Consultant
    Law enforcement is literally drowning in the ``standard'' drugs of 
abuse--cocaine, methamphetamine, heroin and marijuana. Law enforcement 
is now only beginning to realize that we are far behind in accessing 
the depth and breadth of the current drug problem. As a whole, law 
enforcement has failed to notice that 13 of the top 20 drugs of abuse 
are prescription medications. Very few agencies have any resources 
assigned to pharmaceutical diversion issues. Meanwhile, street drug 
``news'' (whether accurate or inaccurate) now travels as fast as the 
click on an icon. Crime laboratory statistics re seizures of trendy 
drugs like MDMA (Ecstasy), gamma hydroxy butyrate (GHB), ketamine 
(Special K) and flunitrazepam (roofies or Rohypnol) are minute compared 
to statistics for the old standard drugs. But, after 25 years as a 
police officer, seven years as a narcotics officer and three years 
fully immersed in the issues of these trendy drugs, it is my opinion 
that those figures do not reflect reality. The trendy drugs have been 
considered to be off in some small segment of society, such as the RAVE 
crowd or the wildest and highest echelon of the Hollywood set, and thus 
not a big issue.
    But, while we weren't looking, those trendy drugs have become 
mainstream. The truth is, the average police officer, the average 
narcotics officer, knows very little about prescription drug abuse and 
even less about violations by the doctors and pharmacists who knowingly 
feed this market. The average police officer/narcotics officer knows 
very little about ketamine, flunitrazepam, GHB and MDMA.
    These now mainstream drugs circulate in subcultures and 
environments where law enforcement either has limited contact or 
doesn't expect to deal with drug abuse issues, such as: 1) in RAVE/Goth 
gatherings, college/high school gatherings, on any beach, 2) in health 
clubs/gyms and on the high school playing field and in after-game 
activities of the athletes and cheerleaders, 3) now predominant in many 
restaurants and clubs catering to 21-35 year olds with college degrees, 
driving fancy cars, 4) in any stripper or exotic dance club, and 5) in 
the hands of sexual predators.
    None of these environments are the focus of narcotics enforcement 
efforts. In fact, most agencies avoid RAVE gatherings like the plague 
unless called in to handle the aftermath of civil disturbances or 
medical emergencies.
    These drugs are becoming more common in drunk driving and sexual 
assault cases, though our standard drug screening does not include many 
of them. Some present unique testing issues, yet we have not adequately 
responded by modifying our testing and rape investigation protocols and 
improving our testing capabilities.
    One would expect the federal Food and Drug Administration (FDA) to 
take the lead, providing prompt and accurate information regarding 
existing and developing drugs and to be definitive as to current/
potential licit status of any drug and its abuse potential.
    One would expect the Drug Enforcement Administration (DEA) to be 
cutting edge on issues of illicit trafficking, manufacturing and abuse 
as it develops. But in my experience, their roles have been quite 
passive, not active. Thus, we are here today talking about drugs that 
are in reality 25-30 years old and have all been abused to varying 
degrees throughout that existence. GHB is perhaps the youngest in terms 
of discovery by abusers, though it is now literally exploding around 
the world.
    Many people do not understand the difference between state and 
federal laws; it is particularly confusing when it comes to drug 
scheduling. Many do not understand how a drug can be scheduled in a 
state, but not federally, and vice versa. There is a logical pattern 
for how drugs are to be scheduled. This is defined by terms such as 
``approved medical use'' and ``abuse risk.'' I don't see the term 
``drug company's desires'' in the formula, though I have seen clearly 
that their desires do drive much of what happens in recent drug 
scheduling efforts.
    In actuality, there have been several dedicated FDA and DEA agents, 
chemists and doctors working on these specific drug issues. But, they 
have not had full support from management and/or issues become lost in 
the tangle of bureaucracy and politics.
                                ketamine
    Ketamine clearly has legitimate medical uses and has endured in the 
legitimate medical world far beyond PCP, its chemical cousin. But we 
have known for decades that it has a high abuse factor, with flashbacks 
worse than PCP. One year ago, while trying to upgrade mere possession 
charges for ketamine in California, I was told that the volume of 
legitimate medical use of ketamine had not changed significantly, but 
manufacturing of ketamine was up 40 percent. If that is true, that 
should be a dramatic indicator of the abuse level of ketamine in this 
country at this moment. Yet ketamine is not federally scheduled. DEA 
has someone ``tracking'' ketamine abuse, but it is a rather passive 
role to date. I've personally seen nothing on this abuse issue actively 
emanating from the FDA.
                             flunitrazepam
    Flunitrazepam (Rohypnol, aka roofies) is already federally 
scheduled (Schedule IV), and from a law enforcement viewpoint, I can 
force myself to ``settle'' for that since at least something can be 
done when this drug is encountered. But philosophically, it bothers me 
because it violates the drug scheduling concept and is a clear case of 
where big money has won, and the poor folks (victims and law 
enforcement) have lost. Even the American medical community has no 
interest in this drug. Flunitrazepam is a Schedule I drug by 
definition. It is not approved for medical use in the United States and 
has a very high abuse factor. There is really nothing this drug does 
that other drugs don't do as well and with less side effects. In seems 
from my exposure that much of the worldwide use of flunitrazepam is 
abuse, especially by those addicted to other drugs who merely use it as 
a facilitator (to extend their heroin) and/or as a transitional drug 
(to cushion the crash from stimulant abuse). I'm not concerned that the 
manufacturer doesn't want to give up this drug worldwide since it 
generates more than $100 million per year for them. I'm not concerned 
with their fears that Schedule I in the U.S. might cause a domino 
effect and cause other countries to gradually drop it. So be it. The 
money spent on flunitrazepam would most likely transfer to other 
benzodiazepines. It is my personal opinion that flunitrazepam is 
Schedule IV for purely political reasons.
                      gamma hydroxy butyrate (ghb)
    Thirty years ago, a doctor researched GHB for a major drug company 
and found that it caused virtually all lab animals to vomit and many to 
convulse. Brain waves went into an epileptic seizure mode. That drug 
company walked away from it, and that doctor predicted that GHB would 
become a horrible drug of abuse. He is only surprised that it took so 
long to happen. Ironically, he recently retired from the FDA, and yet 
the FDA has not been a leader in the fight against GHB. In fact, once 
DEA documents on GHB went to FDA (HHS) for review, it seemed to me that 
time stood still. In the late 80's when GHB was being sold over the 
counter at ``health food'' stores (a strange name for a place that 
sells bizarre chemicals with little or no confirmation as to content or 
actual efficacy) and overdoses became an issue, the FDA merely banned 
GHB from OTC sales. It was not controlled. While the FDA criminal 
investigators could make arrests for manufacturing and interstate 
violations, DEA agents had no power and thus no interest in this drug. 
A few federal manufacturing cases were indeed handled, albeit a very 
long-term process. There are actually very few FDA criminal 
investigators per area, making it difficult to engage in the full-scale 
surveillance/investigation often needed on a criminal case. DEA agents 
could not help them. Unless it was state controlled, most state/local 
agencies might not help them either.
    Overdoses continued to occur and in fact to start a significant 
uphill trend in 1993, especially after highly publicized death of a 
youth idol who MAY have ingested GHB, along with lethal doses of others 
drugs. Still no control. Meanwhile, DEA has had drug diversion 
professionals tracking GHB for years. One doctor was researching both 
GHB and flunitrazepam. Sometime after June of 1996, it became 
impossible for one person to track both, and a second doctor was 
assigned to track GHB. Even with the all the material they amassed, DEA 
formally took no aggressive action. While in California the Los Angeles 
Police Department actively sought to initiate legislation, the first 
federal legislation came not from initiation by DEA, but from 
Congresswoman Sheila Jackson Lee, in response to the death of a 17 year 
old in Texas.
    In my travels, I realized that there was no reporting system in 
place all this time for these drugs, especially GHB; therefore, there 
are not accurate records of overdoses. There is no actual reporting 
system for arrests or seizures or deaths. Statistics depend primarily 
on word of mouth, by polling of agencies or other hit/miss methods. In 
early 1997, DEA was saying there were six or seven GHB related deaths. 
I felt strongly that this was a bizarre understatement, and the DEA 
doctors agreed. Within a few months, the figure jumped to more than 20. 
Many of those ``new'' deaths had already taken place; they just weren't 
being ``reported'' to anyone. It became apparent that if someone simply 
called every coroner in the United States, the figure would simply 
continue to rise. That isn't even allowing for cases missed because the 
vast majority of coroners and toxicologists had never heard of GHB. 
Furthermore, that death list wasn't initially even acknowledged 
publicly by the DEA. It was like an in-house secret.
    Neither the FDA nor DEA has taken a formal leadership role in 
developing testing skills and making them available to law enforcement, 
toxicologists and coroners. Some federal employees taking an interest 
in developing and sharing expertise seemed to be stifled by superiors.
    Neither the DEA nor FDA speak openly to the news media, causing 
more confusion and misinformation. On December 31, 1996, Los Angeles 
experienced a night of horror, caused by 1,4 butanediol, an active 
analog of GHB. A RAVE concert turned into a mini-riot after more than 
50 people suffered medical problems after ingesting ``FX.'' Eight LAPD 
vehicles suffered damage and a 17 year old had a heart attack. We were 
baffled that FX contained no controlled substance and was negative for 
GHB. We had no ability to test further; and the case was turned over to 
the FDA. The news media wanted to help up with this, as they had been 
doing with flunitrazepam the year before. The FDA simply refused to 
release the test results. A private lab had also tested the product and 
identified the GHB analog, 1,4 butanediol. But, the FDA continued to 
refuse to assist the media. One local radio newsman, who had the 
private lab's results, told me he was livid that FDA press relations 
personnel (both in California and Washington) refused to even provide 
him with basic information on 1,4 butanediol. He said he wasn't even 
asking for them to confirm that this matched their test results. 
Federal prosecution of the FX maker was very slow, resulting in minimal 
publicity of the finale.
    FDA agents in California who developed expertise in GHB seemed to 
be discouraged from spending time on such cases. Keeping tabs on one 
GHB trafficker who supplied GHB from Hollywood to the RAVE parties in 
the California high desert where a 15-year-old died (January 1996) from 
ingesting GHB, FDA agents were aware of ongoing purchases of jug after 
jug of the precursor, gamma butyl lactone (GBL). It would be 1\1/2\ 
years before the blood of the dead 15 year old was tested for GHB and a 
criminal investigation actually launched. Once the case actually got 
underway, it has been handled aggressively and I understand is now 
pending. It would be October of 1997 before other members of that 
organization were arrested by the LAPD Clandestine Lab Squad in a 
separate incident. By then, GHB was illegal in California, and the 
Squad worked with the FDA agents to achieve a state-level case. 
Approximately three gallons of GHB was seized. There have also been 
nine and ten gallon seizures in California. Bear in mind, a 16 ounce 
water bottle holds approximately 80 capfuls, each capful being a 
``dose.''
    It is imperative to note that placing GHB Schedule I will not 
impact the orphan drug research underway for narcolepsy. If--and it is 
a very big if--GHB is ever approved for any use, it can easily be 
dropped to Schedule II at that time. I have interviewed narcolepsy 
researchers and read the literature. It is my personal opinion that GHB 
will never be approved for medical use. At best, it may be some distant 
cousin, safer and longer acting, and it is probably years away. One 
leading GHB/narcolepsy researcher apologized to me for a story aired on 
national news in late 1996, calling GHB the wonder drug. He said he had 
been interviewed for three hours and stressed repeatedly how dangerous 
this drug is. He said he keeps only one day's supply in his clinic for 
fear of diversion. He said that GHB was at least six to eight years 
away from qualifying for Schedule II consideration. Then Orphan Medical 
began lobbying to keep GHB from being controlled, and this doctor 
suddenly changed his tune. I was contacted by a man who said he was the 
president of Orphan Medical, trying to change my stance. I was amazed 
that he could not answer some very basic questions about this oh-so-
safe drug he was pushing so hard to protect.
    The FDA has been more outgoing in recent months in response to 
problems arising from over the counter marketing of GHB's precursor and 
dangerous analog, sold as Blue Nitro, Remforce, Renewtrient, 
Revivarant, Re-energize and Firewater. But there is so much more to be 
done on the GHB topic in terms of legislation, education of law 
enforcement and public awareness.
    1) Accurate and immediate federal legislation to control GHB as a 
Schedule I drug needs to be finalized. This will also provide 
guidelines to assist the more than 30 states still needing to complete 
legislation and will hopefully result in more continuity. Currently it 
is listed in Schedules from I to IV in the states who have made an 
effort.
    2) Accurate and prompt training information on this drug and 
improved drug testing protocols need to be provided nationwide to 
assure enforcement intervention in the trafficking and abuse of GHB. 
This drug has numerous active analogs, making testing and standardized 
knowledge throughout law enforcement critical. In California a young 
man made it through the criminal justice system 2\1/2\ times as an 
``alcohol only'' drunk driver, when in fact, he was an alcohol and GHB 
drunk driver. Each time his bizarre behavior didn't match his low blood 
alcohol (BA). Standard drug testing showed no other drugs. Fortunately 
his first case resulted in a conviction, despite the low BA, setting 
him up for more serious punishment later. His second case was treated 
as a ``reckless'' because of a very low BA, though with bizarre 
behavior. The third time, just a few weeks later, an innocent 27 year 
old died instantly, his car exploding on impact by the suspect's 
vehicle. He has since pled guilty and is spending 14 years in prison. 
The victim's mother, who described him as ``a good kid who loved 
basketball and was never a problem,'' would love to have been here 
today to express her pain to you.
    3) Education/publicity is crucial in counteracting the widespread 
misinformation about GHB and its analogs. Approximately 95 percent of 
the information on the Internet about GHB is inaccurate and misleading. 
About six months ago, I would have said 99.9 percent of it was 
inaccurate. The change has been made mostly by citizens and doctors 
trying to make a difference, and especially by one website in 
particular (www.ashesonthesea.com/ghb/), maintained by the parents of a 
25-year-old casualty of GHB. GHB websites overwhelming claim that GHB 
is safe, non-addictive and can cure all things, besides being a lot of 
``fun.'' GHB is truly the Child of the Internet. The truth is, GHB is 
dangerous, addictive and harder than heroin to shake. I have learned 
this not from the FDA, but from the streets and from the referenced 
website. The site is currently being overwhelmed by comments from those 
who can't shake it and those who have had or seen horrid experiences 
from it. The input is coming in from all over the United States and 
Canada. For those of you with any doubts about how dangerous and 
widespread this drug is, the commentary pages of that site will forever 
erase your doubts.
    GHB is the easiest drug on earth to make and the hardest drug to 
recognize.
    What parent would suspect that seeing their son or daughter sip 
repeatedly from a common sports water bottle might foretell a deadly 
addiction?

    Mr. Upton. Thank you. We have a little bad news from the 
House floor in that when this vote is over, we have 10 minutes 
of debate, and then we will have five votes bang, bang, bang.
    I think it would be best at this point to recess until 
probably about 11:30 a.m. So we will give you a little hour to 
visit your Member of Congress, watch what is going on on the 
floor, but we will come back at as close to 11:30 a.m. as we 
can.
    [Whereupon, the subcommittee recessed, to reconvene at 
11:30 a.m., the same day.]
    Mr. Upton. Thank you all for being back here promptly. Our 
votes are over now for a little while, so we will resume with 
testimony by Ms. Dyer.

                   TESTIMONY OF JO ELLEN DYER

    Ms. Dyer. Thank you. Mr. Chairman and members of the House 
committee, I am appearing before you to discuss my concerns 
about the potent new drug of abuse, gamma hydroxy butyrate, 
known as GHB.
    The California Poison Control System has been assisting in 
identification and management of poisonings due to gamma 
hydroxy butyrate since we first identified the syndrome and 
reported cases to the State Department of Health and the FDA in 
1990.
    We reported the severe effects from its misuse. It is used 
as a nutritional supplement for body building, a drug of abuse 
for euphoria, a purported sexual enhancing drug and as an 
incapacitator for assault.
    In 1998, we consulted on 232 cases of poisoning in 
California from GHB and its related products. I will tell you 
about some of our patients' experiences.
    A 26-year-old female poured GHB into a glass to drink as an 
appetite suppressant for dieting. Almost immediately, she felt 
nauseated and went in the bathroom to vomit. She lost 
consciousness, fell on the floor, cut her head. Her sister 
witnessed seizure like jerking. She was vomiting. She was 
incontinent.
    When the ambulance arrived, she was comatose, agitated, 
vomiting. Her heart rate had slowed. Airway support was 
necessary because she was vomiting while she was unconscious. 
She required admission overnight to the critical care unit. The 
life threatening clinical effects of GHB can cause an abrupt 
loss of consciousness, profound coma, and they can compromise 
breathing.
    A 23-year-old female college student and body builder was 
taking three to five capfuls of liquid GHB for 1 year for the 
alleged anabolic effects. Over a 6-week time period, she 
increased her dose and frequency to every 3 hours around the 
clock to prevent the anxiety, tremors and insomnia she 
experienced without it.
    She was admitted to a medical detoxification center, and 
GHB was discontinued. She became increasingly paranoid, 
experienced vivid hallucinations, disorientation and delirium. 
Her rate increased.
    As this delirium syndrome progressed, she was transferred 
to an intensive care unit under heavy sedation and physical 
restraint to prevent injury, muscle breakdown and uncontrolled 
fever. She experienced a withdrawal course over 9 days. 
Frequent ingestion of GHB can lead to addiction and a severe, 
life threatening withdrawal syndrome.
    A 29-year-old woman went to a party with her date. Her last 
memory was dancing with him. She awakened to find a man 
assaulting her. He claimed that her date had passed out and 
that she had consented to have sex with him. The response, when 
she called 911, was that without a description of events and no 
physical evidence of force, there was nothing that could be 
done.
    A second report from that same location established a 
pattern. The victim identified the drug that was used. A search 
at that location revealed greater than 2,000 photos, videos, 
recipes to make GHB and margarita salt containers of GHB. Some 
of the victims that were identified from those photos did not 
even realize they had been raped.
    This serial predator, a 38-year-old male, was convicted on 
43 counts, receiving 77 years for sexual assaults and 
poisoning. He had placed GHB from an eyedropper carried in his 
shirt pocket into the drinks of his unsuspecting victims. GHB 
is easily used to incapacitate a victim, allowing physical or 
sexual assault.
    A 71-year-old man, taking one teaspoon of gamma 
butyrolactone nightly for sleep, mistook the bottle at his 
bedside for water, and he drank some. Within 30 minutes, his 
wife found him slumped in a chair unconscious. She called 911. 
Paramedics found him not breathing.
    In the emergency department, his depressed breathing was 
supported with mechanical ventilation. His heart rate was slow 
at 40 beats per minute, and he was profoundly unconscious. He 
was admitted to intensive care overnight.
    The label on that product instructed, ``Insure that those 
around you are aware that you may be unarousable and that this 
is normal. Unless drugs or alcohol have been ingested, the only 
treatment necessary is to sleep it off.'' Following these 
instructions could have been fatal.
    GHB and its precursors, gamma butyrolactone and 1,4-
butanediol, are promoted for many unsubstantiated health 
claims, while denying the dangers of their use. GHB and their 
precursors have demonstrated their abuse potential, their 
dependence liability, and they have been used to commit 
assault.
    GHB and its precursors are a health hazard, and I want to 
emphasize the importance of placing GHB in a schedule that will 
stop the proliferation of these analogs also.
    Thank you.
    [The prepared statement of Jo Ellen Dyer follows:]
  Prepared Statement of Jo Ellen Dyer, Pharm.D. CSPI, Sr. Toxicology 
Management Specialist, California Poison Control System, San Francisco 
   Division, Assistant Clinical Professor of Pharmacy, University of 
                        California San Francisco
    Mr. Chairman and members of the House Subcommittee on Oversight and 
Investigation: I am appearing before you today to discuss my concerns 
about a potent new drug of abuse gamma hydroxybutyrate, GHB. Individual 
states have legislated GHB as a controlled substance due to the severe 
health effects from its misuse as a nutritional supplement for 
bodybuilding, a drug of abuse for euphoria, a purported sexual enhancer 
and an incapacitator for assault.
    The California Poison Control System has been assisting in the 
identification and management of poisonings due to gamma 
hydroxybutyrate and its related products since we first identified the 
poisoning syndrome and reported the cases to the California State 
Department of Health and the FDA in 1990. Since that time we have 
continued to track, identify and report the new trends in abuse of this 
drug. See the attached reference list of our published medical 
literature on this subject.
The primary dangers of GHB
    1. The life-threatening clinical effects of GHB can include an 
abrupt loss of consciousness, profound coma, and compromised breathing.
    2. Frequent ingestion of GHB can lead to addiction and a severe 
life-threatening withdrawal syndrome.
    3. GHB is easily used to incapacitate a victim allowing physical or 
sexual assault.
    4. GHB and its precursors, gamma butyroiactone and 1,4-butanediol, 
are promoted for many unsubstantiated health claims while denying the 
dangers associated with their use.
    The life-threatening clinical effects of GHB can include an abrupt 
loss of consciousness, profound coma, and compromised breathing. GHB is 
a powerful anesthetic drug, a depressant. It was developed in France in 
1960 and evaluated as an anesthetic because it reliably induced rapid 
onset of coma. However, lack of pain relieving properties and unwanted 
side effects such as delirium decreased enthusiasm for its use. 
Although GHB was considered safe when used under direct supervision of 
a physician in surgical procedures, side effects still occurred. These 
side effects slowed heart rate; muscle jerking; agitation; and vomiting 
were controlled with the addition of other medications. GHB was not 
used as an anesthetic alone nor was it used without qualified medical 
supervision.
    GHB now is abused in unsupervised situations where fatalities have 
occurred from the abrupt loss of consciousness resulting in injury, 
suffocation when the airway is blocked, and depressed breathing. Since 
1995 GHB has been implicated in the deaths of at least six young 
people, ages 15-34, in California. Because blood tests for the presence 
of GHB have only recently become available, many fatalities have not 
been recognized as being caused by GHB, and this number may represent 
only the ``tip of the iceberg''.
    The clinical effects of GHB are well known:
 Profound Coma--not just a deep sleep. Noise or pain cannot 
        awaken you
 Myoclonus--involuntary muscle jerking
 Bradycardia--slow heart rate
 Respiratory depression--slowed or stopped breathing
 Loss of airway protective reflexes that keep breathing 
        passages open and fluid and vomit out of the lungs
 Vomiting
 Incontinence--involuntary passage of urine or stool
 Chemical burns from incorrect manufacture using alkaline 
        chemicals
    GHB became a controlled substance in California in 1997. That year 
the California Poison Control System was consulted about 199 cases of 
poisoning from GHB and related products. Last year (1996) there were 
232 reports to the California Poison Control System. The reporting of 
poisonings to the California Poison Control System is not mandatory and 
the number of reports undoubtedly underestimates the number of GHB 
poisonings in the state. Abuse was seen across all age groups in 1998. 
23% of patients were under 21 years old, 46% were 21-29 years old, 23% 
were 30-39 years old and 6% greater than 40.
    An evaluation of 88 cases treated in San Francisco General Hospital 
over three years revealed 50% of cases ingested GHB with another 
intoxicating substance. Importantly 50% of the patients ingested GHB 
alone. The severity of clinical effects with GHB does not rely solely 
on other drugs ingested. GHB taken alone is dangerous.
    Frequent ingestion of GHB can lead to addiction and a severe life-
threatening withdrawal syndrome. The misleading claims such as improved 
physique with no physical effort are persuasive enough that some 
patients take GHB frequently and as a result become addicted. These 
patients can experience a severe withdrawal syndrome that may last up 
to 2 weeks after GHB was discontinued. The withdrawal symptoms begin 
within just a few hours after the last dose of GHB. Early symptoms, 
insomnia, tremor, confusion, nausea and vomiting are mild and progress 
over 2-3 days. Then the more severe central nervous system symptoms of 
agitation, disorientation, and vivid hallucinations occur. The 
cardiovascular system reacts with a rapid heart rate. As this delirium 
syndrome progresses, heavy sedation and physical restraint are required 
to prevent injury, muscle breakdown, and uncontrolled fever. Intensive 
care is necessary over 1-2 weeks.
    GHB is easily used to incapacitate a victim allowing physical or 
sexual assault. GHB produces a fast onset of profound coma that leaves 
a victim defenseless to assault. These cases are very difficult to 
prosecute due to amnesia for the events and the loss of consciousness 
that occurs minutes after ingestion of GHB. In addition, laboratory 
confirmation is difficult due to the short duration that GHB is 
detectable in the system. The profound central nervous system 
depression that occurs with GHB leaves victims incapable of resisting 
assault.
    GHB and its precursors, gamma butyrolactone and 1,4-butanediol, are 
promoted for many unsubstantiated health claims while denying the 
dangers associated with their use. GHB and its precursors are easily 
available. They can be ordered over the Internet, purchases as kits for 
home manufacture or made according to detailed recipes for kitchen 
synthesis that are posted on the Internet starting with uncontrolled 
chemicals. The information promoting these products often makes 
outrageous claims such as: improved physique with no physical effort by 
increasing muscle mass and definition while decreasing fat, relief from 
depression or chronic fatigue syndrome, enhanced virility, smoother 
younger skin, and reversal of male pattern baldness. GHB products are 
claimed to be ``non-toxic'' and the label on one product instructs you: 
``to ensure that those around you are aware that you may be unarousable 
and that this is normal. Unless drugs or alcohol have been ingested the 
only treatment necessary is to sleep it off.'' Unfortunately, following 
these instructions may be fatal. Many of our patients wake up in a 
hospital intensive care unit shocked that this ``natural'', ``non-
toxic'', substance caused their life-threatening condition.
    The California Poison Control System continues to track and report 
trends in GHB abuse. We also provide education to the public, health 
care practitioners, and emergency medical response teams through phone 
consults, lectures, and publications. We have been active in training 
law enforcement, district attorneys, rape treatment counselors, FDA and 
DEA personnel in recognizing this new drug of abuse.
    GHB and its precursors have demonstrated their abuse potential, 
their dependence liability, and they have been used to commit assault. 
GHB and its precursors are a health hazard. I am concerned about the 
ease of availability of GHB compounds.

    Mr. Upton. Thank you.
    Lieutenant Bane?

                     TESTIMONY OF PAUL BANE

    Mr. Bane. Mr. Chairman and members of the committee, good 
morning, and thank you for the invitation this morning.
    During the week of February 7, 1999, five students were 
admitted to the emergency room at Salisbury Peninsula Hospital. 
We had an opportunity to speak with 3 of the 5 individuals, all 
of whom admitted to taking GHB and knew that they were doing so 
before they took it.
    According to the emergency room staff after this incident, 
it would have been a fatal overdose for one of the individuals 
that had been admitted had she not gotten emergency room 
treatment.
    In the exhibits that I gave you this morning, I have quoted 
a number of statistics involving death and abuse while under 
the influence of GHB. I am not going to regurgitate those 
statistics now. They are also the handiwork of DEA, and I am 
not going to steal their thunder.
    We are just reaching the tip of the iceberg of GHB 
instances in the State of Maryland. After the incident occurred 
in Salisbury, I took a personal approach to contacting all the 
major universities in the State of Maryland to see if they 
could identify the number of abuses and incidents that they 
have had in the State. Much to my surprise, they indicated that 
there were no reported instances of GHB abuse.
    Finding this somewhat to difficult to believe, I began 
questioning the police departments that were at those schools 
and began asking them pointed questions with regards to sexual 
assaults and things of that nature occurring at the schools 
where the victim either could not remember or had very little 
recollection of what had happened to them. Lo and behold, cases 
began to surface.
    In remarks made earlier, I heard some comments with regard 
to education, and I think education is not only going to be 
important for the public, but I also think education is going 
to be necessary for the law enforcement community, as well as 
getting some reliable form of test kit available to the law 
enforcement community.
    Maryland recognizes that these problems are very serious. 
The State police has proposed legislation to the State Senate 
with regards to scheduling Ketamine, and I also have in my 
possession a position paper from the Maryland State Police 
where we are recommending that it be made illegal to administer 
any drug in someone else's drink for the purposes of possible 
sexual advances.
    Thank you.
    Mr. Upton. Thank you.
    Dr. Adatsi?

