AMENDING THE FEderal food, drug, AND COSMETIC ACT 35 small price to pay for judicial review which would effectively control abuses in the exercise of the vast adininistrative power which this bill proposes to grant to the Federal Security Administrator. The majority report, apparently on the basis of views stated in letters from the Federal Security Administrator and the Deputy Attorney General of the United States, expresses doubts as to the constitutionality of any provision providing for judicial review of the Administrator's action in a de novo proceeding, on the ground that this would seek to have Federal "constitutional" courts exercise an improper function-that is, one which is legislative or administrative in character, and therefore "nonjudicial." The views expressed in the letters referred to are based upon a decision rendered by the Supreme Court in the General Electric case (281 U. S. 464) which was decided in 1930. That case held that the Supreme Court (being a "constitutional" court, i. e., one which, because created under the judiciary article of the Constitution, can exercise only "judicial" powers) could not be vested with the power to act as a "superior and revising" administrative agency in reviewing a decision of the Court of Appeals of the District of Columbia (which is not a "constitutional" court) in a case, arising under the Radio Act of 1927, in which the latter court had exercised de novo review of action taken by the Federal Radio Commission. This, the court said, was because it could exercise "judicial powers only," and could not "exercise or participate in the exercise of functions which are essentially legislative or administrative." The argument is that since United States courts of appeals and United States district courts are "constitutional" courts the principle of the General Electric case applies to them, although this specific question has never been judicially decided. However, even if this is so, de novo review of the Administrator's action would not be barred by the principle of the General Electric case. This is because of the difference in the nature of the function which the court would exercise. In the General Electric case the basic question in issue was whether the public convenience and necessity would be served by granting an application for renewal of a broadcasting license. Under this bill, the question in issue would be whether a particular drug is because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use (determined) to to be safe and effi on the basis of opinions generally held among experts qualified evaluate the safety and efficacy of such drug cacious for use only after professional diagnosis by, or under the supervision of, a practitioner licensed by law to administer such drug. It will be seen at a glance that the bill calls for the application of a standard, or test, which is not of the same character as that involved in the General Electric case. The latter case called for the exercise of broad judgment and discretion in deciding whether renewal of a broadcasting license would serve "the public convenience and necessity." It is not surprising that the Supreme Court took the view that substitution of its judgment for that of the agency on that question would have involved exercise of a nonjudicial function. However, under the bill, no similar judgment or discretion would have to be exercised by the court. In applying the standard, or test, provided for by the bill a court would be determining whether a particular drug was or was not included within its terms. The function 200 36 AMENDING THE FEDERAl food, drug, AND COSMETIC ACT of the court would not be essentially different from that exercised by courts every day. It would merely call for application of a statutory standard to the facts of a particular case. In this connection, it is important to bear in mind that the standard written into the bill is essentialy the same as that now contained in the regulation (prescribed under section 502 (f) of the act) which differentiates "dangerous" drugs (which may be sold only on prescription) from those drugs which (if they bear adequate directions for use) may be safely sold over the counter. In criminal prosecutions, and in seizure and injunction proceedings, involving alleged misbranding, the outsome of the case may depend upon the application by the court to the facts of the case of this standard prescribed in the regulation. If the courts exercise a “judicial” function in applying this standard in criminal, seizure, and injunction actions, how can it be reasonably contended that a court would be called upon to exercise a “nonjudicial" function in applying essentially the same standard in de novo review of the Administrator's action? Furthermore, it was urged before the committee that this same standard be written into the bill as the basis for case-by-case judicial decision as to which drugs are "dangerous" and which drugs are not. No one suggested that that proposal would have required the courts to exercise a "nonjudicial" function. The need for trial de novo is emphasized by the narrowness of review of administrative proceedings by the appellate courts. In an increasing number of cases the courts are declaring their impotence to