our trade secrets and the irreparable harm we would suffer through their loss. We strongly recommend that section 201 in H.R. 11581 be limited to drugs, since that is the main scope of the bill. If, for some reason not obvious to us, this is not feasible, then we recommend a revision of section 201 be made which would exempt perfumes and fragrances from this broad factory inspection authority.

The CHAIRMAN. It is expected that the hearings on this proposed bill will conclude perhaps today, if not tomorrow. We have a number of witnesses yet to be heard, and we will undertake to get to them during the day.

If the witnesses and the members of the committee will keep this in mind, I think it can be concluded today.

At the conclusion of these witnesses the record will be kept open for a period of 5 days, and under the usual procedure the committee will receive any additional statements that anyone might desire to file. All statements pertinent to this proposed legislation will be received during that period.

The first witness this morning will be Mr. Philip F. Jehle, Washington representative and associate general counsel of the National Association of Retail Druggists.

Mr. Jehle?

STATEMENT OF PHILIP JEHLE, WASHINGTON REPRESENTATIVE AND ASSOCIATE GENERAL COUNSEL OF THE NATIONAL ASSOCIATION OF RETAIL DRUGGISTS; ACCOMPANIED BY JOSEPH COHEN, ASSOCIATE WASHINGTON REPRESENTATIVE

Mr. JEHLE. I am Philip Jehle, the Washington representative and associate general counsel of the National Association of Retail Druggists. As you know, the NARD is a small business organization having a nationwide membership of more than 36,000 community drugstore owners. It is both an honor and a duty for the NARD to speak for these family pharmacists on all Federal legislative matters affecting their professional and competitive interests. Accompanying me this morning is Joseph Cohen, associate Washington representative of the NARD.

I deeply appreciate your kindness in granting this opportunity to offer the views of the NARD on H.R. 11581, the bill amending the Food, Drug, and Cosmetic Act. I do understand the many practical problems involved in arranging to hear the numerous witnesses desiring to testify on the proposed legislation. Accordingly, I shall try my best to keep my presentation this morning brief and to the point. At the outset, Mr. Chairman, I would like to emphasize that the provisions of H.R. 11581 are directed mainly at the pharmaceutical manufacturers; that is, toward those engaged in the research, development, and production of prescription medications. Only in a few instances do the provisions of the measure have a direct application to those engaged in the retail distribution of prescription drugs. This being the case, our comments on the proposed legislation will be limited to those provisions which would have a significant impact upon retail pharmacy. Not having any drug manufacturers as members, the NARD does not presume to speak for them on legislative matters or

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otherwise. We speak only for our 36,000 independent retail pharmacist members.

As briefly as possible, our comments on H.R. 11581 are as follows:

(A) AMPHETAMINE AND BARBITURATE CONTROLS

In general terms, these provisions of the bill are intended to facilitate efforts of the Federal Food and Drug Administration to check illegal trafficking in amphetamines and barbiturates. With this praiseworthy objective, all concur including the NARD. Yet, such a goal, however commendable it may be in itself, should not be used to justify a move by Government officials to obtain more enforcement authority than is actually needed and which may be abused as a result. Specifically, I am referring to that provision which would enable FDA agents to inspect, among other business and professional records, the pharmacist's prescription files. For years, FDA officials have been trying in one way or another to get authority to search the prescription files of the retail pharmacist. Until now, Congress has consistently withheld such authority on grounds that a case for granting it has never been made. This fact, however, has had but little influence upon those intent upon assuming new and broader powers for themselves.

In the view of the NARD, prescription file inspection authority as it is being sought in H.R. 11581 should be denied the Federal Food and Drug Administration for the following reasons:

(1) It is unnecessary: For many years, the inspection of prescription files, including those relating to amphetamines and barbiturates, has been performed competently and diligently by appropriate State authorities. This is true in every State of the Union. It would be both unwise as well as frightfully expensive for the Federal Government to duplicate the fine enforcement work of State authorities. This committee should certainly find out from the appropriate State officials whether they are doing an effective job of inspecting pharmacists' prescription files.

