Several years ago, for example, FDA began to look into the use of automatic data processing systems to assist its programs, particularly the scientific operations. In October 1961, the Data Automation Branch was established and efforts were begun to staff it. Eight months later a relatively small computer was made available to FDA. Since then various computer programs have been developed that are proving to be of considerable value to our scientists and program planning staff. In October 1962, a special group headed by the Assistant Commissioner for Science Resources was designated to (1) develop recommendations to promote and improve the processing and dissemination of scientific information within FDA and with outside organizations; (2) develop a close relationship with other groups working in the information exchange area; and (3) evaluate FDA's adverse drug reactions reporting program. Among the recommendations that this group made was that FDA needed the services of outside experts to 1. Study some of the basic work processes of FDA to determine the feasibility of establishing an agencywide system or systems for the retrieval, utilization, dissemination, and exchange of scientific information and data; 2. Produce recommendations concerning the feasibility of a unified and agencywide system or systems, including suggested methods of approach and specifications to be used by the agency for the subsequent planning, designing, and implementation of such a system or systems; and 3 Produce recommendations for interim changes in data handling techniques where the contractor finds that such changes are necessary and practical. A formal invitation for bids for this study was issued on June 10, 1963, and a final contract was signed on September 9, 1963, with Arthur D. Little, Inc., of Cambridge, Mass., an organization with experience in the design of information handling systems. The study is nearing completion. Realizing that any study will point out the need for developing new techniques of information handling, FDA is taking collateral measures to assure that it will have both the staff and the organization to implement the study's recommendations. The agency is now recruiting for the scarce talents needed in handling mechanized information systems, it is developing special training programs in modern techniques of information handling for some of its present staff. FDA is also working to investigate ways of applying new techniques of information handling to specific programs and problems peculiar to FDA-particularly in the Bureau of Medicine, the Bureau of Scientific Research, and the Bureau of Scientific Standards and Evaluation. Work is also being done to develop new and improved laboratory operations and systems for both headquarters and field laboratories. Another result of the study made by FDA's own group, under the direction of the Assistant Commissioner for Science Resources, was to emphasize the need for improvements in FDA's adverse drug reaction reporting program. By way of background, this program was instituted several years ago as an experiment. Up until that time, no organization had attempted to systematically collect, record, and disseminate information gathered from clinical records concerning patient reaction to specific drugs. At this point, it must be said quite frankly that FDA is still exporing ways in which to improve this program. The agency must continue to develop better techniques for gathering adverse reaction reports. Experience thus far, and the study by the Assistant Commissioner for Science Resources, have led FDA to adopt the following measures: 1. Employing a medical officer trained in epidemiology and medical information handling to direct the program. 2. Assigning additional professional employees to the program. 3. Promoting more participation by hospitals having general patient loads. (Veterans' Administration hospitals, PHS hospitals, and selected Armed Forces hospitals are now participating.) FDA has also recently completed formal statements of understanding with the National Institutes of Health, the Bureau of Environmental Health, Bureau of Community Health, and the National Library of Medicine for the exchange of scientific information of mutual value. Of particular interest, special arrangements have been made for FDA to take part as observer in the review of certain types of NIH reserach grants and to be recipient of all the information emanating from those grants that deal with studies of concern to FDA. It might be emphasized that these new understandings formalize a working relationship of long standing between FDA and the Public Health Service and they should encourage a more orderly communication between the two agencies. FDA is at this moment negotiating additional agreements with other agencies of Government and plans, in the near future, to extend this effort to selected international organiz: tions. Since the 16th World Health Assembly meeting of the World Health Organization in Geneva in May 1963, FDA has been reporting significant drug recalls and adverse reactions in this country to the WHO. WHO is arranging to report similar information from other countries to FDA. The agency has undertaken for the past year a pilot project in two of its field district office-laboratories to determine the feasibility of applying certain automatic data processing equipment to the job of retrieving important data from inspection reports, sample collection reports, and sample analysis reports, storing such data, and then permitting the data to be quickly disseminated both in the field and in Washington. This pilot program has been s cessful and the new system is being installed in all of the field district offices. Before this time, the job of sorting out the data and coding it was all manual. Now, it is done by machine and can provide important law enforcement data to the field staff and to the headquarters staff rapidly and accurately. It can also provide vital data to assist FDA in planning field manpower utilization and in administering our field operations. Notable among current efforts to improve medical and scientific data handling, is the interim system that has been installed in the Bureau of Medicine to process information coming to FDA in connection with