`
`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
`
`(
`
`55–638CC
`
`U.S. GOVERNMENT PRINTING OFFICE
`WASHINGTON :
`1999
`
`Page 1 of 105
`
` JAZZ EXHIBIT 2010
`Roxane Laboratories, Inc. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
` Case CBM2014-00175
`
`
`
`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
`SHERROD BROWN, Ohio
`Vice Chairman
`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
`KAREN MCCARTHY, Missouri
`RICK LAZIO, New York
`TED STRICKLAND, Ohio
`BARBARA CUBIN, Wyoming
`DIANA DEGETTE, Colorado
`JAMES E. ROGAN, California
`THOMAS M. BARRETT, Wisconsin
`JOHN SHIMKUS, Illinois
`BILL LUTHER, Minnesota
`HEATHER WILSON, New Mexico
`LOIS CAPPS, California
`JOHN B. SHADEGG, Arizona
`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
`
`JOE BARTON, Texas
`CHRISTOPHER COX, California
`RICHARD BURR, North Carolina
`Vice Chairman
`BRIAN P. BILBRAY, California
`ED WHITFIELD, Kentucky
`GREG GANSKE, Iowa
`ROY BLUNT, Missouri
`ED BRYANT, Tennessee
`TOM BLILEY, Virginia,
`(Ex Officio)
`
`FRED UPTON, Michigan, Chairman
`RON KLINK, Pennsylvania
`HENRY A. WAXMAN, California
`BART STUPAK, Michigan
`GENE GREEN, Texas
`KAREN MCCARTHY, Missouri
`TED STRICKLAND, Ohio
`DIANA DEGETTE, Colorado
`JOHN D. DINGELL, Michigan,
`(Ex Officio)
`
`(II)
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`2
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`Page 2 of 105
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`
`
`C O N T E N T S
`
`Testimony of:
`Adatsi, Felix, Toxicology Unit, Michigan State Police ...................................
`Bane, Paul, Drug Enforcement Command, Maryland State Police ..............
`Dyer, Jo Ellen, Assistant Clinical Professor of Pharmacy, University of
`California at San Francisco Bay Area Regional Poison Control Center ..
`Engel, Patti, Orphan Medical, Inc ..................................................................
`Faistenhammer, G. Mark, Detective, Grosse Ile Police Department ...........
`Jackson-Lee, Hon. Sheila, a Representative in Congress from the State
`of Texas ..........................................................................................................
`Maher, Patricia L., Civil Division, Department of Justice ............................
`Porrata, Trinka, D., designer drug consultant ...............................................
`Pruett, Candace, accompanied by Lugene Pruett, Commonwealth of Vir-
`ginia ...............................................................................................................
`Reuter, Nicholas, Associate Director, Domestic and International Drug
`Control Office of Health Affairs, Food and Drug Administration .............
`Snyder, Denise, DC Rape Crisis Center .........................................................
`Woodworth, Terrance W., Deputy Director, Office of Diversion Control,
`Drug Enforcement Administration ..............................................................
`Zukin, Stephen, Director, Clinical and Services Research, National Insti-
`tute on Drug Abuse, National Institutes of Health ...................................
`Material submitted for the record by:
`Meyers, Abbey S., President, National Organization for Rare Disorders,
`prepared statement of ...................................................................................
`Plaisier, Melinda, Interim Associate Commissioner for Legislative Affairs,
`Department of Health & Human Services, letter dated April 27, 1999,
`enclosing response for the record ................................................................
`
`Page
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`39
`38
`
`34
`88
`26
`
`13
`54
`29
`
`24
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`66
`42
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`58
`
`73
`
`99
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`100
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`(III)
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`3
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`Page 3 of 105
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`
`
`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, Bry-
`ant, 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 lead-
`ership that they have shown on this issue, and our ranking mem-
`ber, 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. Trag-
`ically, 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 imag-
`ine 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 ref-
`erence 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
`(1)
`
`Page 4 of 105
`
`
`
`2
`
`amnesia, and by the time the victim wakes up and gets to the hos-
`pital, it may be too late to detect even the presence of the drug be-
`cause the drug moves so rapidly through their system.