                   TESTIMONY OF FELIX ADATSI

    Mr. Adatsi. Thank you, Mr. Chairman, and members of the 
committee.
    The discreet use of sedative drugs to overwhelm and/or----
    Mr. Upton. If you would just pull the mike a little closer? 
Thank you.
    Mr. Adatsi. Thank you.
    The discreet use of sedative drugs to overwhelm or 
incapacitate the victim for purposes of perpetrating a crime is 
an age-old forensic toxicology problem. When used to commit a 
crime of sexual assault, sedative drugs may be classified as 
date rape drugs.
    Recently, attention has focused on the involvement of gamma 
hydroxy butyrate or GHB, gamma butyrolactone, GBL, 
Flunitrazepam, Rohypnol, and possibly Ketamine in drug-induced 
sexual assault cases.
    In the majority of cases, the scenario is fairly similar, 
and it involves women who may be at parties in which alcoholic 
beverages are consumed. My presentation will examine the 
toxicological effects, the abuse potential, and the dangers 
posed by the indiscriminate exposure to these four drugs.
    GHB is naturally occurring, and it is a metabolite of gamma 
aminobutyric acid in the human brain, and it occurs in other 
organs and tissues of the body. When administered in 
pharmacological doses, GHB is a potent central nervous system 
depressant.
    The current availability of the drug is limited to 
investigational use only. GHB is manufactured in illicit labs, 
and simple, home-brewed recipes are available on the Internet 
and other underground publications. The starting material for 
GHB manufacture is GBL, which is fairly easy to obtain.
    GHB is popular with a variety of abusers in the U.S., 
including high school and college students, bodybuilders and 
athletes. In this context, it has various names. It has been 
referred to as Georgia home boy, liquid ecstasy, liquid X, easy 
lay and scoop.
    The popularity of GHB among abusers appears to be related 
to its promotion as a steroid alternative, as a sleep inducing 
agent and also as an agent that is capable of enhancing 
athletic and sexual performance.
    GHB occurs as a clear, colorless, viscous liquid, which is 
heavier than water. It is tasteless and mixes very easily with 
water and other beverages. It can also occur as a powder and is 
found in gel caps. However, it is its property as a clear, 
colorless liquid with high solubility in water that facilitates 
its clandestine introduction into drinks and beverages of 
unsuspecting victims.
    The onset of action of GHB is fairly rapid. In fact, in 
five to 30 minutes following ingestion, GHB can begin to take 
its effect. It has a relatively short half life; that is to say 
that 50 percent of the drug will be metabolized and broken in 
the body in a relatively short time. On the average, after 30 
minutes of full exposure, 50 percent of the drug will be broken 
down.
    The effects are varied and depend on the person who is 
consuming the drug, but include drowsiness, euphoria, 
dizziness, visual disturbance, nausea, unconsciousness, and 
this may persist up to about 3 hours.
    Serious adverse reactions may include hallucinations, 
seizures, vomiting, severe respiratory depression and coma. 
Now, the adverse effects may also last up to 96 hours. If death 
occurs, it is normally due to a collapse of the cardiovascular 
system and respiratory depression.
    The effects of GHB are further enhanced by the simultaneous 
administration of other CNS depressants. GHB has been 
implicated in deaths in your State, in about five cases in 
Michigan.
    Like GHB, GBL has also been implicated in alleged sexual 
assault cases and death. GBL has commercial and industrial 
applications and is used as a solvent, a paint remover and as a 
dietary supplement. GBL is found in products marketed under 
names such as Renewtrient, Revivarant, Blue Nitro, GH 
Revitalizer and Gamma G.
    Both GHB and GBL are chemically very similar. The 
toxicological effects of GBL include CNS depression, seizures, 
unconsciousness, vomiting and coma.
    The next drug, Rohypnol, belongs to the class of compounds 
known as benzodiazepines. In this class of compounds there is 
Valium, except that Rohypnol is only about ten times more 
powerful than Valium. Rohypnol is manufactured by Hoffman 
LaRoche and is used in a number of European countries as a 
hypnotic and as an anesthetic inducing agent. It has also been 
implicated in several sexual assault cases around the country.
    The final drug I want to discuss is Ketamine, which is also 
used to induce anesthesia in the U.S. and has been available 
since 1972. Ketamine is reportedly capable of producing the 
same hallucinogenic effect as PCP.
    Our current findings suggest that GHB has a high abuse 
potential and has no current medical application. GHB is 
controlled as a Schedule I drug in the State of Michigan. It 
has serious toxicological and clinical side effects and has 
been implicated in a number of deaths across the country. It is 
elusive in detection, and controversy exists as to what 
constitutes an endogenous level, which will distinguish it from 
an exogenous level. Because of its close structural 
relationship to GHB and the fact that GBL can be converted to 
GHB, GBL also poses similar toxicological concerns for the 
entire population.
    In light of the mounting evidence of abuse, toxicity and 
use as weapons of crime against these drugs, their use should 
be restricted or controlled.
    Thank you.
    [The prepared statement of Felix Adatsi follows:]
 Prepared Statement of Felix Adatsi, Ph.D Toxicologist, Michigan State 
                        Police, East Lansing, MI
                  Should Date-Rape Drugs be Controlled
    The discreet use of sedative drugs to overwhelm or incapacitate a 
victim for purposes of perpetrating a crime is an age old forensic 
toxicology problem. When used to commit a crime of sexual assault, 
sedative drugs may be classified as date-rape drugs. Recently, 
attention has focused on the involvement of gamma hydroxy butyrate 
(GHB), gamma butyrolactone (GBL), flunitrazepam (rohypnol) and possibly 
ketamine in drug-induced sexual assaults cases. In the majority of 
cases, the scenario is fairly similar, involving women who may be at 
parties in which alcoholic beverages are consumed. This presentation 
examines the toxicological effects, abuse potential and the dangers 
posed by the indiscriminate exposure to the four drugs listed above 
which may warrant their control.
    GHB is a naturally occurring metabolite of gamma-aminobutryic acid 
in the human brain and in most other mammalian tissues in small 
amounts. When administered in pharmacological doses, GHB is a central 
nervous system depressant and has been used clinically as an anesthetic 
and hypnotic agent. The current availability of the drug is limited to 
investigational use only. GHB is manufactured in illicit laboratories 
and simple, home-brew recipes are available on the internet and in 
other publications. The starting active ingredient in these recipes is 
GBL. GHB is popular with a variety of abusers in the U.S., including 
high school and college students, body builders and athletes. In this 
context it has been referred to by several names to include Cherry 
meth, Georgia home boy, Liquid ecstasy, Liquid X, Easy lay, Natures 
quaalude and Scoop. The popularity of GHB among abusers appears to be 
related to its promotion as a steroid alternative, sleep inducing 
agent, and an agent capable of enhancing athletic and sexual 
performance.
    GHB occurs commonly as a clear, colorless, viscous liquid, which is 
heavier than water. It is tasteless and mixes easily with water and 
other beverages. GHB also occurs as a powder and has been found in gel 
caps. However, it is its property as a clear, colorless and tasteless 
liquid with high solubility in water that facilitates its clandestine 
introduction into the drinks and beverages of unsuspecting victims. 
Once consumed in this fashion several effects and symptoms are possible 
and the victim is predisposed to a variety of criminal activities.
    The onset of action of GHB following ingestion occurs within 5 to 
30 minutes. GHB has a relatively short half-life (20-60 minutes). The 
effects are varied and depend upon the individual and the dose 
consumed. Effects include drowsiness, euphoria, dizziness, visual 
disturbance, nausea, and unconsciousness and may persist for about 3 
hours. Serious adverse reactions include hypotension, hallucinations, 
seizures, vomiting, severe respiratory depression, and coma. These 
effects may persist for 2 to 96 hours or longer. Death may be due to 
severe respiratory arrest and collapse of the cardiovascular system.
    The effects of GHB are further enhanced by the simultaneous 
administration of other central nervous system depressants such as 
alcohol and benzodiazepines. GHB has been implicated in about 5 deaths 
in Michigan. Like GHB, GBL has also been implicated in alleged sexual 
assault cases and death. GBL has commercial applications, being used as 
a solvent, paint remover and dietary supplement. GBL is found in 
products marketed under brand names such as Renewtrient, Revivarant, 
Blue nitro, GH Revitalizer and Gamma G. GHB and GBL are chemically very 
similar. Indeed it is reported that GBL is converted into GHB in the 
body. The toxicological effects of GBL include central nervous system 
depression, seizures, unconsciousness, vomiting and coma.
    Rohypnol belongs to the class of compounds known as 
benzodiazepines. In this class of compounds is valium and the effects 
of Rohypnol are believed to be similar to valium but is about 10 times 
more powerful. Rohypnol is manufactured by Hoffman-La Roche and used in 
a number of European countries as a hypnotic and anesthetic inducing 
agent. Rohypnol abuse has been reported in middle schools and high 
schools, as well as by college students. It has been implicated in 
several alleged sexual assault cases around the country. The effects of 
Rohypnol occur within 20 to 30 minutes of ingestion and the symptoms 
include decreased blood pressure, muscle relaxation, dizziness, 
sleepiness, amnesia, mental confusion, and lethargy. When taken in 
combination with alcohol or other central nervous system depressant 
drugs, the side effects may progress to death.
    Ketamine has been used as an anesthetic induction agent in the U.S. 
since 1972. Its structure and pharmacological properties are similar to 
phencyclidine (PCP). Ketamine is reportedly capable of producing the 
same halucinogenic side effects as PCP. Ketamine is usually available 
by intravenous or intramuscular injection. Recently however, Ketamine 
has been implicated in alleged sexual assault cases. Indeed, in a 
recent GHB related case in Michigan, Ketamine reportedly was detected 
in a container which also contained GHB.
    Current findings suggest that GHB has a high abuse potential and no 
current medically accepted application. GHB has serious toxicological 
and clinical side effects and has been implicated in a number of deaths 
across the country. It is elusive in detection and controversy exists 
as to what constitutes an endogenous level to distinguish it from a 
deliberate exposure for prosecution. Because of its close structural 
relationship to GHB, and the fact that it can be converted to GHB in 
the body, GBL also poses similar toxicological concerns for the entire 
populace. Rohypnol has been implicated in several sexual assault cases 
across the country and has very high abuse potential. In light of the 
mounting evidence of abuse, toxicity and use as weapons of crime, 
against the above mentioned drugs, their use should be restricted and/
or regulated as scheduled drugs.

    Mr. Upton. Thank you.
    Ms. Snyder?

                   TESTIMONY OF DENISE SNYDER

    Ms. Snyder. Thank you, Mr. Chairman, and members of the 
committee.
    I work at the D.C. Rape Crisis Center. We have seen upwards 
of two dozen women over the last 3 years who have been sexually 
assaulted in a drug-related situation, and I have started to do 
a lot of trainings around the country for both State and 
national training programs to talk about the issue of substance 
related rapes, and I have heard a lot of stories from other 
cities and States.
    The primary thing that I want to get across today is that I 
am concerned that as we try to address this issue we do it in a 
way that is addressing the problem, which is drug related 
sexual assaults. We must deal with the act and not deal with 
the vehicle specifically that is being used because if we focus 
on specific drugs, I am afraid that what we are going to do is 
2 years down the road find ourselves in the same place that we 
are in now.
    I was a strong advocate of rescheduling Rohypnol, but I 
feel like we spent several years focusing on that. Rohypnol is 
now fading from the scene. Other drugs are taking its place. It 
is important that we not be sitting here 2 years from now 
talking about some other drug and trying to figure out how to 
deal with it. We need to deal with the act and not the specific 
vehicle.
    Some of the specific concerns that come up with women who 
are sexually assaulted using some kind of a substance are a lot 
of mental health issues. Ms. Pruett mentioned some of them in 
her first discussion. Women who are sexually assaulted under a 
substance like this do not have any place to direct their 
anger. They have no idea who their assailant was, so there is 
no way to focus that and work through it in order to heal and 
move on.
    The second issue comes from the anxiety of the unknowns; 
not knowing who was involved or what happened, so every time 
you see an individual who looks at you funny you might be 
thinking: Was he involved? Was he somebody who was there? 
Especially in situations where this happens in a small 
community such as a college campus, it can make it extremely 
difficult to just continue to be there.
    The reactions that are fairly common have already been 
mentioned. I would just say that in general the dynamics of how 
this happens very much parallels any kind of date rape 
situation. We have had clients who were sexually assaulted in 
their home, in the assailant's home, at parties. The assailants 
have been platonic friends, dates, complete strangers or an 
acquaintance that was just met. It has happened in gay and 
lesbian relationships, as well as in straight relationships, 
and the age range is from early teens up through women in their 
forties.
    It is also important to recognize that it is not only using 
alcohol. As several folks have mentioned, we have had cases 
where women were drinking tea, sodas, women who do not drink 
alcohol at all. It makes it very difficult, I think, for a lot 
of women to try to defend themselves.
    I also want to mention that in trying to deal with this 
problem, as a couple of other witnesses have already said, it 
is extremely important that education be a major component.
    For Congress to pass legislation that tries to deal with it 
but the information about it does not get out to the general 
public, to law enforcement, and also to district attorneys and 
to the medical personnel who are dealing with these women, if 
that information is not gotten out there in a way that is 
accessible to them the value of the legislation is going to be 
greatly minimized.
    In closing, again I would just ask that what we do is try 
to make sure we are focusing on dealing with the problem and 
the act of using substances to sexually assault women and not 
focus specifically on vehicles.
    Thank you.
    Mr. Upton. Thank you all, witnesses. I want you to know 
that for many of us we serve on multiple subcommittees, and 
they all seem to meet at the same time in different buildings.
    I know that Mr. Dingell, the ranking member of the full 
committee and a member of this subcommittee, would have liked 
to have been here to introduce a witness from his district. 
Knowing that he is back, I would like to recognize him first 
for the first order of questions. Mr. Dingell?
    Mr. Dingell. Mr. Chairman, thank you. I would like to 
welcome not only my constituents here, but the entire panel. 
Thank you for being here, and thank you for your very fine 
assistance.
    Mr. Faistenhammer, I particularly want to welcome you. Now, 
I would address quickly, and I would note that you have been 
giving good information about the problems associated with 
these kinds of drugs nationwide. I am concerned a bit more 
about how we can assist you in your efforts with regard to GHB 
and Ketamine.
    You are a law enforcement officer. Can you explain in 
detail the problems that Michigan has had with the two drugs 
just mentioned? GHB appears to be more of a problem in Michigan 
than does Ketamine; would you like to comment, sir?
    Mr. Faistenhammer. Yes. One of the key problems is we do 
not have a method for testing on the street. As you can see 
just here in front, it comes in various numbers of containers.
    The uniformed officers that run into these types of 
containers on the street, even if they were smart enough to 
suspect GHB through training, they would not have a method of 
checking on the street as to what is in the container.
    So, it is really a two-pronged assault I think from the 
State of Michigan for us in policing. One, we need to educate 
our officers. Two, we need some method to be able to show that 
there is some sort of field test available, sir.
    Mr. Dingell. Would it be helpful if we federally scheduled 
both GHB and Ketamine?
    Mr. Faistenhammer. Yes, it would be.
    Mr. Dingell. Is that the consensus at the table? Does 
anyone disagree with that?
    [No response.]
    Mr. Dingell. Mr. Adatsi, do you wish to add anything to 
that?
    Mr. Adatsi. Other than the fact that with the schedule at 
the Federal level I think and very stiff penalties, I think 
that will help, and also to improve education nationwide for 
this particular drug and how insidious the drug can be.
    Mr. Dingell. Thank you.
    Mr. Faistenhammer, you, I am sure, are aware that both Mr. 
Stupak, one of my good friends and colleagues from Michigan, as 
a matter of fact a former member of the Michigan State Police, 
and also Ms. Jackson-Lee, a very fine Member, have for a long 
time recognized problems associated with both GHB and Ketamine.
    For some 2 years now they have submitted legislation which 
scheduled both of these drugs. Am I fair in assuming that you 
would support the idea that these drugs should be federally 
scheduled?
    Mr. Faistenhammer. Yes, they should be.
    Mr. Dingell. Mr. Adatsi?
    Mr. Adatsi. I believe so.
    Mr. Dingell. Mr. Faistenhammer, do you believe that 
scheduling would give additional tools for law enforcement? If 
so, could you tell us how those tools might be used?
    Mr. Faistenhammer. I do believe it would give us the tools 
that we need, as least as far as I can think of immediately 
right now as we would be getting Federal assistance. The Drug 
Enforcement Administration, the FBI, those agencies would come 
on board.
    Mr. Dingell. You also would have the benefit of the seizure 
laws, would you not?
    Mr. Faistenhammer. That is correct.
    Mr. Dingell. That would be a particularly significant 
benefit, would it not?
    Mr. Faistenhammer. If it would become scheduled, yes.
    Mr. Dingell. So if somebody set up a manufacturing 
operation in his basement, you could seize the house?
    Mr. Faistenhammer. That is correct.
    Mr. Dingell. That is something of a deterrent, I gather?
    Mr. Faistenhammer. Yes. Yes.
    Mr. Dingell. Mr. Adatsi, do you wish to add anything to 
that?
    Mr. Adatsi. No. We have had precedents here in other cases, 
other drugs before, so by forming a particular type and process 
we would have been doing something that has precedent.
    Mr. Dingell. Now, Mr. Faistenhammer, you mentioned that the 
State police in Michigan are in need of a field test kit. Is 
there a test kit of that sort which does exist?
    Mr. Faistenhammer. No, there is not.
    Mr. Dingell. So you would have to have one developed? Is 
that right?
    Mr. Faistenhammer. That is correct.
    Mr. Dingell. As I understand the chemical processes and 
chemical engineering and so forth, the development of a test of 
that sort with a proper exercise of resources is not awfully 
hard, though. Is that not true?
    Mr. Faistenhammer. It seems to be in this particular case 
that it is in that many of the things that you would utilize to 
break down GBL, as an example, would turn it into GHB.
    Mr. Dingell. All right. Now, Mr. Adatsi, is there anything 
we can do to help you in your efforts on addressing this GHB 
problem in Michigan?
    Mr. Adatsi. Well, my laboratory currently does not test for 
GHB. We do have a lot of support from the Department already.
    Other than the fact that this should be scheduled at the 
Federal level and the education and training for law 
enforcement personnel, I think that would be my request at this 
point.
    Mr. Dingell. Mr. Chairman, I think my time has expired. I 
thank you for your courtesy, and I thank you for holding this 
hearing.
    Ladies and gentlemen of the panel, we appreciate your 
assistance and courtesy. Thank you.
    Mr. Upton. Thank you, Mr. Dingell.
    Ms. Pruett, I know that the night that you were raped you 
also I think had a friend with you that went along. What 
happened to him or her? Tell us a little bit about that.
    Ms. Pruett. Her trial was separate from mine.
    Mr. Upton. She was raped as well?
    Ms. Pruett. They could not prove her being raped, but--I do 
not know much about her trial.
    Mr. Upton. Did she also end up in a coma as you did?
    Ms. Pruett. I am not sure.
    Mr. Upton. Okay. The question Mr. Dingell asked about 
trying to put GHB as a little tighter schedule, I or II. I have 
a question, and one of the concerns I have is how easy it is to 
manufacture GHB and one of its analogs.
    My own personal belief is that we ought to have it on a 
schedule high enough so that one of its analogs, whether it be 
GBL or some other derivative, would not be the next in line and 
would simply take its place, and we would all of a sudden get 
into this game of finding out what is next.
    I would be interested to know what your comments, maybe 
with Ms. Porrata first, having some reference from the State of 
California and others that might want to comment.
    Ms. Porrata. Well, one of the problems is it does have 
several active analogs, and these are only two of them, GBL and 
1,4-butanediol. Most States do have an analog law, as we do, 
and the Federal Government does, too, that covers Schedule I 
and Schedule II.
    I think if you put it in Schedule III or IV, even if you 
put special wording next to it that adds the analogs again the 
system is already in place. Analogs are covered in the top two 
schedules.
    It is really important. There is a slight problem with GBL. 
It is a precursor also, so people get confused by that. It 
might be important to go ahead and actually designate it as an 
analog to clear up that issue so that it is also covered 
because there is some chaos over that.
    Mr. Upton. California was one of the two States I think 
that was referenced. Ms. Sheila Jackson-Lee indicated there 
were two States that on their own had designated it as Schedule 
I, I believe, California and Pennsylvania.
    Ms. Porrata. Actually, there are 17 States that have.
    Mr. Upton. Seventeen States? Okay?
    Ms. Porrata. But some of them are Schedule I. Some are 
Schedule II. We are actually Schedule II. Again, it was because 
of this controversy that a doctor came in and said oh, I want 
to use it for narcolepsy. The legislators said well, we should 
make it available by making it Schedule II.
    Making it Schedule II in California did not approve it, nor 
did it allow it to be prescribed. That was one of the problems. 
It ended up Schedule II, but we do have an analog law so 
technically it is covered.
    Again, the precursor issue became very confusing. I think 
we are probably going to end up clarifying that with 
legislation to make it crystal clear that GBL is equal to GHB 
under California law.
    Mr. Upton. Dr. Adatsi, did you want to comment on that?
    Mr. Adatsi. Well, that----
    Mr. Upton. Again, if you could put that mike particularly 
close?
    Mr. Adatsi. Thank you.
    Mr. Upton. That would be helpful.
    Mr. Adatsi. Yes. In my presentation, I did emphasize that 
because GBL is a precursor to GHB, the use or access to GBL 
should also be restricted.
    As Ms. Snyder did indicate, it will not be a bad idea to 
have a statement that is quite encompassing for this CNS 
depressant so that a year or a couple years from now we do not 
revisit this same issue.
    In the State of Michigan GHB is a Schedule I, and the 
language is isomers or a sort of an isomer. It does not 
specifically speak to GBL. I suppose an aggressive prosecutor 
could find somebody to interpret that to refer to GBL as well.
    However, if the Federal schedule is such that GBL could be 
included, I think that will in the long run serve a very useful 
purpose.
    Mr. Upton. The case that really prompted me to begin the 
work to have this subcommittee hearing today was the case in 
Grosse Ile back in January. I guess my next question would be 
if Michigan has this already labeled as Schedule I, do we know 
what the drug was yet in terms of the woman that died in Grosse 
Ile, the 15-year-old?
    Maybe Sergeant Faistenhammer and you both would like to 
just comment, and I will yield to Mr. Stupak. If we are at 
Schedule I already, how did that impact the death of the young 
woman in Michigan?
    Mr. Faistenhammer. There may have been some GBL involved in 
that case, as opposed to GHB.
    Mr. Upton. And that would have been a loophole because of 
the----
    Mr. Faistenhammer. Because there is some argument as to 
whether GBL is an analog or not.
    The Wayne County Prosecutor's Office has not issued 
warrants on that case and will not until Monday, so they are 
sort of asking me to hold off on saying too much about it.
    Mr. Upton. Okay. Did you want to just quickly comment?
    Mr. Adatsi. Yes, sir, and that is because I had the 
privilege of speaking with a prosecutor who was going to 
prosecute his case only last week.
    He did indicate that they did find GHB in the decedent's 
system and also GBL. The alleged perpetrators are swearing that 
it was GBL they administered to this lady. However, upon 
analysis the levels of GHB found in the decedent are large 
enough to suggest that there must have been some exogenous 
administration to this lady.
    I suppose that together with the law in Michigan, with the 
proper questioning this particular case should not fall through 
any cracks.
    Mr. Upton. Okay. Thank you.
    Mr. Stupak?
    Mr. Stupak. Mr. Chairman, if you have more questions, go 
ahead.
    Mr. Upton. No. Go ahead, Bart. I do have another question 
or two, but I will----
    Mr. Stupak. I would prefer that you----
    Mr. Upton. Do you want me to go? All right. Without 
objection.
    Mr. Stupak. No objection.
    Mr. Upton. I am interested in how these drugs are coming 
into the hands of some of these folks. I know recently we had a 
demonstration here as I opened up my remarks in terms of its 
access on the Internet, but it really is pretty easy. We did 
that in our office a couple weeks ago, to show me just how easy 
it was.
    It was very disturbing in fact when you saw that at the end 
of the scroll where you could plug in your Visa card or your 
American Express and literally have it delivered to whatever 
address you wanted the next day, including a how-to kit and 
eyedroppers and a whole number of different items of 
paraphernalia that I guess would make it easier for someone to 
get this material off the Internet.
    In your relationships on the panel, have you seen the 
Internet being used to get this into the mainstream of our 
society? Maybe I would like to start with Ms. Snyder as one who 
is really on the front lines of these types of issues.
    Ms. Snyder. Yes. Accessibility is not at all an issue. I 
mean, it is very easy to get. One of the problems that comes 
with that, however, is the potency is always varied because you 
took this amount last time, and you got this desired result. 
You take the same amount next time. The potency could be 
completely different, and you could either end up in a coma or 
perhaps death.
    Mr. Upton. Our police officials, do you recognize that the 
Internet has been a great tool for some of these folks?
    Mr. Faistenhammer. Yes. We recently seized computers out of 
several defendants' homes. All are using the Internet. All are 
shipped via UPS and ordered over the Internet.
    Mr. Upton. Ms. Porrata?
    Ms. Porrata. This is truly the child of the Internet. I do 
not think any other drug has been delivered across the board in 
the way that GHB has through the Internet.
    It is illegal to sell the kits to make GHB. The Department 
of Justice has already handled some cases on that. The hard 
part, of course, is finding these people. In one of the cases, 
they----
    Mr. Upton. It is pretty easy in our office.
    Ms. Porrata. Well, I mean it is easy to find them and order 
it. I am talking about physically find them to arrest them.
    I think one of the cases they did he was arrested in 
Florida. There was property actually seized, warehousing seized 
in two or three other States. We took money out of his bank 
account in L.A. and New York and Florida, so it is not really 
easy to physically find them.
    The problem is again the GBL issue. They believe that it is 
more legal to ship GBL around if you are not putting it in a 
kit. That is again where Federal leadership is so critical.
    We need Federal laws and Federal scheduling for two things. 
One, so that that issue is clear cut at the interstate level, 
because that is what it involves here, and, two, you need to 
set a precedent to help these poor States.
    States still have to pass the laws in order to make 
arrests, but they could use some guidelines and some guidance. 
Right now the States that have it, it is Schedule I, Schedule 
III, Schedule IV. We could use some leadership here.
    Mr. Upton. Ms. Dyer, do you have anything to add to that, 
or Lieutenant Bane?
    Ms. Dyer. These products, the Gamma G came in with a 42-
year-old woman. She ordered it over the Internet.
    This is a kit that a 30-year-old man had used and had 
become dependent on it, had repeatedly ordered this kit. This 
is the gamma butyrolactone. This is the sodium hydroxide 
pellets. You mix them together in a pan, and you get GHB.
    Mr. Upton. Lieutenant Bane?
    Mr. Bane. No, sir. As I have indicated, we are kind of just 
getting into this now. We have not had that many cases reported 
before this time, and as such the law enforcement community 
right now is pretty ignorant of this drug right now.
    Mr. Upton. Thank you.
    Mr. Stupak?
    Mr. Stupak. Thank you, Mr. Chairman. Mr. Chairman, let me 
thank you again for holding this hearing.
    I think the scope of this hearing here today with our first 
two panels, and I know we are going to have more, but certainly 
has shown us the scope of the problem we have here, the 
frustrations that law enforcement has and others.
    Thank you again for your leadership and for scheduling this 
hearing. Again, I look forward to working with you to move this 
along.
    Let me ask a few questions. On the street drug kits there, 
Sergeant, any indication of any kind of a common droplets, 
whatever, we are going to use out there? Nothing on GHB?
    Mr. Faistenhammer. No. Really it is so varied. That is the 
problem with it is recognizing it. It is a clear liquid that 
comes in so many different containers.
    Mr. Stupak. In order to have GHB, you have to have GBL. 
Nothing to do to try to detect GBL?
    Mr. Faistenhammer. No. There is nothing out there.
    Mr. Stupak. Okay. Any suggestions?
    Mr. Faistenhammer. No. I have a problem with it. I have 
called around trying to get some method----
    Mr. Stupak. Right.
    Mr. Faistenhammer. [continuing] to street test it so we 
would have probable cause for arrest on contact with these 
people, even just for the driving offense. They are just not 
available.
    Mr. Stupak. Mr. Adatsi, or Doctor, did I hear you say that 
in Michigan the lab does not test for GHB?
    Mr. Adatsi. No. Unfortunately----
    Mr. Upton. Could you use the mike?
    Mr. Adatsi. Unfortunately, we are currently not able to 
test for the GHB. We facilitate, however, the sample 
transportation to other labs that are capable of doing so.
    Mr. Stupak. What labs around the country are capable then 
of doing the testing?
    Mr. Adatsi. There is a lab down south in Mississippi. The 
name of that lab is Elsoli Lab. The FDA lab, I understand, is 
capable of doing that. There is also a lab in California, the 
coroner's office in California. They are capable of doing that.
    Mr. Stupak. Is the reason why, and I am not trying to put 
words in your mouth, but why? Is it a complex test? The cost of 
the test? Why is it that we do not have more labs doing this 
type of testing if it is a law enforcement problem?
    Mr. Adatsi. My opinion is because it is a new drug that is 
out there, and it takes a little bit of time for the research 
and development to be worked out.
    Combine that with the fact that other labs probably already 
have their own backlogs and cases to deal with and have not 
been able to rise to this occasion as quickly as they would 
have.
    Mr. Stupak. Is there any talk within Michigan to put this 
test within your laboratory system?
    Mr. Adatsi. Yes. Actually, I am the head of that lab, and I 
have directed research and development to be initiated to try 
and address the point.
    Mr. Stupak. Okay. Thanks.
    Does anyone on the panel think that we should not schedule 
GHB or Ketamine? Does anyone think we should not?
    [No response.]
    Mr. Stupak. Okay. Since GBL is a precursor for making GHB, 
and GBL is already a readily available solvent in many 
industrial applications, how do we control GBL? Any 
suggestions? Ms. Porrata?
    Ms. Porrata. Frankly, it only has a few industrial 
considerations. It is not really like some huge thing that is 
very common. It is easily accessed, but it is not like widely 
used. Many of the labs only carried one bottle of it until it 
became an abuse factor, and now they carry more.
    I think it can be heavily restricted to where, much more 
like Ephedrine, it can be put on to where it is tracked much 
better. That is a start right there. Again, the issue here 
becomes human consumption----
    Mr. Stupak. Right.
    Ms. Porrata. [continuing] as opposed to industrial use.
    Mr. Stupak. On the Ephedrine, and you are right. That is 
what we did on my legislation to do Ephedrine to get rid of the 
Cat problem. I am sure we do not have it totally wiped out yet.
    Again, in my legislation we do have the tracking for GBL, 
but any other suggestions you would have along that line? I 
mean, you have to have GBL to get GHB, right? That is the key 
ingredient is GBL?
    Ms. Porrata. That is the key ingredient. Again, I think a 
big issue is education with so many of these kids. There is a 
lot of confusion. The whole issue of health food supplements 
and this over the counter type stuff, and these kids believe 
that if you walk in a store and buy something in a bottle that 
that makes it safe.
    I think a lot of education on that aspect even, especially 
if you are drinking something out of a bottle that is not 
labeled and somebody gave you. That is a real clue. There might 
be something in it that is not safe. I think education is 
really critical.
    Mr. Stupak. Is there any other precursor or common 
ingredient in Ketamine that would make that easier to control 
or track?
    Ms. Porrata. No. Ketamine is all legally manufactured.
    Mr. Stupak. Right.
    Ms. Porrata. There is no illicit Ketamine. I think again 
part of the problem with Ketamine misuse is an education thing. 
It is mostly among the young kids, and it is used much like 
crystal meth and stuff.
    It is not a huge factor. It is not used a lot of times in 
raves. I think it needs to be scheduled. It has legitimate 
uses. It could be Schedule II, or Schedule III. Schedule II 
means that the doctors have to track it a little more 
carefully, and I think that is probably adequate for it.
    Mr. Stupak. Ms. Porrata, you seem adamant that GHB should 
be scheduled as a Schedule I drug. Why is that, and what effect 
do you think such scheduling would have on companies like I 
think it is Orphan Medical that currently has an 
investigational new drug application pending with FDA?
    Ms. Porrata. Well, first and foremost, it is a question of 
the integrity of the drug scheduling concept. We have a system 
by which drugs are supposed to be scheduled. It seems like we 
are starting to piecemeal and we should avoid that. That is 
part of the issue.
    Second, there are no approved medical uses. I do not care 
what Orphan Medical says. It has not been approved yet, has not 
been substantially shown that it is safe. They are trying to 
get the cart before the horse here by doing that.
    I understand they are also opposed to Schedule II. Well, 
even the legitimate Schedule II drugs that do have approved 
medical uses, they have to struggle with the security issues. 
They have to struggle with all the safety precautions. I do not 
think there is any reason to say that one drug company and one 
drug should be excluded from that type of security, but at this 
point this is an extremely deadly drug.
    I want to stress the issue is not the bathtub brew. The 
issue is GHB. I do not care if it comes from a research lab. 
GHB is what is dangerous and GBL by themselves, not the 
potency. The potency adds an extra problem, and the addition of 
the sodium hydroxide and the pH factor adds additional hazard, 
but it is GHB that is dangerous. It is GHB that puts people in 
comas and kills them. The other things are instrumental to 
that.
    We need to schedule it where it belongs. We need to then 
let the proper process for research continue, and if and when 
it is approved--I have talked to narcolepsy researchers who 
admit that it will probably be several years before, in their 
opinion, it is really a Schedule II drug. I just cannot 
personally worry about drug companies, you know, and their 
profits.
    Mr. Stupak. In the GHB, some would say if we made it 
Schedule I and II it is not the profits. It is the research 
efforts because it is an orphan drug, which is a small amount 
that is available for the research.
    The application, as you indicated, may be limited, but do 
you believe that research should continue as to see if there is 
some legitimate uses of GHB?
    Ms. Porrata. Oh, absolutely. I think the research should 
continue, and I think it will. History has shown there are 
other drugs that were in Schedule I. They were researched and 
eventually changed. There is nothing that precludes that. 
Obviously it makes it easier if it is not.
    I think there has also been a lot of talk about well, if we 
can get our foot in the door with this, you know, then it will 
be easier. People can use it for more reasons if we can get it 
approved. It is now opening the door.
    We are trying to open Pandora's box here. Again, put it 
where it belongs. Let us try to deal with it to the absolute, 
most serious degree we can because this is a huge epidemic. 
Then we will worry about that.
    I think the research will continue. I think it is always 
easy to say well, we are not going to touch it if it is 
Schedule I. I do not think that is true.
    Mr. Stupak. You indicate in your testimony, and let me 
quote, that you were contacted by a man who said he was the 
president of Orphan Medical and that you were amazed he could 
not answer some very basic questions about this oh so safe drug 
he was pushing so hard to protect.
    What were the questions that you wanted him to answer that 
he could not?
    Ms. Porrata. I asked him some specific questions about some 
of the effects that it has and some of the dangers, and one of 
the questions was did he know what it does to brain waves, 
especially on the research animals, but there is some question 
whether it is in humans also. He did not even know what I was 
talking about, so he did not seem to be terribly familiar with 
the history of the research on this drug.
    Dr. Winters, who researched this drug 30 years ago, 
predicted this would be the most dangerous drug of abuse in the 
world. Nobody really took him seriously at the time. It is not 
really totally a central nervous system depressant. It actually 
is considered also by some of the researchers as central 
nervous system excitant. It puts the brain waves into epileptic 
seizure mode in the research history.
    Dr. McKay from UCLA also feels this way, that it is 
actually a stimulant to the brain and that everything else 
shuts down so we see it as a depressant, but it has some other 
unique features to it that are pretty dangerous.
    There is also a lot of talk about its research and use in 
alcoholism. You know, all I can tell you is sure, an alcoholic 
loves this because it does not have the hangover. You get drunk 
without the hangover.
    I think we are talking some very dangerous territory there 
because it is a terribly impairing drug. These people can go 
into a coma at 60 miles an hour. You can be driving down the 
street at 60 and hit coma level. That is terribly, terribly 
dangerous.
    Mr. Stupak. In your testimony you were also concerned about 
DEA's passivity, if I can say that, or being very passive when 
you felt they should be on the cutting edge.
    Having been in law enforcement and those of us in law 
enforcement, we see these drugs come out. Unfortunately, we are 
always reactive instead of proactive. Maybe Cat was the only 
one we got a little ahead of the curve.
    Can you tell me a little bit more about what you meant or 
elaborate on DEA being passive and not quite active enough on 
this?
    Ms. Porrata. Well, there are a lot of agents and the 
doctors who are involved in the research on this, some of the 
chemists, who have been on top of it and known about this for a 
long time, but we seem to get lost in the bureaucracy when it 
goes to higher levels.
    I think, and I have seen this at State level and some of 
the medical boards and pharmacy boards where sometimes the 
legislatures do not really use those people as resources to be 
on the cutting edge. They do not ask them to be on the cutting 
edge. In fact, their top officials sit around worrying about 
well, we do not want to say too much because this guy might not 
like it, and that might cause trouble.
    Everyone is so worried about politics that people do not 
speak out about what is right. As an agency even sometimes they 
do not speak and say what needs to be said and let you then 
handle that information. You need to task your agencies to be 
on the cutting edge of this kind of stuff so that they can 
provide leadership.
    I do disagree a little bit on one issue. Yes, we need to 
deal with the issues of rape and assault, but we must deal with 
the specific drugs. What we need to do is find a way to 
expedite these issues so that when a new drug does surface we 
can control it. You cannot avoid controlling these and having 
law enforcement handle it. We need to be able to expedite this 
process. It should not take 5 or 6 years.
    Today, because of the Internet and because of the 
sophistication of these kids, kids meaning everyone up to 40 at 
this point, we have to be far faster at dealing with this 
stuff. They are out there systematically searching. If you go 
to the Internet and go to these chat rooms, okay, if they take 
GHB and GBL from us, what are we going to do next?
    Mr. Stupak. Right.
    Ms. Porrata. You know, we need to speed up this process to 
where DEA is on top of it, they are allowed to be on top of it, 
they are asked to be on top of it, and then you have a little 
faster system to where we can address these things in a much 
more rapid manner.
    Mr. Stupak. Well, there is no doubt that we need to be more 
rapid in it, in the synthetic drugs, taking legal substances to 
make them illegal for an illegal use. Certainly as the Internet 
and everything else expands, it is going to become more and 
more of a problem.
    I go back to Ephedrine being a legal substance which was 
being used illegally to make the Cat, the Methcathadone that we 
had. We were able to get in front of that curve.
    Besides, DEA does have some emergency policies, and I am 
going to ask them why they were not used, but the quickest way 
that I know of to get a handle on this stuff is doing it this 
way, is doing a legislative process.
    That is why maybe at times I may have been a little 
frustrated with it has been 2 years to get the hearing, so I 
want to again close my questions by once again thanking my 
friend from Michigan for providing the leadership to at least 
get to the hearing stage.
    I am sure after all your testimony we can move a little 
faster and get this bill or combination of bills moved to the 
floor.
    With that, Mr. Chairman, thank you again. I will yield back 
my time.
    Mr. Upton. Thank you.
    Witnesses, we appreciate your testimony and your indulgence 
with us as we go through our normal day of votes. Your comments 
are well taken. We look forward to working with the entire 
community and moving something positive.
    Thank you for telling your story. You are excused for 
lunch.
    Mr. Upton. We will have the next panel, Mr. Nicholas 
Reuter, Associator Director of the Domestic and International 
Drug Control of the Food and Drug Administration; Dr. Stephen 
Zukin from the National Institute on Drug Abuse, National 
Institutes of Health; Mr. Terrance Woodworth, Deputy Director 
of the Office of Diversion Control for the Drug Enforcement 
Agency; and Ms. Patricia Maher, Civil Division of the 
Department of Justice.
    Again, I appreciate you staying with us today obviously. As 
you heard me explain to the earlier two panels, we do have a 
long history of asking folks to have their testimony sworn in. 
Do you have any objection to that?
    [No response.]
    Mr. Upton. We also allow, if you prefer, to have a counsel 
with you. Do any of you prefer to have a counsel with you?
    [No response.]
    Mr. Upton. If not, if you would stand and raise your right 
hand?
    [Witnesses sworn.]
    Mr. Upton. Thank you very much. You are now under oath. We 
will begin with Ms. Maher. Again, if you can keep your comments 
to 5 minutes, knowing that we will put your full statement into 
the record, it would be appreciated.

 TESTIMONY OF PATRICIA L. MAHER, CIVIL DIVISION, DEPARTMENT OF 
  JUSTICE; TERRANCE W. WOODWORTH, DEPUTY DIRECTOR, OFFICE OF 
 DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION; NICHOLAS 
  REUTER, ASSOCIATE DIRECTOR, DOMESTIC AND INTERNATIONAL DRUG 
CONTROL OFFICE OF HEALTH AFFAIRS, FOOD AND DRUG ADMINISTRATION; 
 AND STEPHEN ZUKIN, DIRECTOR, CLINICAL AND SERVICES RESEARCH, 
NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH

    Ms. Maher. Mr. Chairman and members of the subcommittee, 
good morning. My name is Patricia Maher. I am a Deputy 
Assistant Attorney General in the Civil Division of the 
Department of Justice.
    In that capacity I oversee the Office of Consumer 
Litigation, the Civil Division's office that handles civil and 
criminal cases brought under a number of Federal consumer 
protection statutes, including the Federal Food, Drug and 
Cosmetic Act.
    At your invitation, I will speak to you about our 
experience prosecuting traffickers of illegal drugs that are 
used to get high and that over the last few years have been 
used by perpetrators of sexual assault to incapacitate their 
victims.
    The substance with which the office of Consumer Litigation 
has been most actively involved is gamma hydroxy butyrate or 
GHB. GHB is not approved in this country for general consumer 
use. Twenty-one States have made it a controlled substance, but 
it is not a controlled substance under Federal law. It is 
regulated as a drug under the Federal Food, Drug and Cosmetic 
Act, and Federal prosecutions against distributors are brought 
under that statute.
    The emergence of GHB as a black market street drug can be 
traced to convicted anabolic steroid dealer and amateur chemist 
Mark Thierman in Tucson, Arizona. In 1989, Thierman devised a 
formula for GHB, hired people to make it and began to sell GHB 
throughout the country by mail order. Thierman sold hundreds of 
thousands of dollars of GHB in powder form.
    Although GHB was originally intended by Thierman and others 
as a muscle building product, users found that the drug caused 
euphoria, and it quickly developed a reputation as a widely 
available way to get high.
    GHB is made by combining two relatively common chemical 
compounds, gamma butyrolactone or GBL, which is an industrial 
solvent, and sodium hydroxide, commonly known as lye.
    Shortly after GHB's discovery as a party drug, health 
officials throughout the country began to receive reports of 
serious adverse health effects associated with it, including 
extreme vomiting, sudden and uncontrollable onset of sleep, 
seizure like conditions and coma. On receipt of these reports, 
in November, 1990, the FDA issued a warning to consumers 
against use of the drug.
    Subsequently, our Office of Consumer Litigation, in 
conjunction with the U.S. Attorney's Office in Arizona, 
investigated and indicted Thierman and his distributors for 
felony violations of the Federal Food, Drug and Cosmetic Act.
    Eleven defendants were ultimately convicted of charges, 
including conspiracy, manufacturing and distributing misbranded 
and adulterated drugs with the intent to defraud and mislead, 
and operating an unregistered drug manufacturing facility with 
the intent to defraud or mislead.
    Starting in late 1992, however, GHB began to be used across 
the country. Since 1992, GHB has bee responsible for numerous 
deaths and numerous instances of drug facilitated sexual 
assault.
    A number of factors have contributed to the current 
popularity of GHB. First, in 1992, Daniel Duchaine, a self 
proclaimed steroid guru, published a book entitled The 
Underground Steroid Handbook for Men and Woman, Update, 1992. 
In it, Duchaine tells readers how to make a home brew for 
liquid GHB.
    Second, and even more insidiously, money hungry individuals 
began to market GHB kits over the Internet. The kits provide 
the purchaser with the ingredients and directions for making 
the product in the home. The kits are sold to anyone, including 
children, without any warnings about the extreme dangers 
associated with both the manufacture and the use of the drug. 
Not surprisingly, the number of deaths attributed to GHB has 
increased since the recipe for this dangerous drug was made 
widely available over the Internet.
    Beginning in 1995, GHB was identified with perpetrators of 
sexual assault. Typically the predator surreptitiously places 
liquid GHB into the victim's drink. Within 20 minutes, the drug 
can cause the victim to lose consciousness or to lose the 
ability to control muscle function. The predator then sexually 
assaults the victim.
    In a few hours, the drug wears off, sometimes leaving the 
victim with no memory of the event and with no trace of the 
drug in his or her body, with no physical signs of forcible 
assault. It is this pernicious aspect of GHB, the fleeting 
nature of the evidence, that has made the identification and 
prosecution of the predators who assault with GHB difficult.
    The Civil Division's Office of Consumer Litigation has been 
prosecuting traffickers of GHB for some time. We brought our 
first GHB prosecution against Mark Thierman in 1992 and 
obtained a sentence of 49 months' incarceration. We have 
successfully prosecuted more than 30 individuals in 12 
districts and have numerous pending cases.
    In one particularly egregious case, an adult has been 
charged with manufacturing and distributing GHB to underage 
individuals and with the sexual assault of several young women.
    We spearheaded a multi-district, multi-agency criminal 
investigation of Internet GHB kit traffickers. Working with 
Federal, State and local law enforcement agents, OCL 
coordinated the execution of search warrants directed at the 
largest kit distributors in four States. Those investigations 
are ongoing. OCL attorneys have also provided substantial 
assistance to local prosecutors and other law enforcement 
authorities in a number of GHB related cases.
    Recently we have encountered a GHB precursor product, gamma 
butyrolactone or GBL, which becomes GHB in the body when it is 
ingested. Although some GBL distributors have labeled their 
product a dietary supplement, on January 21, 1999, the FDA 
issued a public notice clarifying that GBL that was marketed 
for human consumption is an illegally marketed, unapproved new 
drug. A number of manufacturers have recently recalled GBL from 
the market.
    Attorneys from the Office of Consumer Litigation have been 
active in the investigation and prosection of distributors of 
these and other dangerous drugs.
    The Office of Consumer Litigation, along with the Criminal 
Division's Narcotics and Dangerous Drugs Section, have served 
as a clearinghouse for prosecutorial information, which 
includes helping local prosecutors prepare cases, distributing 
information to State and Federal prosecutors and presenting 
seminars on date rape drugs in forums such as the National 
Association of Attorneys General, the National District 
Attorneys Association and the National Association of 
Prosecutor Coordinators.
    Despite the steps taken by Federal and State law 
enforcement and prosecuting offices, the availability of GHB, 
GBL and other drugs involving them continues to grow. We remain 
committed to finding and prosecuting the traffickers of these 
drugs.
    Thank you.
    [The prepared statement of Patricia L. Maher follows:]
  Prepared Statement of Patricia L. Maher, Deputy Assistant Attorney 
             General, Civil Division, Department of Justice
    Mr. Chairman and Members of the Subcommittee: Good morning. My name 
is Patricia L. Maher. I am a Deputy Assistant Attorney General in the 
Civil Division of the Department of Justice. In that capacity, I 
oversee the Office of Consumer Litigation (OCL)--the Civil Division's 
office that handles civil and criminal cases brought under a number of 
federal consumer protection statutes including the Federal Food, Drug, 
and Cosmetic Act (FFDCA). This morning at your invitation, I will speak 
to you about our experience prosecuting traffickers of illegal drugs 
that are used to get high and that, over the last few years, have been 
used by perpetrators of sexual assaults to incapacitate their victims. 
At this time, I do not advocate any particular legislative action be 
taken with respect to these drugs, but rather hope to inform you about 
the Office of Consumer Litigation's efforts to combat this serious 
problem.
    The substance with which the Office of Consumer Litigation has been 
most actively involved is gamma hydroxy butyrate or ``GHB,'' known on 
the street as ``easy lay,'' ``liquid ecstasy,'' ``Georgia Home Boy,'' 
and ``scoop.'' GHB is not approved in this country for general consumer 
use. Twenty States have made it a controlled substance, but it is not a 
controlled substance under federal law. It is regulated as a ``drug'' 
under the FFDCA, and federal prosecutions against distributors are 
brought under that statute. GHB was developed in the 1950's as a human 
anaesthetic in Europe.
    The emergence of GHB as a black-market street drug can be traced to 
convicted anabolic steroid dealer and amateur chemist Mark Thierman in 
Tucson, Arizona. In 1989, Thierman devised a formula for GHB, hired 
people to make it, and began to sell GHB throughout the country by mail 
order. Thierman sold hundreds of thousands of dollars of GHB in powder 
form. Although GHB was originally intended by Thierman and others as a 
muscle-building product, users found that the drug caused euphoria and 
it quickly developed a reputation as a widely available way to get 
high. GHB is made by combining two relatively common chemical 
compounds: gamma butyrolactone (GBL), an industrial solvent, and sodium 
hydroxide, commonly known as lye.
    Shortly after GHB's discovery as a ``party'' drug, health officials 
throughout the country began to receive reports of serious adverse 
health effects associated with it, including extreme vomiting, sudden 
and uncontrollable onset of sleep, seizure-like conditions, and coma. 
On receipt of these reports, in November 1990, the FDA issued a warning 
to consumers against use of the drug.
    Subsequently, our Office of Consumer Litigation, in conjunction 
with the U.S. Attorney's Office in Arizona, investigated and indicted 
Thierman and his distributors for felony violations of the FFDCA. 
Eleven defendants were ultimately convicted of charges including 
conspiracy, manufacturing and distributing misbranded and adulterated 
drugs with the intent to defraud and mislead, and operating an 
unregistered drug manufacturing facility with the intent to defraud and 
mislead.
    Starting in late 1992, however, GHB began to be used across the 
country. Since 1992 GHB has been responsible for numerous deaths and 
numerous instances of drug-facilitated sexual assault. A number of 
factors have contributed to the current popularity of GHB.
    First, in 1992, Daniel Duchaine, a self proclaimed ``steroid 
guru,'' published a book entitled the ``Underground Steroid Handbook 
For Men And Women--Update: 1992.'' In it, Duchaine tells readers how to 
make a ``home brew'' for liquid GHB. Second, and even more insidiously, 
money hungry individuals began to market ``GHB kits'' over the 
Internet. The kits provide the purchaser with the ingredients and 
directions for making the product in the home. The kits are sold to 
anyone, including children, without any warnings about the extreme 
dangers associated with both the manufacture and use of the drug. One 
illustrative case involved a GHB kit user who was admitted to an 
emergency room in New York with burned lung tissue that was attributed 
to aspiration of gastric contents containing GHB that had been made 
with too much lye. Not surprisingly, the number of deaths attributed to 
GHB has increased since the recipe for this dangerous drug was made 
widely available over the Internet.
    Beginning in 1995, GHB was identified with perpetrators of sexual 
assault. Typically, the predator surreptitiously places liquid GHB into 
the victim's drink. Within about 20 minutes, the drug can cause the 
victim to lose consciousness or to lose the ability to control muscle 
functions. The predator then sexually assaults the victim. In a few 
hours, the drug wears off, sometimes leaving the victim with no memory 
of the event, or with no trace of the drug in his or her body, or with 
no physical signs of forcible assault. It is this pernicious aspect of 
GHB--the fleeting nature of the evidence--that has made the 
identification and prosecution of the predators who assault with GHB 
difficult.
    The Civil Division's Office of Consumer Litigation has been 
prosecuting traffickers of GHB for some time. As noted above, we 
brought our first GHB prosecution against Thierman in 1992 and obtained 
a sentence of 49 months' incarceration. We have successfully prosecuted 
more than thirty individuals in twelve districts and have numerous 
pending cases. In one particularly egregious case, an adult has been 
charged with manufacturing and distributing GHB to underage individuals 
and with the sexual assault of several young women. We spearheaded a 
multi-district, multi-agency criminal investigation of Internet GHB kit 
traffickers. Working with federal, state and local law enforcement 
agents, OCL coordinated the execution of search warrants directed at 
the largest kit distributors in four states. Those investigations are 
ongoing. OCL attorneys have also provided substantial assistance to 
local prosecutors and other law enforcement authorities in a number of 
GHB-related cases, including cases involving rape, homicide and 
kidnaping.
    Recently, we have encountered a GHB precursor product, gamma 
butyrolactone (GBL), which becomes GHB in the body when it is ingested. 
Although some GBL distributors have labeled their product a ``dietary 
supplement,'' on January 21, 1999, the FDA issued a public notice 
clarifying that GBL that was marketed for human consumption is an 
``illegally marketed unapproved new drug.'' A number of manufacturers 
have recently recalled GBL from the market.
    In addition to GHB and GBL, I would also like to mention another 
drug that has been used by perpetrators of sexual assault to facilitate 
their crimes. It is an animal and human anaesthetic called ketamine 
hydrochloride, known on the street as ``Special K,'' which has also 
been used to get high and has been associated with drug-facilitated 
rape. Traffickers of ketamine, a non-scheduled drug at the federal 
level, could be prosecuted under the FFDCA. Ketamine has been made a 
controlled substance in eighteen states.
    Unlike GHB (which can be made at home), ketamine is only available 
as a legitimate injectable product which is then diverted for street 
use. Ketamine users typically snort the drug rather than inject it. The 
recipe for converting the injectable liquid to powder is widely 
available on the Internet and requires cooking and drying the liquid to 
a solid and grinding the solid into a powder. Users claim that a mere 
0.2 gram dose may induce a ``mellow, colorful wonder-world'' with a 
feeling of being transformed into a robot, sometimes referred to as 
``K-land.'' A 0.5 gram dose can produce ``out-of-body, near-death 
experience,'' called a ``K-hole.'' Ketamine is extremely popular at 
large music parties called ``raves'' where drug use can be abundant.
    Attorneys from the Office of Consumer Litigation have been active 
in the investigation and prosecution of distributors of these and other 
dangerous drugs. For example, OCL recently worked with the U.S. 
Attorney in Minnesota in obtaining an indictment charging a man with 
raping two women after giving them zolpidem (trade name ``Ambien''), a 
schedule IV controlled substance. Significantly, one of the victims was 
15 at the time of the offense. This indictment was the first case in 
the nation under the federal Drug Induced Rape Prevention and 
Punishment Act.
    The Office of Consumer Litigation along with the Criminal 
Division's Narcotics and Dangerous Drugs Section have served as a 
clearinghouse for prosecutorial information, which includes helping 
local prosecutors prepare cases, distributing information to state and 
federal prosecutors, and presenting seminars on date rape drugs in 
forums such as the National Association of Attorneys General, the 
National District Attorneys Association, and the National Association 
of Prosecutor Coordinators.
    Despite the steps taken by federal and state law enforcement and 
prosecuting offices, the availability of GHB, GBL, and ketamine, and 
the number of cases involving them continues to grow. We remain 
committed to finding and prosecuting the traffickers in these drugs.
    Thank you. I look forward to answering your questions.

    Mr. Upton. Thank you very much.
    Mr. Woodworth?