proposals for investigational drugs and applications for new drugs. The recent issuance of regulations requiring sponsors of investigational drugs to report significant information to the Food and Drug Administration demonstrated clearly the need for a better way of handling the very basic and vital medical and technological information that is furnished in support of a plan to use an experimental drug. In a rather dramatic way the new workload brought home to FDA the need for systematic dissemination and utilization of medical and scientific information. The agency is confronted with the job of evaluating and passing on an estimated 1.500 to 2,000 proposals to test experimental drugs each year. It became clear very early that, if the medical officers and other scientists charged with the evaluation of an investigational drug are to be furnished with all pertinent information concerning that drug and similar drugs on a timely basis. it would be necessary to develop an appropriate mechanized system for retrieving significant data. In view of the plan to have an outside organization experienced in advanced scientific information systems study FDA's overall scientific and medical communications operations, it was decided to install a mechanized procedure for investigational drugs that would meet some of the agency's initial requirements but that would not be so elaborate or expensive as to preempt the findings of the outside study group. With approval of the Office of the Secretary, FDA designed and installed a system that utilizes conventional punchcard equipment. Project RAPID, as it is called, was initiated in early June 1963. and is now operational. At the moment, over 1,000 specific chemical structures have already been coded from investigational drug proposals and new drug applications using a modiscation of a chemical coding method developed by the U.S. Patent Office. The information recorded on punchcards concerning drugs consists of 1. The chemical structure of the drug. 2. Its generic and trade name. 3. Route of administration. 4. Dosage form. 5. Pharmacological activity. 6. Potency. 7. Therapeutic indications. 8. Information concerning the manufacturer's name, receipt dates, and dates of various FDA actions. First, this information is abstracted from an investigational drug proposal or new drug application and coded. Next, the coded information is punched into cards. Once on cards, the information can be manipulated, analyzed, and retrieved on short notice. In addition to preparing printed answers to special requests of medical officers and other scientists engaged in the review of actual cases, the system calls for the issuance, periodically, of printed reports summarizing information accumulated over a given period. Because of interest in this particular project, FDA has prepared a brochure which illustrates in graphic form how the system works. Copies of this brochure are available upon request. It should be clear that this system is but a steppingstone to a more comprehensive system envisioned for the future. In attempts to improve procedures in this vital area of scientific information exchange, FDA has studied systems employed by drug firms and by organizations involved in abstracting scientific journals, it has studied systems employed by the National Library of Medicine, and it has also held discussions with the World Health Organization. The foregoing just describes the highights of what has been done and is being done by FDA in this area. There are many other measures that have been taken to improve internal procedures, such as mechanizing the certification procedures for antibiotics and establishing a modern indexing technique for identifying chemical compounds through their infrared spectra. Reorganization of 1963 By far and away, however, the most important recent step taken to prepare FDA to meet more adequately its responsibilities in all areas, including drugs, was the recent reorganization of the agency. This reorganization was the result of the many studies that have been made of the Food and Drug Administration, both by outside groups, such as the Second Citizens Advisory Committee, and by ourselves. It is without doubt the most far-reaching reorganization that FDA has ever experienced in its over half-century of existence. In effect, the reorganization does the following: 1. It facilitates and elevates consumer and industry information and education and enhances the promotion of voluntary compliance through the establishment of a separate Bureau of Education and Voluntary Compliance. This Bureau has sole responsibility for leadership and direction of all educational, informational, and voluntary compliance programs that had heretofore been scattered in a number of organizational units. 2. The reorganization upgrades the agency's scientific programs and elevates the role of the scientist in FDA affairs through the establishment of two new positions. These are an Associate Commissioner for Medicine and Science, responsible for the overall direction of FDA's medical and scientific activities and for representing the scientist at the highest level in important decisions and policies, and an Assistant Commissioner for Science Resources who serves as staff adviser for science communications, professional development, and extramural research. Three scientific bureaus are now in FDA's organizational structure. The Bureau of Medicine, relatively unchanged by the reorganization, will continue to provide expert medical evaluation to all FDA programs. A Bureau of Scientific Research has been established and is responsible for broad and long-range research and for the development of expertise in a number of scientific disciplines necessary for the support of FDA's various activities. Finally, a new Bureau of Scientific Standards and Evaluation has been created to be responsible for the review and evaluation of industry proposals related to drugs, pesticides, food additives, etc., and for the certification of antibiotics, insulin, and colors. Under 37-272-64-pt. 1—8 the former organization, scientific research activities and the scientific review of industry proposals were undertaken by the same organizational unit with re sulting competition between the two functions for time and resources. 