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nations. You say the increase of this staff will permit approximately 18,000 drug inspections and 35,000 drug sample examinations. Does this reflect that the ratio of house staff needed to support a field investigator is about 2 to 1, or what is the ratio?

Dr. GODDARD. It is about 2 to 1. I think this is also related to information contained on the previous page which points out the results during fiscal 1965 with respect to the 4,600 or 14 percent of all drug samples collected were violative and 20 percent of the establishment inspections revealed violations.

Mr. CARDWELL. I may have misunderstood your question. Does it have to do with the ratio of field staff to headquarters staff?

Mr. FARNUM. In-house total to inspection. We are talking here about analytical production of samples taken through inspection. Dr. GODDARD. That is 1 to 1, 1 analyst to 1 inspector. That would be the relationship.

Mr. FARNUM. Is this the relationship, then?

Mr. SPARER. We have three categories of employees: an inspector, a chemist, and what we call other supporting personnel, technicians, clerks, and so on. These are about in a 1-to-1-to-1 ratio, one inspector, one chemist, and one supporting personnel of one kind or another.

Mr. FARNUM. When you take the rest of management into consideration, it is about 2 to 1?

Mr. CARDWELL. Taking headquarters management, voluntary compliance.

Dr. GODDARD. May I add as a post script that analysis of our total staff distribution between the headquarters and field shows 51 percent. in the field and 49 percent in headquarters.

NEED FOR ANALYSTS IN DRUG AREA

Mr. FARNUM. Then on page 53 you ask for 62 analysts and 44 inspectors. It does not bear out your 1-to-1.

Dr. GODDARD. It is to bring balance into the situation.

Mr. SPARER. This is complicated in the drug area. We are pushing harder on drug sample analysis as opposed to inspection.

Mr. CARDWELL. The ratio of analysts to inspectors is higher on drugs. In other areas, where the analytical process is less demanding, You will find the ratio of inspectors to analysts will be higher. The overall mix is as has been stated. In this one case that you have selected out-drugs-there the analyst requirements are more.

NEW METHODS OF ANALYZING SAMPLES

Mr. FARNUM. On the same page, you have an item 7 where you are going to develop new field methodologies to keep abreast of technological changes and improve current methods. Have you any examples or ideas to be developed here?

Dr. GODDARD. May I submit one or two items indicative of the type of approach?

(The requested information follows:)

NEW METHODS FOR ANALYZING SAMPLES

The Food and Drug Administration enforces seven laws which demand testing for safety, purity, and efficacy of foods and drugs. The Bureau of Regulat

Compliance (BRC) establishes methods to implement this responsibility. There are currently some 420 research projects improving methodology to increase the speed, efficiency, and accuracy of analysis, thus giving more depth to the regulatory program.

Research concerned with improving current methods is aimed at adapting to regular field use, experimental methods and techniques. In New York, field scientists are applying the new nuclear magnetic resonance technique to identify and quantify different antihistamines in a single dosage. Research is pointed to the application of this technique for identification of components of many drugs and foods with more exactness and greater efficiency of operations.

Technological advances in the food and drug industry have necessitated development of new and often unique methods of analysis. Two new types of detectors have been developed for the detection of multiple phosphate pesticide residues in foods, one through a contract with the Southwest Research Institute and the other by the Food Chemistry Division of the Bureau of Scientific Research. Field scientists are developing methods and comparing the effectiveness of these devices in field use. Observations are made to prove the validity of results from these devices by checking against proven but more cumbersome methodology of detection. The purpose of this program is to assure that foods consumed do not contain more than the legal tolerances of these pesticides.

The Association of Official Analytical Chemists (AOAC) accepted responsibility to collaborate methodology research to get methods tested to assure accuracy throughout the country. BRC's field analysts do the major portion of this work. For example, methods for testing chemical contamination from packaging material are being studied to determine their extent and hazards. These studies are communicated to other field offices for collaboration to ssure accuracy and uniformity.

A serological method has been developed in FDA to identify staphylococcus enterotoxins found in foods of a moist nature such as cheese and potato salads in the laboratory without the use of animals. This method is being studied under AOAC with cooperation of BRC field bacteriologists to prevent food poisoning which is the result of their presence.