               TESTIMONY OF TERRANCE W. WOODWORTH

    Mr. Woodworth. Thank you, Mr. Chairman, for the opportunity 
to appear before the subcommittee today on the subject of drugs 
of abuse and their use in sexual assault cases. I will very 
briefly provide you with DEA information on the three 
substances that are the subject of today's hearing.
    GHB is not currently a controlled substance and has no 
accepted medical use in the United States. However, there is 
extensive data demonstrating that it is being abused for its 
psychoactive effects, and DEA believes it should be controlled 
under the Controlled Substances Act.
    As required by law, DEA is currently waiting for a 
scientific and medical evaluation and a scheduling 
recommendation from the Department of Health and Human Services 
on GHB.
    Among other reasons, GHB is abused for its ability to 
produce euphoria, and its adverse side effects include 
convulsions, severe respiratory depression and coma. GHB is 
even more dangerous when used with alcohol. Medical examiners 
have reported 32 fatalities since 1995 in which GHB was 
detected, and in many of those deaths GHB was used in 
combination with alcohol.
    Drug Abuse Warning Network data indicates that estimated 
emergency room episodes involving GHB increased from 54 in 1994 
to 764 in 1997. On a national level, GHB related cases have 
been documented by Federal, State and local law enforcement 
officials in 41 States and the District of Columbia. In regard 
to sexual assault cases, DEA is aware of at least 13 sexual 
assault cases involving 22 victims under the influence of GHB.
    The GHB encountered by law enforcement has all been 
clandestinely manufactured. As you have heard, the manufacture 
of GHB is a simple process requiring no special chemical 
expertise. The primary precursor for GHB is gamma 
butyrolactone, GBL, a readily available industrial chemical. 
GBL plays a role in the GHB problem, and it will likely be 
necessary to place some type of control on it after GHB is 
controlled.
    Flunitrazepam, commonly known as Rohypnol, belongs to the 
benzodiazepine class of drugs and is abused by high school 
students, college students, gang members, rave party attendees 
and heroin and cocaine abusers. The drug produces profound 
intoxication, boosts the high of heroin, modulates the effect 
of cocaine. It is also commonly used in combination with 
alcohol, which potentiates its toxic effects.
    The DEA has documented approximately 4,500 Federal, State 
and local law enforcement investigations involving the illegal 
distribution and possession of Flunitrazepam in 38 different 
States. The majority of these cases have been in Florida and 
Texas.
    The data from the Drug Abuse Warning Network includes 167 
emergency room episodes involving Flunitrazepam from 1994 
through 1997. Flunitrazepam has also been used to facilitate 
sexual assault. Since 1994, DEA is aware of nine people who 
have been convicted of sexual assault in which there was 
evidence that Flunitrazepam was used to incapacitate the 
victim.
    Flunitrazepam was placed into Schedule IV of the Controlled 
Substances Act back in 1984 due to international treaty 
obligations. At that time, there was little abuse of 
Flunitrazepam in the United States. More recently, with the 
increase in trafficking and abuse, DEA began to consider the 
merits of transferring Flunitrazepam into another schedule.
    As the subcommittee is aware, HHS has recommended that 
Flunitrazepam remain in Schedule IV. After considering the 
relevant data and the HHS recommendation, DEA concluded that we 
did not have sufficient grounds to justify administratively 
rescheduling Flunitrazepam.
    Ketamine. Ketamine is the only drug of these three 
discussed that has been approved for marketing in the United 
States. It is primarily used in veterinary medicine as a fast 
acting, general anesthetic. The pharmacological profile is 
essentially the same as Phencyclidine, PCP, which leaves the 
individual anesthetized, detached or disconnected from their 
pain and the environment. It has both analgesic and amnesic 
effects.
    As a drug of abuse, Ketamine has become common at rave 
parties and is largely abused by teenagers and young adults. It 
produces a dose related progression of effects from a state of 
dreamy intoxication to delirium, accompanied by the inability 
to move, feel pain or remember what has occurred while under 
the drug's influence.
    There has been no reported clandestine manufacture of 
Ketamine to date, and it has been diverted primarily from 
distributors and veterinarians. From 1993 to 1997, there were 
145 emergency room episodes in DAWN. The DEA is aware of one 
incident of rape.
    The HHS has recommended on two occasions that Ketamine be 
placed in Schedule III of the Controlled Substances Act based 
largely on the pharmacological profile of the drug. On both 
occasions, DEA determined that the incidence of actual abuse 
was not sufficient to sustain the proposed scheduling action.
    However, Ketamine's recent emergence as a drug of abuse 
prompted DEA to request another evaluation by HHS in April 
1998. They have already responded and again recommended that 
Ketamine be placed in Schedule III. DEA will be publishing a 
notice in the Federal Register very shortly.
    In conclusion, Mr. Chairman, the DEA is on record and 
continues to support rescheduling of Flunitrazepam and the 
control of both GHB and Ketamine. These drugs are being abused 
for their psychoactive effects and also used by rapists to 
incapacitate their victims.
    At least in the case of GHB, it may well be that 
legislative action is the quickest way to achieve control 
status. However, DEA is not opposed to congressional action in 
regard to any of these substances.
    I would like to thank the subcommittee for the opportunity 
to offer DEA's comment.
    [The prepared statement of Terence W. Woodworth follows:]
Prepared Statement of Terrance W. Woodworth, Deputy Director, Office of 
           Diversion Control, Drug Enforcement Administration
    Mr. Chairman, distinguished members of the Committee, I want to 
thank you for the opportunity to address you today on behalf of the 
Drug Enforcement Administration (DEA) Administrator, Thomas A. 
Constantine. I will provide you with some specific data on three drugs, 
gamma-hydroxybutyrate (GHB), flunitrazepam and ketamine. Additionally, 
I will discuss the GHB precursor, gamma-butyrolactone (GBL). While each 
of these drugs has a unique chemical structure and specific 
pharmacological properties, as drugs of abuse, they share a number of 
similarities. Before I talk about each of these drugs individually, I 
would like to take a few moments and comment about some of the things 
they have in common.
    Collectively, these three substances are referred to as ``party'' 
drugs because of their availability and distribution at bars, night 
clubs and all-night dance parties called raves or techno parties. 
Gamma-hydroxybutyrate (GHB, Goop), flunitrazepam (Roofies) and ketamine 
(Special K) are new additions to a long list of substances that have 
often been encountered in these settings. In the 1980s we saw the abuse 
and trafficking of psychedelics like MDMA (Ecstasy) and its analogues 
and the depressant, methaqualone (Ludes). Other drugs that are also 
encountered in these settings include LSD (Acid), PCP (Angel Dust), 
amphetamine, cocaine and marijuana. As their street names imply, these 
drugs are touted to be fun. They have a wide range of pharmacological 
effects and are often taken in combination with each other or with 
alcohol. A disturbing factor is that these three substances are 
primarily being abused by teens and young adults.
    While the illicit trafficking and abuse of these substances are 
DEA's primary considerations with regard to Federal control measures, 
we are aware and concerned about the use of these substances to 
facilitate the commission of sexual assault. As such, these three 
substances are referred to as ``date rape'' drugs implying this more 
sinister aspect of their illicit use. Individuals intent on sexual 
assault are aware of the availability of these substances, especially 
at bars and night clubs, and of their pharmacological profiles, both of 
which provide some insight into why they might find these drugs so 
appealing.
    Each of these substances has gained popularity among drug abusers 
in recent years. Since their emergence as drugs of abuse, the DEA has 
been collecting data on their illicit manufacturing, distribution, 
trafficking and abuse. I will provide you with a summary of that data. 
Based on that data, the DEA now views these substances as having 
significant abuse potential. There is evidence that individuals are 
taking these substances in a manner and amounts sufficient to create a 
hazard to their health or to the health and/or safety of others. There 
is significant clandestine production of GHB and significant diversion 
of the pharmaceutical products containing flunitrazepam and ketamine. 
Large quantities of flunitrazepam have been illicitly smuggled into the 
U.S. and ketamine has been diverted from legitimate veterinary supplies 
within the U.S. Individuals are taking these substances on their own 
initiative rather than on the advice of a medical practitioner. 
Actually, only ketamine is approved for medical use in the U.S.--
neither GHB nor flunitrazepam has been approved for marketing as a 
medicine by the Food and Drug Administration (FDA). In addition, these 
substances share many of the same pharmacological properties of drugs 
that have been identified as having serious abuse potential and are 
already controlled in the Controlled Substances Act (CSA). This data 
indicates that each of these drugs should be placed under control in 
the CSA. At this time, however, only flunitrazepam is controlled at the 
Federal level.
    Although Congress has passed legislation that expedites the 
scheduling of drugs and other substances under the CSA, the temporary 
or emergency scheduling provision of the CSA could not be used for any 
one of these three substances. Emergency scheduling action is not 
possible when a substance is (1) being evaluated as part of a DHHS 
approved research program as is the case with GHB; (2) already a 
controlled substance as is the case with flunitrazepam; or (3) already 
marketed in the United States as is the case with ketamine. As a 
consequence, all three of these drugs have proven to be a challenge 
with regard to more effectively controlling their abuse. Action to curb 
the trafficking and diversion of these drugs has been difficult and 
time consuming. Prior to changing the control status or placing any new 
substance under control using administrative or traditional scheduling 
process of the CSA, the DEA must gather the necessary data, forward 
that information to the Department of Health and Human Services (DHHS) 
and request, receive and consider a scientific and medical evaluation 
from the DHHS. In addition, the CSA requires specific findings for each 
of the five schedules that must be based on scientifically valid and 
legally defensible data (See Attachment). Scheduling actions must be 
substantiated by the available evidence. From the time the DEA 
identifies a new drug of abuse to the time that substance is finally 
placed under control in the CSA, if warranted, a significant amount of 
time may elapse when the administrative scheduling process is utilized.
Gamma-hydroxybutyrate (GHB)
    GHB is a central nervous system depressant which is abused for its 
ability to produce euphoric states and its alleged role as a growth 
hormone releasing agent to stimulate muscle growth. Although GHB gained 
early favor with health enthusiasts as a safe and ``natural'' food 
supplement sold in health food stores in the late 1980s, the medical 
community soon became aware of overdoses and related problems caused by 
its abuse. In 1990, the FDA issued an advisory declaring GHB unsafe and 
illicit, except under FDA-approved, physician-supervised, study 
protocols. GHB has not been approved by the FDA for marketing. Doctors 
do not prescribe it, pharmacists do not sell it and patients do not use 
it. However, it is currently under investigation for use in treating 
narcolepsy under the FDA's Orphan Drug program.
    Although its importation, distribution and use as a drug are not 
allowed in the U.S., the abuse of GHB has increased. As a drug of 
abuse, GHB is generally ingested orally after being mixed in a liquid. 
The onset of action is rapid and in overdose, unconsciousness can occur 
in as little as 15 minutes and profound coma can occur within 30 to 40 
minutes. GHB produces dose-dependent drowsiness, dizziness, nausea, 
amnesia, visual hallucinations, reduced blood pressure, decreased heart 
rate, hypnotic effects resembling petit mal epilepsy, convulsions, 
severe respiratory depression and coma. Overdose frequently requires 
emergency room care, including intensive care for respiratory 
depression and coma. Most individuals regain consciousness within two 
to four hours. However, since 1995, Medical Examiners have reported 32 
fatalities in which GHB was detected in the decedent. Many of these 
deaths involved the use of GHB in combination with alcohol which 
potentiates the depressant effect of GHB. Of these 32 cases, GHB was 
found to be the sole cause of death in eight cases.
    Since 1993, more than 3,500 GHB-related cases of abuse, overdose, 
possession, illegal manufacturing, illicit diversion and trafficking 
have been documented by Federal, state and local officials. This data 
has been obtained from DEA case files, state and local law enforcement 
case files, state and Federal forensic laboratory reports, the Drug 
Abuse Warning Network (DAWN) data, the FDA Office of Criminal 
Investigations and poison control center data bases. This data shows 
that GHB is frequently taken in combination with other drugs that often 
heighten its effects, and it is frequently found at bars, night clubs, 
rave parties and gyms. The primary users are teenagers and young 
adults. The populations abusing this drug fall into three major groups: 
(1) users who take GHB as an intoxicant or euphoriant or for its 
alleged hallucinogenic effects; (2) bodybuilders who abuse GHB for its 
alleged utility as an anabolic agent or as a sleep aid; and (3) 
individuals who use GHB to commit sexual assault. These categories are 
not mutually exclusive and an abuser may use the drug illicitly to 
produce several effects.
    The number of cases in which GHB has been used facilitate sexual 
assault is impossible to determine; many such cases may go unreported 
or unsubstantiated due to the difficulty of detecting its use. GHB is 
quickly eliminated from the body making detection in the body fluids 
unlikely. In addition, GHB's fast onset of depressant effects and its 
amnesiac effect render victims unable to recall the details of the 
attack. Nonetheless, DEA is aware of 13 sexual assault cases involving 
22 victims under the influence of GHB since 1996. These assaults 
occurred in California, Florida, Louisiana, Maryland, Massachusetts, 
Michigan, Texas, and Wisconsin.
    GHB is illicitly produced in clandestine laboratories. Since 1997, 
the DEA is aware of at least 100 cases involving GHB illicit 
laboratories and over 200 submissions to DEA and state and local 
forensic laboratories. GHB has been encountered in every region of the 
United States and both small (personal use amounts) and large (intended 
for distribution) clandestine laboratories have been encountered. It is 
marketed as a ``legal high'' or a substitute for MDMA (Ecstasy) and is 
sold in solid and liquid forms.
    The clandestine synthesis involves the use of two common, non-
regulated chemicals: gamma-butyrolactone (GBL), the primary precursor 
chemical, and sodium hydroxide (lye). The synthesis is a simple one-pot 
method requiring no special chemical expertise. 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. 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 DEA is reviewing various control measures for GBL. If GHB is 
placed under Schedule I or II of the CSA, GBL could be treated as an 
analogue for the purposes of criminal prosecution if it is being 
distributed for human use outside of an FDA approved Investigational 
New Drug (IND). As there are no regulatory controls imposed on handlers 
of analogues, the licit industrial or pharmaceutical use of GBL would 
be unencumbered by this method of control. Alternatively, if GHB is 
controlled in any schedule of the CSA, GBL can be controlled as an 
immediate precursor in the same or lower schedule as GHB. The full 
range of CSA drug control measures would then apply to GBL. Another 
method of controlling GBL distribution and use by clandestine 
manufacturers would be to make GBL a listed chemical with a level of 
control commensurate with its current industrial use. Both of these 
last two measures (immediate precursor and listed chemical) could be 
taken by the DEA following a notice and comment rulemaking process. In 
October 1998, the DEA published a Federal Register notice seeking 
information about the industrial uses and handling of GBL. The DEA is 
currently evaluating this information.
    The abuse of GHB is associated with significant adverse effects to 
the abuser and health risk to the general public. The DAWN estimated 
that there were 54 GHB emergency room mentions in 1994 compared to 764 
in 1997. In 62 percent of these episodes, recreational use was cited as 
the reason for taking this drug. Alcohol, which intensifies the 
depressant and psychoactive effects of GHB, was reported in 86 percent 
of the mentions. Poison control centers reported over 600 GHB incidents 
in 1996 and over 900 GHB incidents in 1997. GHB is repeatedly detected 
in driving under the influence (DUI) cases indicating the public health 
and safety hazards associated with its abuse. As previously mentioned, 
there have been 32 GHB-related deaths since 1995 and 22 GHB-related 
sexual assaults reported to DEA since 1996.
    Despite data indicating that the continued, uncontrolled 
clandestine manufacture, distribution and abuse of GHB is an imminent 
hazard to the public health and safety, the DEA cannot place GHB under 
temporary control because it has an active IND exemption. As a 
consequence, the DEA is pursuing measures to administratively schedule 
GHB. In September 1997, the DEA forwarded its scheduling review to the 
Department of Health and Human Services (DHHS) and requested their 
scientific and medical evaluation and a scheduling recommendation. The 
DEA continues to document law enforcement encounters and GHB-related 
abuse cases and, as required by law, awaits a response from the DHHS 
before proceeding with any proposed scheduling action. The DEA has also 
conducted an informal field survey on GHB. Forty-one states and the 
District of Columbia reported incidents involving GHB. Most of the 
incidents reported in the survey occurred between January 1996 and 
March 1998. Reports were received from hospitals, poison control 
centers, coroners, police and sheriffs departments, public health 
department laboratories, security departments of colleges and 
universities and drug rehabilitation centers. Georgia, California and 
Texas reported the highest number of incidents with 312, 237 and 223 
reports, respectively.
    Twenty states have already controlled GHB. Alabama, Delaware, 
Georgia, Hawaii, Idaho, Illinois, Michigan, Nebraska, Nevada, Oklahoma, 
Rhode Island, and Wisconsin have placed GHB in Schedule I. California, 
Florida, Indiana, Louisiana and New Hampshire have placed it in 
Schedule II and Alaska, North Carolina, and Tennessee have controlled 
GHB in Schedule IV. In addition, New Jersey and Texas have criminalized 
the sale and possession of GHB and placed it in the same penalty group 
as LSD and marijuana.
Flunitrazepam
    Flunitrazepam, commonly known as Rohypnol, belongs to the 
benzodiazepine class of drugs. Like other benzodiazepines (such as 
Valium, Librium, Xanax and Halcion), flunitrazepam's pharmacological 
effects include sedation, muscle relaxation, reduction in anxiety and 
prevention of convulsions. With respect to its sedative effects, 
flunitrazepam is approximately 7 to 10 times more potent than diazepam 
(Valium). The effects of flunitrazepam appear approximately 15 to 20 
minutes after oral administration, and last approximately 4 to 6 hours. 
Some residual effects can be found 12 hours or more after 
administration. Although it is in Schedule IV of the CSA along with 
other benzodiazepines (due to compliance with the Psychotropic 
Convention), flunitrazepam has never been approved for medical use in 
the United States. Doctors cannot prescribe it and pharmacists cannot 
sell it. However, flunitrazepam is legally prescribed in over 50 other 
countries, and is widely available in Mexico, Colombia and Europe where 
it is used for the treatment of insomnia and as a preanesthetic 
medication.
    Flunitrazepam is abused by a wide variety of individuals including 
high school students, college students, street gang members, rave party 
attendees and heroin and cocaine abusers. It is abused to produce 
profound intoxication, to boost the high of heroin, and to modulate the 
effects of cocaine. Flunitrazepam is primarily abused orally and 
frequently in combination with alcohol. To a much lesser extent, it is 
also abused by crushing the tablets and snorting the powder.
    Flunitrazepam causes anterograde amnesia in which individuals are 
unable to remember certain events that they experienced while under the 
influence of the drug. This anterograde amnesia is particularly 
problematic when flunitrazepam is used to aid in the commission of 
sexual assault; victims may not be able to clearly recall the assault, 
the assailant, or the events surrounding the assault. Since 1994, at 
least nine individuals have been convicted of sexual assault in five 
state court cases in which there was evidence that they used 
flunitrazepam to incapacitate the victim. The DEA is aware of 17 other 
sexual assault cases from 1994 to 1998 in which there is evidence to 
suggest that flunitrazepam was used to facilitate the assault.
    For a variety of reasons, it is difficult to estimate just how 
large a problem flunitrazepam-facilitated sexual assault is across the 
country. One problem is the documentation of the use of flunitrazepam 
in sexual assault cases. Very often in these cases, biological samples 
are taken at a time when the effects of the drug have already passed 
and only residual amounts remain in the body fluids. These residual 
amounts are difficult, if not impossible, to detect using standard 
screening tests available in the United States. If flunitrazepam 
exposure is to be detected at all, urine samples must be collected 
within 72 hours of ingestion and subjected to sensitive analytical 
tests. The problem is compounded by the onset of amnesia after 
ingestion, a factor on which the assailant relies to conceal the facts 
surrounding the rape. This amnesiac effect may lead to critical delays 
in reporting the assault, making it difficult or impossible to obtain 
appropriate biological samples for toxicology testing.
    The abuse of flunitrazepam, like other controlled substances, is 
associated with clear risk to the abuser and to the safety of the 
surrounding community. Flunitrazepam abuse causes a number of adverse 
effects in the abuser, including drowsiness, dizziness, loss of motor 
control, lack of coordination, slurred speech, confusion, and 
gastrointestinal disturbances, which may last for 12 or more hours. 
Higher doses produce respiratory depression. Chronic use of 
flunitrazepam can result in physical dependence and the appearance of a 
withdrawal syndrome when the drug is discontinued. Flunitrazepam 
impairs cognitive and psychomotor function which affect reaction time 
and driving skill. The use of flunitrazepam in combination with alcohol 
is a particular concern because they both potentiate each other's toxic 
effects. There were 167 flunitrazepam emergency room episodes reported 
in DAWN from January 1994 through December 1997. Nearly half of the 
episodes involved males under the age of 20. In nearly 50 percent of 
the episodes drug dependence was reported as the motive for taking the 
drug. Eighty percent of the episodes involved other drugs, including 
alcohol (59%), marijuana (44%) and cocaine (35%).
    The increased popularity of flunitrazepam has led to smuggling and 
illegal distribution of flunitrazepam into various parts of the United 
States. Flunitrazepam has most often been smuggled into the U.S. from 
Mexico, primarily at border crossings located in Texas, Arizona and 
California. In addition, approximately 25 other countries have been 
identified from which flunitrazepam has been directly smuggled into the 
U.S.
    Since 1985, the DEA has documented approximately 4,500 Federal, 
state and local law enforcement cases involving the illegal 
distribution and/or possession of flunitrazepam in 38 states. The 
largest number of cases in the past has been concentrated in Texas 
(1,600) and Florida (1,500). Significant numbers of cases also occurred 
in Louisiana, Oklahoma and Arizona with the majority of these cases 
occurring between January 1994 and December 1996.
    An examination of both DEA case files and the DEA System to 
Retrieve Information from Drug Evidence reveals 212 cases involving 
over 544,000 flunitrazepam tablets for the period of January 1, 1985 to 
February 28, 1999. Most of these investigations were conducted in Texas 
and Florida. There were 34,000 tablets of flunitrazepam seized in 1994, 
227,199 tables seized in 1995, 155,000 tablets in 1996; and 35,000 
seized in 1997. However, during 1998, the number of tablets seized 
increased over the previous year with 56,000 tablets being seized. The 
vast majority of these tablets were either the one milligram (mg) 
pharmaceutical (Rohypnol) tablet or counterfeit two mg tablets which 
contain flunitrazepam and are designed to look like the pharmaceutical 
Rohypnol tablet.
    The two mg pharmaceutical tablet, until recently, has been the most 
frequently encountered form of flunitrazepam seized by law enforcement 
officials. However, the manufacturer, Hoffman La Roche has discontinued 
production of the two mg tablet. As a result, there was a significant 
reduction in law enforcement encounters with the pharmaceutical two mg 
tablets. This was followed quickly by increases in encounters with the 
one mg pharmaceutical tablets and with counterfeit tablets containing 
two mgs of flunitrazepam. Counterfeit tablets demonstrate that there is 
an established illicit market in the U.S.
    Flunitrazepam was placed into Schedule IV of the Controlled 
Substances Act (CSA) in 1984 due to international treaty obligations. 
At that time there was no known abuse of flunitrazepam in the United 
States. However, over the last several years, DEA has been concerned 
with the problem of flunitrazepam abuse and approximately four years 
ago, began to consider the merits of transferring flunitrazepam to a 
different schedule. While the abuse and trafficking of flunitrazepam 
are considered to be an imminent hazard to the public safety, the DEA 
could not take immediate steps to curb this abuse by using the 
temporary scheduling provision of the CSA because this drug was already 
a controlled substance. As a consequence, the DEA proceeded with the 
administrative scheduling process and, as required under the CSA, the 
DEA submitted its data on the abuse and trafficking of flunitrazepam to 
the DHHS in April, 1996. Along with DEA's document was a request to the 
DHHS for a scientific and medical evaluation and a scheduling 
recommendation. In January, 1997, after the appropriate scientific and 
medical review, the DHHS provided its scheduling recommendation to the 
DEA which stated that flunitrazepam has no accepted medical use in the 
United States (consistent with Schedule I placement) but that its abuse 
potential was no different than other benzodiazepines, a finding which 
is consistent with Schedule IV control. The DHHS recommended that 
flunitrazepam remain in Schedule IV. After careful analysis of the 
relevant data and in consideration of the DHHS recommendation, the DEA 
concluded that sufficient grounds did not exist to administratively 
reschedule flunitrazepam. Several states, however, have determined that 
the existing controls were inadequate to address the abuse and 
trafficking of flunitrazepam within their jurisdictions and have 
rescheduled flunitrazepam through their state administrative process or 
by state legislation. Florida, Idaho, Minnesota, New Hampshire, New 
Mexico, North Dakota, Oklahoma, and Pennsylvania have rescheduled 
flunitrazepam into Schedule I and some states have increased the 
penalties for illegal distribution.
    Even though the control status of flunitrazepam has not changed, 
other actions have been taken. Congress passed The Drug-Induced Rape 
Prevention and Punishment Act of 1996 which made it a crime to give any 
unconsenting individual a controlled substance with the intent of 
committing a violent act, including rape, against that individual. In 
addition, the law established stricter Federal penalties for the 
possession and distribution of flunitrazepam without changing the 
schedule of the drug. In implementing these new penalty provisions, the 
United States Sentencing Commission established sentencing guidelines 
for flunitrazepam that were above those generally applicable to 
Schedule I and II depressant drugs. These guidelines became effective 
on November 1, 1997. Also, since March 5, 1996, the U.S. Customs 
Service has been seizing personal use amounts of flunitrazepam 
encountered at border points of entry. This action was taken in 
response to the growing abuse and trafficking problem and the fact that 
it is not approved for use in this country.
Ketamine
    The final drug I would like to discuss is ketamine. It is the only 
one of the three which has been approved for marketing in the United 
States although its primary use is in veterinary medicine. It is a 
rapidly acting, general anesthetic whose pharmacological profile is 
essentially the same as phencyclidine (PCP). Like PCP, individuals 
anesthetized with ketamine feel detached or disconnected from their 
pain and environment. In addition, ketamine has both analgesic (pain 
relief) and amnesic (memory loss) properties. The use of ketamine as a 
general anesthetic for humans has been quite limited due to its adverse 
effects including the delirium and hallucinations which some experience 
after awakening from anesthesia. However, it does have some utility for 
emergency surgery in humans and surgery of short duration in children 
and the elderly, groups which experience delirium and hallucinations 
less frequently.
    As a drug of abuse, ketamine (street name ``Special K'') has become 
common at dance parties or ``raves.'' It produces a dose-related 
progression of effects from a state of dreamy intoxication to delirium 
accompanied by the inability to move, feel pain or remember what has 
occurred while under the drug's influence. The ``Special K'' trip is 
similar to that of LSD or PCP but lasts only 30 to 60 minutes as 
opposed to several hours. Ketamine is less potent than PCP: 25 mg of 
PCP can produce a full psychedelic experience whereas it would require 
at least 100 mg of ketamine (depending on body size) for a similar 
effect.
    ``Special K'' is prepared by evaporating the liquid from the 
legitimate pharmaceutical injectable product and grinding the residue 
into a powder. Ketamine is difficult to synthesize and there have been 
no reports of its clandestine manufacture. All of the ketamine 
encountered by law enforcement to date has been diverted from licit 
sources, primarily distributors and veterinarians. The ``Special K'' 
powder is snorted like cocaine or to a lesser extent smoked on tobacco 
or marijuana. In addition, the liquid form has been added to drinks. A 
typical dose would be 20 mgs snorted in each nostril, repeated at 5 to 
10 minute intervals (usually 3 or 4 times) until the desired effect is 
achieved. It is distributed as powder in small bottles, ziplock bags, 
capsules, paper, glassine or aluminum ``folds'', or as a liquid in 
small vials or bottles.
    Prior to 1993, there were few documented law enforcement 
encounters, emergency room mentions, or reported thefts of ketamine. 
However, since 1993, the frequency of law enforcement encounters as 
well as emergency room and medical examiner's reports has increased, 
indicating the increased abuse of ketamine. Abuse of ketamine is 
indicated in the 145 emergency room episodes reported to DAWN during 
the period 1993 to 1997. Alcohol, cocaine and marijuana were the most 
frequently reported substances identified in the DAWN reports as being 
used in combination with ketamine. This drug can be used by individuals 
intent on committing sexual assault due to its effect on victims who 
become extremely compliant and later may not be able to remember what 
happened. However, the DEA is aware of only one documented case in 
which it was demonstrated that ketamine was used to facilitate a rape. 
Of course, the same factors which could lead to the under-reporting of 
the use of flunitrazepam and GHB in sexual assault apply to ketamine as 
well.
    The DHHS has, on two occasions, in 1981 and 1986, recommended that 
ketamine be placed in Schedule III of the Controlled Substances Act 
(CSA) based on a scientific and medical review. These recommendations 
were based largely on the pharmacological profile of the drug. On each 
occasion, the DEA determined that the incidence of actual abuse, along 
with its status as a prescription drug with limited distribution, did 
not provide sufficient cause to place ketamine under CSA control. 
Ketamine's recent emergence as a drug of abuse has prompted the DEA to 
reevaluate its placement in the CSA. The DEA requested a new scientific 
and medical evaluation and scheduling recommendation from DHHS in April 
1998. The DHHS conducted an expeditious review and responded to our 
request in December 1998. The DHHS again recommended Schedule III 
placement. The Federal control of ketamine is proceeding and a notice 
of proposed scheduling should be published within 60 days.
    Eighteen states have already controlled ketamine: California, 
Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, 
Louisiana, New Hampshire, New Jersey, New Mexico, New York, Oklahoma, 
and Wisconsin have placed it in Schedule III; Missouri and Tennessee 
have placed it in Schedule IV; and Massachusetts has placed ketamine 
under the same penalty category as LSD and PCP.
Conclusion
    GHB, flunitrazepam and ketamine are three recent drugs of abuse. 
Their continued illegal distribution and abuse pose serious risks to 
the American public health and safety. In reviewing the data presented 
here today, it is clear that GHB and ketamine should be placed under 
control in the CSA and that the actions taken to deter flunitrazepam 
smuggling and illegal distribution and abuse must be continued. The DEA 
applauds the actions taken by various states authorities to quickly 
address the abuse, diversion and trafficking of these substances in 
their areas. Such actions are also part of the evaluation process for 
Federal control of these drugs when warranted. Emergency scheduling 
action to increase the regulatory controls and curb the illicit 
availability and abuse of certain substances is not possible when those 
substances are: (1) already controlled [flunitrazepam]; (2) already 
marketed in the U.S.[ketamine]; or (3) are being evaluated as part of a 
DHHS approved research program [GHB]. We are working within the 
Executive Branch with DHHS to examine alternatives to current 
procedures.
    The continued abuse and trafficking of GHB are of grave concern to 
the DEA. Congress may legislatively place any of these substances under 
the CSA and the DEA would not be apposed to Congress taking this action 
especially in regard to GHB. Congress has taken similar action in the 
past. It directed that methaqualone be moved from Schedule II to 
Schedule I in 1984 and it added anabolic steroids to Schedule III in 
1990.
    Mr. Chairman, in closing, I would like to thank you and the 
Committee for providing me with the opportunity to offer the DEA's 
position and comments on the very serious problem of abuse of GHB, 
flunitrazepam and ketamine. I will be happy to answer any questions you 
may have.
 findings required to place a substance in schedules i-v as set out in 
                            21 u.s.c. 812(b)
Schedule I:
    (A) The drug or other substance has a high potential for abuse.
    (B) The drug or other substance has no currently accepted medical 
use in treatment in the United States.
    (C) There is a lack of accepted safety for use of the drug or other 
substance under medical supervision.
Schedule II:
    (A) The drug or other substance has a high potential for abuse.
    (B) The drug or other substance has a currently accepted use in 
treatment in the United States or a currently accepted medical use with 
severe restrictions.
    (C) Abuse of the drug or other substance may lead to severe 
psychological or physical dependence.
Schedule III:
    (A) The drug or other substance has a potential for abuse less than 
the drugs or other substances on schedules I and II.
    (B) The drug or other substance has a currently accepted medical 
use in treatment in the United States.
    (C) Abuse of the drug or other substance may lead to moderate or 
low physical dependence or high psychological dependence.
Schedule IV:
    (A) The drug or other substance has a low potential for abuse 
relative to the drugs or other substances in schedule III.
    (B) The drug or other substance has a currently accepted medical 
use in treatment in the United States.
    (C) Abuse of the drug or other substance may lead to limited 
physical dependence or psychological dependence relative to the drugs 
or other substances in schedule III.
Schedule V:
    (A) The drug or other substance has a low potential for abuse 
relative to the drugs or other substances in schedule IV.
    (B) The drug or other substance has a currently accepted medical 
use in treatment in the United States
    (C) Abuse of the drug or other substance may lead to limited 
physical dependence or psychological dependence relative to the drugs 
or other substances in schedule IV.