(2) Unaccountably, the prescription file inspection authority being sought in the proposed legislation would cover all pharmacies while, at the same time, expressly exempting all medical practitioners, many of whom do a rather large business in the dispensing of prescription medications. Frankly, the NARD and its members are unable to understand why such unjust discrimination against the profession of pharmacy should exist in this bill. No satisfactory explanation has ever been offered.

(3) FDA agents already have sufficient legal authority to investigate all records including prescription files of any person who may be illegally handling or disposing of amphetamines and barbiturates. Where a search warrant for such investigation becomes necessary, it may be easily obtained by FDA agents. Once probable cause has been shown, the warrant may be issued and the search may begin. Every competent, experienced law enforcement officer would tell you that he has no trouble getting a search warrant when he needs it. I am also confident he would let you know that he is satisfied with existing procedures for obtaining it and has no need of legislative

shortcuts. He is happy to perform his job according to the Constitution.

For this committee to make it abundantly clear that H.R. 11581 does not authorize carte blanche prescription file inspection authority for amphetamine and barbiturate irregularities, a simple amendment may be made. Change line 6 of page 27 of H.R. 11581 to read as follows: "in subsection (b) (3) and (4)" et cetera.

The addition there is (3). That will make it clear that the exemption applies to the profession of pharmacy as well as to the profession of medicine.

(B) PRESCRIPTION DRUG ADVERTISING

Simply stated, these provisions of H.R. 11581 would require all prescription drug advertising, regardless of type of publication or other medium involved, to set forth clearly and fully such "basic information" as the medication's (a) quantitative analysis and generic name; (b) contraindications, and (c) side effects. The apparent purpose of such "affirmative disclosure" is to assure physicians of receiving all relevant information concerning the safety and efficacy of advertised prescription drugs.

In judging the merits of these provisions, our main concern has been the impact they would have upon the advertising of prescription drugs to the Nation's retail pharmacists. For, whether intentional or not, the informational requirements would apply to prescription drug advertising in our NARD journal and to the numerous State and local pharmaceutical association publications. By no means should it be thought that the scope of the challenged provisions would be limited to medical journal advertising.

Of course, the NARD understands and is sympathetic to H.R. 11581's avowed purpose of making certain physicians are fully informed concerning the unfavorable as well as the favorable aspects of all prescription medications. In fact, we are sure this is a universally supported objective. At the same time, however, we do not believe H.R. 11581 is an appropriate means of accomplishing such a laudable purpose. Among the major considerations militating against the proposed legislation in this regard are the following: (1) It would be unnecessary: Physicians obtain information about the therapeutic effects of prescription drugs from recognized professional authorities, such as the Drug Index and the Merck Manual. Pharmacists, too, have their professional sources for such information. They use such sources as the United States Pharmacopoeia, National Formulary, and the United States Dispensatory.

No reputable physician would ever prescribe a medication that he know about only through advertising seen in a professional journal. Nor would a responsible pharmacist base his knowledge of the purpose, safety, efficacy, and dosage forms of a prescription drug upon the manufacturer's advertising statements. To even suggest that physicians and pharmacists would so conduct themselves seems almost scandalous.

Also to be noted in this regard are the FDA administrative regulations which became effective in March of this year requiring drug manufacturers to attach to or enclose with their prescription medicines and devices brochures (package inserts) containing all necessary

information for the sale, effective use of such drugs and devices. Such brochures or package inserts are filed by pharmacists for use in advising physicians of the therapeutic properties and effects of prescription drugs and devices. Through such means, physicians have another ready, competent source of technical information and advice.

(2) It is impractical: In effect, these provisions would compel prescription drug advertisers to ground their advertising copy upon their new drug applications and supporting materials. Although such extensive technical data could probably be condensed somewhat and the salient points extracted for advertising use, the process would be complex and extremely time consuming. As a result, many drug manufacturers would find such advertising inadvisable. Many others would shy away from the formidable legal risks involved in passing upon "full disclosure" or the propriety of the relative emphasis given favorable and unfavorable therapeutic aspects of a particular drug. Drug advertising in professional journals is primarily for "reminder" purposes. It is not intended to be educational, except in a very general way. Drug advertisers recognize the virtual impossibility of using an advertisement to explain in a responsible manner the therapeutic properties and effects of a highly complex prescription medication.

