Hearings, Reports and Prints of the House Select Committee on Small Business

It has been suggested that the clinical data submitted by one firm should be made available to all other firms who might wish to market the same drug. Long standing FDA policy has been that these data, developed and paid for by the first firm and involving reports of investigations using human patients in clinical research, and subjects as well, is privileged information-both because it is business and commercial information and because it is concerned with doctor-patient relationships.

It would reduce much duplicative research to make these data available upon request to competitive firms and to the medical profession, making it usable by all once it has been the basis for a new drug approval.

The present requirements of duplicative research may be particularly difficult for smaller firms with limited research capabilities. Our present policy permits these firms to utilize in their NDA's any published data and any other data that are not privileged. But in such cases, it is required of them that the NDA contain enough clinical data to establish that the drug about to be introduced into widespread clinical use will perform properly when given to a sick patient. This arises out of our knowledge that apparently minor changes in formulation and manufacturing procedures may sometimes affect the clinical behavior of the drug. We must in all cases have sufficient evidence to insure clinical reliability.

And to satisfy the needs of the medical community for reliable prescribing information about all new drugs, it is essential that our new drug approval process continue to give careful attention to the proposed labeling that is to be used in promoting the use of all drugs submitted for approval.

We recognize that a change in policy in opening these files raises legal questions, as well as practical questions about the circumstances under which data developed through privately supported research should be made available by the Government to potential competitors. We also realize that the change in policy would serve the scientificmedical community whenever it has a valid need to examine the detailed scientific basis for our approval of a new drug.

This is indeed such a basic policy question that it deserves the most careful attention of all concerned, including, of course, the Congress. Another area of FDA's responsibilities which I believe is particularly relevant to the committee's considerations concerns our regulatory surveillance of those drugs which are on the market. The Drug Amendments of 1962 established new requirements, and demanded new assur ances, in respect to drug quality. To carry out the new provisions of the law, good manufacturing practices standards were written into our regulations to define the principles of production and quality control that are necessary if drugs are to be reliable, pure, and potent.

These regulations apply with equal force to all drug firms, large and small. It has been said that these requirements favor the big corpora tions, which are better able to afford the investment to establish a good quality control program. We cannot compromise here by minimizing safety controls because of the cost. There is one law, and there can be only one standard of enforcement. We cannot enforce the law in a strong manner among big companies and in a weaker way among small companies. And I might point out, Mr. Chairman, that there are many

small companies which do have sound quality control programs, just as there are large firms in which we find deficiencies.

There is a need for improvement in the drug industry generally in the area of product quality. During fiscal 1966, there were 446 drug recalls; the number of recalls climbed to 651 during the last fiscal year. In addition to our enforcement activities, we have stepped up the effort to encourage voluntary compliance through education. More than 900 firms participated in 22 regional seminars and workshops sponsored last year. There also were five national conferences on good manufacturing practices.

We have also established a National Center for Drug Analysis in St. Louis to act as a control laboratory for the public. Using automated equipment, the newest assay techniques, and a constantly evolving technology, this national center will help our agency keep abreast of industry's output and assure the consumer that drugs in the marketplace are closer to perfection than ever before. The national center is, however, an endpoint; it is after the fact. The samples are collected from commercial channels and provide us with a consumer-level reading of the drug supply. This leaves us with the disadvantage of having to go back through the entire drug distribution system if we find anything seriously wrong with any drug sample.

The national center is currently in its beginning phase, and we are checking out our equipment and giving our chemists and pharmacists additional experience which later expanded efforts will necessitate. Our eventual goal is to analyze many thousands of samples each year. We are making good progress, but it is too early to draw any definitive conclusions from the relatively few samples that have been tested. In the future, however, the reports from the national center, combined with those from our 17 district laboratories, will give a much better picture of drugs throughout the Nation than we have now.

But there is also the question of therapeutic equivalency of identical drug compounds, a subject of growing interest which has a manifold bearing on the cost of drugs. When we speak of equivalency, we mean that when two drugs containing the same quantity of active ingredients are administered, the results should be clinically identical. Unfortunately, there is a lack of scientific data in this area, and it is impossible to say at this time that therapeutic equivalency is certain in all cases. The explosion in pharmacological knowledge we have seen in the last few years and the increased sophistication of our drug supply make it more important than ever for us to assure that all drugs will produce the desired results. Accordingly, FDA will sponsor studies of therapeutic equivalency in about 50 widely used drugs. One such study has already started under a contract with Georgetown University; others will begin shortly. The Public Health Service also is contributing substantially to such studies.

At this time, however, our feeling is that only in a limited number of instances will two drug products with the same active ingredients not produce clinically equivalent results. For most drug preparations, the identical dosage forms seem, for practical purposes, to perform

the same.

It is our purpose to discover the reasons for any drug failures that we learn about, and to eliminate them. We still have much to do in this

field. It will require a great deal of research in the laboratory and in the clinic.

We are anxious to see the day when the quality of a drug product is beyond question, for with that assurance there would be a concrete basis for price comparison and drugs could be prescribed solely on cost basis, if desired.

