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National Institute on Drug Abuse

Director's Report to the National Advisory Council on Drug Abuse

February, 1997

Congressional Affairs

I. 104TH Congress

Congressional interest in overall NIH research priorities, activities, and funding continued throughout the 104th Congress. By the close of the 104th Congress on October 4, 1996, a total of 7,991 bills had been introduced, of which 2,486 were related to health and medicine. Some 240 of these bills were related to medical research and development and the subject of diseases and conditions in humans. Although many of these bills received limited or no action, 12 bills (excluding appropriations) were enacted that have some impact on NIH programs. These included bills such as the Paperwork Reduction Act, The Biotechnology Process Patents Protection Act, and the Federal Reports Elimination and Sunset Act. In addition, provisions regarding parity for insurance coverage for mental health conditions (specifically excluding substance abuse or chemical dependency) is included in language in the Department of Defense Appropriations Act for FY 1997, which became the vehicle for passage of the Omnibus Consolidated Appropriations Act of 1997 (P.L. 104-208).

Several bills specifically relating to drug abuse received considerable attention late in the second session. The Rohypnol Control Act (HR 4137) established new criminal penalties for anyone who attempts to use a controlled substance to reduce a victim's resistance to sexual assault. The bill provides for up to 15 years in prison for possession of the drug flunitrazepam. The bill was signed into law on October 13, 1996 to become P.L. 104-305.

On October 3, 1996, President Clinton signed into law the Comprehensive Methamphetamine Control Act (PL 104-237), introduced by Senator Joseph Biden (D-DE). The bill was designed to help authorities respond quickly to an upsurge in methamphetamine use. The law lets authorities seize chemicals used to make the drug. It also increases penalties for trafficking in the chemicals and for possessing equipment to make the drug.

Senator Biden introduced the Pharmacotherapy Development Act on September 3, 1996. The intent of the bill was to create financial incentives to encourage pharmaceutical companies to develop and market anti-addiction medications and to develop a partnership between private industry and the public sector in order to encourage the active marketing and distribution of new medicines. The bill, which did not pass before the 104th Congress adjourned, has been reintroduced as part of another bill in the 105th Congress.

Appropriations -- FY 1997

The Congress determined that it would not be possible to pass all 13 of the regular FY 1997 appropriations bills individually before adjournment. Therefore, negotiators pieced together an omnibus spending bill that included appropriations for the Departments of Commerce, Justice, State (H.R. 3814); Defense (H.R. 3610); Foreign Operations (H.R. 3540); Interior (H.R. 3662); Labor, HHS, Education (H.R. 3755); and Treasury-Postal Service (H.R. 3756). The bill, which took the number of the Department of Defense bill, H.R. 3610, passed the House on September 28 by a vote of 370-37, cleared the Senate on September 30 by a vote of 84-15, and was signed by the President on the same day. Included in the measure is funding for each of the agencies, including NIH, as well as major legislative language affecting immigration law, banking law, and Federal personnel law.

For NIH, and the remainder of the agencies covered by the FY 1997 Labor, HHS, Education Appropriation, this meant there would be a mechanism for resolution of the House-passed bill with the Senate Committee version, since the Senate had not passed H.R. 3755, the FY 1997 Labor, HHS, Education appropriations bill.

The House Committee Report language [HRpt. 104-659] was included in the September 1996 Director's Report. The Senate Committee Report language [SRpt. 104-368] is as follows:

The Committee applauds NIDA for its recent breakthroughs in research on drug abuse and addiction. The Committee recognizes that neuroscience research has fundamentally changed our understanding of addiction and that this understanding provides the foundation for new kinds of treatments. Research supported by NIDA has made tremendous progress in identifying the neurobiological bases of all aspects of addiction, including craving, which is one of the major factors that can precipitate relapse. Among the most remarkable accomplishments of the past year was the successful immunization of animals against the psycho stimulant effects of cocaine. NIDA-supported researchers have also made substantial progress that is critical in directing their efforts to identify potential anticocaine medications. The Committee expects that neuroscience research will to continue to be a top priority and encourages NIDA to continue its research efforts in this area."