`I want to clarify that date rape drugs are in many cases a mis-
`nomer. They may be used by near strangers or others to incapaci-
`tate 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 lead-
`ing 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 de-
`tecting this drug. Neither GHB nor Ketamine is under Federal con-
`trol.
`The DEA has documented over 3,500 overdoses in law enforce-
`ment 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 unaccept-
`able.
`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 pro-
`tect our vulnerable young people from the vile misuse of these sub-
`stances.
`We have impressive witnesses to assist the subcommittee with
`its fact finding. We will hear first from Sheila Jackson-Lee, our col-
`league 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 Jack-
`son-Lee on this issue and others.
`We will then hear from a panel of witnesses offering various per-
`spectives on the problem. Those perspectives will be those from vic-
`tims, victim advocates, law enforcement and the medical commu-
`nity. 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 de-
`veloping a GHB derivative drug in clinical trials for the terribly de-
`bilitating 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 mem-
`ber of the subcommittee, recognize Bart Stupak for an opening
`statement.
`
`Page 5 of 105
`
`
`
`3
`
`[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 pub-
`lic health and safety problem: so-called ‘‘date rape’’ drugs. I want to thank full Com-
`mittee 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, anes-
`thetic-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 rec-
`ipes for making it, and the difficulty in detecting the drug. Neither GHB nor
`ketamine is under federal controls. The Drug Enforcement Administration has docu-
`mented 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 sub-
`stances.
`We have impressive witnesses to assist the Subcommittee with its fact finding.
`We will hear first from Congresswoman Sheila Jackson-Lee, who has introduced leg-
`islation 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 en-
`forcement, and the medical community.
`We will hear from experts representing the Department of Justice, the Drug En-
`forcement Administration, the Food and Drug Administration, and the National In-
`stitute 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 impos-
`sible 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.
`
`Page 6 of 105
`
`
`
`4
`
`Mr. STUPAK. Thank you, Mr. Chairman, and thank you for hold-
`ing 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 Ju-
`venile 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 prior-
`ities 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, simi-
`lar 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. Con-
`gress has required similar tracking with Ephedrine, a bill that I in-
`troduced 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.
`
`Page 7 of 105
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`5
`
`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 Rep-
`resentative 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 Michi-
`gan.
`Yes, we did oppose putting this on the omnibus bill because the
`ranking member of the full committee, the gentleman from Michi-
`gan, Mr. Dingell, contacted me about many proposals that were
`being suggested for the omnibus bill last fall that fell in the juris-
`diction 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 sub-
`committee.
`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 chair-
`man 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 emer-
`gence 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 admis-
`sions for overdoses, drunk driving accidents, and other injuries which are related
`
`Page 8 of 105
`
`
`
`6
`
`to these drugs are all increasing. In addition, some of these drugs and their precur-
`sors 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 pros-
`ecuting 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 par-
`ticularly 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 list-
`ed 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 prob-
`lem 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 fu-
`ture.
`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 col-
`league, 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 defense-
`less 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 drows-
`iness, 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 sub-
`stances 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.
`
`Page 9 of 105
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`7
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`We also directed the DEA to study the appropriateness of re-
`scheduling Rohypnol as a Schedule I drug. After analysis and con-
`sultation 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 pret-
`ty 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 dis-
`cussed, GHB, and Ketamine. Representative Jackson-Lee intro-
`duced a bill to reschedule these substances I believe under the Con-
`trolled Substances Act as Schedule I substances. The bill was re-
`ferred 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 ev-
`eryone 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 legisla-
`tion. 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
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`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 con-
`trols 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 an-
`swer.
`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 every-
`thing 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 some-
`thing really should have been done earlier, but I am glad that the
`chairman has really taken the bull by the horns and moved for-
`ward 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 actu-
`ally on questions.
`I was listening to the engaging way in which Mr. Burr was re-
`sponding, and I thought that we were at a question time.
`Mr. Chairman, I, too, want to applaud you for having this hear-
`ing 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.
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`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 Investiga-
`tions Subcommittee to look into this important matter, I wish that
`we could do it jointly with the Subcommittee on Health and Envi-
`ronment so we could mark up one of these bills that have been in-
`troduced 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 schedul