AUDIT ACTIVITIES

Mr. FARNUM. I would like to talk about your field programs under the Bureau of Drug Abuse Control, and especially the audit function that you now are getting into. As you say, the law requires within 3 years you have a need to audit.

Dr. GODDARD. That is correct.

Mr. FARNUM. What kind of people are you going to use here in the auditing program?

Dr. GODDARD. You mean their basic qualifications? They are generally college graduates who are brought into the agency and given special training.

Mr. FARNUM. What kind of majors, particularly?

Dr. GODDARD. Biological and physical sciences. Some of them might be business administrators, too.

Mr. SPARER. In the audit program.

Mr. FARNUM. To what depth do you intend to go in this audit program? I notice within a 3-year period it is a postaudit function practically, and many things could happen in 3 years.

Dr. GODDARD. Of course, not all of them would be deferred 3 years. The completion date is stated to be 3 years. It takes approximately 40 hours to audit an individual firm. That is my recollection of the analyses we have done to date.

Mr. FARNUM. That is what it says in here. It says, I believe, after an 8-week course it takes 40 hours to be able to do an audit of a manufacturer or a wholesale druggist or jobber or distributor. Is this on a spot check basis or is this an indepth audit?

Dr. GODDARD. It is an indepth review and audit.

Mr. FARNUM. What percentage-100 percent, 80 percent, 40 percent, over the 3-year period?

Dr. GODDARD. We are required to do all of them.

Mr. FARNUM. I am talking about what depth of audit of the individual jobber or manufacturer in terms of checking them.

Mr. RANKIN. The thing that we contemplate here is to have the inspector go into the manufacturer's plant and determine what inventory the producer had on hand as of February 1, 1966.

Mr. FARNUM. By his records?

Mr. RANKIN. By his records. Each firm was required to make an inventory at that time. We determine what shipments have been made, taking one barbiturate or one amphetamine against the inventory as of February 1 plus the production since that time.

I judge from your question that the same thing has occurred to you that has occurred to us: Some people, if they want to violate the law, are not going to keep accurate records.

Mr. FARNUM. You see, I am asking it from the point of view of your checking a specific item. Are you going to do it from inventory control records maintained by the distributor or the wholesaler or the manufacturer, or are you going to do it by spot checking the accounts and various other things or the bottles or compounds in terms of total number of pounds manufactured and what they have in inventory by weight? How are you going to do it?

Mr. RANKIN. This will vary with the factory. We will have bins of raw materials. We will have spot checks. The most significant part of our total effort is that this audit is not the only method of control. We also have criminal investigators out in the field detecting diversions. If we pick up a large amount of drug in illicit channels coming from manufacturer A, that will be a signal to go back to manufacturer A and do an unusually thorough inventory job or audit job.

Mr. CARDWELL. Is it not true, Dr. Goddard, that sampling techniques will be employed? An examiner would also go out and check purchases and suppliers of raw commodities, the raw goods from which these drugs are made. You can check that against manufacturing records and sales and get some test of how much of the end product is a legitimate end product and whether these things match up.

I think in answer to your question, sampling techniques would be employed within each examination.

Dr. GODDARD. At each point in the system.

Mr. FARNUM. Basically, your 40-hour course that you are talking about for making the determination was based strictly upon a records inventory?

Mr. RANKIN. That is right.

UNDERGROUND TRAFFIC IN BARBITURATES AND AMPHETAMINES

Mr. FLOOD. Is the underground engaged generally in burglary of drug warehouses for the purpose of black marketing and whatnot? Dr. GODDARD. I do not know. There have been robberies committed for the purpose of obtaining these kinds of drugs.

Mr. FLOOD. There are cases periodically, but is there anything to indicate a planned attack underground?

Dr. GODDARD. I have no knowledge of this at this point.

Mr. Rankin, do you know of any?

Mr. RANKIN. There have been indications that the traffic in barbiturates and amphetamines has been going underground as increase the pressure on druggists and other normal outlets of supply. Yes, we are finding underground traffic now.

