EXHIBITS PROVIDED BY THE DRUG RESEARCH BOARD, NATIONAL ACADEMY OF SCIENCES

STATEMENT BY James A. Pittman, Jr., M.D., Executive Dean
University of Alabama School of Medicine, Birmingham, Alabama 35294,

BEFORE SUBCOMMITTEE ON MONOPOLY;

SENATE SMALL BUSINESS COMMITTEE

on 16 May 1975.

Mr. Chairman and Members, I am glad to comply with your request to appear before you to discuss interprofessional relations between physicians and pharmacists with particular reference to drug antisubstitution laws. Your letter to me of April 29 requested that I discuss the following:

"(a) the development of the Drug Research Board resolution concerning

drug substitution;

"(b) the respective role of the physician and pharmacist;

"(c) the need for justification by the physician when he designates

a more expensive product of a specified manufacturer;

"(d) the cause of the conflicting and confusing reports appearing in the medical and pharmaceutical press, as well as the pressures exerted by various outside interests on the deliberations of the Drug Research Board;

"(e) any change in the NAS/NRC position since the promulgation of

the original resolution on January 21, 1975."

I must emphasize that I speak only for myself and cannot represent the entire DRB (Drug Research Board), the NRC/NAS (National Research Council/ National Academy of Sciences) or any other organization, institution, group, or individual. Furthermore, I speak as an individual physician who has practiced medicine for more than 20 years, during which time I have myself written plenty of prescriptions.

follows:

With regard to item (a), the resolution under discussion is as

RESOLUTION OF THE DRUG RESEARCH BOARD WITH REGARD TO DRUG PRODUCT

ANTI-SUBSTITUTION LAWS

1. WHEREAS, The patient's welfare should be the ultimate goal of statutes and regulations concerning drug product selection, which in operational terms means the best product for the lowest cost, and

2. WHEREAS, The physician must have the ultimate responsibility and authority in drug product selection, since he has the fullest knowledge of the patient's needs and responses with attendant obligation to be held accountable for his selection of particular drug products, and

3. WHEREAS, The pharmacist may, in some situations, have greater knowledge of drug products than other health professionals, including knowledge of both quality and costs, and

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4. WHEREAS, It is appropriate that decisions with regard to the choice
of drug products be made by the health professional possessing the
greatest amount of information involved in the particular selection
in question, with the attendant accountability, therefore be it

5. RESOLVED, That the physician, having selected the chemical entity
to be used for therapy, should be required either to delegate to the
pharmacist, or explicitly to retain to himself, selection of the particular
drug product to be dispensed and received by the patient.

Washington, D. C.

25 October 1974

This resolution was approved by the DRB at its regular fall meeting 25 October 1974. Thirteen of the 14 members present at that meeting voted in favor of the resolution. The fourteenth member, Dr. Richard Crout, abstained because of his position as Director of the Bureau of Drugs of the FDA (Food and Drug Administration).

The chronology of the seven formal meetings involved in the development and promulgation of the resolution was as follows:

1) 11 July 1973 - At an executive meeting between representatives
of the DRB and of the PMA (Pharmaceutical Manufacturers
Association) it was suggested that the DRB might review
existing drug antisubstitution legislation, with a view
to endorsing existing legislation and strengthening the
stand against attempts to change it.

2) 30 November 1973 - At another executive session of DRB
and PMA representatives a draft resolution was passed
which strongly endorsed existing antisubstitution laws.
3) 25 March 1974 - The draft resolution was presented to
the full DRB at its regular spring meeting. During the
discussion the liaison representative of the APhA
(American Pharmaceutical Association) to the DRB
objected on two grounds: that the DRB misunderstood
the position of the APhA on drug prescribing and dispens-
ing, and that the APhA had not had an opportunity to
present its case, while the PMA had. Chairman of the DRB
appointed two representatives from DRB, Dr. Hugh Hussey of
the AMA (American Medical Association) and myself to meet as
an ad hoc committee with representatives from the APhA.