3. The reorganization improves long-range and policy planning by the establishment of an Assistant Commissioner for Planning position to give full time to the important job of developing long-range and policy plans for FDA. In turn, responsibilities for developing day-to-day operational plans have been lodged with the bureaus closest to the operations for which such plans are required. In the former organization, both top level planning and day-to-day planning came under the same direction and competed for time and resources. 4. The reorganization facilitates coordination and leadership by the Office of the Commissioner by removing from this office and reassigning elsewhere programs and operational workloads, such as those relating to education, information, Federal-State relations, food additives, color additives, and activities, falling under the Hazardous Substances Labeling Act, that were formerly undertaken by the Office of the Commissioner. In addition, new Assistant Commissioner positions have been created to provide the Commissioner with top-level staff advice in specific areas. 5. The reorganization improves the supervision and coordination of regulatory and enforcement operations, including improved communications between field and headquarters operations, by the establishment of a Bureau of Regulatory Compliance to be responsible for all field activities, as well as for all work related to the processing and development of regulatory actions. Prior to the reorganization, responsibility for field operations was in one unit and responsibility for taking regulatory actions, such as seizures, inspections, and prosecutions, was in another unit, making coordination of these important activities difficult. 6. The reorganization facilitates the utilization of assistance from sources outside FDA. This is accomplished by the creation of a National Advisory Council to the Food and Drug Administration. The Council will permit FDA to establish a closer relationship with any outside groups and persons having special interests in FDA and knowledge and ex perience of value to FDA. The reorganization also establishes in the Office of the Commissioner the position of Special Assistant to the Commissioner for the National Advisory Council who will serve as liaison between the Council and FDA. 7. It establishes a more effective means of processing proposals submitted by industry for new drugs; investigational drugs; pesticide, food additive, and color additive tolerances; food standards, etc. This is accomplished by consolidating into one new bureau all responsibilities and operations required in the processing of industry proposals. FDA is convinced that this reorganization will contribute to a more effective and efficient FDA consumer protection program. NEW LEGISLATION On February 5, 1964, in his message to the Congress on the American comsumer. President Johnson called attention to a number of gaps existing in the statutes FDA administers. Unless bridged by new legislation, these gaps will continue to handicap seriously the agency's ability to provide adequate consumer protection. As charts 31 and 32 show, among the gaps that must be filled are the following: Factory inspection authority The Kefauver-Harris Drug Amendments of 1962 strengthened FDA's inspection authority with regard to Rx drugs. It did this by permitting inspectors to look at formula files, consumer complaint files, records pertaining to manufac turing controls, data on the qualifications of key technical and professional employees, and other data never before available to FDA except on a voluntary basis. The type of information that this new authority makes available is vital if FDA is expected to make thorough and truly meaningful inspections. FDA still lacks this authority as far as the food, cosmetic, therapeutic device, and nonprescription drug industries are concerned. Preclearance of therapeutic devices As in the case of cosmetics, there is today no requirement that therapeutic devices be tested for safety before they go onto the market. Nor is there a requirement that they be proved effective as claimed by the manufacturer. In DRUG SAFETY PROPOSALS FOR NEW LAWS New legislative requirements have been REQUIRE COSMETICS TO BE TESTED AND PROVED SAFE 29 • STRENGTHEN FDA'S FACTORY INSPECTION AUTHORITY. • REQUIRE THERAPEUTIC DEVICES TO BE TESTED AND New legislative requirements (cont) • PROVIDE BETTER CONTROL OVER THE DISTRIBUTION OF HABIT FORMING BAR-BITURATE AND STIMULANT DRUGS CHART 31 • REQUIRE WARNINGS AGAINST MISUSE ON CON-TAINERS OF HAZARDOUS SUBSTANCES SUBJECT TO THE FOOD, DRUG AND COSMETIC ACT • PROVIDE SUBPOENA POWER FOR FDA'S ADMINISTRATIVE HEARINGS CHART 33 general, FDA is able to protect consumers of devices only after the products have caused harm or when samples collected on the market have been found to be harmful. The use of therapeutic devices has grown to an amazing extent since World War II, and the area is a prime breeding place for quackery. In addition, there is increasing reliance upon therapeutic devices by practicing physicians who are not equipped to and should not have to test each new product that comes to them. Hazardous household substances In 1960 the Congress passed the Federal Hazardous Substances Labeling Act requiring adequate cautionary and warning labels for packages of hazardous substances intended or suitable for household use. The purpose of this law was to try to prevent some of the needless deaths and injuries that occur every year, because poisonous, flammable, and other dangerous household products are misused or left within the reach of children. The 1960 act, however, excluded packages of foods, drugs, and cosmetics from coverage. This means that certain packages, such as pressurized food containers and packages of highly flammable or toxic cosmetics do not have to contain warning statements on their labels. Subpena authority Some of the laws FDA administers provide that administrative hearings be scheduled under certain circumstances to allow the regulated industry to voice its position and to enable FDA to obtain needed information. These hearings are usually on matters vitally affecting the public health and welfare. Yet, under the present law, FDA does not have the authority that other regulatory |