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from the order of the Administrator shall be in the nature of a trial de novo, reverses what has been for 20 years or more a uniform trend in the Federal Government to provide for the hearing and decision of appeals from orders of administrative agencies by the courts of appeals upon the record made before the agencies. This procedure has been repeatedly provided for by the Congress, most recently by a law passed at the end of the Eighty-first Congress and approved December 29, 1950, in relation to the review of certain orders of the Federal Communications Commission, the Secretary of Agriculture, and the United States Maritime Commission (Public Law 901, 81st Cong.). That law originated in a recommendation of such legislation by the Judicial Conference.

The considerations underlying the act are stated in House Report No. 2122 of the Eighty-first Congress. The report states that review by the court of appeals of orders of administrative agencies upon the record made before the agencies "has important advantages in simplicity and expedition” over a trial de novo by a three-judge court. From the report I quote pertinent portions as follows:

“First, the submission of the cases upon the records made before the administrative agencies will avoid the making of two records, one before the agency and one before the court, and thus going over the same ground twice

“Second, in many cases in which hearing in the district courts by panels of three judges is now required there will be a large saving of judicial time and energy. It is generally recognized that three-judge courts are not well adapted for conducting hearings. The necessity of holding conferences whenever questions arise in the course of the proceedings, as they repeatedly do in relation to such matters as the admissibility of evidence, very much slows the trial. In addition the proceeding takes the time of three judges, whereas one would be sufficient at this preliminary stage of the case. The method of review prescribed by the proposed bill would secure the collaboration of three judges at the stage where it is useful, namely, in the decision without consuming their time unnecessarily in the preceding phases of the case.

While the practice which was changed by Public Law 901 of the Eighty-first Congress in reference to the agencies there concerned was trial de novo by a three-judge district court and the trial de novo on appeal from orders of the Administrator in the field of the pending bill would be such a trial by three judges of a court of appeals, all the disadvantages of trial de novo by a three-judge court referred to in the report of the last Congress would apply. There would be the same going over the ground twice in two records, the same difficulty inevitable in a court of three judges in conferring upon questions of the admission of evidence and other interlocutory matters arising during the proceedings, thus slowing the trial, and the same absorption of the time of three judges where one would be sufficient. It may be added that in no case at present, with perhaps an occasional extraordinary exception, does a court of appeals sit as a trial court or hear evidence. The present statute which the pending bill would change, provides that even in those instances in which the court allows the petitioner to adduce additional evidence, such evidence shall be taken before the Administrator and adduced to the court rather than taken by the court of appeals directly.

The precedent which would be set by the pending bill of having the hearing on review conducted by the court of appeals as a trial de novo would be a radical departure. It would be contrary to the general judgment in reference to the effective procedure for the review of orders of administrative agencies as expressed in the report and law of the last Congress which have been cited. Such a change of method at this time when there is serious congestion in a number of Federal courts would tend to increase the present difficulties and delays in the handling of the judicial business. Sincerely yours,




Washington, D. C., April 12, 1951. Hon. ROBERT CROSSER,

House Office Building, Washington, D. C. DEAR CONGRESSMAN CROSSER: In further reference to the bill to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act (H. R. 3298) about which you inquired of me on March 22, 1951, I would point out that the provision for judicial review of actions of the Administrator contained in the next to the last paragraph of subsection (b) of section 503 of the statute as proposed to be amended

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(p. 4, lines 11 to 14 of the bill) is in conflict with the criterion prescribed in such long-considered and deliberate enactments of the Congress as the Administrative Procedure Act approved June 11, 1946 (60 Stat. 237), and the Labor-Management Relations Act, 1947, commonly known as the Taft-Hartley Act approved June 23, 1947 (61 Stat. 136). The legislative policy in reference to the weight to be given to the decisions of administrative agencies by the courts and the evidence necessary to sustain them were recently considered at length by the Supreme Court of the United States and reviewed in detail in the case of Universal Camera Corp. v. National Labor Relations Board (No. 40 at the present term of the court). At the same time the court rendered a brief corollary opinion applying the same standard of review in the case of National Labor Relations Board v. Pittsburgh Steamship Co. (No. 42 at the present term of court). Briefly, the development of the standard to be applied by the courts on the review of orders of administrative agencies as set forth in the opinion in the case of the Universal Camera Corp., supra, is this:

