led to a larger number and variety of products to please an ever greater diversity of tastes and demands. Without a doubt, history has never recorded a time when so many people had available to them so many products. All this adds directly to FDA's workload. One has only to look at our sprawling supermarkets with their thousands of different products and annual sales of more than twice the value of all the gold in Fort Knox to get a dramatic idea of what has been happening. In this connection, it should be said that supermarkets have increased from 6,175 in 1940 to well over 24,000 today. Chart 7 shows the relationship between per capita consumption expenditures for foods, drugs, and cosmetics and the per capita cost invested in the Food and Drug Administration over the past years. As is shown, each American has been spending from 2 to 15 cents a year for the protection provided by the programs administered by FDA. COMPARISON: CONSUMER EXPENDITURES vs COST OF ENFORCING FOOD, DRUG AND COSMETIC ACT The third major factor that has contributed to FDA's workload and responsibilities during the past years has been the technological advances made by this country. Chart 8 shows that during the period 1957 to 1962 the Nation's SCIENCE AND TECHNOLOGY LEAD TO NEW industries producing foods, drugs, and therapeutic devices more than doubled their outlays for research and development of new products. This merely reflects the growing emphasis being placed on scientific research since the end of World War II. All of this research and development adds directly to FDA's job because science, advanced technology, and automation (1) increase the production of foods, drugs, and cosmetics; (2) develop new methods of production and distribution that require new enforcement techniques; and (3) produce new and complex products, such as more sophisticated drugs, new food additives and color additives, increasingly toxic pesticides, an ever greater variety of convenience foods, and the like. It is interesting to note that while industry was spending anywhere from $155 to $375 million a year on research to develop new products, FDA's appropriations for research to protect consumers ranged from $1 to $4.6 million a year. The past for FDA can best be summarized as having been essentially characterized by (1) an opportunistic approach by our Nation to the job of improving its consumer protection laws, an approach wherein action was often taken only after tragic or dramatic situations had occurred; and (2) a constant attempt to administer with most inadequate resources a set of highly complicated laws that deal with complex scientific, medical, and technological problems. The current organization FDA TODAY Today, as a result of recent appropriation increases, FDA has a budgeted staff of 3,824. If the President's 1965 budget is enacted, the staff will be 4,039. Of the staff currently budgeted, 1,636 are assigned to headquarters here in Washington and 2,188 are dispersed in 18 field district laboratory offices and about 50 resident insepctor posts. The above staff is now organized under an entirely new organizational structure approved by the Secretary of Health, Education, and Welfare on November 1, 1963. This new organization is shown in chart 9. Later in this document there is a discussion of the steps that have been taken and are being taken to help solve some of the problems facing the agency. At that point a more detailed presentation of the reorganization appears with emphasis on how the new structure will improve the agency's programs, operations, and management. Current problems facing FDA The problems that FDA faces today essentially fall into two catgeories: First, those that are directly related to the programs needed to protect consumers and, secondly, those that deal primarily with administration and management. A look at a few of the more important problems in each of these categories may be helpful. First, the consumer problems. DRUGS A growing population, an expanding economy, new technology, and scientific breakthroughs are creating significant problems in the drug area. The Food and Drug Administration has tremendous drug responsibilities and workloads which fall essentially into four broad areas as shown in chart 10. 1. Premarketing control of clinical investigations of new drugs and proof of safety and effectiveness of new drugs. 2. General control of the purity, potency, labeling, and promotion of drugs. This is accomplished through inspections, sample collections and examinations, education, and consultation. 3. Attempts to curb illegal sales of prescription drugs. 