    Mr. Upton. We thank you for being here as well.
    Mr. is it Reuter or Reuter?
    Mr. Reuter. It is Reuter----
    Mr. Upton. Reuter.
    Mr. Reuter. [continuing] from the news agency.
    Mr. Upton. So I had it right.
    Mr. Reuter. I answer to Reuter as well.
    Mr. Upton. All right. Thank you. Thank you for coming.

                  TESTIMONY OF NICHOLAS REUTER

    Mr. Reuter. Thank you. My name is Nick Reuter, and, Mr. 
Chairman, members of the committee, thank you for the 
opportunity to testify on the role of the Food and Drug 
Administration in the scheduling of drugs under the Controlled 
Substances Act. We recognize and share your interest and 
concern in this matter.
    Before we begin, we wish to express our sympathy with all 
those affected, especially the families of the young women 
involved in the tragic incidents in Michigan and Texas. These 
types of incidents certainly highlight the problems with the 
use of illicit substances.
    You have asked us today to focus on FDA's role in the 
scheduling process and to specifically discuss three drug 
substances of interest to the committee. As requested, I will 
restrict my oral comments to 5 minutes and ask that my full 
written statement be included in the record.
    The primary role of FDA under the CSA is to provide the 
Secretary of Health and Human Services with our scientific and 
medical evaluation of drugs. FDA's consultative role stems from 
the provisions of the CSA. This role is consistent with FDA's 
mission of public health protection.
    Under this act, the Secretary is charged with evaluating 
certain medical and scientific factors and making 
recommendations to the Attorney General as to whether the 
substance under review should be managed as a controlled 
substance or removed from control and the appropriate level of 
control.
    The CSA establishes the factors and findings determinative 
for control. The eight factors set forth in this law allow the 
Attorney General, and by delegation the Drug Enforcement 
Administration, to schedule a drug if she finds that the drug 
has a potential for abuse that warrants control.
    The Attorney General must also take into account whether 
the drug has a currently accepted medical use within the U.S. 
and the extent to which the use of the drug may lead to 
physical or psychological dependence. The Attorney General also 
must request from the Secretary of DHHS a scientific and 
medical evaluation of the drug and make a recommendation as to 
whether the drug should be controlled and, if so, under what 
schedule.
    After evaluating the eight factors, the Secretary must make 
a scheduling recommendation. The Secretary of HHS has delegated 
the responsibility for this recommendation to the Assistant 
Secretary for Health, who relies on FDA and NIDA to develop the 
medical and scientific evaluation and consider the appropriate 
factors and scheduling criteria, which are all set forth in the 
law.
    These evaluations and recommendations are unique to the 
drug in question and are based on the substance's relative 
abuse potential, its medical usefulness and its capacity to 
produce dependence. Upon completion, the medical and scientific 
evaluation and scheduling recommendation of FDA and NIDA are 
forwarded to the ASH, who makes the final determination on 
behalf of the Secretary.
    The medical and scientific evaluation and the 
recommendation as to the appropriate schedule for the drug are 
then forwarded to the Drug Enforcement Administration. I would 
refer you to my written statement for details on the importance 
of the Department's mandated scientific and medical review 
under the Controlled Substances Act.
    A detailed discussion of the three drugs, GHB, Ketamine and 
Rohypnol, you asked FDA to address are contained in my written 
statement as well. Given the time, I will not discuss those in 
great detail.
    I would like to discuss the effort of FDA, and particularly 
FDA's Office of Criminal Investigations, to address the abuse 
of GHB. It is important to stress this because FDA is not only 
reviewing drugs for control under the Controlled Substances 
Act, but we are also enforcing provisions of the Food, Drug and 
Cosmetic Act.
    Indeed, the Office of Criminal Investigations has initiated 
aggressive enforcement actions against the manufacture and 
interstate distribution of GHB. These initiatives are directed 
at large scale interstate manufacturers and distributors, 
including Internet website vendors as we saw this morning.
    Working with the Office of Chief Counsel and FDA's Center 
for Drug Evaluation and Research, OCI has developed 
investigation and prosecution strategies that have been highly 
effective in identifying and convicting violators.
    Also, OCI and the Center for Drugs within FDA and the 
Department of Justice have developed and maintained a list of 
scientific experts available to testify in court proceedings. 
OCI also uses its expertise and resources to assist State and 
local police departments in conducting numerous investigations.
    As part of our systematic efforts to combat the abuse of 
GHB, FDA's Office of Criminal Investigations has initiated and 
supported a number of Federal and State prosecutions throughout 
the U.S. related to the illegal manufacture and distribution of 
the drug.
    To date, the Government has obtained over 33 GHB related 
convictions nationwide, and it really does not stop there. Our 
technical and investigative assistance is invaluable to the 
approximately 20 States that have enacted legislation to make 
GHB a controlled substance. We have held a number of training 
seminars for Federal, State and local enforcement 
administration agencies.
    Let me conclude by saying that drug control evaluations and 
recommendations under this CSA can be complex. They definitely 
require the balancing of more than one public health interest.
    FDA would agree that there is a critical need to protect 
the public health from the dangers posed by drugs and 
substances of abuse. At the same time, we have to recognize 
that many drugs that have the potential for abuse may also be 
medically beneficial, and a large segment of the population 
might benefit from the optimization of drug development. These 
interests sometimes create tension in this scheduling process.
    In FDA's dual role as the evaluator of products that 
promote public health and the evaluator of substances that 
present a danger to the public, we will use the best available 
scientific data to make the speediest and best decisions.
    We are committed to optimizing our interactions with our 
critical partners, Federal, State and local officials, 
scientific, the clinical and industrial community. There is no 
question that FDA needs to move quickly to assist in the 
evaluation of these drugs and substances so that scheduling 
under the CSA can move forward.
    I want to thank the committee and the chairman for the 
opportunity to testify, and I will be glad to answer questions.
    [The prepared statement of Nicholas Reuter follows:]
  Prepared Statement of Nicholas Reuter, MPH, Associate Director for 
Domestic and International Drug Control, Office of Health Affairs, Food 
    and Drug Administration, Department of Health and Human Services
    Mr. Chairman, thank you for the opportunity to testify on the role 
of the Food and Drug Administration (FDA or Agency) in the scheduling 
of drugs under the Controlled Substances Act (CSA), 21 U.S.C. Sec. 811. 
We recognize and share your interest and concern in this matter and 
before we begin, we wish to express our sympathy with all those 
affected, especially the families of the two young women involved in 
the tragic incident in Michigan. These types of incidents certainly 
highlight the problems with the use of illicit substances. You have 
asked us today to focus on FDA's role in the scheduling process and to 
specifically discuss three drug substances of interest to the 
Committee.
                                fda role
    The primary role for FDA under the CSA is to provide the Secretary 
of the Department of Health and Human Service (DHHS) with our 
scientific and medical evaluation of drugs. FDA's consultative role 
stems from the provisions of the Comprehensive Drug Abuse Prevention 
and Control Act (Act) of 1970. Pub. L. 91-512 (October 27, 1970). Such 
a role is consistent with FDA's mission of public health protection. 
Under the Act, the Secretary of DHHS is charged with evaluating certain 
medical and scientific factors and making recommendations to the 
Attorney General as to whether the substance under review should be 
managed as a controlled substance, or removed from control, and the 
appropriate level of control. Title II of the Act, now fully 
incorporated into the CSA, establishes the factors and findings 
determinative for control. The factors set forth under 21 U.S.C. 
Sec. 811 allow the Attorney General and, by delegation, the Drug 
Enforcement Administration (DEA), to schedule a drug if she finds that 
the drug has a potential for abuse. The Attorney General also must take 
into account whether the drug has a currently accepted medical use 
within the United States and the extent to which the use of the drug 
may lead to physical or psychological dependence.
    When evaluating a particular drug, the Attorney General must, under 
21 U.S.C. Sec. 811 (c), consider the following factors:
        (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 or 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.
    Before proceeding to control a drug under this process, the 
Attorney General also must request from the Secretary of DHHS a 
scientific and medical evaluation of the drug and make a recommendation 
as to whether the drug should be controlled and, if so, under what 
schedule. In making such a recommendation, the Secretary of DHHS must 
take into consideration factors (2), (3), (6), (7) and (8) and any 
scientific and medical considerations involved in factors (1), (4) and 
(5) as described above.
    After evaluating the eight factors, the Secretary must make a 
scheduling recommendation based on the substance's relative potential 
for abuse, its accepted medical use and its capacity for producing 
physical and psychological dependence. Under the CSA, substances in 
Schedule I have a high potential for abuse and no accepted medical use. 
Substances in Schedule II have a high potential for abuse but do have 
an accepted medical use. Substances in Schedules III-V have an accepted 
medical use and a relatively lower potential for abuse.
    The legislative history of the CSA is replete with hearings, 
discussion and statements that the scientific and medical evaluation of 
DHHS is important and critical to the process. The operative provisions 
of the CSA reflect that history. In particular, 21 U.S.C. Sec. 811(b) 
states:
        The recommendation of the Secretary 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 substance.
    The Secretary of DHHS has delegated responsibility for DHHS's 
recommendation to the Assistant Secretary of Health (ASH). The ASH, in 
turn, relies on FDA and the National Institute on Drug Abuse (NIDA) to 
develop the medical and scientific evaluation and consider the 
appropriate factors and scheduling criteria. Under an interagency 
Memorandum of Understanding (MOU), FDA and NIDA cooperate in completing 
the medical review, evaluation, and recommendation that DHHS conducts 
as part of the domestic drug scheduling process.1
---------------------------------------------------------------------------
    \1\ Memorandum of Understanding With the National Institute on Drug 
Abuse and the FDA, March 3, 1985 (50 FR 9518)
---------------------------------------------------------------------------
    Proceedings to add, delete or change the schedule of a drug or 
other substance may be initiated by DHHS, DEA or by petition from any 
interested person such as a drug manufacturer, medical society, 
pharmacy association, public interest group or state and local 
government. Typically, FDA will not begin its medical and scientific 
evaluation until it receives, through the ASH, a formal request for 
such an evaluation from DEA. FDA may also initiate such an evaluation. 
FDA typically will do so during the investigational stages of drug 
development or at such time that an application to market a new drug is 
received by FDA and the Agency believes that the substance may be a 
candidate for scheduling under the CSA as provided for in 21 U.S.C. 
Sec. 811(f) which states:
        If, at the time a new drug application is submitted to the 
        Secretary for any drug having a stimulant, depressant, or 
        hallucinogenic effect on the central nervous system, it appears 
        that such drug has an abuse potential, such information shall 
        be forwarded by the Secretary to the Attorney General.
                           process within fda
    The scientific and medical evaluation process is a complex one 
which is a part of the balancing of the interests of various agencies. 
There is a critical need to protect the public from the dangers posed 
by drugs and substances of abuse. At the same time, we recognize that 
many drugs that have the potential for abuse also may be medically 
beneficial and a large segment of the population might benefit from the 
optimization of drug development. These interests can create a tension 
in the scheduling process.
    The FDA Office of Health Affairs (OHA) is responsible for the 
coordination of the DHHS activities in preparation of the report and 
recommendation on scheduling. Internally, once a scheduling request is 
referred to FDA, there is a review period during which FDA's Center for 
Drug Evaluation and Research (CDER), with assistance from others within 
the Agency, conducts a review of the drug. The data review includes 
review of the chemical properties, pharmacology studies and clinical 
studies and reports related to the drug.
    This evaluation involves the careful analysis of many kinds of 
data: data on chemical synthesis and solubility; data on absorption and 
metabolism; information gathered from studies designed to investigate 
whether animals develop physical dependence and will work to self-
administer the drug; and, whether an animal can distinguish a given 
drug from other controlled substances. Interaction studies with other 
agents, including alcohol, also may be evaluated. Human adverse events 
(relating to the drug's ability to cause physical dependence, alter 
moods, cause hallucinations, etc.) are collected and reviewed from 
clinical trial reports and from postmarketing experience if applicable.
    In the case of a new drug under investigation, the data specific to 
the issue of abuse potential may not already be developed by the 
sponsor unless there has been some reason to suspect that it may indeed 
have abuse potential. These kinds of specialized studies are not a 
routine aspect of the drug development process. The development of this 
information, therefore, may take many years as studies are initiated 
and completed and as more clinical trial experience becomes available.
    FDA has an Advisory Committee, composed of non-FDA employees, 
available if necessary, to review the data and provide recommendations 
to FDA concerning the medical and scientific evaluation, abuse 
potential and the need for scheduling controls. The CDER Division will 
then forward a recommendation for review by CDER's Center Director. 
Once the recommendation is signed by the Center Director, it is 
reviewed by the Office of Commissioner, including OHA. The 
recommendation is then forwarded for formal interagency review, a 
process coordinated by OHA.
    During this period, there are informal consultations with NIDA. 
Under the MOU, FDA transmits the scheduling request from DEA upon 
receipt from DHHS to NIDA for concurrent review. An interagency group, 
the Interagency Drug Scheduling Working Group (IDSWG), which includes 
representatives from FDA, NIDA and the Substance Abuse and Mental 
Health Services Administration (SAMHSA), convenes periodically to 
assess the status of the scheduling review. Occasionally, the IDSWG 
will identify the need for additional abuse liability testing, or, on 
rare occasions, a public hearing under Part 15 of FDA regulations.
    The MOU, noted above, describes procedures for sharing information 
between the agencies, and outlines FDA's role in preparing the initial 
recommendation and eight factor ``basis'' document. Upon completion, 
the medical and scientific evaluation and scheduling recommendation of 
FDA and NIDA are forwarded to the ASH who makes the final determination 
on behalf of the Secretary. The medical and scientific evaluation and 
the recommendation as to the appropriate schedule for the drug are then 
forwarded to the DEA.
    Since the inception of the scheduling process in 1970, there have 
been dozens of substances reviewed for control under the CSA. On 
average, DHHS completes its response to a scheduling request within 8-
10 months. In addition, FDA, DEA and NIDA meet monthly to discuss 
issues of mutual concern in the drug abuse control area. The 
Interagency Committee on Drug Control, formed in the early 1970s, 
provides a forum to discuss emerging drug issues and monitor the status 
of ongoing activities within the agencies.
    It should be noted that there are other scheduling mechanisms that 
I will not discuss in detail but I do want to mention. Many substances 
were controlled under the CSA at the time the law was enacted in 1970. 
Scheduling also can be accomplished by legislation. The scheduling of 
Methaqualone (Qualuudes) and anabolic steroids are examples of 
legislative control. In addition, there is scheduling to fulfill treaty 
obligations. Finally, DEA can ``emergency'' schedule certain substances 
not subject to an investigational new drug application, under certain 
conditions on a temporary basis if there is an imminent hazard to the 
public health. 21 U.S.C. Sec. 811(h)(1).
Ketamine, Rohypnol (Flunitrazepam) and GHB (Gamma-Hydroxybutyrate)
    There are three drugs you requested that we specifically discuss in 
our testimony, Ketamine, Rohypnol and GHB. These drugs have been the 
subject of abuse in varying degrees for a number of years.
    Ketamine--Ketamine is an anesthetic and has been approved both for 
human and animal use as an anesthetic. It was approved both as a human 
and veterinary drug in 1970. Ketamine has powerful analgesic and 
amnesic actions in humans and is typically used in humans in pediatric 
and obstetric procedures and is prominently used in veterinary 
procedures. Approximately 90% of the Ketamine legally sold today is for 
veterinary use. In the 1980s, Ketamine emerged as a recreational street 
drug because consumption of large doses cause reactions similar to 
those associated with use of PCP. Symptoms associated with recreational 
use of ketamine include dream-like states and hallucinations. The Drug 
Abuse Warning Network (DAWN) documented at least two Ketamine related 
deaths between 1993 and 1997 in which no other drugs, including 
alcohol, were used.
    DHHS has evaluated Ketamine three times pursuant to requests from 
DEA for a medical and scientific evaluation and has forwarded a 
scheduling recommendation each time. The first time was in 1981; the 
second in 1986 and recently in 1998. Each time a recommendation was 
made to DEA from DHHS that Ketamine be placed in Schedule III of the 
CSA. Each time a request for a recommendation was made, FDA had to 
review current medical and scientific data to ensure that the Schedule 
III recommendation was appropriate. To date these recommendations have 
not been finalized.
    Rohypnol--Rohypnol (flunitrazepam) is an unapproved drug in the 
United States, although it is approved in Europe and is used in over 60 
countries. The drug belongs to the class of drugs known as 
benzodiazepines (such as Valium, Halcion, Xanax, and Versed ) and is 
used outside the United States as a treatment for relief of insomnia, 
to induce sedation and as a pre-anesthetic. The drug can cause 
anterograde amnesia, thus, individuals may not remember certain events 
they experienced while under the effects of the drug. This effect is 
presumably what has lead to the drug's use in sexual assaults. Without 
the ability to recall the sexual assault or rape, the victim is 
hindered in assisting law enforcement officials in providing 
information leading to the prosecution of the perpetrator. For these 
reasons, one of the street names for Rohypnol is ``the forget me 
pill.'' The drug is tasteless, odorless and dissolves easily in 
carbonated beverages.2 The sedative and toxic effects of 
Rohypnol also are aggravated by the concurrent use of alcohol. Even 
without alcohol, doses as small as 1 milligram can incapacitate a 
victim for 8-12 hours.
---------------------------------------------------------------------------
    \2\ It should be noted that the drug manufacturer, located in 
Ireland, has indicated that efforts are underway to change the 
solubility of the drugs and to introduce a coloring to the drug that 
will appear when dissolved.
---------------------------------------------------------------------------
    Rohypnol is not approved or available for medical use in the United 
States, but it is temporarily controlled in Schedule IV pursuant to a 
treaty obligation under the 1971 Convention on Psychotropic Substances. 
At the time flunitrazepam was placed temporarily in Schedule IV 
(November 5, 1984), there was no evidence of abuse or trafficking of 
the drug in the United States.
    In March 1996, DEA requested that DHHS conduct a scientific and 
medical evaluation and provide a permanent scheduling recommendation 
for Rohypnol. DHHS provided a recommendation to DEA in January 1997 
that it remain in Schedule IV. This action has not been finalized.
    FDA continues to work with the United States Customs Service 
(Customs) and DEA to control the illegal importation of Rohypnol into 
the United States through smuggling from other countries. FDA issued an 
import bulletin in December 1995 and the Agency continues to work to 
help control the illegal entry of the drug.
    GHB--GHB is an unapproved drug in the United States and currently 
is not scheduled under the CSA. It is approved in other countries for 
use as an anesthetic in humans. The drug is a central nervous system 
depressant that can induce deep sleep. GHB is presently the subject of 
several investigational new drug applications (IND) and is being 
studied for commercial development in the United States. FDA designated 
GHB as an orphan drug in 1987 for the treatment of patients with 
narcolepsy and the constellation of symptoms of cataplexy, sleep 
paralysis, hypnagogic hallucinations and automatic behavior. FDA also 
has issued orphan product grants for the study of GHB in the treatment 
of narcolepsy. Orphan Medical, Inc., has submitted an IND to FDA to 
review the use of GHB in the diagnosis and /or treatment of narcolepsy.
    At the same time, GHB also is being abused as an intoxicant, 
depressant, euphoriant, growth hormone releasing agent and as an agent 
in sexual assaults. Unlike the two drugs discussed above, GHB poses a 
particularly acute law enforcement problem in that it can be easily 
synthesized by individuals with a limited knowledge of chemistry. Gamma 
Butyrolactone (GBL) and Sodium Hydroxide are the chemicals necessary to 
make GHB. Both of these chemicals are readily purchased from numerous 
chemical supply houses. Also, the recipe to manufacture the drug can be 
obtained easily over the Internet.
    FDA has been involved in evaluating the reports of abuse of GHB and 
investigating the adverse events suffered as a result of the abuses. 
Since it was established in 1992, FDA's Office of Criminal 
Investigations (OCI) has tried to take aggressive enforcement actions 
against the manufacture and interstate distribution of GHB. OCI's 
investigative initiatives are directed at large scale interstate 
manufacturers and distributors including Internet web site vendors. 
Working with the Office of Chief Counsel and CDER, OCI has developed 
investigative and prosecution strategies that have been highly 
effective in identifying and convicting violators. From 1993 until the 
present, OCI has worked closely with CDER and FDA's National Forensic 
Chemistry Center to develop an expertise in the safe handling and 
processing of GHB when collected as evidence. Also, OCI, CDER and the 
Department of Justice have developed and maintained a list of 
scientific experts available to testify in court proceedings. OCI also 
utilizes its expertise and resources to assist state and local police 
departments in conducting numerous investigations. As a part of our 
systemic efforts to combat abuse of GHB, FDA/OCI has initiated and 
supported a number of federal and state prosecutions throughout the 
United States related to the illegal manufacture and distribution of 
the drug. To date the government has obtained over 33 GHB-related 
convictions nationwide.
    Our technical and investigative assistance is invaluable to the 
approximately 20 states that have enacted legislation to make GHB a 
controlled substance. In March 1997, the OCI San Diego Field Office 
conducted a training seminar for federal, state and local law 
enforcement agencies who were responsible for controlling the rapid 
growth in the use and abuse of GHB in Southern California. In July 
1997, OCI continued to assist state and local law enforcement efforts 
when its San Francisco Resident Office conducted a GHB training seminar 
for law enforcement personnel in Northern California.
    OCI also has responded to a request from DEA's Office of Drug 
Diversion, Drug and Chemical Evaluation for all available information 
related to the synthesis, tracking, usage and other illicit commerce 
involving GHB. The recent surge in the popularity of GHB and its 
precursors (GBL or 1, 4 butanediol) has made combating its illegal use 
increasingly difficult. Investigations are resource intensive and the 
laws used to prosecute distribution under the Federal Food Drug and 
Cosmetic Act are relatively complex.
    FDA has issued several alerts and warnings concerning GHB. FDA also 
has worked with Customs to stop the importation of GHB and in May 1992, 
FDA issued an Import Alert providing for automatic detention of the 
product.
    Most recently, FDA moved to alert consumers not to purchase or 
consume products, some of which are labeled as dietary supplements, 
that contain GBL. When taken orally, GBL is converted in the body to 
GHB. FDA pressed the companies that manufacture these products to cease 
the manufacture and distribution of these products and to voluntarily 
recall them. As of this date, all of the manufacturers that were 
contacted agreed to cease the manufacture and distribution of their 
GBL-containing products. All but one has agreed to recall the products. 
The Agency had received reports of serious health problems--some that 
are potentially life-threatening--associated with the use of these 
products. Although some of these products were labeled as dietary 
supplements, the products were, and are, illegally marketed unapproved 
new drugs. They are promoted with fantastic and unsubstantiated claims 
to build muscles, improve physical performance, enhance sex, reduce 
stress and induce sleep.
    GBL related products have been associated with reports to FDA of at 
least 55 adverse health events, including one death. In 19 cases, the 
individuals became unconscious or comatose and several required 
intubation for assisted breathing. Other reported effects included 
seizures, vomiting, slow breathing and slow heart rate. There have been 
reports of at least five children under 18 years of age who have been 
injured or who have suffered these kinds of effects.
    As a result of the increased abuse of GHB, DEA requested in 
September 1997 that DHHS conduct a scientific and medical evaluation of 
GHB and submit a scheduling recommendation for GHB. In response to 
DEA's request, the Department has continued to gather and evaluate 
scientific data on GHB's potential for abuse. These activities have 
proceeded in conjunction with the OCI enforcement actions and the 
ongoing clinical investigation of GHB for the treatment of narcolepsy.
    In December 1998, FDA determined that the sponsor could provide GHB 
under a treatment IND. Once under a treatment IND, the product may then 
be legally prescribed to appropriate patients before general marketing 
is allowed. Treatment INDs are a means of facilitating, even before 
general marketing of the product, the availability of promising new 
drugs to desperately ill patients for whom no other therapy is 
available. FDA approves treatment INDs if there is preliminary or 
presumptive evidence of drug efficacy and the drug is intended to treat 
a serious or life-threatening disease, or if there is no comparable 
alternative drug or therapy available to treat that stage of the 
disease in the intended patient population. The drug also must be 
considered safe for its intended use under a physician's care. Patients 
who receive the drug under the treatment IND are not eligible to be in 
the definitive clinical trials, which must be well underway, if not 
almost finished. These ongoing investigations may allow FDA to learn 
more about GHB's relative potential for abuse, to aid in the scheduling 
review and to develop additional information for the product labeling.
    FDA is completing its evaluation and recommendation on GHB to DHHS. 
As part of the review, the Agency is determining if GHB's abuse 
potential is ``high'' relative to substances controlled currently in 
Schedules I and II (such as heroin, PCP, LSD, marijuana, etc.) or if 
its abuse potential is closer to anabolic steroids or benzodiazepines, 
currently controlled in Schedule III and IV.
                               conclusion
    Increasingly, our citizens have had to face the increasing 
availability and abuse of drugs and other substances. In FDA's dual 
role as the evaluator of products that promote public health and 
evaluator of substances that present a danger to the public, we will 
use the best available scientific data to make the speediest and best 
decisions. We are committed to optimizing our interactions with our 
critical partners--federal, state and local officials, scientific, 
clinical and industrial. There is no question that FDA needs to move 
quickly to assist in the evaluation of these drugs and substances so 
that scheduling under the CSA can move forward.
    Thank you for the opportunity to testify.

    Mr. Upton. Thank you very much.
    Dr. Zukin?