Medications. As a result of NIDA's research program, basic research now has progressed to the point where at least six molecular targets have been identified, now allowing NIDA to strategically focus its research on antiaddiction medications. The Committee commends NIDA for progress in medications development and urges NIDA to continue research aimed at developing effective medications for the treatment of addictions, particularly for cocaine. The Committee is pleased to note that NIDA has issued a program announcement to encourage expedited transition of ground-breaking research from advanced preclinical findings to applied clinical applications. The Committee recognizes this is an extremely valuable tool in advancing the discovery and development of medications for cocaine addiction."

Methamphetamine. Methamphetamine represents the most commonly used synthetic drug in the United States. The Committee is concerned that there is mounting evidence of a growing methamphetamine epidemic, which bears the potential of becoming a truly national epidemic. The Committee recognizes NIDA's strong history of funding research on amphetamines and methamphetamine; however, there is an urgent need at present for attention to treatments of human populations, particularly those in the Western United States, including rural populations, and those who have been infected with HIV. A most pressing priority is the development of effective pharmacological treatments for methamphetamine abusers, in conjunction with behavioral treatments and prevention efforts. The Committee encourages NIDA to continue this critical research area as well as develop new mechanisms to expedite research on methamphetamine."

Research Centers. The Committee commends NIDA for encouraging applications for comprehensive research center grants to support research training, continuing education for health care professionals, dissemination of information to the public, and conduct of both basic and clinical research. The Committee notes that in fiscal year 1996, NIDA supported two new research centers and looks forward to NIDA's continuing commitment to this approach. The Committee strongly encourages NIDA to support multi disciplinary comprehensive approaches to under served populations including minorities, rural populations, children, women, and those already infected with HIV and at an elevated risk for HIV. The Committee hopes that such centers will be representative of the varying regional epidemiological profiles of drug problems in the United States; including consideration of methamphetamine abuse in at least some of the centers."

Behavioral Research. The Committee understands that behavioral research is essential to solving problems of drug abuse and addiction, and that behavioral and psychosocial interventions are the most frequently administered treatments for drug addiction and in some cases, are the only available treatment. The Committee commends NIDA for expanding both its basic and clinical behavioral science activities in order to better identify who may be at risk for falling victim to drugs, and to develop effective approaches for breaking the cycle of addiction. Of particular interest is NIDA's behavioral therapies development program, which applies the same controlled evaluation process as is used in evaluating new medications to the assessment of behavioral therapies. The Committee also commends NIDA's initiatives in the fight against AIDS/HIV because of the increasing link between HIV infection and drug use and related behaviors.

The Committee understands that NIDA is in the process of expanding innovative community-based epidemiological and ethnographic research in relation to HIV transmission and prevention. The Committee encourages NIDA to continue to place high priority in this area of research, particularly with regard to documentation of the growing methamphetamine epidemic in the West, Midwest, and South.

The Committee notes that NIDA has initiated the B/START program to increase the supply of young investigators in behavioral science. The Committee is pleased to see that NIDA has initiated this program, which invites newly independent investigators to submit applications for small scale pilot research projects related to the behavioral science mission."

Treatment and Prevention. Drug abuse treatment and prevention techniques must be grounded in research in order to be effective with patients, providers, and insurers. The Committee urges NIDA to continue its efforts to strengthen the scientific basis for treatment and prevention interventions, and recommends that NIDA conduct research on ways to prevent drug use, interrupt the progression of drug abuse, reduce the likelihood of relapse, and lessen the adverse health and social consequences of drug abuse."

Social Work Services. The Committee commends NIDA's support for research on families and drug abuse, behavioral and psychosocial treatment research, and health services. The Committee also applauds NIDA for its initial effort to increase the number of social work
researchers conducting drug abuse research, and encourages NIDA to expand these efforts in fiscal year 1997."

Information Dissemination. The Committee believes that disseminating research findings in a timely manner is essential to the mission of NIH. Therefore, the Committee commends NIDA for hosting a series of town meetings with educators, health care providers, State and local antidrug coalitions, and civic organizations to disseminate research findings and foster information exchange."

Advanced Instrumentation. The Committee understands that magnetic resonance imaging holds great promise for enhancing understanding of mental illness. The Committee encourages the Institute to support advanced instrumentation projects related to the study, diagnosis, and treatment of mental disorders."

