FOOD AND DRUG ADMINISTRATION

II. METHODOLOGY

• The resources used in this program area are determined by the actual workload expended in carrying out the Food and Drug Administration's (FDA) efforts through: 1) the expeditious review of applications for new drugs intended to alleviate narcotic addiction; and, 2) the review, approval, and monitoring of narcotic treatment programs to ensure compliance with Federal regulations for registration and treatment of narcotic addiction.



• The resources used in the Alcohol and Tobacco program area are determined by the active workload expended in carrying out FDA's efforts to implement the President's Executive Order calling for the regulation of nicotine - containing tobacco products.

III. PROGRAM SUMMARY

Goal 1: Educate and enable America's youth to reject illegal drugs as well as alcohol and tobacco.

• As a result of an Executive Order in 1996 restricting the sale and availability of tobacco products to minors, FDA is working to reduce the availability and appeal of tobacco products to children and teenagers and educate young people about the health risks of tobacco use. As a result of this program's activities, FDA expects a 50 percent decline in young people's use of tobacco over the next seven years.



• FDA will develop a strong outreach program geared toward retailers, state and local health and law enforcement officials, the public and the media, as one of the most effective ways to increase compliance with the new Executive Order. Specifically, regional conferences with major organizations; distributing briefing materials to retailers informing them of their responsibilities; establishing a toll-free hotline for retailers; and distributing information on the rule through trade publications are planned for implementation in FY 1998.



• In addition, FDA will produce and distribute compliance policy guides to each affected industry -- manufacturers, distributors, and other affected parties. Individual outreach efforts will include the development of briefing materials and the initiation of conferences with a wide array of public health, law enforcement and other officials. Community organizations, parent groups, voluntary health groups and others will be provided information to help raise awareness of the tobacco rule and encourage compliance.



• FDA will establish necessary training experiences for those state and local officials who will help enforce FDA's rule. Following this training, selected state and local officials will be commissioned to conduct compliance and enforcement activities on behalf of the Agency.

Goal 3: Reduce health and social costs to the public of illegal drug use.

• FDA reviews new drug applications for alternatives to alleviate narcotic dependency. The Agency works closely with the National Institutes of Health (NIH), especially the National Institute on Drug Abuse (NIDA), to expedite the development of such drugs that are under study by NIH Institutes.



• FDA also reviews applications from hospitals and narcotic treatment program centers that provide treatment of narcotic addiction. FDA monitors over 1,000 approved narcotic treatment programs, including hospital based programs, for compliance with Federal treatment standard regulations that are issued and periodically revised by FDA.



• FDA evaluates and processes over 3,000 requests annually from individual narcotic treatment programs for exemption from the regulations received.



• FDA's short-term goal is to conduct periodic inspections at treatment programs, to evaluate the results, to determine the level of regulatory conformance, and if any follow-up administration actions are warranted.



• Recently, many narcotic treatment programs have come into compliance, reducing the frequency of inspection's required "for cause." The number of recommendations for approval of Warning Letters from the various field districts that conduct these inspections has decreased from 165 in FY 1990 to only 13 in FY 1995. FDA anticipates this trend to continue into FY 1996 and throughout the near future.

IV. BUDGET SUMMARY

1997 Base Program

• The total FY 1997 drug control budget request is $5.6 million. Of that amount, $4.6 million is for underage tobacco use prevention, and $1 million is for other drug prevention programs.

1998 Request

• The total FY 1998 drug control FY 1998 budget request is $35 million, an increase of $29.4 million over the FY 1997 enacted level.

Goal 1: Educate and enable America's youth to reject illegal drugs as well as alcohol and tobacco.

• The total drug control request for Goal 1 activities for FY 1998 is $34 million, an net increase of $29.4 million over FY 1997 for outreach and enforcement activities. The 1998 request includes the following program enhancements:



• Outreach activities will include in-person conferences and a video conference for all interested members of the public to learn about the provisions of the final rule [on youth tobacco use] that goes into effect in August 1997. Printed materials describing the problem of young people's use of tobacco, and describing the new provisions in the final rule will also be created and disseminated. A toll-free hotline will already have been established earlier in 1997. Promotion of the hotline's availability will be an activity funded with FY 1998 dollars.



• The main use of FY 1998 dollars for enforcement will be for contracting. FDA will contract with state and local officials who will help enforce the final rule by conducting compliance checks to make sure retailers do not sell tobacco products to minors. Part of the budget for enforcement will be spent training these officials so that they can perform their duties. Other activities in FY 1998 include covering the expense of assessing and receiving civil money penalties from retailers who are found to have violated the final rule a second time; maintaining the toll-free hotline, which will be used by the public to report violations of the final rule; and monitoring and evaluating the tobacco industry's advertising and promotion activities.

Goal 3: Reduce health and social costs to the public of illegal drug use.

• The drug control request for Goal 3 activities for FY 1998 is $1 million, the same level as FY 1997.



• For FY 1998 and beyond, however, the budget reflects anticipated changes in the system for approving and monitoring narcotic treatment programs. FDA is assisting SAMHSA and other HHS agencies and ONDCP in developing a new system to replace the current one of direct regulation by FDA inspections. The new system will rely on private accrediting bodies to develop standards and to accredit individual programs.



• SAMHSA has indicated that it will accept the lead agency responsibility for managing this new system and FDA anticipates that a three-year tradition period will be necessary. The out-year budget levels reflect this phase-in period, and assume that the program would be fully in place by FY 2002. The proposal was highlighted as part of the Department's participation in the National Performance Review, and is consistent with ONDCP's policy, specifically, the goal to reduce health, welfare, and crime costs resulting from illegal drug use through objectives such as increasing treatment efficiency and effectiveness. These changes should increase the quality of treatment provided, thereby increasing treatment effectiveness and efficiency.

V. PROGRAM STATISTICS

FDA does not report program statistics directly related to implementation of the National Drug Control Strategy.

VI. PROGRAM ACCOMPLISHMENTS

• In FY 1996, FDA's anti-drug activities focused on: (1) a continuation of the Agency's investigation of the role of nicotine in tobacco use and the design and manufacture of tobacco products that had begun in FY 1994; and (2) the development and promulgation of the Agency's final rule on youth tobacco use issued in August 1996.



• Many narcotic treatment programs have come into compliance, reducing the frequency of inspections required "for cause." The resources planned for FYs 1997 and 1998 will enable FDA to continue its activities of review of applications and inspection of treatment programs, which support Goal 3.



• In 1996, the Food and Drug Administration (FDA) conducted joint program reviews and site visits with the Substance Abuse and Mental Health Services Administration's Center for Substance Abuse Treatment (CSAT), which provided a better coordinated effort related to substance abuse.



• Also in 1996, FDA initiated cross-training of addiction counselors on issues related to drug treatment, HIV, and sexually transmitted diseases (STDs), which made referrals more effective.