                   TESTIMONY OF STEPHEN ZUKIN

    Mr. Zukin. Mr. Chairman and members of the subcommittee, I 
am grateful for this opportunity to testify.
    I am the Director of the Division of Clinical and Services 
Research at the National Institute on Drug Abuse, which is the 
research institute at the National Institutes of Health 
responsible for supporting research in the health aspect of 
drug abuse and addiction.
    I will provide you with a brief overview of what science 
has shown concerning gamma hydroxy butyrate. Although GHB will 
be the main focus of my attention today, I will be happy to 
answer questions about Ketamine or Rohypnol or other drugs.
    As you heard from earlier panels, GHB is one of a number of 
drugs reportedly being used to sedate women to facilitate 
sexual assault. Many of the drugs discussed today, including 
GHB, are predominantly central nervous system depressants which 
relax or sedate the body.
    GHB is a naturally occurring compound which is found in the 
brain. Research suggests that GHB itself may act as a 
neurotransmitter. However, more research needs to be conducted 
to determine the true psychological function of GHB.
    The predominant effects of GHB are sedative, though GHB can 
produce a wide range of pharmacological effects, depending upon 
the dose. At lower doses, GHB can relieve anxiety and produce 
relaxation. However, as the dose increases, the sedative 
effects result in sleep, then seizures and eventually coma or 
death.
    Research also shows that GHB increases dopamine levels in 
the brain. This is relevant because we have come to believe 
that the ability to increase brain dopamine levels is a common 
characteristic of most drugs of abuse.
    GHB has also been found to stimulate the release of growth 
hormone. Plasma levels of growth hormone rise quickly and 
steadily after administration of GHB, which probably accounts 
for the popularity of GHB among body builders.
    The existing scientific data makes it difficult to 
determine with precision the abuse liability of GHB. Abuse 
liability is a composite term used to assess the likelihood of 
a drug's abuse potential through evaluation of its 
pharmacological and behavioral effects and review of its actual 
abuse and consequences.
    Animal studies suggest that GHB may be reinforcing. For 
example, when rats are given a choice between water and a 
solution containing GHB, they tend to prefer the GHB and appear 
to regulate their intake to maintain a constant GHB 
concentration in the body. Primate studies, however, are more 
ambiguous. Some primates will self administer GHB, but not all, 
and not to the same extent as other drugs such as heroin or 
cocaine.
    There have been very few clinical studies conducted on GHB 
abuse in humans. However, there have been reports that GHB 
causes both tolerance and dependence in human subjects. 
Research has shown that GHB's effects are usually seen ten to 
20 minutes from the time the drug is taken. The effects 
typically last up to 4 hours, depending on the dosage. Low 
doses can sedate an individual, whereas high doses can be 
lethal. The drug's relatively short half-life makes it 
difficult to detect in emergency rooms and other such 
facilities.
    GHB is relatively easy to make from common ingredients with 
recipes available on the Internet and in underground 
literature. The chief ingredient used to make GHB is gamma 
butyrolactone or GBL, which is converted by the body into GHB. 
GBL is used in a number of dietary supplements found in health 
food stores and health clubs.
    The fact that GHB is relatively easy to make may be one of 
the reasons why a number of monitoring mechanisms are 
suggesting that GHB use is increasing. For example, NIDA's own 
Community Epidemiology Work Group is seeing increases, 
particularly among young adults who attend raves or private 
clubs. Poison control centers have documented numerous cases of 
acute poisonings associated with GHB.
    According to the Drug Abuse Warning Network or DAWN, there 
has been a significant increase in the number of emergency room 
mentions associated with GHB. The number has grown from one in 
1991 to 629 in 1996. The DAWN medical examiner's report shows 
that there has been one GHB related death in combination with 
alcohol reported between 1992 and 1995. However, the Drug 
Enforcement Administration has documented 32 deaths associated 
with GHB, some of which were attributed to GHB alone.
    In conclusion, NIDA and the Department remain concerned 
about the harmful effects of GHB. Therefore, NIDA will continue 
to support research that examines the behavioral and 
pharmacological mechanisms of action and the relative abuse 
liability of drugs such as GHB.
    We will share this information, as well as information 
gleaned through our surveillance systems, with the general 
public and policymakers to insure that everyone has the most 
current and accurate information that science has to offer.
    Thank you again for the opportunity to testify.
    [The prepared statement of Stephen Zukin follows:]
Prepared Statement of Stephen Zukin, Director, Division of Clinical and 
     Services Research, National Institute on Drug Abuse, National 
                          Institutes of Health
    Mr. Chairman and Members of the Subcommittee, I am Dr. Stephen 
Zukin, Director of the Division of Clinical and Services Research at 
the National Institute on Drug Abuse (NIDA), one of the research 
institutes at the National Institutes of Health. I am here today with 
my colleagues to present what the science has come to show about drugs 
such as ketamine, rohypnol and gamma hydroxybutyrate (GHB), drugs that 
are reportedly being used in sexual assault incidents.
    Gamma hydroxybutyrate (GHB) is the drug that I will focus much of 
my discussion on today, though I will be pleased to answer questions 
about the other drugs as well. GHB is one of a number of drugs that 
have been reported to be used as a ``date rape'' drug. These drugs are 
predominantly central nervous system (CNS) depressants. Because these 
drugs are often colorless, tasteless and odorless, they can be easily 
added to beverages by individuals who want to intoxicate or sedate 
their victims.
    There is some evidence that GHB is a naturally occurring compound 
found in the brain. Research suggests that GHB itself may be a 
neurotransmitter. Brain receptor sites have been reported, as well as 
brain mechanisms for synthesis, release and uptake of GHB. GHB has been 
found to be related to the brain's major inhibitory neurotransmitter, 
GABA. There is also some evidence that the brain has the ability to 
convert GHB into GABA. However, more research needs to be conducted to 
determine the true physiological function of GHB.
    The predominant effects of GHB are sedative, though GHB can produce 
a wide range of pharmacological effects depending on the dose. At lower 
doses GHB can relieve anxiety and produce relaxation. However, as the 
dose increases, the sedative effects result in sleep and eventual coma 
or death.
    Research also shows that GHB increases dopamine levels in the 
striatum of the brain. Dopamine is a neurotransmitter that is 
intimately involved in reward and pleasure. We have come to believe 
that the ability to increase brain dopamine levels is a common 
characteristic of most drugs of abuse.
    GHB also stimulates the release of growth hormone from the anterior 
pituitary gland. Plasma levels of growth hormones rise quickly and 
steadily after administration of GHB, which probably accounts for the 
popularity of GHB among some bodybuilders.
    From the existing preclinical and clinical scientific data it is 
difficult to determine with precision the ``abuse liability'' of GHB. 
Abuse liability determinations, simply put, assess pharmacological and 
behavioral effects of drugs relative to known drugs of abuse, as well 
as their consequences. It is a way for scientists to assess the 
likelihood that a drug will be abused. Factors such as the reinforcing 
appetitive effects that the drug has on the individual, the possible 
physical dependence that may develop from using the drug, and the 
potential consequences associated with use of the drugs, are considered 
in the abuse liability determination.
    Animal research has confirmed that GHB is anxiety-reducing and 
sedating. Other animal studies suggest that GHB may be reinforcing in 
self-administration studies. For example, rats given a choice between 
water and a solution containing GHB prefer the GHB and appear to 
regulate their intake to maintain a constant GHB concentration in the 
body. Self-administration studies of GHB in primates are more 
equivocal, primarily because high dose evaluations are limited due to 
solubility difficulties and sedation of the animals. However, some 
primates will also self-administer GHB but not to the same extent as 
other drugs such as heroin or cocaine.
    There have been relatively few human or clinical studies conducted 
on GHB. Investigators report that some individuals experience pleasure 
after taking the drug. GHB's intoxicating effects are usually seen 10-
20 minutes from the time the drug is taken. The effects typically last 
up to four hours, depending on the dosage. The behavioral and 
physiological effects of GHB are dose dependent. Low doses can relax an 
individual, whereas high doses can be lethal. The drug has a relatively 
short half-life, making it difficult to detect in emergency rooms and 
other such facilities.
    Tolerance, and as I mentioned earlier physical dependence, are also 
factors used to determine a drug's abuse liability. Both tolerance to 
GHB's euphoric and sedative effects and physical dependence have been 
reported. These properties may contribute to continued abuse. Case 
studies describe the illicit purchase of GHB for abuse of its sedative, 
euphorigenic, and anabolic effects and also that some users tend to 
escalate doses. Physical dependence is evidenced by a withdrawal 
syndrome characterized by insomnia, muscle cramps, tremor and anxiety 
when GHB is discontinued. Various sources describe instances of dose 
escalation, compulsive use, unsuccessful efforts by individuals to 
decrease or discontinue use, drug-seeking, and continued use despite 
adverse consequences.
    The available data on the actual abuse of GHB and its associated 
consequences is largely anecdotal. GHB is usually abused either (1) for 
its intoxicating/sedative/euphoriant properties or (2) for its growth 
hormone releasing effects.
    GHB was widely available over the counter in health food stores 
during the 1980s, purchased largely by body builders for its ability to 
stimulate release of human growth hormone, which aids in fat reduction 
and muscle building. GHB has not been sold over-the-counter in the 
United States since 1992. However, products containing gamma 
butyrolactone (GBL), a chemical that is converted by the body into GHB, 
are used in a number of dietary supplements in health food stores and 
gymnasiums. GHB is still being marketed in Europe as a general 
anesthetic, a treatment for insomnia and narcolepsy, an aid to 
childbirth, and as a treatment for alcoholism.
    GHB is relatively easy to make from common ingredients with recipes 
available on the Internet and in underground literature. GHB is now a 
popular drug with the young adults who attend ``raves'' or private 
clubs. An advance report from NIDA's Community Epidemiology Work Group 
(CEWG), a network of epidemiologists and researchers from 21 major U.S. 
metropolitan areas who meet semiannually to monitor community-level 
trends in drug use and abuse, found that GHB was used at ``raves'' in 
Miami, Minneapolis/St. Paul and Seattle. Overall, of the 21 areas 
included in the CEWG Report, 10 areas reported increased incidences of 
GHB use.
    Poison Control Centers have documented numerous cases of acute 
poisonings associated with GHB. Initial symptoms of acute GHB toxicity 
include vomiting, drowsiness, dream-like state, decreased muscle tone, 
and vertigo. Loss of consciousness, irregular and depressed 
respiration, tremors, or myoclonus sometimes followed. Seizures, 
bradycardia, hypertension, and/or respiratory arrest have also been 
reported. Symptom severity and durations of action are dose dependent 
and also relate to the absence or presence of other CNS depressants.
    The only systematic reporting of harm associated with GHB abuse is 
the data from the Drug Abuse Warning Network (DAWN), which is a 
surveillance system run by our colleagues at the Substance Abuse and 
Mental Health Services Administration. The number of emergency room 
(ER) mentions associated with GHB has grown from one in 1991 to 629 in 
1996 for a total of 892 GHB-related ER mentions. Most of the reports 
involve white males. 95% of the patients are between the ages of 18-34. 
Most were using GHB to receive its pleasurable effects. GHB was abused 
most often in combination with other drugs, usually with alcohol, but 
also with stimulants, hallucinogens, marijuana, and sedatives. Most 
DAWN ER reports were from San Francisco, Dallas, Los Angeles, San 
Diego, and Atlanta.
    The DAWN Medical Examiners have reported one GHB-related death in 
combination with alcohol between 1992-1995, occurring in 1995 in the 
Midwest. However, the Drug Enforcement Agency (DEA) has documented 32 
deaths associated with GHB (4-attributed to GHB alone).
    Another drug that the Subcommittee asked us to address is ketamine. 
Ketamine is also reportedly being used as a ``date rape'' drug. 
Ketamine is a rapid-acting general anaesthetic. It has sedative-
hypnotic, analgesic, and hallucinogenic properties and is marketed in 
the United States and a number of foreign countries for use as a 
general anesthetic in both human and veterinary medical practice. 
Ketamine is similar to phencyclidine (PCP), although ketamine is more 
rapid in onset and less potent. We have quite a bit of information on 
this particular drug, which we would be happy to provide if that would 
be helpful to the members.
    Given that the Food and Drug Administration has included 
information on Rohypnol in their testimony, I will not address this 
drug in my formal statement. I will be happy to provide additional 
information if it would be useful.
The Role of the Department of Health and Human Services
    As the government's principal agency for protecting the health of 
all Americans, the Department of Health and Human Services is involved 
in making recommendations on domestic scheduling of drugs of abuse. 
Once the Attorney General initiates a scheduling proceeding, a request 
is made to the Secretary of HHS to provide a scientific and medical 
evaluation of the drug and a recommendation as to whether the drug 
should be controlled domestically. The Food and Drug Administration 
takes the lead role in gathering data from relevant HHS agencies.
    As the world's leading research institute on drug abuse and 
addiction, NIDA has a memorandum of understanding with FDA (Memorandum 
of Understanding With the National Institute on Drug Abuse and the FDA, 
March 3, 1985 (50 FR 9518)) to provide expertise to the FDA in 
investigating and evaluating the abuse liability of drugs.
    NIDA advises the FDA on the Department's ``Eight Factor Analysis.'' 
The factors taken into consideration in evaluations and recommendations 
for each substance under consideration include: Its actual or relative 
potential for abuse; Scientific evidence of its pharmacological 
effects; The state of current science regarding the substance; Its 
history and current pattern of abuse; The scope, duration and 
significance of abuse; What, if any risk there is to the public health; 
Its psychic or physiological dependence liability; Whether the 
substance is an immediate precursor of a substance already controlled.
Conclusion
    In conclusion, as a protector of the public's health, the 
Department realizes the harmful effects that drugs like GHB can have. 
That is why NIDA continues to support research on all drugs of abuse. 
In particular, NIDA will continue to support research that examines the 
behavioral and pharmacological mechanisms of action and relative abuse 
liability of drugs like GHB and Ketamine. We will share this 
information with our federal colleagues to ensure the best available 
science informs important decisions, such as scheduling, which impact 
the overall health of our Nation. We will also disseminate this 
information to the general public and policy makers to ensure that they 
also have the most current and accurate information about the effects 
of these drugs. Information that we retrieve through NIDA's drug 
monitoring mechanisms, particularly NIDA's Community Epidemiological 
Work Group (CEWG) will also be useful in alerting us to emerging drug 
problems. This information will also be shared as expeditiously as 
possible.
    Thank you for the opportunity to testify before this Subcommittee.

    Mr. Upton. We thank all of you for testifying.
    As you heard those buzzers, that means we are called again. 
We have a series of votes, two votes, and I think what we will 
do is reconvene at 1:30 p.m. Sorry about that. We will come 
back at 1:30 p.m.
    [Brief recess.]
    Mr. Upton. I do not think we will be interrupted again 
unless we go a long time. We have a couple hours before the 
next vote.
    We thank you for your testimony, and we will proceed with 
the 5 minute rule for the members that come back. Again, I 
apologize for the members that are not here as there are a 
number of subcommittee marks and hearings all over the place, 
so we will be having members come in and out.
    I guess, from my perspective when I first heard about the 
case in Michigan and asked myself and my staff what are we 
doing to prevent drugs like these from getting out particularly 
to young girls like we heard testify here. Ms. Pruett, was age 
15 when she was raped, as was another 15-year-old in Michigan.
    I noticed in some press clips from Michigan, I guess this 
was from the Detroit News, an Ecorse High School date rape 
fight goes to the schools. I talked to some of my 
superintendents in my district when I was back last week about 
it as well.
    The bottom line for me, and I am not a lawyer. I am not a 
scientist. I am not an engineer. I am not a lot of things, but 
I am interested in the bottom line. Whether it is a piece of 
legislation or whether it is an agency rule or regulation to 
try to restrict something. It seems to me to make sense that we 
ought to take it.
    As I heard the testimony from the first two panels, 
including Ms. Sheila Jackson-Lee, who, like me, was impacted by 
a death of a young woman in her district and as I talked to 
other members who have had the same type of experience in their 
States and as we assembled this panel, I just want to know what 
else is there that we need to know about this, to know that 
this is a bad drug, that it ought to be banned somehow, some 
way?
    As I listen to the testimony of you four, and I have read 
it at length as well, I end up with that same question. I just 
wonder. Is there any more evidence that we need to submit? I 
guess I am going to make a little bit of a rambling statement, 
but then I would like you all to comment.
    As I read, Dr. Reuter, your testimony where it says on page 
6 that on average DHHS completes its response to a scheduling 
request within eight to 10 months, and I read the testimony 
from the DEA and others, Dr. Zukin's folks as well, that the 
request had been I think originally to schedule this, you know, 
somewhere along the line I, II, even III or IV, even as early 
as September 1997. If you add it up, that is what, 18 or 20 
months. I mean, we are twice as long as what the average 
timeframe is.
    Is there something else that we need? Do we need to proceed 
with legislation to get the job done? Can we do this 
administratively so we do not need that, though certainly I am 
prepared to speak and encourage my colleagues to co-sponsor 
such legislation and begin to move it through the process and 
see where we are in the Senate, as well as where we are in the 
House? What else do we need to do?
    Maybe, Mr. Woodworth, if you want to comment on that and 
Dr. Zukin? I do not know if there is any more evidence. Then, 
Mr. Reuter, maybe you can respond. Has all your evidence been 
submitted? Have you been asked for anything else to provide?
    Mr. Woodworth. The normal process is that once we have done 
our piece, we forward it to the Secretary of Health. Once it is 
returned, then we will complete some further analysis because 
we continue to collect data during the interim, so we are 
continuing to collect data with regard to GHB.
    Mr. Upton. Okay. So the ball is not in your court is what 
you are saying at the moment?
    Mr. Woodworth. At this time.
    Mr. Upton. Okay. Dr. Zukin?
    Mr. Zukin. Well, I think----
    Mr. Upton. If you could use the mike?
    Mr. Zukin. Yes.
    Mr. Upton. I can hear okay, but I am not sure everybody 
else can. It is for the stenographer here, too.
    Mr. Zukin. Under our memorandum of understanding with FDA, 
FDA does take the lead, as indicated in their testimony. 
Perhaps Mr. Reuter could also respond.
    In other words, when FDA forwards a copy of their final 
recommendation to us, at that point we officially become 
involved in the process in terms of whether we concur with the 
FDA recommendation or not and so forth.
    Of course, there has been extensive staff discussion 
between NIDA and FDA through this process, but we have not yet 
seen their final recommendation.
    Mr. Upton. Mr. Reuter?
    Mr. Reuter. Yes. You talked a little bit about the language 
in the written testimony about the length of time, eight to 10 
months, ten to 12 months. It might be good to understand a 
little bit about why sometimes----
    Mr. Upton. Sorry. You are not saved by the bell this time. 
You have to finish.
    Mr. Reuter. [continuing] in carrying out these scientific 
and medical evaluations under the CSA, which is the law that 
controls us here, how sometimes it is difficult to find the 
appropriate level of control for a substance.
    What is it about GHB? First of all, it is a drug that is 
under development for medical use and, you know, that balancing 
act they talked about a little bit this morning, the medical 
need versus the need to protect the public from these 
substances that pose a danger.
    It is easily manufactured clandestinely with ingredients 
that have extensive industrial uses, which presents a bit of a 
complication. There is a specific subculture that appears to 
abuse these drugs more than one other group, and there is a 
sense that scheduling itself might not solve the problem.
    I mean, with Rohypnol we had an interagency effort with 
Customs, with DEA, with FDA. There were States involved. All 
these things taken together call out for an expansive, 
coordinated Federal role.
    I would say that we take this problem very seriously. We 
are moving to expedite the review within HHS for the scheduling 
recommendation on this substance.
    Mr. Upton. Just a last quick question, and then I will 
yield to Mr. Stupak.
    As we were over on the floor today on these last votes, one 
of our first questions any member asks is what time are we 
going to be done today. Are we going to be done by 7 p.m.? Are 
we going to be done by 10 p.m.? Are we going to be in tomorrow 
with votes? When do we get to go back?
    Do you have a sense as to when a final recommendation is 
going to be made? Is it going to be made in the spring? Is it 
going to be made, you know, at Easter? Is there some sense in 
terms of when the timing is in terms of a final decision being 
made in terms of Schedule I, II, III or IV? Next year?
    I am a Cubs fan. You know, we all say next year, although I 
hope it will be this year.
    Mr. Reuter. I am an Oriole fan, and we are looking at the 
year after.
    We are actively working on the recommendation, and I can 
tell you that it will be soon. It will be forwarded very soon.
    Mr. Upton. But you cannot be better? You know, if we ask 
when are we going to out of session, soon, that is not good 
enough. Do we know? Spring? Fall? Do you have any better sense 
of----
    Mr. Reuter. I wish I could. It is still under very active 
deliberation, and it really would be premature and 
inappropriate to pick a specific date or even a general date.
    I guess it would surprise me if it went past next year. I 
mean, at the outset that would be well beyond the pale. It is 
under active investigation. We are taking it very, very 
seriously.
    Mr. Upton. So you would not mind then if the Congress moved 
ahead with a piece of legislation then? You would not object to 
us moving ahead with legislation along the lines of Ms. Sheila 
Jackson-Lee or Bart Stupak, my colleague, or other folks?
    Mr. Reuter. I think along with all the other panelists 
here, we are looking for ways to optimize the process. DEA had 
some language in their testimony about what might be an 
appropriate way to expedite control.
    We participated in a technical assistance endeavor last 
fall. You know we are committed. We are willing. We are ready 
to work with the committee to move this along.
    Mr. Upton. Mr. Stupak?
    Mr. Stupak. Thank you, Mr. Chairman.
    Have you looked at any of the legislation, either my 
legislation or the Jackson-Lee legislation, from a technical 
point of view, Mr. Reuter, to suggest if it could be approved 
or it should be approved?
    Mr. Reuter. We have not carefully studied it. It has not 
been submitted for formal review. You know, just in glancing at 
it in the package this morning, you can see differences.
    Mr. Stupak. Sure.
    Mr. Reuter. We have recommended Ketamine for Schedule III, 
but legislation appears to place it in a different schedule. 
No, we do not have formal views to offer on it at this time.
    Mr. Stupak. My concern is it has been a long time. If I am 
reading your testimony correct, it says since it was 
established in 1992, FDA's Office of Criminal Investigations 
has tried to take aggressive enforcement actions against the 
manufacture and interstate distribution of GHB. That is found 
on page 10 of your statement.
    It is now 1999. This is just going on and on and on, and I 
can understand some frustration with FDA and others. Why is it 
taking so long to do this?
    You know, this first came to my attention in 1996, early 
1997. We put some bills in to try to address it. When we did 
the Families First Juvenile Justice bill we tacked it in there. 
Then we did a freestanding bill because it is a very pressing 
problem. I am just concerned that we continue to push back that 
time line. Nothing is being done.
    When can we expect some action? Fred was being polite. Soon 
is not a good enough answer.
    Mr. Reuter. Unfortunately, that is the best answer I can 
give, Mr. Stupak.
    I tried to explain a little bit about the balancing we need 
to do and the weighing of factors and how GHB presents these 
kind of unique situations on a case by case basis that we have 
to take into consideration.
    Mr. Stupak. But it seems we have been balancing since 1992. 
Can we get some commitment to get technical assistance on any 
type of legislation then that we would propose?
    Mr. Reuter. Yes. I think I mentioned earlier that we are 
ready to work with Congress to move this along as best we can. 
We provided technical assistance on legislative matters in the 
past, and we are willing to work with you to move it along.
    Mr. Stupak. Okay. Let me go to some other questions.
    In the 20 or 21 States that have GHB, how do they have it 
scheduled, Schedule I, Schedule II, Schedule III or Schedule IV 
or V? Do you know?
    Mr. Reuter. Well----
    Mr. Stupak. Does anyone know, any one of you? Mr. 
Woodworth?
    Mr. Woodworth. There are 20 States, I believe, as far as 
DEA information, that control GHB.
    Mr. Stupak. Right.
    Mr. Woodworth. Twelve States control it in Schedule I, 
including Michigan.
    Mr. Stupak. Right.
    Mr. Woodworth. If you would like the names of those, I can 
give them to you.
    Five States control GHB in Schedule II, no one schedules it 
in III, and three States, Alaska, North Carolina and Tennessee, 
have put it in Schedule IV. Three other States, Texas, New 
Jersey and Massachusetts, have criminalized activity.
    Mr. Stupak. Thank you. So only three States have 
criminalized it?
    Mr. Woodworth. Yes, sir.
    Mr. Stupak. Okay. Go ahead.
    Mr. Woodworth. Three States have criminalized without 
putting it under schedule.
    Mr. Stupak. Right.
    Mr. Reuter, I want to go back to where we were a little bit 
more about the time line that has been taken. Let me ask you 
this question.
    If these States have already scheduled Ketamine and GHB 
into various schedules, do you know how the States have been 
able to move so quickly on this? Why have the States been able 
to move quicker, and we have not been able to make any solid 
recommendations here?
    Mr. Reuter. Well, in referring to my written testimony in 
this case and a little bit of the oral testimony as well, I 
think we explained that our Office of Criminal Investigations 
has been active in assisting the States, usually through their 
legislative process, in adding Ketamine to the various 
schedules of control available within their State offices.
    There is a sense, I do not know precisely how many, but I 
think there is a sense that many of the States have gone 
through a legislative procedure to effect control.
    Mr. Stupak. So if the feds did it legislatively, that is 
fine too then? I mean, if the States can do it, we should be 
able to take a lead and put it underneath one schedule so we 
all know what schedule we are dealing with at least.
    Mr. Reuter. Yes. I think in some of the testimony we even 
cite some cases where legislative scheduling has been 
accomplished with anabolic steroids and I also believe----
    Mr. Stupak. Right.
    Mr. Reuter. [continuing] with Methaqualone.
    Mr. Stupak. My 5 minutes are up. Thanks.
    Mr. Whitfield [presiding]. Thank you.
    Mr. Bryant?
    Mr. Bryant. Thank you, Mr. Chairman.
    Ms. Maher, let me ask you a question. You may not have the 
answer to this. Someone else may, but I want to ask this, and I 
have several other questions I would like to follow with, so if 
you could keep your answer as concise as possible that would be 
great.
    I ask you this because you are from the Department of 
Justice. Again, you may know this, and you may not. Do 
hospitals and law enforcement personnel have the resources to 
adequately test for the presence of these date rape drugs in 
the blood system?
    Ms. Maher. I am not sure I am the person to ask on that. My 
understanding is that they do not have, you know, all the tests 
that might be helpful in testing for these, but I would defer 
to others in answering that question.
    Mr. Bryant. Okay. I have been in and out of the committee 
in other committees, so I have missed some of I guess the 
middle panel, which would probably have been the better one to 
ask this to, but I understood there was a concern about the 
inability in the testing to pick this up after the fact. Okay. 
Maybe I can submit that to the other panel.
    I also am very concerned about the length of time, the 
delay involved at least on the administrative side of 
reclassifying this drug. Mr. Reuter, going back to Mr. Upton's 
question about the average time, the FDA's role in this is 
typically eight to 10 months and this is going on I think 
longer, and not just the FDA, but perhaps DEA to some extent 
and Human Services to some extent.
    This just does not seem to be a priority in terms of the 
issues that we have heard from the first two panels, the 
concerns that are out there. Tell me I am wrong.
    Mr. Reuter. This is a very high priority. This is a very 
serious matter to the Food and Drug Administration, and we have 
been actively reviewing this. We have been actively gathering 
more information to aid in our assessment on GHB. While we have 
been doing that, we have been pursuing enforcement actions 
under the Federal Food, Drug and Cosmetic Act.
    I talked a little bit about our Office of Criminal 
Investigation activities. It is one of the highest priorities 
within our Office of Criminal Investigation, so indeed we do 
place a very high priority on this.
    Mr. Bryant. This decision by the FDA, is the paperwork not 
in the Office of the Commissioner right now to make a decision? 
My understanding is it has been there since early January of 
this year, and I am wondering why are we still here in March 
waiting for a decision?
    Mr. Reuter. Well, I will go back and say we are very 
actively reviewing this. It is an interagency review and 
recommendation process. The ultimate decision on this is by the 
Assistant Secretary for Health, as delegated under the CSA.
    Mr. Bryant. Well, again my understanding is that the DEA 
had made a request of the FDA in September 1998 for a 
scientific determination on scheduling GHB, and the Division 
had made a recommendation for Schedule III, which now resides 
in the Commissioner's office. This is as of January 14, 1999. 
Is it still in the Commissioner's office?
    Mr. Reuter. It is still in the review process within the 
Department of Health and Human Services.
    A recommendation is not a recommendation until it really 
leaves the Department of Health and Human Services. It is 
probably not beneficial to split it out where it is in the 
process because sometimes it could be in the Commissioner's 
office, and my experience is it can go back for more thorough 
review and rewriting. So, when it leaves the Department of 
Health and Human Services, my experience is that is when the 
recommendation is complete.
    Mr. Bryant. Mr. Woodworth?
    Mr. Woodworth. You asked also with DEA if it was a 
priority, and I just wanted to tell you that it was an 
extremely important priority.
    Of the three drugs that we are discussing today, the other 
two are made by legitimate manufacturers. Even though 
Flunitrazepam is not available for use in the United States, it 
is made by a pharmaceutical company.
    GHB is not. It is of clandestine manufacture. That is what 
is found here in the United States. It is made by criminals. 
They make it mixing an industrial solvent with a drain cleaner.
    Mr. Bryant. Is that against the law now?
    Mr. Woodworth. Not federally.
    Mr. Bryant. Okay. Just real quick, Mr. Reuter, if you would 
give us a report, an answer? Could you tell me at least and 
perhaps the committee precisely if the Commissioner has this 
recommendation, exactly where it is in the FDA?
    I understand that, you know, it can mean a lot of different 
things, but really what we are looking for is just where it is 
in the FDA in the process. You can do that after the hearing. 
You can just submit a letter or something.
    Mr. Reuter. Thanks. I prefer to do that.
    Mr. Bryant. Thank you.
    Mr. Whitfield. Thank you, Mr. Bryant.
    Since I have not asked any questions, I think I will take 
the prerogative as the chairman and ask some questions myself, 
giving me 5 minutes. Thank you.
    Ms. Maher, I notice you are with the Civil Division at the 
Department of Justice. Maybe you are not the appropriate person 
to ask these questions to, but when Representative Lee was 
testifying she talked about the importance of an education 
program to make young people more aware of the dangers out 
there related to these types of drugs.
    We were talking to her about funds available for 
educational purposes as it relates to drug education, and she 
mentioned that in the community relations department of the 
Department of Justice that there was money available. Do you 
know if that is the case?
    Ms. Maher. I do not know specifically what she was 
referring to.
    Mr. Whitfield. Are you aware of any pool of money at the 
Department of Justice that can be used for educational 
purposes?
    Ms. Maher. I am just not aware of that.
    Mr. Whitfield. Okay. Is there any money over at FDA for 
something like that or any of the other agencies represented 
here today?
    [No response.]
    Mr. Whitfield. We will talk about that later.
    Mr. Reuter. I would just say that I would be glad to check 
and respond to that in writing.
    Mr. Whitfield. You all are not really aware of any then. 
Okay.
    I also asked Representative Lee about what States already 
have laws on the books relating to possession of GHB, and she 
said two States, California and Pennsylvania. Someone mentioned 
today that there are 18 States that already have this drug 
classified as a Schedule I, II or III. Is that correct?
    Mr. Woodworth. Twenty. Correct.
    Mr. Whitfield. Twenty. Okay. When we say classified as 
Schedule I, II or IV, does that mean that it is a felony? 
Schedule I, II and IV, are those felonies or misdemeanors or a 
combination thereof?
    Mr. Woodworth. I would imagine it is a combination. Each 
State is different, and I am unable to answer that other than 
to speculate that possession would be covered by the States 
that have it under control.
    Mr. Whitfield. Okay. So there are more States than just two 
that are dealing with this presently then, this issue?
    Mr. Woodworth. Yes, sir.
    Mr. Whitfield. Okay. The States of Texas, New Jersey and 
Massachusetts were specifically mentioned. Who mentioned those 
States?
    Mr. Woodworth. I did.
    Mr. Whitfield. What did you say about this?
    Mr. Woodworth. They had criminalized the activity involving 
GHB without placing it under a specific schedule.
    Mr. Whitfield. Okay. So it is not under a schedule, but it 
is criminalized.
    Does the Department of Justice have an official position on 
whether or not GHB should be placed on schedule?
    Ms. Maher. When we were asked to testify, we had understood 
that the committee was seeking our testimony on the experience 
of the Office of Consumer Litigation in prosecuting cases under 
the Federal Food, Drug and Cosmetic Act.
    Since we learned earlier this week that the committee would 
like a position from the Department as a whole, we have 
commenced the process to seek input from other components other 
than our office that would have views on that, and we can 
provide that to the committee.
    Mr. Whitfield. Okay. Okay. We would look forward to 
receiving that then.
    I think that is all the questions that I have. Are there 
any other questions for this panel?
    Mr. Stupak. Yes, Mr. Chairman.
    What are the views then? What have you learned?
    Ms. Maher. We have only begun this 2 days ago. We have 
begun the process of seeking input from other components that 
are interested, and we will provide that to the committee, but 
I am not prepared to do that today.
    Mr. Stupak. Would it help or hurt to?
    Ms. Maher. Well, from a law enforcement perspective, 
scheduling a drug will always provide additional tools to 
prosecutors, but we understand that there are other 
considerations in scheduling a drug other than simply the law 
enforcement considerations so----
    Mr. Stupak. Sure.
    Ms. Maher. [continuing] from a law enforcement perspective 
it would certainly help.
    Mr. Stupak. Before you schedule a drug, you have to be 
concerned about what schedule or what class you put it in, I, 
II, III, IV, V, or liability reasons if there is a drug 
manufacturer out there or someone else who wants to use the 
drug for legitimate purposes because if it is not properly 
classified you are subject to civil litigation. Is that 
correct?
    Ms. Maher. I do not----
    Mr. Stupak. Maybe FDA can answer that.
    Mr. Reuter. Yes.
    Mr. Stupak. I mean, you just cannot willy nilly put one of 
these drugs in Schedule I, II, III, IV, V. There are 
consequences if it is illegally classified. I do not want to 
say illegally. Improperly classified, correct? It has to stand 
up in Court subject to judicial review, subject to lawsuits, 
correct?
    Mr. Reuter. Yes.
    Mr. Woodworth. I would just----
    Mr. Stupak. Yes. Go ahead.
    Mr. Woodworth. [continuing] respond to that. For a 
controlled substance, the Drug Enforcement Administration has 
the final responsibility for defending the Federal decision on 
a scheduling action.
    Regardless of the schedule, it is possible to conduct an 
activity to develop a drug. For example, if a drug is in 
Schedule I, we do have a registration category for a 
researcher, so research and development of the drug can 
continue while it is placed under control.
    Mr. Stupak. If the Congress passes a piece of legislation 
that made GHB Schedule III, that would be Congress' statement 
and, therefore, you would be not subject to these liability or 
legal challenges? Is that correct?
    Mr. Woodworth. I have maybe a three part response to that--
--
    Mr. Stupak. Sure.
    Mr. Woodworth. [continuing] if I might. Absolutely. 
Congress can do that without regard to the criteria under 21 
USC 812.
    If Congress did so, I would suggest perhaps that a couple 
of other things would apply. Schedule III would not include GBL 
as an analog.
    Mr. Stupak. Correct.
    Mr. Woodworth. It would have to be in Schedule I or II. 
Schedule III, of course, has a connotation of legitimate 
medical use, and GHB does not have legitimate medical use.
    Schedule III has a connotation of a lower level of abuse 
than I and II, which DEA does not feel applies to GHB. We feel 
that abuse is very high, if not severe, so there are some other 
considerations that we would make.
    Mr. Stupak. Sure. Go ahead.
    Mr. Whitfield. I thought of a couple more questions.
    Ms. Maher, do you have any idea when the Justice Department 
might complete its study?
    Ms. Maher. I guess I should not say soon, right? We can get 
a view to the committee promptly, within I would imagine the 
next several weeks.
    Mr. Whitfield. The next several weeks. Okay. Good.
    One other question for Mr. Woodworth. Does DEA have a 
position on whether GBL meets the definition of an analog to 
GHB?
    Mr. Woodworth. We do, and it is in several pieces.
    Mr. Whitfield. Okay.
    Mr. Woodworth. First of all, GBL could not be considered as 
an analog unless GHB is controlled----
    Mr. Whitfield. Okay.
    Mr. Woodworth. [continuing] in Schedule I or II only. If it 
is scheduled in III, IV, V, it cannot be considered as an 
analog.
    Mr. Whitfield. Okay.
    Mr. Woodworth. If GHB is scheduled in I or II, GBL would be 
considered an analog if it met the definition of an analog, 
which is to have a similar chemical structure to drugs in 
Schedule I and II, has a stimulant, depressant or 
hallucinogenic effect similar to drugs in Schedule I or II, or 
has been represented to do so and is intended for human 
consumption. That is a very important piece there.
    What the analog provision does is it criminalizes the 
illegal activity outside of the investigational new drug 
process where development can continue. The only activity that 
is criminalized is that illegal activity, but it must be 
intended for human consumption.
    This has to be proven in Court. There is not a list of 
analogs. You would testify at Court that this met the 
definition for an analog and was intended for human use.
    I would point out one small possible difficulty with that 
is that that would address GBL as a drug, not as a chemical, so 
if GBL is----
    Mr. Whitfield. Correct.
    Mr. Woodworth. [continuing] given and represented to be for 
human consumption, then it is covered. If GBL is just sold to 
someone, there is not a further representation, then it would 
not be considered as an analog.
    Therefore, DEA would recommend that it be considered as a 
listed chemical also covered under the Controlled Substances 
Act as a List I chemical, and certain measures could be taken 
to accommodate the industry, which has been very cooperative.
    You may be aware that we have published a notice in the 
Federal Register in October soliciting comments about GBL, and 
the industry has been very cooperative and told us what their 
concerns and needs are. That would be a possibility.
    Mr. Whitfield. Okay.
    Mr. Woodworth. I hope that answers your question.
    Mr. Stupak. Mr. Chairman, may I?
    As a listed chemical, that means tracking then, right, who 
sold that chemical? We have some track as to the means and 
where it went----
    Mr. Woodworth. Absolutely.
    Mr. Stupak. [continuing] and the amount, basically what our 
legislation addresses?
    Mr. Woodworth. Yes, sir.
    Mr. Whitfield. You all are a popular panel.
    Mr. Bryant?
    Mr. Bryant. We just do not want you to go. Mr. Woodworth, 
do I understand you to say that it would be DEA's position that 
GHB ought to be scheduled as a Schedule I or II, as opposed to 
III or IV, were Congress to act?
    Mr. Woodworth. Yes, sir.
    Mr. Bryant. And that GBL, the DEA's position would be that 
preferably that it be scheduled itself on the CSA as a Schedule 
I?
    Mr. Woodworth. No, sir.
    Mr. Bryant. No. As a chemical?
    Mr. Woodworth. As a chemical. As a List I chemical, not as 
a drug. That would cover the chemical aspects, and then the 
analog provision would apply and address its use as a drug if 
it is represented for human consumption.
    Mr. Whitfield. Okay. We are going to have one more question 
from Mr. Stupak, and then that is it.
    Mr. Stupak. Thanks, Mr. Chairman.
    I would just like to ask each on this panel has industry 
been cooperative in your efforts and research and trying to 
track and things like this, GBL especially?
    Mr. Woodworth. With regard to GBL, the industry has been 
extremely cooperative, yes.
    Mr. Stupak. We have mentioned about four different drugs 
here or byproducts. Has industry not been cooperative on any of 
them, Ketamine or GHB or any of the others? Well, GHB is an 
illegal drug, but Ketamine or the----
    Mr. Woodworth. No. Not from DEA's point of view, no.
    Mr. Stupak. Okay. Ms. Maher?
    Ms. Maher. We would not really have occasion to seek 
cooperation from industry.
    Mr. Stupak. Mr. Reuter or Mr. Zukin?
    Mr. Reuter. They have been cooperative, as far as I know.
    Mr. Stupak. Okay.
    Mr. Zukin. NIDA has not dealt directly with industry on 
this matter.
    Mr. Whitfield. Okay. I want to thank----
    Mr. Stupak. Just one follow up.
    Mr. Woodworth, if you listed GBL, would it put any burden 
on industry? Can they live with it?
    Mr. Woodworth. We would design it with their comments in 
mind----
    Mr. Stupak. Sure.
    Mr. Woodworth. [continuing] where there would be specific 
exemptions to prevent sale to consumers, for example.
    Most of the activity is very large quantities of GBL. There 
are tens of thousands of tons produced in the United States. 
What people need for GHB production is a very small quantity. 
That is what we would focus on. We would craft our regulation 
to do exactly that.
    Mr. Stupak. Sure. You just would not allow it to show up at 
Post Office Box 143 up in Menominee, Michigan.
    Mr. Woodworth. Right. Yes, sir.
    Mr. Whitfield. I want to thank this panel for your 
patience. We really appreciate your testimony. We look forward 
to hearing from you and working with you on this important 
issue. Thank you.
    Now at this time we will call Ms. Patti Engel, who has also 
been very patient. We apologize that she has had to wait so 
long.
    Mr. Upton. Ms. Engel, welcome to the subcommittee.
    Ms. Engel. Thank you.
    Mr. Upton. As you have heard undoubtedly the other 
panelists, do you have any objection to swearing under oath, 
and do you have a counsel that you need to have?
    Ms. Engel. No.
    Mr. Upton. Terrific.
    [Witness sworn.]
    Mr. Upton. Thank you very much. I recognize you for 5 
minutes. Your whole statement will be made as part of the 
record.
    Ms. Engel. Thank you.
    Mr. Upton. We appreciate you having the indulgence to stay 
with us most of the day.