I have outlined FDA's activities designed to move us closer to the time when complete reliability of our drug supply is assured, no matter what the size or description of the manufacturer.

There is one additional step which I have urged. Education of the physician to the existence of the many drugs available is one of the most important goals we have. To this end, I support the establishment of a drug compendium which would list every available prescription drug product by generic name, with trade names indicated. Price could also be included in such a compendium as a supplement to it. It seems obvious that this is a logical beginning step; we must have a readily available, easily understood, and complete handbook of drugs. It will do much to aid the physician who wishes to prescribe generically. It will do much to put before the prescriber the alternative remedies that are available to him. Included in such a volume would also be the approved prescribing information for drugs in summary form. This information is now disseminated in package inserts, which do little good, for they rarely, if ever, reach the physician for whom they are intended. It is my belief that this valuable tool should be encouraged and undertaken by the private sector. Up to now, however, a beginning has been made only by the FDA, which is currently producing a labeling compendium on microfilm for agency use-this is quite a different kind of compendium from the one described above. I can only urge, again, the creation of a comprehensive, widely available compendium as a vital forward step in the health-care field.

In closing, Mr. Chairman, may I again express my appreciation for this opportunity to appear. We have discussed many controversial areas of concern today, problems which require the attention of scien tists, elected officials, and all those engaged in drug production and formulation. The issues are complex and preclude easy solution. But we have also seen the many measures enacted by Congress to assure a healthy, growing Nation. We at FDA are proud to be a part of the medical-scientific complex involved in these increasingly important health and consumer protection activities.

I would be happy to try to answer my questions which you and the committee may have.

Mr. DINGELL. Doctor, the committee is grateful to you for your presence. I am sure that you will recall that in the years I have had the privilege of working with your fine agency, I have found it to be a remarkable protector of the public interest. In the reports and evidence I have seen of your activity as the head, it is not only continuing, but expanding that fine record.

Dr. GODDARD. Thank you.

Mr. DINGELI. Mr. Potvin has a few questions at this time that he would like to ask.

Mr. POTVIN. Thank you, Mr. Chairman.

Dr. Goddard, I would like, if I may, to show you an advertisement from the October 9 issue of Drug News Weekly. That was placed by a firm, United Research Laboratories, in, I believe, Philadelphia.

Doctor, is there any reason why a pharmacist should not use a firm such as this as their source of supply in dispensing prescription orders da for the drugs listed when they are prescribed generically? The ad indicates that many of the products are FDA certified, and certainly, the prices are most attractive.

I would like, if I may, to point out that we recently had testimony from Dr. Apple of APhA that pharmacists simply cannot compete for VA and OEO business because the Government can buy at a fraction of their cost. As an example, Ciba's bid to Defense Supply Agency in April of this year was $3.95. The winning bid was 90 cents for 1,000 tablets of reserpine. While the price to pharmacists for the same dosage was $39.50, the United price appears to be 58 cents. On the other drugs, there seem to be similar reductions.

The question is, Doctor, why should not pharmacists acting in the public interest, take advantage of this kind of source of supply and pass the savings on to their customers?

(The advertisement referred to follows on page 374.)

Dr. GODDARD. Our objective as an agency is to make certain that exactly that kind of practice can be engaged in by physicians and pharmacists as well, in order to conserve the funds of the public.

Now, in two specific categories where the drugs are certified, there is reasonable assurance that the pharmacist can buy these and expect to have an active agent available. I must point out that we do have problems, and we have not answered the questions scientifically in these other areas, to make certain that there is therapeutic equivalency in all cases. Just enough examples crop up to give me concern.

Now, our objective is by 1971 to be able to assure any physician or pharmacist that he can buy any drug from any manufacturer and it will do the job it is intended to.

Mr. POTVIN. Doctor, let me ask you this: You have indicated that on an interim basis, at least, one cannot always precisely guarantee therapeutic equivalency between manufacturers. Can you advise the committee if United makes the drugs advertised therein?

Dr. GODDARD. No, United is a distributor only, a repackager.
Mr. POTVIN. Despite their name laboratories?

Dr. GODDARD. Yes.

Mr. POTVIN. If they do not, can you advise us which company does make those items?

Dr. GODDARD. No, I would have to look that up.

Mr. POTVIN. Would not pharmacists be able to function more perfectly as purchasing agents if they know who actually made the products?

Dr. GODDARD. If we can provide the assurance that I have indicated as our objective, it really should not matter to the pharmacist who produced the product.

Mr. POTVIN. But in the iterim, sir.

Dr. GODDARD. In the interim, it might or might not be helpful. You see, there is absolutely no assurance that a product from a major firm cannot have the same problems as one from a smaller firm.

Mr. POTVIN. Are not the pharmacists entitled to know so that they can at least intelligently discuss their source of supply when physicians who do want to prescribe generically inquire? It is difficult, after all, to have to say, "Doctor, I really do not know who made the pill."

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