4) 21 June 1974 - A meeting of this DRB ad hoc committee and APhA representatives was held. Dr. Hussey and I had expected exhortations but instead were impressed by the data presented by the APhA representatives (see below); a revised draft resolution was prepared and endorsed by both DRB representatives (see below).

5) 26 September 1974 A joint meeting was held of representatives of DRB, APhA, and PMA. Another draft of the resolution was prepared and worked over in considerable detail. It contained six points, the last of which stated that any financial savings resulting from the altered procedures should be passed on in full to the patient. Despite considerable discussion of possible mechanisms, those attending this meeting concluded that it would probably be unwise to include details of operational mechanisms for the actual prescribing in the recommended resolution (see below).

6) 25 October 1974 - A formal resolution drafted from the minutes of the meeting of 26 September was presented to the full DRB at its regular fall meeting. The anticipated presentation to the DRB had been announced prior to the meeting on the agenda, mailed to the DRB members before the meeting, as "Resolution on Antisubstitution Legislation." After further discussion and reworking of the exact wording, the resolution was adopted unanimously by the DRB, with Dr. Richard Crout abstaining because of his position in the FDA (Food and Drug Administration). Four regular members of the DRB were absent from this meeting (Drs. Calabresi, Drill, Hodges, and Papper).

7) 14 March 1975 - At the regular spring meeting of the DRB
there was heated discussion of the resolution, largely
from DRB members who had missed the October 25 meeting.
Uninvited officials of the AMA obtained last minute
permission from the DRB Chairman to appear and presented
statements against the resolution. After much discussion,
there was another vote on the unchanged resolution, and
its adoption was confirmed by a vote of 13 to 1. However,
the discussion was continued, and finally a "clarifying
statement" was adopted, which included in the terminal
sentence the statement that the DRB did not intend to take
a position on antisubstitution laws.

A more complete chronology is given in the appendix.

I shall add further comments on several of these meetings and related

discussions.

The draft resolution passed at the executive session between representatives of the DRB and the PMA on 30 November 1974 stated strong opposition to any legislation that would contravene the physician's right to choose specific drugs and recommended that, if the Assembly of Life Sciences (ALS) concurred, the sense of that resolution be transmitted to the relevant government agencies and professional groups.

The data presented at the meeting of 21 June 1974 were interesting and are probably unknown to most physicians of the United States. They show that, although a given chemical entity, such as chloral hydrate or tetracycline, may be dispensed under the brand name of a major company or by a smaller less well known company, and although these may vary widely in cost to the customer, these differences do not preclude the fact that all of these can have been made in a single laboratory unidentified to the customer. These data, which were published in the journal California Pharmacist in October and November 1973 and February and March 1974, were presented in part to you at your hearings of February 21, 1974 (Hearings before the Subcommittee on Monopoly of the Select Committee on Small Business, United States Senate, Ninety-Third Congress, Second Session, on Present Status of Competition in the Pharmaceutical Industry, Part 24, pages 10168 through 10172).

In particular, data such as those immediately below impressed us:

In the case of chloral hydrate there were recorded 17 distributors with prices varying from $1.48 per hundred to $5.00 per hundred, implying some sort of qualitative differences, despite the fact that all 17 had been manufactured in a single laboratory R. P. Scherer. Thus, differences in brand name and price do not quarantee differences in manufacturer, and it is difficult to believe that there are really any important differences between the various brands made in the same place by the same process.

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On the other side of the coin, the APhA representatives at the meeting of 21 June 1974 presented data showing a change in active ingredient despite continuation of the same trade name. Thus, "Liquiprin" suspension (Thayer) formerly had salicylamide as the active ingredient; but this was changed to acetaminophen with no change in trade name, which remained "Liquiprin" suspension (Thayer). They also presented data showing that the manufacturer of a given drug product might change with no change in the trade name and other data showing that a single manufacturer sometimes marketed a single entity under two trade names. I shall attach copies of the 4 tables handed out by the APhA representatives at this meeting of 21 June 1974.