         TESTIMONY OF PATTI ENGEL, ORPHAN MEDICAL, INC.

    Ms. Engel. Mr. Chairman and members of the committee, my 
name is Patti Engel, and I work for Orphan Medical, a very 
small company in Minnesota that specializes in developing 
medications for people who suffer from rare diseases, life 
threatening rare diseases that most people have never even 
heard of.
    Mr. Chairman, before I begin my comments, I want to respond 
to two comments that were previously made. First, I want to 
state unequivocally that Orphan Medical does not believe that 
scheduling GHB as a Schedule III will magically somehow produce 
an FDA approval. We know that the data in our NDA will be the 
basis for approval; nothing less.
    Second, I want to assure you that Orphan Medical does 
indeed understand how this drug affects the human brain in 
patients with narcolepsy.
    I would like to say at the outset that Orphan Medical 
agrees with this subcommittee and others that the use of GHB or 
any other chemical to commit a crime, especially a rape, is 
unconscionable, and they must be severely punished. We know, 
too, that home-brewed GHB is dangerous.
    We agree that the illicit use of GHB must be stopped, but 
we also believe that dealing with complex issues that can at 
one time save lives and other times hurt them is complex and 
should be looked at from various perspectives. We appreciate 
the opportunity to share this perspective with you.
    Orphan Medical first learned about GHB in 1994. At that 
time, the FDA did something that it does not often do. The FDA 
Office of Orphan Products asked us to develop this drug to 
treat the disabling symptoms of narcolepsy called cataplexy. 
The FDA believed GHB was a promising medication, but had been 
unable for 20 years to generate any commercial interest in this 
agent. Because orphan drugs are our business, we accepted this 
challenge.
    While the daytime sleepiness component of narcolepsy is 
treated with a number of medications, including a newly 
approved medication called Modafanil, there is virtually 
nothing that works for cataplexy, the condition that GHB 
treats. For many years, doctors have treated cataplexy with 
anti-depressants. Unfortunately, these medications do not 
really treat the disease itself and thus are not truly 
effective.
    About 10 years ago, FDA learned that GHB could treat 
cataplexy in a very different way. The drug appears to induce a 
restful sleep that people with narcolepsy do not typically 
experience. It promotes REM or rapid eye movement sleep, 
thereby reducing cataplexy attacks.
    About 5 years ago, after Orphan Medical was contacted by 
FDA about developing this medication, I myself had the chance 
to visit sleep centers and talk to patients who had used this 
experimental agent in clinical trials. I spoke firsthand to 
patients who told me that GHB had changed their lives. The use 
of GHB had reduced cataplexy attacks in some patients from 50 a 
day to two a month. It enabled patients to work, to go to 
school, to live normal lives.
    Frankly, these testimonials sounded too good to be true, 
and we were skeptical and knew that we had to put this drug to 
scientifically rigorous tests to validate or to disprove the 
claims of the patients and the researchers with whom we talked.
    In 1998, under FDA's guidance, we initiated rigorous, well-
controlled clinical trials at sleep centers in 14 States to 
study the use of GHB. The FDA considered our findings of GHB 
safety and efficacy for controlling the symptoms of narcolepsy 
to be significant and asked us to conduct a treatment IND to 
increase patient access to this promising new medication.
    The data collected under the treatment IND will be added to 
the years of evidence we have already collected and will be 
used in our NDA. We expect to submit our NDA later this year or 
early next.
    During the time that we have been developing GHB as a 
treatment for cataplexy, concern about its illicit use has 
grown, but it is very important to note that no medical grade 
GHB has ever been diverted for illicit use despite its use in 
clinical trials in 14 States.
    We share the concern for public safety that has been 
eloquently described today, and over the past 3 years we have 
worked with FDA, DEA and Members of Congress to find an 
appropriate way to control this illegal use.
    Our goal and message have been consistent. Severely punish 
those who illegally manufacture, distribute or possess GHB and 
its analogs. Severely punish sexual predators who would use 
this and any chemical to commit assaults, but do so without 
denying narcolepsy patients access to the only medication that 
will treat their cataplexy.
    We suggested to various Members of Congress that one 
solution to this extremely serious problem is to amend the CSA 
to list GHB as a Schedule IV controlled substance, but to 
punish anyone who manufactures, distributes or possesses GHB or 
its analogs with Schedule I penalties.
    It is important to recognize that the chemical precursor, 
GBL, needs to be considered. Today, GBL, as you have heard, is 
used legally by manufacturers of paints, beer and electronics, 
but there is absolutely no reason for any individual to possess 
GBL.
    You have heard this morning about the problems associated 
with GBL, which is called scoop. GBL will not be stopped by 
making GHB a Schedule I. Some have suggested that the solution 
to this problem is to take action at a national level, and we 
agree wholeheartedly.
    We believe that the proposal to solve this terrible problem 
by listing GHB as a Schedule I or controlled substance would in 
fact have dire consequences for patients with narcolepsy, 
whether the scheduling is done during research or after the 
drug is approved by FDA, and let me explain.
    The fact that Schedule I drugs can be used in research, 
while technically accurate, does not respond to the real world 
difficulties of working with such a product. Research studies 
can only be done if a company can manufacture the drug or find 
a manufacturer willing to make it and if doctors are willing to 
participate in the clinical trials.
    If GHB were put as a Schedule I, the company which 
currently manufactures the pharmaceutical grade GHB for the 
clinical trials will cease production. We have also been told 
that sleep centers now participating in the clinical trials 
would not participate if GHB were a Schedule I substance.
    While theoretically we could find another manufacturer, we 
have been unable to locate someone willing to do so to date 
because of the very limited commercial potential of this agent.
    Even if GHB were listed as a Schedule II agent, a 20,000-
square-foot vault made of 8-inch thick concrete walls would be 
required. At an estimated $20 million, that would more than 
double the cost of developing this agent, which is an agent 
used for a very rare disease. We would be forced to tell FDA to 
find another company willing to develop this drug, and the 
patients who need this for narcolepsy would be forced to wait 
many more years.
    We hope that you will agree that the medical grade GHB 
should be listed as a Schedule III or IV and that criminals who 
use this and other chemicals to perpetrate crime should be 
penalized.
    Mr. Stupak's bill and, as we have heard this morning, Ms. 
Jackson-Lee's proposed amendments to her bills are approaches 
that strike the right balance between punishing wrongdoers and 
preserving patient access to crucial medicines.
    I also want to mention that statements are attached to my 
testimony from the American Sleep Disorder Association, from 
the National Association for Rare Diseases and the National 
Sleep Foundation, and I respectfully request that these 
statements be included in the hearing record along with my full 
written statement.
    Thank you for the opportunity to testify.
    [The prepared statement of Patti Engel follows:]
Prepared Statement of Patti Engel, Vice President, Orphan Medical, Inc.
    Mr. Chairman and Members of the Committee, my name is Patti Engel. 
I work for Orphan Medical, a very small company in Minnesota that 
specializes in developing medicines for people who suffer from rare 
diseases--life-threatening rare diseases that most people have never 
heard of.
    One such disease is Congenital Sucrase-Isomaltase Deficiency. This 
is a genetic disorder that leaves children unable to digest common 
table sugar and some starches, leading to malnutrition and 
developmental delays. Another orphan disease for which we have 
developed a drug is Homocystinuria, which affects children by making 
them unable to metabolize homocystine. This condition leads to mental 
retardation, blindness, and death.
    Both of these conditions affect fewer than 1,000 children in the 
US. The medicines we've developed help people with these orphan 
conditions and others live more normal lives.
    Currently, Orphan Medical is working to complete the studies needed 
for approval of a New Drug Application (NDA) for the drug 
gammahydroxybutyrate (GHB) to treat the most severe form of narcolepsy.
    I'd like to say at the outset that Orphan Medical agrees with this 
Subcommittee and others that use of GHB or any other chemical or drug 
to commit a crime--especially a rape--is unconscionable and must be 
severely punished. We know too that ``home-brewed'' GHB is dangerous. 
We agree that illicit use of GHB must be stopped. But we also believe 
that dealing with a substance that can at once save lives and hurt them 
is complex and should be looked at from various perspectives. We 
appreciate the opportunity to share our perspective with you.
    Orphan Medical first learned about GHB in 1994. The FDA Office of 
Orphan Products asked us to develop this drug to treat the disabling 
effects of narcolepsy. The FDA believed GHB was a promising therapy, 
but had been unable for 20 years to generate any commercial interest in 
the drug. Because orphan drugs are our business, we accepted this 
challenge.
    Narcolepsy is a rare, disabling sleep disorder that affects about 
180,000 Americans. Many think of narcolepsy as a disease that causes 
people to fall asleep at inappropriate times, but actually it is much 
more serious than that. About 65% of narcolepsy patients experience a 
symptom of the disease called cataplexy--sudden and total loss of 
muscle control. A total cataplectic attack results in immediate, 
complete body collapse. This can happen anywhere or at any time, no 
matter what a person is doing--walking, driving, swimming, or holding a 
baby. During these attacks the patient appears unconscious; in reality, 
however, the person is quite alert and awake, but unable to talk, move, 
or even remove himself or herself from a potentially dangerous 
situation. Cataplexy is often triggered by stress, fatigue, or 
emotional reactions such as laughter, fear, surprise, or sadness.
    Because of the unpredictability and frequency of attacks, people 
with cataplexy are unable to live normal lives. They often can't work 
outside the home or drive a car. They can't go to a movie, mow the 
lawn, or hold a baby.
    While the daytime sleepiness component of narcolepsy is treated 
with a number of medications, including a newly approved medication 
called Modafanil, there is virtually nothing that works for cataplexy. 
For many years, doctors have treated cataplexy with antidepressants in 
an effort to ``flatten'' the emotional outbursts which can lead to an 
attack. Unfortunately, these medicines do not really treat the disease 
itself and thus are not truly effective. Furthermore, antidepressants 
often have undesirable side effects, not to mention that patients are 
unable to experience fully the emotions that you and I associate with 
normal life.
    About 10 years ago, the FDA learned that GHB could treat cataplexy 
in a different way. This drug appears to induce a restful sleep that 
people with narcolepsy don't ordinarily experience. It promotes REM, or 
rapid eye movement sleep, thereby reducing cataplexy attacks.
    Early on, FDA approached some drug companies about developing GHB 
as an orphan drug, and several actually started development. However, 
as they ran into challenges, each of these companies abandoned the 
project, in part because the very limited commercial market potential 
made this an unfavorable investment of research funds.
    About 5 years ago, after Orphan Medical was contacted by FDA about 
developing GHB, I had the chance to visit some sleep centers where the 
drug was being used as an experimental treatment for narcolepsy 
patients. I spoke first-hand to patients, who told me that GHB had 
changed their lives. Use of GHB reduced cataplexy attacks in some 
patients from 50 a day to 2 a month. It enabled patients to work, go to 
school, live a normal life.
    Frankly, these testimonials sounded too good to be true. We were 
skeptical and knew we had to put this drug to a scientifically rigorous 
test to validate or disprove the claims of the patients and the 
researchers with whom we had talked.
    In 1998, with FDA's guidance, we initiated rigorous, well 
controlled clinical trials at sleep centers in 14 states to study the 
use of GHB as a treatment for narcolepsy. In August 1998 we presented 
the clinical findings from this study to FDA.
    The FDA considered our findings of GHB safety and efficacy for 
controlling the symptoms of narcolepsy to be so significant that they 
asked us to conduct a ``treatment IND,'' to increase patient access to 
this promising new drug. It is important to note that a treatment IND 
is a mechanism to make available to patients, outside of clinical 
trials, promising therapies for serious and life-threatening diseases 
for which there are no satisfactory alternative treatments. In the 
past, drugs for cancer, AIDS, severe Parkinson's' Disease, multiple 
sclerosis, respiratory distress syndrome in infants, and diabetes have 
been made available under treatment INDs. Now, narcolepsy patients also 
will benefit from this.
    The data collected under the treatment IND will be added to the 
years of evidence we've already collected, and will be used in our NDA. 
We expect to submit our NDA later this year or early next year.
    During the time that we've been developing GHB for the treatment of 
narcolepsy, concern about its illicit use has grown. As you already 
have heard, information about how to make and use GHB is readily 
available on the Internet. Its chemical precursor, gammabutyrolactone 
(GBL), is readily available and can be obtained easily. Anyone with a 
computer, credit card, and the inclination to surf the Net can find the 
recipe, buy the ingredients, and make a batch of ``home-brewed'' GHB. 
Because the material is home-brewed, the levels of toxicity vary 
dramatically, a capful of one batch may be as toxic as a cup of 
another.
    It is very important to note that no medical grade GHB has ever 
been diverted for illicit use, despite its use in clinical trials in 14 
states.
    The ``reputation'' of GHB and its easy manufacture have caused 
tremendous problems for law enforcement. We share the concern for 
public safety that has been so eloquently described this morning. Over 
the past three years, we have worked with FDA, DEA, and members of 
Congress to find an appropriate way to control the illegal use of GHB.
    Our goal and message have been consistent: Severely punish those 
who illegally manufacture, distribute, or possess GHB or its analogs. 
Severely punish sexual predators who would use this chemical to commit 
an assault. But do so without denying narcolepsy patients access to the 
only medication which will treat their cataplexy.
    We have suggested to various members of Congress that one solution 
to this extremely serious problem is to amend the Controlled Substances 
Act to list GHB as a Schedule IV controlled substance, but to punish 
anyone who manufactures, distributes, or possesses GHB or its analogs 
with Schedule I penalties. That is, on conviction of these illegal 
acts, a person would be subject to imprisonment of up to 15 years and a 
fine of up to $250,000.
    Mr. Chairman, we maintain that such Schedule I level penalties are 
at the heart of the issue. As the recent tragedy in Michigan has shown, 
simply having a substance on Schedule I is not a deterrent. But knowing 
that you are going to get 15 years in prison and a quarter-million-
dollar fine is.
    A similar approach was taken in the 1996 Date Rape Act, supported 
by both Republicans and Democrats. This Act effectively adds 10 years 
to the rape conviction of anyone who used any substance to facilitate a 
sexual assault.
    Mr. Chairman and members of the committee, it is also important to 
recognize that the chemical precursor of GHB, GBL, and chemical analogs 
of GHB also need to be considered. Today, GBL is used legally and 
appropriately by manufacturers of paints, beer, and electronics. One 
key to stemming the illicit manufacture of GHB is to criminalize the 
illegal use and possession of GBL. There is absolutely no reason for 
any individual to possess GBL. If an individual, as opposed to a 
legitimate manufacturer, has GBL, it is for one reason, and that is to 
make GHB, or to use it as if it were GHB.
    GBL is the necessary ingredient in making GHB. As I mentioned 
earlier, GBL is easy to find and purchase. Nearly 100% pure GBL can be 
purchased off the Internet for as little as $35. Or, if a person is 
looking to run a major GBL trafficking operation, the chemical can be 
obtained in bulk with little if any screening of the purchaser. As a 
test, last summer we contacted four reputable chemical suppliers. We 
used a false company name, a false phone number, and a credit card. Two 
of these suppliers quickly offered to set up an account for us to 
obtain GBL in huge quantities.
    Florida authorities tell us that last year illicit manufacturers of 
GHB learned they did not have to bother going to the trouble of brewing 
GHB. They discovered that GBL is naturally converted in the body to 
GHB. Now, they are just selling caps full of diluted GBL. They call it 
``Scoop.'' A small bottle of GBL can be diluted to make 50 doses of 
``Scoop.'' At about $20 per dose, that's a lot of money for the dealer. 
A sexual predator could use the GBL in a small bottle to help him 
commit as many as 15 sexual assaults.
    In Florida, GHB abuse is dropping as GBL abuse is increasing. 
Florida law enforcement officials tell us that the demographics of 
abusers have changed, and that while GHB abuse was occurring among 20-
30 year olds, GBL abuse is occurring among 15-20 year olds. This is an 
outrage. Making GHB a Schedule I agent will do nothing to prevent this. 
Florida has responded to this problem by modifying its statutes and 
including GBL as a controlled substance.
    Some have suggested that the solution to this problem is to take 
action at the national level. We agree wholeheartedly. However, we 
believe the proposal to solve this terrible problem by listing GHB as a 
Schedule I or II controlled substance would have dire consequences for 
patients with rare diseases, whether that scheduling is done during the 
research or after the drug is approved by FDA. Let me explain what I 
mean.
    The fact that Schedule I drugs can be used in research, while 
technically accurate, does not respond to the real-world difficulties 
of working with such a product. Research studies can only be done if a 
company can manufacture the drug or find a manufacturer willing to make 
it, and doctors are willing to participate in trials which use a 
Schedule I drug. If GHB were listed as a Schedule I substance, the 
company which currently manufactures pharmaceutical grade GHB for our 
clinical trials would cease production. We also have been told that 
sleep centers now participating in our clinical studies in at least 
some cases would not participate if GHB were a Schedule I substance.
    While theoretically we could find another manufacturer, we have 
been unable to date to locate one willing to manufacture a product of 
such low volume and potential profitability, even if the drug is not a 
controlled substance. This difficulty would be exacerbated if we were 
seeking a manufacturer to make a Schedule I substance. The reason for 
this is the enormous investment a manufacturer would have to make, for 
the small financial return of an orphan drug.
    Even if GHB were listed as a Schedule II agent, a 20,000 square 
foot vault (the size of a small airplane hangar) with 8-inch concrete 
walls would be required to store the pharmaceutical-grade GHB. The cost 
of construction, estimated at $20 million, would more than double the 
costs of developing this drug. The economic disincentive alone would 
result in a discontinuation of the clinical trials, the NDA process, 
and the hopes of narcoleptic patients with cataplexy. We would be 
forced to tell FDA to find another company willing to develop this 
medication for this rare disease. The history of GHB tells us that 
narcolepsy patients would have to wait many more years for GHB to be 
available to them.
    We hope you will agree that medical grade GHB should be listed as a 
Schedule III or IV drug and that criminals who use this or other 
chemicals to perpetrate crimes should be severely penalized.
    I want to thank you for the opportunity to testify and would be 
happy to answer any questions.
                                 ______
                                 
