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 29 FDA MD's AND SCIENTISTS 11 FDA ORGANIZATIONAL UNITS 6 PLUS 2 SPECIAL PLANT INSPECTIONS BY FDA 3 19 CONTACTS BY INDUSTRY CHART 14 DRUGS: AN INSPECTION WORKLOAD 13.800 ESTABLISHMENTS TO BE INSPECTED 7,000 INSPECTED LAST YEAR (1963) FDA MUST ALSO REGULATE 12,000 CHART 15 FDA hopes to begin more adequate coverage of these very important phaseS of the work soon. At present the agency does not have the experienced manpower required to do the job here that the public and the Congress have a right to expect. Another job is that of attempting, under the provisions of the HumphreyDurham amendment, to control nonmedical distribution of dangerous and potent drugs which should be sold only on prescription. This is a growing responsibility largely because of the increasing misuse of drugs, such as the amphetamines and barbiturates. These two drugs are used for widely different purposes; the amphetamines are stimulants, and the barbiturates are depressants. As chart 16 shows, the production of these drugs has grown phenomenally since 1949. It is certain that a considerable part of this production finds its way into illegitimate channels. This is borne out by the fact that, on an average, 90 percent of all illegal drug sale cases referred by FDA to the Justice Department involve these drugs. Traffic accidents, juvenile delinquency, and other social problems have frequently been linked to these products. There is no question but, that FDA needs stronger law, a larger force, and new imaginative techniques, including undercover operations, to attack this problem. Chart 17 illustrates the problem of medical quackery. MEDICAL QUACKERY FDA ASSIGNS CHART 17 A relatively conservative estimate indicates that somewhere in the neighborhood of $500 million are wasted every year by American consumers on worthless or extravagantly misrepresented drugs and therapeutic devices. In many cases these fake products are sold to people suffering from chronic illnesses who are easy victims of unscrupulous spielers, but who could obtain greater relief from bona fide drugs and medical care. In many other cases, people who are suffering from illnesses that could be cured are worsening their condition by depending on these fake remedies. The problem, therefore, goes beyond that of simply cheating the American consumers of their hard-earned cash. There is a definite health problem involved as well. In this fiscal year, FDA will be able to assign about 20 inspectors to fight this menace. This means that each inspector, on the average, will have to wage the campaign in 21⁄2 States during the year. FOODS Another area presenting more and more serious problems to consumers is that of foods, and here again, FDA has a tremendous workload. For example, as shown in chart 18, it is estimated that there are about 88,500 interstate establishments that produce, process, package, distribute, and store foods. Each is subject to FDA inspection, and in 1963 the agency estimates to have inspected approximately 20,300 of them. At this rate, FDA can inspect each of the 88,500 establishments on the average of once every 4.3 years. One major trend that has complicated the food picture has been the growing use of chemical food additives. As shown by chart 19, there are today an estimated 2,200 chemicals used by 73,000 food establishments that fall under FDA's Jurisdiction. FOODS 88,500 ESTABLISHMENTS SUBJECT TO FDA Establishments Inspected in 1963: 20,300 (ONCE EVERY 4 YEARS) CHART 18 FOOD ADDITIVES • 2,200 .... CHEMICAL ADDITIVES USED • UNDER 1958 FOOD ADDITIVES AMENDMENT These food additives are used as coloring agents, preservatives, emulsifiers, and for a host of other purposes. They are essential to the production of our modern convenient foods. Under the 1958 Food Additives Amendment to the Food, Drug, and Cosmetic Act, FDA has the job of establishing safe conditions for use including safety levels, where necessary, for each food additive. In other words, FDA must determine how much of any given chemical can be present in any given food product without endangering health. These tolerances are established after careful review and evaluation of petitions submitted by the industry. Considerable research is often necessary to validate the data submitted in these petitions. A single petition might involve hundreds of chemicals, and the number of petitions received by FDA has grown from 30 in 1959 to 352 received in 1962. The food problem that most consumers are very much aware of at this time involves pesticides. As chart 20 shows, there are an estimated 500 chemicals used today in approximately 55,000 formulas registered with the U.S. Department of Agriculture. Of these, it is estimated that 375 chemicals and 40,000 formulations are specifically for use on food crops. However, since almost any chemical applied for nonfood purposes can accidentally contaminate foods, most of these chemicals and formulations are of concern to FDA. PESTICIDES 500 CHEMICALS USED 55,000 FORMULATIONS REGISTERED WITH USDA 600,000,000 POUNDS SQLD ANNUALLY 2.500,000 INTERSTATE SHIPMENTS OF FRUITS FDA SAMPLES 1% CHART 20 Annually, some 600 million pounds of pesticides are used by over 5 million agricultural employees on every imaginable crop grown in the United States, and FDA estimates that each year there are approximately 2.5 million interstate shipments of raw fruits and vegetables that have probably been treated at some time or other with an agricultural chemical. FDA sampled and analyzed over 25,000 shipments or 1 percent last fiscal year. This year FDA will collect approximately the same number of samples but will subject them to more extensive analyses. The results of these 2 years of study will be analyzed to determine with greater accuracy what steps must be taken to provide sound consumer protection in this area. This sampling program is being supplemented by more visits to producing areas and by research to learn more about the effects of various pesticides when ingested as residues in or on foods. Although the more startling problems, such as chemical additives and pesticides, captivate the imagination, it should not for a moment be forgotten that FDA also has the immense task of protecting consumers against filthy, insanitary, and harmful foods, and from the unscrupulous fringe that is to be found in all walks of life who try to short-change the American public by deceptive packaging, misleading labeling, and the like. As chart 21 shows, in 1963 FDA seized over 79 million pounds of foods in the course of 368 seizure actions because of filth and insanitation, and over 3 million pounds in 68 actions because of direct health factors. In addition, it seized over half a million pounds in 186 actions because of cheats. Another problem area confronting consumers today is that of cosmetics. The growth of this industry over the past 20 years has been phenomenal as chart 22 shows. The high standard of living enjoyed by most Americans is largely the reason for the growth of this industry. People today can afford to buy more cosmetics, and the industry can afford to undertake research providing consumers with more sophisticated products. At the present time, FDA does not have the authority to require proof of safety of cosmetics before they are marketed. In addition, the cosmetic industry has a few operators who are unscrupulous and promote their products with false and misleading claims. At this time, FDA can devote about 2 percent of its resources to cosmetics. COSMETICS KEEPING THEM SAFE (2% OF FDA'S RESOURCES ARE DEVOTED TO COSMETICS) CHART 22 |