1. Consumer inquiries.-Based on increase consumer awareness and our expanding consumer information activities, consumer inquiries are projected to increase in fiscal year 1967. It is anticipated that the majority of these can be answered by form letters, but about one-third of them will require individual replies. To meet this anticipated increase in inquiries one new position is requested for fiscal year 1967.

2. Radio-motion pictures-TV.-Recent studies report a daily radio audience of 80 million in the United States, a daily TV audience of 139 million, with 70 percent of all men, 78 percent of all women, and 81 percent of all teenagers viewing TV at some time during each day. A 1964 survey showed usage of FDA radio and television spot announcements in every State of the Union (except Alaska). FDA currently distributes its radio TV packets quarterly. Plans for fiscal year 1967 call for production of these kits to be stepped up to one a month, with each TV packet accompanied by visual support. The visuals used would be 1-minute, sound-animated film clips, 1-minute sound filmographs, and 1-minute spots featuring an FDA executive or prominent personality. It is proposed that several TV programs be produced in fiscal year 1967. These would combine filmed laboratory sequences with live material originating in the local district and would portray the scientific basis for consumer protection programs. In addition, in order to meet demand, tapes or disks will be supplied with our radio packets instead of mimeographed scripts. For these purposes, an increase of $45,000 is requested.

One major education TV show will be produced to service the growing number of education channels serving both formal school situations and the wider adult public. A timely subject for the show is the "Safe Use of Drugs." A movie to serve this purpose is proposed at a cost of $30,000.

The library of consumer information materials should be increased by at least two 30-minute movies for 1967. These could be used on TV and for school and consumer groups covering such subjects as: food safety, wise "buymanship," quackery, etc. In addition, two special movies on drug abuse are planned for 1967, one for school-age audiences and the other for adults. They will stress the need for proper administration of psychotoxic drugs and be written in such a way as to present experimenting with drugs as being unrewarding. In order to produce these movies with a suitable number of prints, an increase of $82,000 is requested. FDA filmstrips have been well received in the schools where they serve as instruction or discussion aids. FDA plans to develop 15 filmstrips for school and general use in fiscal year 1967. An increase of $29,000 is requested for this purpose. An increase of three professional positions is requested for fiscal year 1967 to assist on the projects outlined above.

3. Exhibits. In addition to the mass media and publications programs diseussed elsewhere, one of the most effective ways of teaching the general public is through exhibits. Consumer consultants need additional portable exhibits, story panels, and drug abuse exhibits. In addition, other exhibit techniques will be tried. A consumermobile is proposed on a pilot basis in fiscal year 1967. The consumermobile would be similar to bookmobiles which have long since proven their value. The consumermobile, a tractor-drawn van, would be placed on display at shopping centers, fairs, and schools. It would be manned by consumer consultants from the district offices. An increase of $40,000 is requested for the exhibits and the consumermobile.

4. Senior citizen education.-FDA currently is engaged in several projects aimed at the Nation's 18 million senior citizens, a group particularly subject to quack health promotions. By fiscal year 1967 a vigorous educational program will be underway. A quarterly newsletter is planned that will contain information on false promotions and worthless cures, etc., for distribution through senior citizen's clubs, retirement homes, etc. Also, some of FDA's current publications will be adopted for distribution to the elderly. Use of special spot announcements on radio and television will be increased.

5. Drug abuse education.-Increased enforcement powers under the drug abuse amendments means that FDA will become, by necessity, involved in one of the major social problems facing the country.

The problems arising from the information program on drug abuse are expected to be considerably more difficult than those encountered in the traditional food and drug programs. To reach the groups that should be informed, it will be necessary to develop new approaches and vehicles to get the message across. By fiscal year 1967 it is expected that groups requiring specialized program development will be identified and programs developed to reach them. These programs will provide a specifically tailored content, language, format, media,

and audience approach. Development work, to be performed by outside specialists, will begin in fiscal year 1966. They will recommend program concepts for implementation by the agency. An increase of $130,000 is requested for the program in fiscal year 1967. To direct and coordinate the overall consumer program on drug abuse, three new positions are requested in fiscal year 1967.

6. Special population groups. To reach the low-income groups, particularly those with literacy and language problems, $26,000 is requested for simplified writing and translation services, and publication of consumer information.

The industry information program assists the regulated industries toward improved compliance through self-regulation. The increase in FDA's responsibilities for premarketing clearance of new drugs, food and color additives make it essential that adequate communications exist between FDA and regulated industries. As a result of recently reported labeling mixups, contamination of one drug with another, and other errors, FDA is cosponsoring an FDA-industry course on drug controls in fiscal year 1966. To assist industry in carrying out its responsibilities under the Drug Abuse Amendments a special program is being mounted, which will employ pamphlets, posters, and the novel technique of a traveling briefing team which will conduct workshops for manufacturers, trade associations, wholesalers, and similar groups.