                  American Sleep Disorders Association
                 the use of ghb in treating narcolepsy
            position statement & recommendations of the asda
Rationale
    The following position statement was commissioned by the American 
Sleep Disorders Association (ASDA) Board of Directors and provides a 
review of the evidence on gamma-hydroxybutyrate (GHB) as well as 
recommendations for its classification schedule. The report focuses on 
proven scientific and therapeutic uses of GHB; potential for abuse; and 
how GHB might best be classified if it becomes a controlled substance. 
The best, published evidence from peer-reviewed, scientific journals 
about GHB was considered and primary observations other than reviews, 
editorials, letters, or reports in newspapers and magazines were 
concentrated on.
Proven Therapeutic Use Of GHB In Narcolepsy
    Several independent investigators have reported beneficial effects 
in narcolepsy with GHB but only 2 double-blind studies have been 
published (Scrima et al, 1989 and 1990; Lammers et al., 1993). The 
first was performed by Scrima (1989 and 1990) in 20 patients using 50 
mg/kg/night. A significant decrease in cataplexy was observed but no 
significant effects on daytime sleep attacks were reported when 
compared to placebo. The second study was performed by Lammers (1993). 
Twenty-four patients received GHB, 60 mg/kg/night. Hypnagogic 
hallucinations and daytime sleep attacks decreased significantly. 
Cataplexy was also reduced by 50 percent, but the effect was not 
significantly different from placebo due to large inter-individual 
variation. In both studies, sleepiness as measured using MSLT sleep 
latencies was only slightly affected (maximum difference in mean sleep 
latency: 1 minute).
    Based on these two reports, there is little doubt that the drug is 
helpful to narcoleptic patients. Several other independent 
investigators have confirmed the findings in open labeled studies 
(Broughton and Mamelak, 1979; Mamelak et at., 1986). The most 
consistent and least controversial effects are improved cataplexy and 
improved nocturnal sleep disruption with GHB treatment (Scrima et al., 
1990; Broughton and Mamelak, 1980: Bedard et al., 1990). Further 
investigations would be needed to confirm a possible beneficial effect 
for daytime sleepiness.
    Importantly, GHB anti-cataplectic effects are clearly mediated by a 
different mode of action when compared to those produced by 
antidepressant compounds. As such, patients who do not tolerate 
classical antidepressant treatment because of side effects, tolerance 
or contraindications would not have any other choice if GHB were not 
available to them.
Therapeutic Use Of GHB In Other Medical Disorders
    Besides its demonstrated efficacy in narcolepsy, GHB has proved 
useful when evaluated in controlled trials for anesthesia (Kleinschmidt 
et al., 1997; Kleinschmidt et al., 1998) and for treatment of 
withdrawal syndromes (Gallimberti ct al., 1989; Gallimberti et al., 
1992; Gallimberti et al., 1993).
Use Of GHB In Basic Neuroscience Research
    GHB is a unique tool in neuroscience research. Maitre (1997) just 
reviewed the neurobiology of GHB. The compound is a natural metabolite 
of GABA; it is synthesized and accumulated in neurons in the brain. 
Investigators have shown that GHB behaves as a genuine CNS 
neurotransmitter distinct from GABA. GHB receptors have been identified 
and a pharmacological antagonist of the compound (NCS-382) has been 
synthesized. The most established pharmacological effect of the 
compound is to dramatically decrease the firing rate of 
mesocorticolimbic dopaminergic neurons in the brain while activating 
dopamine synthesis. This effect produces an acute increase in dopamine 
stores. Higher doses are also believed to activate GABA-B receptors.
    One of the most interesting properties of the compound is its 
ability to increase both REM and Slow Wave Sleep (SWS). Almost all 
other hypnotic compounds available to us suppress REM and SWS, thus GHB 
produces a more ``natural'' sleep architecture. This difference in 
profile has been established in several animal species including 
humans. It is also clear that not only the hypnotic profile of GHB but 
also its mode of action is distinct from all other commonly prescribed 
hypnotic compounds. No other known compound has the paradoxical effect 
on dopaminergic transmission described above. As such, it is not only 
an interesting compound but research in the area may lead to the 
discovery of novel hypnotics that may have clinical application far 
beyond narcolepsy.
Prevalence And Severity Of GHB Abuse
    GHB, also known as sodium oxybate, is a naturally-occurring fatty 
acid derivative that is neuroactive and has abuse potential. GHB has 
powerful depressant effects on the central nervous system and has been 
used as an anaesthetic, however in lower doses it can produce a state 
of euphoria which has led to popular recreational use (Li et al, 1998). 
Also, GHB has been used by bodybuilders because of its anabolic 
effects. Physical dependence can occur. In addition, prolonged abuse 
may result in seizures and withdrawal symptoms. The withdrawal syndrome 
includes insomnia, anxiety and tremor that usually resolves in 3-12 
days.
    GHB has been referred to as a ``date rape'' drug when combined with 
flunitrazepam, because of the tendency to induce initial euphoria and 
subsequent CNS depression. Excessive intake of GHB has led to serious 
sequelae including respiratory arrest and death.
    Typically, profound unconsciousness occurs in severe GHB toxicity, 
and despite full (and often rapid) recovery, most patients require 
medical intervention, including intubation and mechanical ventilation. 
Interestingly, GHB has hypoxia-sparing effects that may aid the total 
recovery seen in the majority of cases of severe toxicity. The adverse 
effects are more serious when GHB is used with other illicit drugs and 
alcohol (Ryan et al., 1997). Of the 10 deaths reported with GHB all 
have been associated with the use of mixed drugs (Li J, personal 
communication). However, in lower doses, the drug has been used to aid 
withdrawal from opiate and alcohol addiction. GHB has led to abstinence 
of alcohol in 78% of 179 alcohol dependent subjects (Addorato et al., 
1996).
    Although available since 1990, the current prevalence of GHB use is 
not known, however it is believed that it is relatively low compared 
with cocaine and marijuana. In 1995-1996, poison control centers in New 
York and Texas reported 69 acute poisonings and one death attributed to 
GHB (JAMA, 1997).
    Since the recent widespread publicity about GHB there have been 
numerous sources of information available on how to make GHB, 
particularly on the internet. GHB can be easily synthesized from 
Lactone (ganuna hydroxybutyral lactone), also a potent euphoric drug 
that is inexpensive and occasionally sold as GHB. Lactone is widely 
used and available in industry with little prospects of regulation of 
its availability. Two states have made GHB a schedule I drug, and 20 
states have made it a misdemeanor or felony to distribute GHB (Li J, 
personal communication). Most states have legislation pending.
Recommendations Of The ASDA
    GHB has demonstrated therapeutic usefulness in narcolepsy, cardiac 
anesthesia, and withdrawal syndromes. GHB abuse is a problem, but there 
is no documented evidence that supplies of GHB from the medical and 
scientific community have been diverted for illegal uses. 
Classification of GHB as a Schedule I drug is likely to impede further 
research into clinical and scientific applications of GHB. The ASDA 
opposes a Schedule I classification of GHB.

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    Li J, Stokes SA, Woeckener A. A tale of novel intoxication: a 
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    Maitre M. The Gamma-Hydroxybutyrate signalling system in brain: 
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    Mamelak M, Scharf M, Woods M. treatment of narcolepsy with 
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effectiveness of gammahydroxybutyrate in patients with narcolepsy. J. 
Clin Psychiatry 1985;46:222-225.

    Mr. Upton. Without objection. We again appreciate you 
waiting this long during the day to come before us.
    I do not really have a question. I have a comment, and that 
is I sense that we are all on the same page. I do not know the 
best way to do it, but from Fred Upton speaking I want to see 
this stuff stopped from getting into our kids' systems. I want 
to do it in a way that it is not going to trigger or see it 
trigger some precursor or some analog which is going to come 
about, whether it be GBL or some further hybrid later on.
    As I begin to scratch the surface on this, I do not know 
whether it is better to have a Schedule I, II, III or IV with 
appropriate penalties, but I think based on what I heard you 
just say as part of your testimony is that from industry's 
perspective, at least yours, you would like to see it at least 
Schedule IV, if not Schedule III--I understand your concerns 
with Schedule II--with some type of penalty along the lines 
that we have seen in either Ms. Sheila Jackson-Lee's bill or my 
colleague Bart Stupak's bill with the penalties so that you 
cannot move to that second or third or fourth step where we 
heard so much testimony particularly from the States.
    Actually, one of the questions I wanted to ask Panel 2, and 
I think it stemmed from Mr. Dingell's question. We do not 
really have a kit to even decipher where we can find it, and it 
is because it is odorless. It is tasteless. It is easily passed 
off as water.
    If we get the appropriate stop gates to prevent it, it 
seems to me that at least your industry, and probably other 
industry folks, would be happy. Is that correct?
    Ms. Engel. That is correct, Mr. Chairman.
    I would like to add that Orphan Medical has in fact a 
validated assay for GHB and is very willing and has shared its 
willingness with law enforcement and whatnot as to working 
together to be able to help come to solutions to these 
challenging problems.
    While we are a small company and, unlike what you heard 
earlier, we are, frankly, not profitable----
    Mr. Upton. I know Minnetonka. I do not think there is 
anything big in Minnetonka.
    Ms. Engel. We are not able to do that ourselves, but we 
would welcome the opportunity to work with law enforcement to 
assist them with the already in hand knowledge that we have 
about this compound and about its assay methodology.
    Mr. Upton. Thank you.
    Mr. Stupak?
    Mr. Stupak. Thank you.
    Ms. Engel, I take it then you could support our bill, which 
would place this GHB as a Schedule III with Schedule I 
penalties?
    Ms. Engel. Yes, we would support that bill, especially 
given the penalties as Level I for the possession, distribution 
and manufacture of not only GHB, but all of its precursor 
chemicals and analogs.
    Mr. Stupak. So the tracking of----
    Ms. Engel. Exactly.
    Mr. Stupak. There is no problem then with the chemical 
with----
    Ms. Engel. No.
    Mr. Stupak. [continuing] your use?
    Ms. Engel. No. As I mentioned earlier, the GBL is widely 
used in much commercial manufacture.
    Mr. Stupak. Right.
    Ms. Engel. Paints, beers, plastics components. These 
manufacturers are quite accustomed to dealing with regulated 
chemicals.
    Mr. Stupak. Tell me a little bit more about your testing 
that you think may be of some help to law enforcement to do a 
test kit, an on the road test kit.
    Ms. Engel. Currently in our clinical trials, we assay the 
patient's blood for the presence of GHB. I am not a scientist 
by training so I do not want to mis-speak, but I believe the 
test is a GC mass methodology.
    Mr. Stupak. So you would have to draw blood?
    Ms. Engel. Yes.
    Mr. Stupak. So then we are back to the idea of search 
warrants.
    Ms. Engel. What we learned from Dr. Ward Donovan just a few 
days ago, who runs the Poison Control Center at Penn State-
Geisinger in Pennsylvania, is that it is not impossible by any 
means to do GHB levels.
    It is very common, however, that the typical emergency room 
screening that is used when a patient is admitted----
    Mr. Stupak. Sure.
    Ms. Engel. [continuing] does not include that, so unless a 
physician is aware of GHB and GBL and knows to ask for a GHB 
screening, it does not happen, but those tests are available.
    Mr. Stupak. But that would be more emergency room setting, 
right?
    Ms. Engel. That is exactly right. As----
    Mr. Stupak. Does it become--I am sorry.
    Ms. Engel. I am sorry. I was going to mention as I 
mentioned, we would be willing to work with whatever agencies 
would be willing to assist us in the development of forensic 
testing, would that be possible.
    Mr. Stupak. Having been in law enforcement, you try to do 
it in the field. We usually have a kit, and we put a drop of 
this or a drop of that and see what kind of color it turns, 
which would indicate, not conclusively conclude, that a drug 
may be present in this substance.
    With the vials and little containers that Ms. Porrata had 
earlier, that is what law enforcement is running into, and they 
need some kind of field test to see if GHB or whatever is 
present in those substances.
    Ms. Engel. Yes.
    Mr. Stupak. I have no further questions, Mr. Chairman.
    Mr. Upton. Mr. Whitfield?
    Mr. Whitfield. I just have one question, Mr. Chairman.
    If you placed GBL into a Schedule III, which Mr. Stupak's 
bill does, I believe----
    Mr. Upton. GHB or GBL?
    Mr. Whitfield. I think it is GHB. GHB into Schedule III, 
which you recommend, it is my understanding that there are like 
17 or 18 different analogs out there and that in doing that you 
are not able to take care of the other analogs or cover those. 
How would you respond to that?
    Ms. Engel. Well, what I can tell you is that in the State 
of Florida they have utilized legislative language that deals 
with gamma hydroxy butyric acid. It is esters, it is ethers, it 
is salts and any isomers of esters, ethers or isomers.
    They believe there that no matter how you do this language, 
you are going to have some very bright bathtub chemist within a 
few years find a loophole, so in Florida what they have 
attempted to do is make the legislative language so very broad 
that any creative chemist would not find a loophole around it. 
We would support that same approach.
    By utilizing the scheduling process and to put GHB in a 
gross schedule of a I suggesting no appropriate medical use or 
a Schedule II or the easy fix, if you will, of being able to 
deal with its analogs, we appreciate that that may be easy for 
law enforcement, but, unfortunately, this is not an easy 
problem.
    There are patients out there with a condition called 
cataplexy who have no other options, and we believe that a 
complex situation like this will and does require some complex 
thought and thus have supported very strongly Mr. Stupak's bill 
and these more encompassing languages.
    Mr. Whitfield. I yield to Mr. Stupak.
    Mr. Stupak. My legislation does that with the ethers, the 
salts and all that, but how is it working in Florida? Is it 
working?
    Ms. Engel. The language there was only recently passed. 
From what we hear from law enforcement there is that they are 
now able to go after the GBL issue, so, you know, that is what 
I know today.
    Mr. Stupak. Has any derivative drug developed from it?
    Ms. Engel. Not that we know of.
    Mr. Stupak. Thanks.
    Mr. Whitfield. I yield back the balance of my time. Thank 
you.
    Ms. Engel. Thank you.
    Mr. Upton. Again, I appreciate your testimony and all those 
folks that came and were with us for the day.
    I think we have outlined a very serious trouble that really 
does need some action. I certainly am prepared to work with my 
colleagues to address this situation so that it no longer could 
remain as a nightmare for parents across the country.
    Thank you very much. This hearing is adjourned.
    [Whereupon, at 2:25 p.m. the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]
Prepared Statement of Abbey S. Meyers, President, National Organization 
                           for Rare Disorder
    Mr. Chairman and Members of the Subcommittee: as many on this 
Committee already know, the National Organization for Rare Disorders 
(NORD) represents patients and families of patients with rare, or 
orphan, diseases and disorders. For most of these people, there is no 
therapy or treatment; for many, treatments are offered that are costly 
and ineffective. Orphan conditions are often life-threatening, 
frequently disabling, and always physically and psychologically 
debilitating.
    NORD's interest in the controlled substance scheduling of the drug 
product gamma-hydroxybutyrate (GHB) relates to our concerns about the 
impacts on current research, on the future availability of this drug 
for patients with cataplexy, the most severe and debilitating form of 
narcolepsy, and on the future of orphan drug research in general.
    If GHB is placed on Schedule I or II, current research almost 
certainly will stop because of the prohibitive cost of meeting security 
and control requirements for the manufacture and distribution of the 
drug for research use.
    If the clinical research is not completed, no New Drug Application 
will be filed with FDA and no safe and effective drug will be available 
to patients. We are thus depriving very ill people of their best chance 
to live normal lives despite the presence in their lives of an 
incurable illness.
    Finally, a decision to place GHB on Schedule I has the very real 
potential to disrupt the system that has led to progress in the 
development of orphan drugs. The reason GHB is under development today 
is that a small company, Orphan Medical, responded to FDA's request to 
develop the product for the treatment of cataplexy. If we are to hope 
for similar success in the future, we must not send a message that if 
you agree to take a financial risk and begin development of an orphan 
product, the government might later throw you a curve that will prevent 
you from ever completing your work.
    NORD's roots are with patients and families who worked together for 
the enactment of the Orphan Drug Act of 1983, which provides modest 
financial incentives to encourage companies to invest in the research 
and development of drugs for small patient populations--drugs for which 
there are small markets and small potential profitability. In the years 
before the Orphan Drug Act was signed into law, fewer than ten orphan 
drugs were developed. Now, there are more than 850 designated orphan 
drugs; 170 have been approved by FDA. For many patients NORD 
represents, this is miraculous progress. But we are not at the end of 
the road. Our objective is a solution for every patient and every 
family. This is a long course which only can be finished step by step. 
We can reach the finish line if the hurdles along the way are 
manageable--but not if they are insurmountable.
    We are convinced that scheduling GHB as a Schedule I or II 
controlled substance would be such an insurmountable obstacle.
    it is important to keep in mind that the patient population for GHB 
is extremely small. This drug is not the same as one FDA recently 
approved, and it is not intended for the same narcolepsy patients. GHB 
currently is being studied in a subset of narcolepsy patients, and it 
is for this subset that the drug will be indicated. These are 
narcolepsy patients who suffer from cataplexy, the most severe form of 
narcolepsy. Patients with cataplexy literally can become unconscious 
and fall to the floor as a result of an emotional reaction such as 
laughter or anger, or when they become excited; during sleep, they 
become paralyzed as though in a coma. This means the market for the 
drug is very limited, and the ability of a company to make a return on 
its research investment is extraordinarily limited. If the cost of that 
research were more than doubled, as it would be if the company had to 
meet the requirements for making a Schedule I controlled substance, the 
possibility of a profit virtually could disappear--as would the 
possibility that the drug, once marketed, could be priced so that 
cataplexy patients could afford it.
    In carrying out its responsibilities under the Orphan Drug Act, 
FDA's Office of Orphan Product Development works hard to identify 
promising drugs and companies willing to develop them. With GHB, FDA 
not only recognized the promise of the drug but also provided funding, 
through an Orphan Drug Research Grant, for the first U.S. clinical 
trial of the drug. Then, the office took steps to find someone willing 
to do the work necessary to get this drug approved. They found one and 
only one company.
    Early on, FDA recognized the abuse potential of this chemical, and 
took steps to try to prevent its being sold through various 
nontraditional channels. In doing this, FDA also knew that the only 
option for patients was to get an approved prescription drug on the 
market as soon as possible. Orphan Medical, a small company in 
Minnesota dedicated to the development of orphan drugs, has brought the 
research on GHB close to completion, and there is a strong likelihood 
that an approved product will be available to patients in the fairly 
near future. To take an action now that would impede this process would 
be a tragic mistake not only for patients whose lives depend on this 
drug, but for the signal such an action would send to other companies. 
If other drug companies see that FDA can encourage them to develop an 
orphan drug but the government can come along at any later point and 
place the substantial research investment of the company in jeopardy, 
this would spell disaster for future orphan drug development.
    It has been suggested that the pharmaceutical industry is big 
business and if one company won't develop a drug, another company will, 
or if one drug can't be developed, another can that will serve the same 
purpose. For orphan drugs, this is simply not the reality. For patients 
with orphan diseases, it is a virtual wonder when a single therapy is 
developed. For these patients, choice among drugs is never an option; 
for them, it is only a choice of one thing or nothing. For this very 
small market, and for these often extremely complicated conditions, it 
simply is not the case that drug companies are competing to put 
multiple products on the market. For patients with cataplexy, GHB is 
their only hope. For the development of GHB, Orphan Medical is our only 
hope. Making GHB a Schedule I or II controlled substance destroys that 
hope.
    We agree with those who say this drug should be controlled. We know 
it has been abused, and that abuse cannot go unchecked or unpunished. 
We are aware that GHB has been implicated in the heinous crime of rape. 
Those who have committed that crime, possibly using GHB or its 
precursor chemical Gamma-butyrolactone (GBL) as an agent, must receive 
the strongest possible punishment. Severe penalties should also be 
imposed on individuals who possess GHB for no reason other than to use 
it improperly and illegally. This can be done without placing the drug 
under Schedule I and thus jeopardizing cataplexy patients. Controlling 
GHB under Schedule III or IV, but providing the authority to the 
Department of Justice to levy the maximum penalty for abusing the 
drug--the same penalty as for a Schedule I drug provides a deterrent 
against criminal use and gives law enforcement officers the ability 
both to punish wrongdoers severely.
    But probably the most significant action that could be taken right 
now would be to get control of the Internet and get the formula for GHB 
off of the World Wide Web! In none of the crimes involving GHB or GBL 
has the medical version of GHB been used. In every case, either GBL has 
been purchased and used in a crime or amateurs have purchased the raw 
ingredient and made GHB themselves. This is NOT diversion of the drug 
GHB. It is diversion of the raw ingredient and illegal ``manufacture'' 
of GHB.
    As we have done so often in the past, we are ready and willing to 
work with this Subcommittee, the Health and Environment Subcommittee, 
and the full Commerce Committee to try to solve this problem. We will 
happily provide you with any additional information you may need 
regarding orphan diseases, the Orphan Drug Act, or the importance of 
GHB for patients with cataplexy. We urge you to remember that some 
well-intentioned actions, which may seem to be helping some people, 
have unintended consequences of harming others. Placing GHB on Schedule 
I or II would be such an action. Thank you for the opportunity to 
present our views.
                                 ______
                                 
              Department of Health & Human Services
                               Food and Drug Administration
                                                     April 27, 1999
The Honorable Fred Upton
Chairman
Subcommittee on Oversight and Investigations
Committee on Commerce
House of Representatives
Washington, D.C. 20515
    Dear Mr. Chairman: This letter is to provide responses of the Food 
and Drug Administration (FDA or Agency) to two questions posed at the 
March 11, 1999 hearing on ``date rape'' drugs. FDA's witness at the 
hearing, Mr. Nicholas Reuter, Associate Director for Domestic and 
International Drug Control, Office of Health Affairs, had agreed to 
provide responses to these questions for the record.
    The first question, posed by Representative Ed Bryant, was to 
ascertain the status of Agency review of the recommendation for 
scheduling gamma hydroxybutyrate (GHB) under the Controlled Substances 
Act.
    Jane E. Henney, M.D., Commissioner of Food and Drugs decided in 
late March what FDA's proposal for a scheduling recommendation by the 
Department of Health and Human Services (DHHS) will be. At this time, 
the Agency is finalizing the documentation in support of the 
Commissioner's decision. This proposal has been shared with the 
National Institute of Drug Abuse for review and comment. We expect the 
proposed recommendation to be forwarded to the Assistant Secretary for 
Health, DHHS, early next month.
    The second question, posed by Representative Ed Whitfield, was 
whether a pool of money is available at FDA to fund efforts to educate 
young people about the dangers of drugs used in sexual assaults.
    FDA does not have such a fund. Nothing in our Congressional 
appropriation is specified for education on drugs of abuse. FDA, 
however, does undertake educational efforts on using prescription drugs 
in a safe manner and we do pursue public education efforts to alert 
consumers to dangerous drugs or substances that are being promoted 
either as health aids or for recreational use. As an example of these 
efforts, enclosed are two FDA Talk Papers, alerting the public to the 
dangers of GHB and of gamma butyrolactone (GBL), a GHB analogue.
    We hope this information is helpful to the Subcommittee. If we can 
be of further assistance, please let us know.
            Sincerely,
                                        Melinda K. Plaisier
             Interim Associate Commissioner for Legislative Affairs
2 Enclosures

cc: The Honorable Thomas J. Bliley, Jr.
   Chairman, Committee on Commerce

   The Honorable John D. Dingell
   Ranking Minority Member
   Committee on Commerce

   The Honorable Ron Klink
   Ranking Minority Member
   Subcommittee on Oversight and Investigations
   Committee on Commerce
                                 ______
                                 
                             FDA TALK PAPER
FDA Warns About Products Containing Gamma Butyrolactone or GBL and Asks 
                      Companies to Issue a Recall
    The Food and Drug Administration is alerting consumers not to 
purchase or consume products, some of which are labeled as dietary 
supplements, that contain gamma butyrolactone (abbreviated as GBL). FDA 
has also asked the companies that manufacture these products to 
voluntarily recall them. The agency has received reports of serious 
health problems--some that are potentially life-threatening--associated 
with the use of these products.
    Although labeled as dietary supplements, these products are 
illegally marketed unapproved new drugs. Products containing GBL are 
marketed under various brand names including Renewtrient, Revivarant or 
Revivarant G, Blue Nitro or Blue Nitro Vitality, GH Revitalizer, Gamma 
G, and Reinforce. They are promoted with claims to build muscles, 
improve physical performance, enhance sex, reduce stress and induce 
sleds.
    GBL is also known by the chemical names 2(3H)-furanone dihydro; 
butyrolactone; gamma-butyrolactone; 4-butyrolactone; dihydro-2(3H)-
furanone; 4-butanolide-2(3H)-furanone, dihydro; tetrahydro-2-furanone; 
and butyrolactone gamma.
    GBL related products have been associated with reports of at least 
55 adverse health effects, including one death. In 19 of those cases, 
the consumers became unconscious or comatose and several required 
intubation for assisted breathing. Other reported effects included 
seizures, vomiting, slow breathing, and slow heart rate. There are 
reports of at least 5 children under 18 years of age who have been 
injured or who have suffered these kinds of effects.
    When taken orally, GBL is converted in the body to gamma 
hydroxybutyrate or GHB. GHB is a very potent unapproved drug. It is 
currently being investigated under the supervision of doctors for the 
treatment of narcolepsy. Because of its serious side effects, GHB 
should not be taken unless in the context of these FDA approved 
investigations. FDA and the Justice Department have ongoing criminal 
enforcement actions against GHB. GBL should not be taken.
    Products containing GBL are sold in liquid and powder form. They 
are sold via the Internet, in some health food stores, and in some 
gymnasiums and fitness centers.
    Consumers are advised to dispose of any products of this type in 
their possession. If they have experienced adverse health problems from 
use of these products, they should promptly contact a physician. FDA 
requests consumers and physicians to report adverse events to FDAs 
MEDWATCH 1-800-332-1088.
    The Trimfast Group, Inc. has agreed to recall the product 
Revivarant, 32 ounces of liquid in a plastic bottle, and Revivarant G, 
200 grams of powder in a pill bottle. Other companies manufacturing 
products containing GBL are being asked by the FDA to voluntarily 
recall them.
    FDA is considering all potential regulatory actions at its disposal 
if products containing GBL are not recalled. The agency will act 
expeditiously to protect the public health.
                                 ______
                                 
                             FDA TALK PAPER
                      FDA Re-Issues Warning on GHB
    In recent months there has been a resurgence of media and public 
interest in the use of gamma hydroxybutyric acid (GHB) for body 
building and ``recreational'' uses. Despite renewed claims that it is 
legal, GHB continues to be an unapproved and potentially dangerous drug 
and cannot be legally marketed in the U.S. Therefore, FDA is renewing 
its warning against the use of this product. The following can be used 
to answer questions:
    GHB is a chemical that has been promoted as a steroid alternative 
for body building and other uses for several years. Recently it has 
gained favor as a recreational drug because of its intoxicating 
effects. Although in the past GHB has undergone clinical testing for 
several indications, it has never been approved for sale as a medical 
product in this country.
    Starting in 1990, FDA began an intense investigation of GHB 
distribution after numerous cases of GHB-related illness were reported. 
Reported symptoms have included vomiting, dizziness, tremors and 
seizures. Many of those injured required hospitalization, and some 
deaths have been linked to the consumption of GHB products.
    By the end of 1991, FDA and the Department of Justice had taken 
enforcement action against several firms and individuals involved in 
manufacturing, distributing and promoting GHB. The agency also 
instituted an automatic detention policy to prevent products containing 
GHB from being imported. These actions--along with embargoes, public 
education campaigns and other measures taken by state and federal 
authorities--appeared to temporarily diminish the distribution and 
abuse of GHB.
    Recently, however, there appears to be a resurgence in the abuse of 
GHB: virtually all of the products now encountered have been produced 
in clandestine laboratories. This increase in use has been accompanied 
by an increase in reports of GHB-related injuries, including deaths.
    Although some promotion schemes occasionally make unlawful claims 
that GHB is a legal drug, it is illegal for any person to produce or 
sell GHB in the U.S. FDA's Office of Criminal Investigations is working 
with United States Attorneys offices around the country to arrest, 
indict and convict individuals responsible for these illegal 
operations. FDA, the Centers for Disease Control and Prevention and the 
Drug Enforcement Administration are continuing to monitor GHB abuse and 
to develop the most effective measures to protect the public health.
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