4. Work directed against quackery. The latter two responsibilities are dealt with primarily through investigation and surveillance work. The speed with which the drug picture changes is well illustrated in chart 11. DRUGS • PREMARKETING CONTROL INVESTIGATIONAL DRUGS NEW DRUGS • PURITY, POTENCY, LABELING AND PROMOTION SAMPLE COLLECTIONS AND EXAMINATIONS • ILLEGAL SALES OF PRESCRIPTION DRUGS INVESTIGATIONS, SURVEILLANCE • DRUG QUACKERY INVESTIGATIONS, SURVEILLANCE CHART 10 It is estimated that 90 percent of the drugs used on prescription today were not on the market 15 years ago. In addition, the growth of the drug industry is indicated by the extremely sharp increase in consumer spending for prescriptions. This has grown from $150 million in 1940 to approximately $2.2 billion today. Initially, FDA fulfills its responsibilities in the drug field by exercising the premarketing controls that are provided under the law as shown in chart 12. On an average, FDA receives for attention each working day of a normal year 4 requests for approval for marketing of new human and veterinary drugs; 13 proposals to change previously granted approvals on drugs now on the market; and about 8 proposals for clinical tests to determine the safety and effectiveness of drugs. Considering that a proposal for marketing may involve from one to several volumes of scientific data to be reviewed by medical officers, pharmacologists, chemists, and other scientists, it can be appreciated that this phase of FDA's operations does indeed constitute a massive workload. This is illustrated in the next two charts by the case history of a new drug application (No. 13-934), one of more than 1,100 human and veterinary NDA's received during fiscal year 1963. As chart 13 shows, this NDA was made up of 9 volumes representing about 4,000 pages of facts and figures submitted by the industry following about 4 years of research. In all, it took FDA personnel, mostly medical officers and scientists, 195 calendar days to evaluate carefully all this data to make sure that the drug was both safe and effective. NEW DRUGS: FDA, NORMAL YEAR WORKLOAD ON AN AVERAGE WORKDAY, FDA RECEIVES FOR REVIEW, EVALUATION, • 4 APPLICATIONS FOR APPROVAL OF NEW HUMAN AND VETERINARY DRUGS • 13 REQUESTS FOR MODIFICATION OF DRUGS ALREADY APPROVED • 8 PROPOSALS FOR CLINICAL TESTS OF NEW DRUGS UNDER INVESTIGATION CHART 12 CASE HISTORY OF A NEW DRUG APPLICATION (NDA NO. 13-934) DATA SUBMITTED BY INDUSTRY WAS NDA 13-934 THE NDA CONSISTED OF 9 VOLUMES TOTALING OVER 4000 PAGES FDA SPENT 195 FULL WORK DAYS EVALUATING CHART 13 247 DATA As chart 14 shows, FDA's evaluation required the work of 29 professional members of the staff representing 11 different organizational units, 6 outside expert consultants, 2 special field inspections, tests by the laboratories of 2 field district offices, 3 special conferences by the Bureau of Medicine staff, 1 conference with industry, and 19 contacts by industry. Some new drug applications are shorter and some longer, some require less time and some more. But each application requires an institutional decision that bears on the health of the Nation for years to come. FDA's record in discharging this awesome responsibility is one in which the agency takes pride. FDA has done a good job under difficult circumstances. Once drugs are commercially marketed, the Food and Drug Administration conducts inspections and sample examinations to determine their purity and potency, the adequacy of their labeling, and the propriety of promotional methods employed for them. As shown in chart 15, FDA has an obligation to inspect almost 14,000 establishments (exclusive of the producers of medicated feeds of which there are over 12,000) and it is now able to inspect these firms at a rate of approximately once every 2 years. This is far from adequate coverage of an industry whose output is so closely associated with the health and well-being of every citizen. These inspections are followed by collection and examination of samples to confirm the observations made in the factory. However, two very important phases of FDA drug work are not as yet adequately dealt with in either the inspection or sampling operations. These are the requirements: 1. That drug labeling-particularly of a prescription drug-give full disclosure of the bad effects and contraindications as well as of the claimed good effects, and 2. That the advertising of a prescription drug give a brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations. THE PROCESSING OF NDA NO. 13-934 DRUGS: AN INSPECTION WORKLOAD 13.800 ESTABLISHMENTS TO BE INSPECTED FDA MUST ALSO REGULATE 12,000 CHART 15 |