In fiscal year 1967 cooperative work with trade associations in planning industry information programs has revealed a great demand for visual aids such as short motion pictures on the essentials of drug control, food plant sanitation, and good manufacturing practices in medicated fees. Five short motivational films are planned for showing to plant personnel, local trade associations, local unions with apprenticeship programs, and vocational agriculture and food technology students. Four headquarters and six district workshops are planned. These will be supplemented by three seminars, mainly covering subjects of concern in the drug area. Exhibits are a necessary adjunct of FDA industry workshops and seminars. A properly designed and manned exhibit provides an effective contact with representatives of industry groups and distribution point for "compliance" literature and other publications. To supplement the workshop and exhibit program, fiscal year 1967 plans call for: (1) the preparation of Guidance Manual for publishers, advertising agencies, and drug firms; (2) the preparation of special articles for drug and advertising trade journals; and (3) the preparation and distribution of trade press releases on FDA requirements and programs on prescription drug advertising and drug abuse.

Studies conducted in consultation with the U.S. Office of Education indicate that instructors of vocational agriculture would benefit by having instructional materials on FDA programs related to agriculture; i.e., pesticides and feed additives. Filmstrips and information material will be produced to reach a potential 828,000 students. From experience with a pilot series, it is estimated that in 1967 industrial training kits on six FDA subjects will be needed. A total of 600 kits, 100 on each subject will reach a significant percentage of a given industry when distributed through trade associations.

Three professional and two clerical positions and $63,000 in nonstaff funds are requested for 1967 to support the above enumerated activities. To expand the traveling briefing team program begun in fiscal year 1966, four specialists and a clerk are requested for fiscal year 1967. This will permit more in-depth presentations and greater coverage of the industries, trade associations, and similar groups.

Advisory opinions

The principal responsibility of the advisory opinions program is to promote voluntary compliance by providing industry with a free advisory service. This service through consultation, telephone contacts, meetings, and corresponder

helps the industry and the individual businessman understand how FDA regulations apply to their operations. As industry learns more about the Food, Drug, and Cosmetic Act, it asks increasingly more difficult and technical questions. Therefore, the average time required for research and consultation in answering written inquiries has risen from 1.5 to 2 hours. Time spent on industry contacts, telephone inquiries, and interagency communications is projected to rise in fiscal year 1967. Accordingly, three professional positions are requested to provide the additional manpower required to keep current with the increasing workload in this program.

The clerical unit prepares drafts and finals of advisory opinions, phone inquiries, industry interviews, and conferences. In addition, the branch handles approximately 1,000 inquiries per year from Congress and the White House. To provide the necessary manpower, an increase of two clerical positions is requested.

The staff and programs of the Bureau of Education and Voluntary Compliance have been expanding to play a larger role in active consumer protection. The filling of key positions for the most part has been accomplished. No new positions are requested for bureau direction in fiscal year 1967.

Visual materials and services

This function provides graphic and display services to all FDA bureaus and district offices. It produces and contracts for still and motion pictures to support FDA's education, scientific, administrative, and enforcement activities. The current staff of 10 employees is taxed to meet the demands placed upon it for various visual services. As the agency moves more and more toward the use of mass-media, the visual services staff must devote more of its resources to photographic services, especially motion pictures and television production. BEVC proposes 40 new titles for publications in fiscal year 1967. The scientific bureaus will require about 240 slides, charts, etc., and a central on-the-spot photographic service. The consumer and industry information program plans calls for 18 slide shows or filmstrips in addition to still photography for exhibits and public information. Ten motion pictures, 15 filmed TV productions, and 20 exhibits, ranging from a table-top display to a mobile unit, are planned for fiscal year 1967. To meet these demands an increase of four positions is requested.

Editing and publications

This function provides a pool of skilled writers and editors for Bureau-wide services. It also is responsible for several FDA publications. Two new positions are requested for fiscal year 1967 to strengthen the writing services in the Branch. Two other positions are requested to meet growing workloads in the Branch's ongoing publication program, primarily the Notices of Judgment and the Monthly Report on Enforcement and Compliance.

Exhibit area and mailroom

Two positions are requested to operate the recently opened FOB-8 exhibit area, on a regular basis in fiscal year 1967. They are needed to manage, coordinate and support the tours to be arranged by BEVC and the science bureaus. In addition, one position is requested to handle increased workload in the mailroom.

The main responsibility of the Bureau of Regulatory Compliance is to assure that consumers receive foods, drugs, and cosmetics which meet established standards of purity, efficacy, and wholesomeness. These products must be properly labeled, and manufactured in plants that meet standards of accepted good manufacturing practices from appropriate raw materials. The Bureau also provides essential field support to almost every other activity of FDA.

The Burean's compliance problems are complicated by technological changes which demand systematic evaluation to establish acceptable standards for new production processes, use of synthetics, unique packaging materials, etc. Health and ecocomic dangers from filth to fraud demand constant surveillance to prevent harm to the consumer.