Dr. GODDARD. I suspect this will intensify as the currently used channels become dried up.

CHECKING CLINICS AND PHARMACIES

Mr. FARNUM. With some 400,000 outlets in terms of clinics and pharmacies in the country, and the 16 hours you say it will take to check a pharmacy or a clinic, are you going to have enough staff to do this job within a 3-year period?

Dr. GODDARD. We also will have the assistance of State personnel in this type of activity. We are requesting their help on the pharmacies. Our best estimate now is that with this four-phase program we will have sufficient manpower. We have no operational experience. I must be very candid.

Mr. FARNUM. Is this again a record check?

Dr. GODDARD. To a large extent it is.

Mr. FOGARTY. What would the percentage be?

Dr. GODDARD. I do not know the percentage. The record check on pharmacies.

Mr. RANKIN. We do not have that.

Mr. FOGARTY. In the country how many inspections do you make? Mr. CARDWELL. There are 56,000 retail pharmacies operating in the country.

Mr. FARNUM. It says 65,000 here, and 330,000 clinics. That is 395,000 or 400,000, the figure I used.

Mr. RANKIN. The bulk of the pharmacies and practitioners are law abiding, and they do not divert these drugs into illicit channels. We will follow up initially leads that we get from police departments, informers, and other sources, and concentrate on those areas.

Mr. FOGARTY. What would the percentage be?

Dr. GODDARD. Are you asking in terms of those who engage in illicit traffic, or the percentage that we will examine? Mr. FOGARTY. Yes, both. Supply it for the record. (The requested information follows:)

ESTIMATED PERCENTAGE SAMPLING OF DRUG ABUSE WORKLOADS

Approximately 5 percent of the dispensers (hospitals, pharmacies, etc.) will be inspected on a spot check basis by 1970. The major emphasis in the fiscal year 1967 phase, will be to inspect and audit about 45 percent of the 1,600 manufacturers and 2,400 wholesalers who handle amphetamines and barbiturates.

In the field of hospitals, pharmacies, and doctors, experience will determine in which areas inspections on a spot check basis need to be concentrated. The following table approximates the relative coverage in each area.

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A small number of doctors handle the bulk of these drugs, thus few inspections are planned for this category.

EXTENT OF ILLICIT TRAFFIC

Figures on violations which are available at this time do not reveal the extent of the illicit traffic on a nationwide basis. Such data will become available only as investigational activity increases. Police departments all over the country report that the traffic in dangerous drugs is heavier than ever: in California, according to the State attorney general, dangerous drugs arrests increased 75 percent from 1960 to 1963; the Illinois Division of Narcotic Control reported a 100-percent increase in dangerous drug cases in the same period. These statistics indicate only that the problem of drug abuse is increasing.

ARTHUR D. LITTLE STUDY

Mr. FARNUM. Can somebody tell me what is going on in relation to your systems analysis, which I understand is going full force in FDA? Dr. GODDARD. We are about to receive the final report from the Arthur D. Little Corp. on the second phase of their study of our scientific information system.

Mr. FARNUM. I though they already submitted a report.

Dr. GODDARD. They submitted a first report which indicated the need for further analysis and further detailed work in order to assist us in the development of a proposed information system. That is due this next month.

Mr. SPARER. We have received the final design report.

Mr. FARNUM. There are two parts. The first was a feasibility study. Could I have a copy of the feasibility study?

Mr. SPARER. Yes, sir.

Mr. FARNUM. I do not know whether the chairman or any of the rest of the members want it, but I would like to have it. Could I also have a copy then of the system design which you have signed a contract with them to perform, which they are supposed to render this month sometime?

Mr. SPARER. Yes.

ADP METHODS SUGGESTED BY STUDY

Mr. FARNUM. Do you know whether or not the system design employs new methods of ADP?

Dr. GODDARD. I have not seen their final report. In fact, I was not aware that the final report had been received.

Mr. CARDWELL. There is one thing basic to this system, going back will probably be within the system random access devices. The technique and system. The whole concept is to innovate. There system is centered around the idea of a central retrieval index which

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