review the findings of fact. Particularly is this true where the administrative decision is of a quasi-judicial nature, as in the instances of appeals from the Federal Trade Commission, which is a fact-finding body. The courts have repeatedly held that they are bound by the Federal Trade Commission's judgment as to the quality and sufficiency of evidence. Such evidence may consist of biased testimony-Segal v. Federal Trade Commission (142 Fed. (2d) 255); incompetent evidence-Bene v、 Federal Trade Commission (299 Fed. 468); and the testimony of selected experts-E. Griffith Hughes, Inc. v. Federal Trade Commission (77 Fed. (2d) 886). In the Segal case the court observed that a part of the testimony was "obviously biased" and said: Even so, if the Commission wished to rely upon such testimony, we may not intervene, whatever might be our own indisposition to accept what he said. The courts refuse on appeal to weigh the evidence. They hold that they are bound by the Commission's findings, if supported by evidence, despite the fact that the weight may be to the contrary. Thus, they need read only the Commission's side of the case and if there is evidence to support the findings, the record to the contrary may be ignored. The principles of a trial de novo are outlined in my opinion, by Chief Justice D. Lawrence Groner of the Circuit Court of Appeals for the District of Columbia in a letter to the Attorney General— report of the Committee on Administrative Procedure, Seventy-ninth Congress, page 248: The correct decision of this question is one of immense importance. It should, in my opinion, be considered by Congress in the light of the real and true purposes which the founders of our Government sought to achieve for themselves and their ༢1( AMENDING THE FEDERAL FOod, drug, and COSMETIC ACT 37 posterity. These were free action, free enterprise, free competition. They Believed that equal justice between man and man and between citizen and state was one of the impartial rewards which encouraged to efforts that produced great and lasting results. Therefore, they made no provision for exemptions from legal auty. What they did provide for was that there should be no oppression, no exaction by tyranny, no spoliation of private right by public authority, and that there should be a fair, honest, effective government to maintain the things which were thought to be the prerogatives of every individual man. As in the case of the Federal Trade Commission, the Federal Security Administrator is not only a regulator but he will adjudicate issues of fact between the Government and the citizen as a judicial tribunal. The Administrator, under this bill, will be asked to determine the question of fact of some 30,000 drug items— because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use * (determined) to be safe and effica * * * on the basis of opinions generally held among experts qualified to evaluate the safety and efficacy of such drug . * cious for use only after professional diagnosis by, or under the supervision of, a practitioner licensed by law to administer such drug. In the light of the above-quoted section of this bill, the Adminis trator will be called upon to make decisions of fact "on the basis of opinions generally held among experts qualified." It may be upon the decision of one expert who is opposed by many experts, upon testimony which may be biased or unbiased; and yet, under existing decisions, even if the Administrator made his decision on testimony which was obviously biased, that decision of the Administrator, for all practical purposes, would be final without a trial de novo. In the light of the Supreme Court decisions and the sweeping scope of the powers granted the governmental administrative agency, unless there is to be complete administrative absolutism, it is obvious that both the Government and the individual should have a “day in court." JOSEPH P. O'HARA. 82D CONGRESS 1ST SESSION House Calendar No. 61 H. RES. 354 [Report No. 756] IN THE HOUSE OF REPRESENTATIVES JULY 25, 1951 Mr. MITCHELL, from the Committee on Rules, reported the following resolution; which was referred to the House Calendar and ordered to be printed 1 RESOLUTION Resolved, That immediately upon the adoption of this 2 resolution it shall be in order to move that the House resolve 3 itself into the Committce of the Whole House on the State 4 of the Union for the consideration of the bill (H. R. 3298) 5 to amend section 503 (b) of the Federal Food, Drug, and 6 Cosmetic Act. That after general debate, which shall be 7 confined to the bill and continue not to exceed two hours, to 8 be equally divided and controlled by the chairman and the 9 ranking minority member of the Committee on Interstate 10 and Foreign Commerce, the bill shall be read for amendment 11 under the five-minute rule. At the conclusion of the con12 sideration of the bill for amendinent, the Committee shall 2 1 rise and report the bill to the House with such amendments 2 as may have been adopted and the previous question shall be 3 considered as ordered on the bill and amendments thereto 4 to final passage without intervening motion except one motion 5 to recommit. eral Food, Drug, and Cosmetic Act. Providing for the consideration of H. R. 3298, RESOLUTION |