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body from which redress can be had in a democratic way, such as is provided by H. Ř. 3298 on page 2, lines 12 to 16, inclusive?

Is it bureaucratic to ask for those who are amenable to a law that its provisions be standardized and clarified so as to enable them to more adequately and more economically serve the public?

Is it bureaucratic to petition Congress to amend the provisions of an existing law which experience has proven to be unworkable, impractical, and confusing so that even those charged with its enforcement cannot adequately interpret its applicability in order to better serve the public health?

I maintain in behalf of the proponents of H. R. 3298 that the assertion made by the opponents that the measure provides unprecedented bureaucratic control is just another smoke screen to becloud the issues and create confusion in the minds of the members of this committee. As a matter of fact, the provisions of H. R. 3298 are not new or unprecedented. In the sections of this act dealing with food standards, misbranded foods, emergency permit controls, and tolerances for poisonous ingredients in food and certification of coal-tar colors, this committee in 1938 wrote into law provisions which left to the judgment of the Administrator to promulgate regulations fixing and establishing, for any food, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of filling of container.

In section 502 (d), dealing with drugs, this committee has already written into the law a list of drugs which are declared to be habit forming as well as the further provision: “or any chemical derivative of such substance, which derivative has been by the Administrator, after investigation, found to be, and by regulations designated as habit forming.

In 502 (h) this committee in 1938 provided and permitted the Administrator, in his discretion, to promulgate rulings dealing with proper packaging and notices of deterioration of drugs, and to contain such precautions as are necessary for the protection of the public health.

In section 507 of this act, this committee also further provided for the Administrator to promulgate regulations for the certification of drugs containing penicillin or streptomycin.

And again in sections 406, 504, and 604 of the act, this committee provided that the Administrator shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in foods, drugs, and cosmetics and for the certification of batches of such colors, with or without harmless diluents.

Why then, when dealing with unsafe or ineffective drugs or devices, which no one will conscientiously maintain should be left to promiscous use by the lay public without the supervision of a licensed practitioner, is it such a radical departure for the Congress in the interest of the public health to provide, as is sought to be provided in H. R. 3298, for a listing of drugs, which after investigation by the Administrator and an opportunity for public hearing, to be declared unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law. Isn't such a provision in line and in harmony with the entire spirit and philosophy of the Food, Drug, and Cosmetic Act? The provisions of H. R. 3298 is a democratic means of regulating interstate commerce in line with the very basis of our extended present constitutional democratic form of government. In this respect, paraphrasing Judge Stephens' stat ment before this committee, which commences on page 432 of the record, with which this witness agrees, and further without bias demonstrates our position when Judge Stephens said: “With the great growth of administrative agencies and the great increase in the complexity of our society, industrially and socially, there is an immense need of regulation and adjudication of a quasi-judicial nature to regulate our interrelated and complex industrial and civic conduct, and we have had to build up these great commissions.”

The proponents of H. R. 3298 therefore maintain that the delegation to the Administrator to select and/or delete a list of drugs which are dangerous or ineffective when used without medical supervision is a proper and from experience a practical as well as a needed delegation in order to safeguard the public health as well as to clarify and standardize interpretations thereunder for a proper understanding by those who are charged with compliance therewith.

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Fifth, the opponents of H. R. 3298 have also raised an objection to that portion thereof which provides for an appeal from the Administrator's ruling proposing a list of drugs or deletion therefrom to the circuit court of appeals, in the manner as is already provided by this committee in sections 701 (f) and (g), with the exception that in the present measure it is provided that an appeal in this respect instead of being conclusive, if based on substantial evidence, shall be without presumptions in favor of either party to such an appeal, that is, it should be in the nature of a trial de novo.

The proponents of this measure hasten to assert that this provision with reference to the manner of an appeal, was recommended by them only after numerous negotiations to palliate the opponents' repeated assertion that in an appeal from an Administrator's ruling to the circuit court of appeals, a litigant goes to the appellate court with three strikes against him.

The proponents of this measure accordingly hasten to assert that they were and are fully satisfied with the provisions of section 701 (f) and (g) of this act, and section 10 of the Administrative Procedure Act, dealing with the scope of review from an Administrator's ruling.

The proponents are in agreement with the statement of Judge Stephens when on page 428 of the record, he said:

"Substantial evidence, I think, is adequate protection, in view of the Administrative Procedures Act, and in view of the Universal Camera case, which requires the court to review the entire record.

And again when Judge Stephens on pages 438–439 of the record said:

“I think that the litigants in court and industry of the country under the supervision of the Administrators, are sufficiently protected by the requirements of Congress under the Administrative Procedures Act and by these new decisions of the Supreme Court, and it can hardly be expected that they would not be fully abided by, because it is recognized that the terms of the earlier review were narrow.

And also on page 440, last paragraph of the record, when Judge Stephens said:

“Thank you, sir. I would like to add just this before I close. I can assure you that the circuit courts of appeals of this country, who are the court of last resort in the Federal system, except in the few cases that go to the Supreme Court, feel a very real responsibility in dealing with these Commission appeals. We feel the same responsibility we do in reviewing the decisions of the United States district courts, to see that the litigrants have had a fair hearing and that the Administrator's findings are supported by substantial evidence and are not arbitrary.