To carry out its responsibility, the Bureau makes periodic establishment inspections to gather and analyze intelligence information to determine the level of compliance and simultaneously develop enforcement actions. About 1,600 manyears are required in the basic inspection and sample analysis operation. As trends develop, followup and special inspections are made to assure compliance to accepted standards and prompt correction of violations. About 345 man-years are devoted to this work. Legal activities which may follow involve some 75 man-years in necessary preparation of cases. Promotion of voluntary compliance is constantly the aim of inspectors during establishment inspections and of professionals talking to consumer and industry groups. Over 100 man-years are devoted to education which will directly promote nationwide compliance to assure safe and wholesome foods and drugs. Research and development work in improved methodology requires approximately 98 man-years of the Bureau's scientific staff. This work involves about 400 projects to improve methods of analysis and develop field analyses for new innovations constantly introduced by industry. FDA recently reviewed fiscal year 1965 data relating the reason for an inspection to violative findings. Statistics indicated that more time spent in inspection and sample analyses would pay off in terms of the elimination of additional health hazards and that we are far from reaching the point of diminishing returns. We found that the routinely inspected establishments turn up almost as many violative practices as the establishments inspected for the first time. It would appear that about 30 percent of older establishments previously found violative are willing to risk getting caught as opposed to investing time and capital in improving practices.

A projection of current violations would indicate that an additional 700 health violations can be uncovered in the drugs and imports areas with 130 additional inspectors and chemists. This is the amount requested in the fiscal year 1967 budget exclusive of supervisory and supporting staff. An analysis of the scope of violations will depend on further detailed operational research studies (feasibility studies) currently underway.

Fiscal year 1967 budget

The fiscal year 1967 budget request for regulatory compliance reflects the following major objectives:

1. To improve the current level of consumer protection in areas which pose a potential hazard to health, i.e., all drugs and food products with high potential for hazard to consumers' health, and similar aspects of FDA's import obligation.

2. Maintain current minimal levels of coverage for the balance of the domestic and import obligation, reallocating resources as indicated by emerging compliance problems.

3. Increase the percentage of research methodology and analysis in drugs and hazardous foods areas from the level of 8 percent in fiscal year 1965 to 15 percent as an integral part of the scientist's functions.

To accomplish these objectives, a total increase of 200 positions and $1,555,700 is requested.

1966 estimate:

Positions

Amount..

1967 estimate:

Positions.

Amount.

1967 increase: Positions Amount...

Drugs

718 $7,604, 000 888

$8, 612, 000

170

$1,008,000

FDA's drug responsibilities are of critical importance to the general public, the health professions, and the drug industry. Each improvement made or violation resolved may save a life, prevent serious injury, or enhance the quality of these products.

The 1962 Drug Amendments require FDA to inspect all establishments 1 (23,000) that process or manufacture drugs at least once every 2 years; i.e., 11,500 each year. In fiscal year 1965, FDA made 14,613 inspections. Approximately 10 percent or about 1,400 of these inspections fall in the category of repeat inspections necessitated by violations, complaints, voluntary recalls, etc. Thus, the manpower available in fiscal years 1965 and 1966 will permit coverage of about 55 percent of the 23,000 drug establishments in each year.

During fiscal year 1965, 14 percent (approximately 4,600) of all drug samples collected were violative and 20 percent (approximately 3,200) of establishment inspections revealed violations. Of prescription drug establishments, 32 percent violations. Drug seizures numbering 322 were necessitated by:

No effective NDA

Inadequate directions for use

False and misleading claims

Low potency

Noncompliance with USP standards
Imitations

Below purported quality

Shortcomings and deficiencies in the production of firms in processing and marketing of drugs required more than 300 separate drug recalls during fiscal year

1965 for:

Label mixups

Penicillin cross-contamination

Two different drugs in one bottle

Subpotency

The number of serious violations demonstrates that sufficient protection is not being given the American consumer in this critical area-even by the most conservative standards. To insure drug safety and effectiveness and maintain the quality of the Nation's drug supply, FDA proposes a 12-percent increase in establishment inspections and a 13-percent increase in sample examinations. This will permit 18,000 drug inspections and 35,000 drug sample examinations during fiscal year 1967, compared to 16,000 inspections and 31,000 examinations scheduled for fiscal year 1966. The new manpower will increase FDA's ability to: 1. Increase the regulatory pressure to locate and remove from the market, drug products not in compliance with the act.

2. Improve surveillance of drug industry control procedures and changing technology.

3. Improve the education and voluntary compliance activities to promote adequate scientific control and manufacturing practices during the course of regulatory inspections.

The term "establishment," as used throughout this activity, means a major category of drug products within a plant, such as prescription drugs, vitamins, nonprescription drugs, etc. In many cases, a manu facturer is involved in producing or processing several of these categories or "establishments."