The original National Labor Relations Act, commonly known as the Wagner Act, provided in section 10 (e) in reference to the judicial review of decisions of the National Labor Relations Board that, “The findings of the Board as to the facts, if supported by evidence, shall be conclusive." (49 Siat. 449, 454, 29 U. S. C. 160 (e)).

The Supreme Court in Washington, V. & M. Coach Co. v. Labor Board (301 U. S. 142), construed "evidence' to mean substantial evidence. In the early years of application of the Wagner Act the opinion became current that on judicial review of an order of the National Labor Relations Board, if there was in the record made before the Board evidence which taken by itself would justify the Board's decision, that would be enough to satisfy the tesü of substantial evidence irrespective of other parts of the record. The Supreme Court in its opinion supra siated that there were expressions in some of the opinions of that Court which were cited (Labor Board v. Waterman Steamship Corp., 309 U. S. 206; Labor Board v. Bradford Dyeing Assn., 310 U. S. 318; and Labor Board v. Nevada Consolidated Copper Corp., 316 U. S. 105) that whether or not so contemplated gave color to that view.

The doctrine stated brought criticism which was reflected in the passage in 1940 of the Walter-Logan bill. Even so, the bill adopted the test for judicial review of orders of administrative agencies which was expressed in the Wagner Act as construed by the Supreme Court, that the findings of fact by an agency could be set aside by a court if “not supported by substantial evidence.' President Roosevelt vetoed the bill partly because it limited too strictly the administrative process and partly because an experienced committee appointed by the Attorney General of the United States was then engaged in a study of the actual operation of the administrative process. That committee submitted its final report in 1941. The majority report observed that there was dissatisfaction with the fact-finding procedures then being used by administrative bodies but concluded that it would be inadvisable to depart from the test on judicial review of substantial evidence which then applied to the review of orders of administrative agencies. Three members of the committee, however, registered dissent on the ground that the recommendations of the committee did not go far enough to correct defects in the procedures of administrative agencies. Among other things, the dissenting members of the committee recommended as one principle of judicial review applicable generally to administrative agencies, that review should extend to "findings, inferences, or conclusions of fact unsupported, upon the whole record, by substantial evidence.The Supreme Court in the Camera Corporation case supra states that reference to the whole record appears for the first time in the recommendation of the minority of the Attorney General's committee. The opinion of the Court goes on to state that this idea found its way into the Administrative Procedure Act enacted in 1946 (pp. 6–8 of the opinion in the Camera Corp. case supra). So the Administrative Procedure Act in section 10 (e) provided that on judicial review the Court should hold unlawful and set aside agency action if,

"(5) unsupported by substantial evidence in any case subject to the requirements of sections 7 and 8 or otherwise reviewed on the record of an agency hearing provided by statute; or (6) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court. In making the foregoing determinations the court shall review the whole record or such portions thereof as may be cited by any party, and due account shall be taken of the rule of prejudicial by substantial evidence" shall "review the whole record or such portions thereof as may be cited by any party.” In short, in adopting the Administrative Procedure Act the Congress did not do away with the presumption on review in favor of the decision of an administrative agency if supported by substantial evidence, but made it unmistakably clear that the reviewing court in determining whether there was substantial evidence to justify the conclusion must take into account the whole record, or any portions cited by any parties which doubtless would be all the pertinent parts.

(50 Stat. 244, 5 U. S. C. 1009 (e).) It is important to note that the statute requires that a court in determining whether or not an order of an administrative agency under review is "unsupported


The Supreme Court in its recent opinion in the Camara Corporation case points out that the amendment of the Wagner Act by the Taft-Hartley Act adopted in effect the same standard for judicial review of decisions of the National Labor Relations Board, that was prescribed for administrative agencies generally by the Administrative Procedure Act. The provision of the Taft-Hartley law appears in section 10 (e) that the findings of the National Labor Relations Board "with respect to questions of fact if supported by substantial evidence on the record considered as a whole shall be conclusive.” (29 U. S. C. 1946 ed., supp. III, 160 (e).)

The Supreme Court points out in the Camera Corporation case that the effect of the Administrative Procedure Act and the Labor Management Relations Act, 1947, has been to require reviewing courts to carry the scrutiny of decisions of administrative agencies farther than was thought in some legal circles to be necessary prior to the passage of the Administrative Procedure Act. Upon this the Court said:

“Whether or not it was ever permissible for courts to determine the substantiality of evidence supporting a labor board decision merely on the basis of evidence which in and of itself justifịed it, without taking into account contradictory evidence or evidence from which conflicting inferences could be drawn, the new legislation definitively precludes such a theory of review and bars its practice. The substantiality of evidence must take into account whatever in the record fairly detracts from its weight. This is the clear meaning of the reference in both statutes to the whole record.' Committee reports and the adoption in the Administrative Procedure Act of the minority views of the Attorney General's committee demonstrate that to enjoin such a duty on the reviewing court was one of the important purposes of the movement which eventuated in that enactment."

The Supreme Court is careful to point out in its recent decision that it does not mean that in reviewing the decision of an administrative agency a court shall consider the record before the agency de novo and substitute its judgment for that of the agency. The Court expressed its meaning upon the necessity of considering “the whole record” as follows:

“To be sure, the requirement for canvassing 'the whole record in order to ascertain substantiality does not furnish a calculus of value by which a reviewing court can assess the evidence. Nor was it intended to negative the function of the labor board as one of those agencies presumably equipped or informed by experience to deal with a specialized field of knowledge, whose findings within that field carry the authority of an expertness which courts do not possess and therefore must respect. Nor does it mean that even as to matters not requiring expertise a court may displace the board's choice between two fairly conflicting views, even though the court would justifiably have made a different choice had the matter been before it de novo. Congress has merely made it clear that a reviewing court is not barred from setting aside a board decision when it cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the board's view."

The provision of the pending bill that the review before a court of appeals of a decision of the Administrator under the Federal Food, Drug, and Cosmetic Act "shall be in the nature of a trial de novo, without presumptions in favor of either party” is plainly contrary to the policy of the Congress deliberately adopted in the Administrative Procedure Act after years of discussion and consideration and followed in the Taft-Ilartley law. That policy is that the judicial review of orders of administrative agencies shall be upon the record made before the agencies and not in the nature of a second trial, and that if the action of the agency is supported by substantial evidence when considered in the light of the entire record, it shall stand. It would seem that the Congress might hesitate to change a policy based upon experience and finally crystallized in outstanding legislative acts, as the pending bill would do. Sincerely yours,




Mr. DURHAM. Mr. Chairman and members of the committee: First, I should like to thank the chairman and the members of the committee for this hearing. I know full well how busy you are, as all of us are; but I do think it is an important matter not only to us druggists, but it concerns the field of medicine, the dispensing of medicine throughout the United States.

There are approximately 52,000 drug stores in this country and approximately 110,000 druggists who dispense most of the drugs in the country. * I should like to say for the record also that I have myself been a registered pharmacist for more than 30 years, active in the drug business for almost that number of years; and so my background is in this field of pharmacy.

In my opinion, the Federal Food and Drug Act, which we are going to talk about here this morning, has been an excellent piece of legislation. I believe I can say this as a fact, that the pharmacists, beginning in 1906, when this law was enacted, have always favored the act. That is true again in 1938 when the act was revised by this great committee and again in 1944 when it was amended.

For many centuries we in America depended upon Europeans for most of our basic and fundamental research in the field of drugs and chemicals. Over the past few years we have seen a shift of that responsibility to us here in America and therefore it has thrown a great responsibility on the profession of pharmacy, in the name of public health, in the matter of the dispensing of the drugs.

New drugs have been flowing into the channels of commerce by the thousands. In my opinion, this will be accelerated in the future because of the fact that more effort and more money and better personnel are seeking ways and means, not only to protect humanity from disease but also to prolong life by application through basic and fundamental research. Today, the sciences of biology, physiology, and pharmacology are of greater importance than ever before in the history of mankind. The pharmacist, of course, is interested in the public health and he is stationed at various strategic points throughout the country.

I introduced into the Congress H, R. 3298, a bill to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act. A companion bill was introduced in the Senate by Senator Humphrey. The purpose of the bill is to eliminate the detrimental confusion that exists at the present time and that handicaps the profession of pharmacy in its efforts to provide adequate service to the public.

The Food and Drug Commissioner, Dr. Paul B. Dunbar, in an interpretation of the law, holds that once a prescription has been filled it is "like a canceled check” and therefor that it is unrefillable. He insists that a new written prescription from the prescriber is required before a pharmacist can provide another supply of medicine.

Also it has been held that a legal prescription must be in written form and in the handwriting of the prescriber. Thereby a physician is prevented from giving an oral prescription to a pharmacist; and the use of the telephone is barred for the transmittal of a prescription from a physician. The proposed measure will legalize modern methods of communication in the field of medicine. The oral prescription is safe and in line with the welfare of the public, in my opinion. My bill leaves untouched the present necessary restrictions on narcotics.

The Food, Drug, and Cosmetic Act was enacted to protect the public from deleterious drugs and those considered to be dangerous for lay consumption except on diagnosis and under the supervision of a medical practitioner. In this I concur most heartily.

Here is what the Durham-Humphrey bill allows, which is not permissible now:

(a) A pharmacist may receive an oral prescription from a practitioner, put it down in his own handwriting, compound or dispense it, and the pharmacist's own handwriting constitutes an authorized prescription or order from a practitioner licensed by law to administer the prescribed drugs (narcotics excepted).

(6) Nonrestricted drugs—that is, those which it is permissible to sell across the counter may on the request of a customer be refilled without authorization from the prescriber.

(c) Drugs which are restricted by the prescription legend may be refilled on an oral or written order from a practitioner licensed by law to administer the prescribed drugs. If it is an oral order the pharmacist again reduces it to written form.

(d) The Administrator of the Federal Security Agency will determine what medicants shall carry the prescription legend. Likewise, he will stipulate those medicinals for which adequate directions may be written. Provision is made for the manufacturer to present his views in person or through a spokesman or by a written statement to the Administrator. Then within 90 days after the Administrator has issued an order on the decision he has made, the manufacturer (or any other interested person) may carry the decision to a United States Court of Appeals.

(e) The Federal Security Agency may remove drugs from section 505 of the present law when he finds it is unnecessary to keep them there for protection of public health.

() The proposed new legend—that is "Caution-Federal law prohibits sale or dispensing without prescription"—is much more explicit than the one now in use.

The bill will solve various troublesome problems of the profession of pharmacy and at the same time provide adequate protection for the public. Also it is in line with the advancement of modern therapeutics. Furthermore, it legalizes the traditional relationship of the physician and pharmacist with the patient.

The improvement in the field of drug administration by the manufacturers, physicians, and pharmacists, and also by those who have spent their lives in laboratories searching for improved production is, in my opinion, for one purpose—for the public in general.

The prescription-drug law of the Food, Drug and Cosmetic Act is essentially in section 503 (b); and, of course, it finally applies to the dispensing of such a drug by the pharmacist. It exempts a drug dispensed on the prescription of a physician, dentist, or veterinarian from specified label requirements of that act; but it only does so within certain limitations. They are: (1) the drug must not be dispensed pursuant to a mail diagnosis; (2) the prescription must be in writing and signed by the prescriber; (3) he must be licensed by law to

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