(3) It entails much added expense: Under the provisions of H.R. 11581, lawyers trained in pharmacy and expert in food and drug law, including pertinent sections of the FTC Act, would be needed in passing upon all prescription drug advertising. Similar qualifications would be needed in the case of the advertising copy writers. Such technical authorities would be used by both advertisers and the professional journals. After all, the journal editors and publishers would want to be sure improper drug advertising were never run in their publications. Easily imaginable are the vigorous arguments which would arise between advertisers and publication representatives over whether advertisements complied with the requirements of H.R. 11581.

(C) FACTORY INSPECTION

As drafted, these provisions of H.R. 11581 would empower FDA agents to conduct the broadest kind of search of all places in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, either before or after entry into interstate commerce. Practically speaking, one can hardly imagine Congress granting more unlimited inspection powers over food, drugs, devices, and cosmetics. to any Government agency. Such sweeping language would apply to all food and drugstores and hundreds of thousands of other retail and wholesale distributors handling food, drugs, devices, and cosmetics in any form. Retail pharmacists, as an example, would be faced with an army of FDA agents swarming over their business and professional records, including prescription files. And to refuse an FDA agent an opportunity to inspect would be a crime.

The NARD is opposed to the coverage of retail pharmacists by the factory inspection provision of H. R. 11581 for the following reasons, among others:

(1) Already, all retail pharmacists are subject to inspection of their facilities and records by appropriate State authorities. Those inspections by competent and diligent investigators should not be duplicated

by Federal FDA agents. Duplication by State and Federal agents would also be extremely costly as well as quite burdensome to the affected small drug retailers.

(2) Vague, rambling fishing expeditions by FDA agents should be discouraged by Congress, not encouraged. Advise the FDA inspector to seek a search warrant if the party he wishes to inspect refuses permission for a search.

And I might add that there are very few such instances of a drug retailer refusing an FDA inspector an opportunity to make an inspection, but if the agent believes probable cause exists, he can go to court and a warrant will be issued promptly.

I might add that, even now, most retail pharmacists, virtually all, I might add, are happy to cooperate with FDA inspectors by letting them enter the premises for the desired inspection.

As reviewed by the NARD, the committee should give its earnest attention to an amendment adopted by the Senate Judiciary Committee to exclude retail pharmacies. The text of the applicable amendment is as follows:

(1) Pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs, upon prescriptions of practitioners licensed to administer such drugs, or patients under the care of such practitioners in the course of their professional practice and which do not manufacture, prepare, propagate, compound, or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail.

In conclusion, I think it highly significant to point out that a very large majority of the numerous business organizations appearing during your committee's consideration of H.R. 11581 have agreed upon the desirability of strengthening existing Federal drug laws so as to better protect the public health. Almost all have subscribed to the proposed legislation in both principle and purpose, asking only that the bill be carefully studied and, where appropriate, revised to insure that its provisions not be broader than is necessary to bring about a system of better, safer prescription drugs for the American people. With these views, the NARD concurs. We do believe, of course, that H.R. 11581 should be revised to protect the pharmacists' prescription files from Federal inspection and thus bring the bill into conformity with its Senate counterpart.

Thank you very much, Mr. Chairman.

The CHAIRMAN. Mr. Jehle, on page 3 of your statement you propose a change on line 6, page 27 of the bill. The bill now reads "in subsection (b) (4)," with respect to drugs and so forth, and you suggest that it read "in subsection (b) (3) and (4)"?

Mr. JEHLE. Yes, sir.

The CHAIRMAN. (b) (3), I assume, has to do with pharmacists?
Mr. JEHLE. Yes, sir.

It would refer back to page 23 of the bill, line 16, which reads as follows:

Pharmacies, hospitals, clinics, and public health agencies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine.