Dr. GODDARD. There is close cooperation between our investigative agents and the agents of the Bureau of Narcotics and responsible State agencies where this is indicated.

I personally met with the Director of the Bureau of Narcotics within the past week, and there are many instances in the past where there have been collaborative efforts aimed at stopping the illicit traffic of drugs that come primarily under our jurisdiction, so we exchange information frequently.

Mr. FLOOD. Do you work with State people who enforce State laws in these general areas?

Dr. GODDARD. Yes, we do, sir.

COOPERATION WITH THE FEDERAL TRADE COMMISSION

Mr. FLOOD. Do you work with the Federal Communication people, if anyone can work with them, on these weird TV advertisements"This is not a sleeping pill, this does not put you to sleep, this simply lets you sleep"?

Dr. GODDARD. We provide information to the Federal Trade Commission and the code authority.

Mr. FLOOD. I am not naming any particular product.

This is not a sleeping pill. This is not a narcotic. This is not a drug. This does not put you to sleep. This merely helps you sleep, like a punch in the mouth.

What about that sort of thing?

Dr. GODDARD. We are jointly considering these kinds of problems with the Federal Trade Commission.

Mr. FLOOD. This is semantics. Is this not a narcotic? Is this not a drug? What is a drug?

Dr. GODDARD. It is not a narcotic, sir.

Mr. FLOOD. What is a narcotic as distinguished from a drug? Dr. GODDARD. A narcotic has the quality of being habituated with its continued use. One becomes dependent on it.

Mr. FLOOD. It has to produce that condition. If it does not do that, it is merely some kind of a drug?

COUNTERFEIT DRUGS

What is a counterfeit drug?

Who are you?

Mr. RANKIN. I am Acting Deputy Commissioner.

Mr. FLOOD. How long have you been around?

Mr. RANKIN. I have been with the Food and Drug Administration for 26 years.

Mr. FLOOD. Go ahead and talk.

Mr. RANKIN. A counterfeit drug is a drug that is manufactured to imitate an established drug product.

Mr. FLOOD. A clandestine manufacturer?

Mr. RANKIN. Generally, it is a clandestine manufacturer. The drug generally also is manufactured under poor control conditions. We have even found counterfeit drugs being manufactured in the basement of a private residence, in garages, or in attics under deplorable conditions. The problem with counterfeit drugs is that because of the poor manufacturing conditions we must expect periodically

bad batches will be put out which will cause harm. This is in addition to the economic problem.

Mr. FLOOD. Do they counterfeit the whole package or just the drug?

Dr. GODDARD. We have found the whole package being counterfeited.

Mr. FLOOD. They would have to counterfeit the whole package, or there would not be any point to it.

Dr. GODDARD. That is right.

Mr. FLOOD. They are produced under conditions that invite filth. Dr. GODDARD. Low potency, or even the incorporation of the wrong drug in the tablet, or other medication.

Mr. FLOOD. How do they market a thing like that? Here is a drugstore, or a physician. Is it just corruption and bribery? Why would a druggist who knows and buys from BC & D company, and knows the drug, buy from Joe Zilch?

Mr. RANKIN. We broke up a counterfeit ring a few years ago operated by a man and his son, the Palmers, in the Midwest.

Mr. FLOOD. I remember reading about that.

Mr. RANKIN. They secured counterfeit drugs. They put them up in packages that looked like the genuine articles and then traveled from one drugstore to the other and they represented to the purchaser that through special buying arrangements they had been able to get a special price so they offered the drugs at a special price.

Mr. FLOOD. They were con men besides?

Mr. RANKIN. They were con men. I am not trying to excuse the druggists who bought. They ought to have sense enough to know you do not get good drugs at a very low price.

Mr. FLOOD. Is this much of a problem?

Mr. RANKIN. It is a periodic problem.

Counterfeiting will spring up. We will take care of it and then for a few years we do not hear of it and it springs up again.

Mr. FLOOD. When some sharp character gets an idea, you have a problem?

Mr. RANKIN. That is correct.

SELF-POLICING OF LARGE PHARMACEUTICAL HOUSES

Mr. DUNCAN. Along that same line, it has always seemed to me as far as the major pharmaceutical houses are concerned this business ought to be largely self-policing.

Dr. GODDARD. It is my impression that the major pharmaceutical manufacturers are concerned that their image remain good and they do attempt to protect their buyers in terms of producing a good product.

REVIEW OF EVIDENCE ON PROPOSED DRUG

Mr. DUNCAN. If Squibb or any of the rest of them should submit a new drug and in your justification you say it is quite common now to have 10 or 20 volumes of supporting evidence do you have to go through all those experiments again, or do you just check their technology?

Dr. GODDARD. We do not go through the experiments again.

May I also add that the same attitude I have found exists in small manufacturers, some of whom I have met. They are anxious that

their reputation be preserved. Size alone is not a determinant. We do not redo the experiments. We review the protocols they have submitted so we understand the methods used to arrive at their conclusions.

We determine whether or not the conclusions that they have arrived at are supported by the raw data they have submitted. Then we review the labeling they propose to accompany the product to determine whether this is consonant with the scientific evidence submitted.

Mr. DUNCAN. Do they submit samples of their product along with their justification?

Dr. GODDARD. No; except in certain areas, certain categories of drugs may have samples accompanying it.

Mr. DUNCAN. So when that occurs, you will make a chemical analysis of it?

Dr. GODDARD. That is correct.

REASON FOR BATCH CHECKS

Mr. DUNCAN. That brings me to this next subject that you mentioned that you have to have batch checks, or lot checks.

Dr. GODDARD. That is on special products.

Mr. DUNCAN. Not on all of these drugs?

Dr. GODDARD. No, sir; specifically we do it on insulin products and antibiotics. The rationale is that the product must possess certain potency in order to protect the patient, a diabetic, against a sudden rise in blood sugar.

If the potency varies too greatly, it can be life-threatening to the diabetic.

In the antibiotics, the physician, if he is using what he assumes to be a potent antibiotic and has in fact one which varies beyond the allowable limits, the patient's illness may progress to a point where recovery cannot occur, so it is necessary to have these kinds of batchby-batch certifications take place for which the manufacturers are charged a fee directly related to the task performed.

PILL-BY-PILL CHECKS

Mr. DUNCAN. I see in here somewhere that you occasionally have to make pill-by-pill checks because there will be variations within lots. The immensity of this job you people have appalls me.

Is this pill-by-pill check in the same type of product, insulin, for example?

Dr. GODDARD. That is on the sample itself rather than on every pill manufactured, which would be impractical.

Mr. DUNCAN. I would think so.

You do not have to get into cough medicines and aspirin tablets and things of that sort?

Mr. CARDWELL. This is just where the law requires that samples be taken. There are specific provisions in law that require this kind of sampling.

Mr. RANKIN. There are some pill-by-pill checks in other products where a variation from one table to the other would be of significance to the patient.

Mr. DUNCAN. Those are spot checks, I suppose?

Mr. RANKIN. Yes.

ENORMITY OF THE TASK FACING FOOD AND DRUG ADMINISTRATION

Mr. DUNCAN. Is there any indication your job is getting any easier, aside from the multiplicity of new drugs that are coming in?

Are you in a position to say these companies are becoming selfpolicing at all?

Dr. GODDARD. I am studying this problem now because I am also aware of the enormity of the task. So far, I have-not seen any evidence that would say that the job is getting easier.

Mr. FOGARTY. It is going just the other way, I should think.

ZERO TOLERANCE

Mr. DUNCAN. On the pesticides, I served on the Agriculture Committee, and I still get considerable correspondence on the question of zero tolerance. I have been told that the problem arises because the detection equipment used on products which formerly had zero tolerances attached to them, was being constantly improved and now you have machines that are smarter than the ones you used to have.