The last-quoted statement by Judge Stephens further illustrates the proponents' unbiased assertion that the provisions of H. R. 3298, dealing with delegation of authority to promulgate a list of unsafe or ineffective drugs, is not to be an arbitrary bureaucratic unchangeable rule, but that such a rule, which must be based on substantial evidence, and lacking this can and will be set aside.

The proponents accordingly suggest that that part of the provisions of H. R. 3298 contained on page 4, commencing on line 11, after the comma is changed to a period, the words commencing with: “Except that an appeal from the Administrator's order issued hereunder shall be in the nature of a trial de novo, without presumptions in favor of either party to such an appeal,” be stricken therefrom.

In conclusion, this witness in behalf of the National Association of Retail Druggists maintains that upon the evidence before this committee, the experiences of the druggists brought to its attention, H. R. 3298 is, in every respect, in the public interest and ought to be enacted into law.

SUPPLEMENTARY STATEMENT WITH RESPECT TO H. R. 3298, FROM Dr. Hugo

H. SCHAEFER, DEAN, BROOKLYN COLLEGE OF PHARMACY AND CHAIRMAN OF THE COMMITTEE ON LEGISLATION OF THE AMERICAN PHARMACEUTICAL AssoCIATION

When Commissioner Paul B. Dunbar of the Food and Drug Administration in his speech before the National Association of Retail Druggists, in October 1948, stated that the Food and Drug Administration considered it unlawful for pharmacists to refill prescriptions of any kind, the American Pharmaceutical Association consulted the law firm of Arnold, Fortas & Porter to ascertain whether such an interpretation of the law was correct and, if not, what could be done to test its legality.

Judge Arnold advised the officers of the association that in his opinion the Food, and Drug Administration was overstepping its authority under the Federal Food, Drug and Cosmetic Act in making such an interpretation. Since the interpretation was not in the form of an official ruling but merely in the form of a statement in a speech, it was decided to ask the administration for an official ruling on the subject, which would be made the basis of an appeal for a declaratory judgment from a court of law and thus provide adequate guidance for the pharmacists of the Nation.

A copy of the communication from Arnold, Fortas & Porter to the Federal Security Administrator requesting such a ruling is attached to this letter. It would be appreciated if you would read this letter, dated August 31, 1950, carefully, as it sets forth the original contention of the American Pharmaceutical Association and asks for relief in the form of a simple, understandable statement for the guidance of the pharmacists of the United States.

Mr. Ewing replied to this letter on September 28 and enclosed a copy of a memorandum from Commissioner Dunbar objecting to the granting of a hearing.

Mr. Ewing set October 5, 1950, as the date to hear argument on the question of whether or not a hearing was to be granted, and I am enclosing the stenographic report of this hearing.

On December 4, Mr. Ewing wrote to us denying our request for a hearing, but issuing a finding with respect to the refilling of prescriptions. A copy of Mr. Ewing's letter of December 4 and the proposed rule making and the press release which accompanied this, are also attached.

Opportunity was given under Mr. Ewing's proposal to submit written comments with respect to the proposed order within 30 days from the date of its publication in the Federal Register on December 6.

Out attorneys filed such a written statement, which is also attached, and we have heard nothing further about the issuance of the ruling since then.

On June 7, 1951, our attorneys addressed another communication to Mr. Ewing, of which a copy is enclosed, setting forth the fact that the original request for a hearing and a regulation on the subject of prescription refilling had been filed on August 31, 1950; an informal hearing had been held in Mr. Ewing's office on October 5, 1950; the proposed ruling had been issued on December 5, 1950; and comment had been submitted by us on January 5, 1951, but that nothing has been heard since.

In the communication of June 7, our attorneys are informing Mr. Ewing that an interpretation of the law with respect to prescription refilling will be circulated to the pharmacists from the offices of the American Pharmaceutical Association after June 15, so that pharmacists may be advised as to how to proceed with respect to renewal of prescriptions.

You will note from the enclosed correspondence and records that our interest lies principally in clearing up the intolerable situation with regard to the refilling of prescriptions which was precipitated by the interpretation given to the law in Commissioner Crawford's speech. The confusing label or "legend” discussion brought about by the inclusion of this proposal in H. R. 3298 has no bearing on the refilling of prescriptions which is the matter the pharmacists of the Nation want to have clarified. Enclosures:

Arnold, Fortas & Porter to Oscar Ewing, August 31, 1950. (See p. 132.)
Oscar Ewing to Arnold, Fortas & Porter, September 28, 1950 (filed with

committee).
Transcript of meeting on October 5, 1950 (filed with committee).
Oscar Ewing to Arnold, Fortas & Porter, December 4, 1950. (See p. 135.)
Press release, December 5, 1950 (filed with committee).
Arnold, Fortas & Porter to Oscar Ewing, January 5, 1951 (filed with

committee).
Arnold, Fortas & Porter to Oscar Ewing, June 7, 1951 (filed with com-

mittee). (Thereupon, at 12 m. Saturday, May 5, 1951, the hearings were concluded.)

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