Medical Applications of Marijuana. During the fiscal year 1997 budget hearings, the Committee received testimony regarding the possible therapeutic applications of marijuana on certain medical conditions. Furthermore, the Committee was advised that while research on the therapeutic use of marijuana has been conducted on disorders, such as HIV wasting syndrome, multiple sclerosis, glaucoma, and on relieving the side effects of chemotherapy, further research is needed to conclusively answer questions of efficacy, particularly in comparison with existing conventional therapies."

"The Committee understands that the NIH currently is supporting studies on the effects of marijuana on human performance and health. However, no studies are being supported, or marijuana provided, for trials examining its possible therapeutic benefit. The Committee encourages the Institute to review its policy with regard to support of studies examining possible medical benefits of marijuana, which have Food and Drug Administration approval to ensure that the scientific questions of the medical applications can be investigated and resolved.

Conference Report and Bill

Following are the major features of the conference report affecting NIH (House Report 104-863):

Budget: NIH was appropriated $12,747,203,000, the same amount as the House-passed level, which is an increase of $370.6 million over the President's request, $332.6 million over the Senate Committee reported level, and $819.6 million, or 6.9 percent, over the comparable FY 1996 level.

Advanced Instrumentation: The conferees concur with the Senate report language regarding the promise magnetic imaging may hold for treating drug abuse and mental illness and are supportive of extramural clinical research in this area.

AIDS: The conference agreement does not contain a separate appropriation for the Office of AIDS Research (OAR). The agreement does contain a general provision that directs that the funding for AIDS research as determined by the Directors of the NIH and OAR be allocated directly to the OAR for distribution to the Institutes consistent with the AIDS research plan. The Directors of NIH and OAR have indicated that they expect to allocate $1,501,720,000 for AIDS research. The conference agreement also includes a general provision permitting the Directors of NIH and the OAR to shift up to 3 percent of AIDS research funding between Institutes and Centers if needs change or unanticipated opportunities arise. The conference agreement also provides an earmark of $35,589,000 for the operations of OAR within the OD appropriation.

1 Percent Transfer: The NIH Director continues to keep the 1 percent transfer authority.

Administrative Costs: The conference report notes concurrence with House report language regarding the definition of administrative costs and the restriction of FY 1997 administrative costs to the FY 1996 level. House language directed that, beginning in the FY 1998 Congressional Justification, for reporting purposes, NIH should use the definition of administrative costs included in P.L. 99-158, which means Aexpenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. The Committee expressed intent that NINR, FIC, NLM, and the CC be included in this definition.

Third Party Payments: The bill authorizes NIH to collect third party payments for Athe cost of clinical services that are incurred in National Institutes of Health research facilities and that such funds shall be credited to the National Institutes of Health Management Fund. The bill further provides that the funds credited to the management fund are to be available for 1 fiscal year after the fiscal year for which they are deposited.

SBIR: The Conferees deleted a provision that was in the House bill regarding SBIR grants. The Conferees Aencourage NIH to convene a conference to discuss further improvements (in the SBIR program) that can be made to address the quality concerns raised by some in the biomedical community.

The following shows FY 97 funding levels for the NIH Institutes.

NEI ---------------332,735,000
NCHGR ---------------189,657,000

NIH Total---------------$12,747,203,000

II. Looking Ahead - The 105TH Congress

Although Republicans maintained control of the House and the Senate as a result of the November 5 election, changes in Committee leadership and rosters as a result of retirements and/or election defeats are expected in a number of cases. It is not yet clear what impact these changes will have on interest in NIH or NIDA research issues. However, NIH reauthorization legislation, the subject of action in the 101st through 104th Congresses, is certain to be taken up again in the 105th as selected NIH authorities expired in FY 1996. Also in need of reauthorization are authorities of NIDA, NIAAA, and NIMH to bring these institutes onto the same schedule as that of other NIH entities.

Drug abuse related issues are expected to be of particular interest to Congress this session. Specifically the areas of needle exchange research, legalization of drugs, drug testing (particularly hair testing), medications development, and purported medical uses of marijuana are likely to be the subject of Congressional briefings and hearings during the first session. Continued congressional interest is also expected in areas relating to AIDS, genetic privacy, biomedical ethics, technology transfer, and emerging infections.

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