Are you at the same time, in addition to developing more refined instrumentation, reanalyzing the question of tolerances and whether the zero tolerance items ought to have some tolerances attached to them?

Dr. GODDARD. Yes; we are specifically studying this question at the present time.

Mr. DUNCAN. In conjunction with the Department of Agriculture, I assume.

Dr. GODDARD. Yes.

Mr. DUNCAN. We can look forward to a report on that in whata year?

Dr. GODDARD. Less than that. I would estimate within approximately 60 days.

IMPLANTATION OF GROWTH-STIMULATING SUBSTANCES

Mr. DUNCAN. Then I had a letter the other day along the line of one of Mr. Flood's questions, about implantation. This chap, a veterinarian, was convinced that testosterone-these little pills you stick in the steer's neck

Dr. GODDARD. It is estrogen on the steers, stilbestrol on the capons. Mr. DUNCAN. Whatever it is, he was firmly convinced that the meat produced by these growth-stimulating substances was not fit for human consumption, that it was watery. Have you any comments on that?

Dr. GODDARD. This matter is one of the reasons for our Bureau of Veterinary Medicine's existence, to provide the technical competence to maintain surveillance over this field.

Mr. FOGARTY. The question, as far as fowl are concerned, came up a few years ago. It was found that if they injected it into poultry the residue was found in the meat, but in beef cattle it did not seem to affect the meat.

Mr. RANKIN. At that time, on beef cattle very sensitive analytical methods failed to show residues of the stilbestrol in the edible parts of the animal. The reason the pellet is implanted in the ear is because the ear is discarded from the beef.

Mr. FOGARTY. But in chickens it was different.

Mr. RANKIN. We found residues in the chickens and had to stopthe use of the material in them.

Mr. DUNCAN. You found no residue of this substance in the meat. in beef?

Mr. RANKIN. That is right.

Mr. DUNCAN. What about the quality of the beef? Have you gone into this question at all? Has it ever gotten down to the point. that it is undesirable even esthetically?

Mr. RANKIN. That is a matter that the Department of Agriculturelooked into. It is my recollection that Agriculture did not find a deterioration in quality, but we should defer to them for the answer.

Mr. DUNCAN. The only argument I have heard up to this point is between the breeder and the feedlot operator as to who was going to get to put the pill in and get the benefit of the gain. Now there is some indication that there is a health problem there.

Mr. RANKIN. We are not aware that there is a health problem in this area. We do not have evidence indicating that.

ACTIVITIES TO SUPPLEMENT PRESIDENT'S COMMITTEE ON CONSUMER INTERESTS

Mr. DUNCAN. You have quite an elaborate consumer information and education program involving labeling and public education, senior citizens and those who speak foreign languages, special lowincome groups. Is this limited to drugs, or does this go into the general field of food?

Dr. GODDARD. It goes into both foods and drugs. It is an acrossthe-board program for consumers.

Mr. DUNCAN. Does this not get into Mrs. Peterson's field? She was in here this morning wanting a few dollars to expedite her work in the field of consumer protection.

Dr. GODDARD. We do work with Mrs. Peterson in this, and make certain that our efforts supplement rather than duplicate hers.

PHENACETIN

Mr. DUNCAN. What is phenacetin? Is that one of those Dramamines?

Dr. GODDARD. It is a compound that has been available and used in medications for many years. It antedates the compound that you are mentioning. I believe it is a coal tar derivative. It is an analgesic used for the relief of pain.

Mr. DUNCAN. Is this one of those that you are reinvestigating, which has been approved since 1938?

Dr. GODDARD. No; not reinvestigating it, to my knowledge.

Mr. RANKIN. It was on the market before 1938.

Mr. DUNCAN. You are doing something with it on page 39. You are investigating it because you found kidney damage associated with overuse.