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“Any interested person may file with the Administrator a petition proposing the addition to, or deletion from the list of drugs promulgated by the Administrator in accordance with clause (2) hereof. Such petition shall set forth the proposal in general terms and shall state reasonable grounds therefor. The Administrator shall give public notice of the proposal and an opportunity for all interested persons to present their views thereon, orally or in writing, and as soon as practicable thereafter shall make public his action upon such proposal. At any time prior to the thirtieth day after such action is made public any interested person may file objections to such action, specifying with particularity the changes desired, stating reasonable grounds therefor and requesting a public hearing upon such objections. The Administrator shall thereupon, after due notice, hold such public hearing. As soon as practicable after completion of the hearing, the Administrator shall by order make public his action on such objections.

“An order so issued by the Administrator may, within ninety days after its issuance, be appealed by any interested person in accordance with the provisions prescribed in section 701 (f) and (g) of this Act, 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 appeal.

"The provisions of this section of the Act shall not be applicable to drugs now included or which may hereafter be included within the classifications stated in section 3220 of the Internal Revenue Code (26 U. S. C. 3220), or to marijuana as defined in section 3238 (b) of the Internal Revenue Code (26 Ú. S. C. 328 °(b))." (The following reports were submitted on H. R. 3298:)

FEDERAL SECURITY AGENCY,

Washington, April 30, 1951. Hon. ROBERT CROSSER, Chairman, Committee on Interstate and Foreign Commerce,

House of Representatives, Washington 25, D. C. DEAR MR. CHAIRMAN: This letter is in response to your request of March 21, 1951, for a report on H. R. 3298, a bill to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act.

This bill is in substantially the same form as that introduced as H, R. 8904 in the Eighty-first Congress, second session, which this Agency endorsed. Section 503 (b) of the present law recognizes only written prescriptions, whereas the section as amended by the bill would recognize oral prescriptions as well, with the safeguard under certain circumstances that the pharmacist reduce the oral order to writing and file it. The present law does not provide a clear differentiation between those drugs which should be dispensed solely on prescription and those which may be sold over the counter. It is the intent of the bill to supply this deficiency by requiring the dispensing on prescription only of specified habitforming drugs and those specifically designated in regulations or new drug applications which cannot be safely and effectively used without professional diagnosis and supervision. The bill provides that the labels of such drugs bear a caution against dispensing without prescription.

This Agency is sympathetic to the purposes of the bill. It would clarify the obligations of pharmacists, would promote the operations of all on the high standards now followed by the majority, and would afford better protection to the public health than the present law against absuses by a minority in dispensing highly potent drugs by over-the-counter sales or by refilling prescriptions without the knowledge and approval of the prescriber.

The bill contains, however, three new paragraphs beginning at line 15 of page 3 and continuing to line 14 of page 4. The most significant feature of the new paragraph is a “trial de novo" (lines 12-14 on p. 4) in a United States court of appeals on appeals from the Administrator's orders. An outline of the procedure leading up to the proposed "trial de novo” is relevant. Clause (2) of new sectior. 503 h) requires that an opportunity for public hearing be afforded before the Admninistrator promulgates a list of drugs that are unsafe or ineffective for use without professional diagnosis and supervision and thus must therefore be dispensed only on prescription. This public hearing, it would seem, may be held under the informal rule-making procedure of section 4 of the Administrative Procedure Act. No appeal would lie at this stage from the resulting action of the Administrator (see Administrative Procedure Act, sec. 10).

The last paragraph on page 3 of the bill provides for a formal hearing and judicial review when any interested party disagrees with the order of the Administrator issued under clause 2. The procedural steps provided are as follows: (1) Any interested person may file a petition setting forth the proposal for addition to or deletion from the list of drugs, with a statement of reasonable grounds; (2) public notice of the proposal and an opportunity to present views by interested parties are given; (3) a decision of the Administrator with respect to that proposal is made; (4) objections to the decision may be filed within 30 days, with a request for a public hearing on such objections; (5) a hearing on the objections is held. The formal hearing provisions of sections 7 and 8 of the Administrative Procedure Act would apparently apply to that hearing; (6) an order is issued. This order is subject to judicial review in accordance with section 701 (f) and (g) of the Food and Drug Act, except that such review shall be “in the nature of a trial de novo, without presumptions in favor of either party to such appeal."

These provisions are in general patterned after section 507 (f) (21 U. S. C. 357 (f)) relating to the certification of antibiotic drugs. The Administrator's order with respect to objections filed by interested parties concerning his regulations under section 507 (f) is subject to the provisions of section 701 (f) and (g) (21 U. S. C. 371 (f) and (g)). Section 701 (f) provides that the findings of the Administrator as to the facts, if supported by substantial evidence, shall be conclusive. But the bill expands the scope of review. The bill directs that the appeal is to be in the nature of a trial de novo without presumptions in favor of either party to such appeal. The concept of a trial de novo at the appellate level departs radically from legislation governing the review of rules and regulations issued by administrative agencies, and goes beyond the requirements of the Administrative Procedure Act which was intended to bring uniformity to administrative proceedings and their judicial review. The scope of judicial review now embodied in section 10 (e) of the Administrative Procedure Act is that agency action shall be upheld where it is supported by substantial evidence, but the court is directed to review the whole record in determining whether the evidence is substantial. This provision has recently been examined by the Supreme Court in Universal Camera Corp. V. National Labor Relations Board, decided February 26, 1951. The specific provision to this effect in section 701 (f) of the Federal Food, Drug, and Cosmetic Act, and its conformity to the Administrative Procedure Act, was judicially approved in Willapoint Oysters v. Ewing (174 F 2d 676, cert. den. 338 U. S. 860).

The proposed bill, in contrast, would extend the function of the reviewing court beyond that contemplated by the Administrative Procedure Act. The appellate court in a “trial de novo" would become a trier of facts with respect to difficult questions of drug action, questions which are not at all suited for judicial determination but which require expert scientific knowledge for informed judgment. The determination of such a question is peculiarly within the expert competence of an administrative agency, yet the court would be expressly enjoined to attach no "presumptions” to its action, i. e., to give no weight to it. The Administrative Procedure Act has recognized the principle of deference to administrative expertise by providing for review as to the legal sufficiency of the evidence presented in support of a regulation, not a complete and needless retrial of the facts in an appellate court.1

There is serious question, moreover, as to the propriety of conferring the power to make a determination that is essentially legislative upon a "constitutional

This was declared objectionable by the Supreme Court in Federal Radio Commission v. General Electric Co. (281 U. S. 464 (1930)) and in the cases there cited. In the General Electric case, the Radio Act of 1927 had authorized the Court of Appeals, after decision by the Commission, to take additional evidence, hear, review, and determine the appeal upon the recor andd the evidence, and alter or revise the decision appealed from-in short, a review de novo. While the opinion acknowledged that Congress may make the Court of Appeals for the District of Columbia a "superior and revising” agency, it concluded that the Supreme Court could not be invested with similar powers. In this connection, it should be noted that section 701 (f) (4) of the Food and Drug Act, which is incorporated in the bill by reference, would confer jurisdiction on the Supreme Court to review decisions of the courts of appeals. Moreover, under the bill proceedings for judicial review could be filed in the court of appeals for the circuit in which the petitioner resides or has his principal place of business, which, in most cases, would be outside the District of Columbia. Such other courts of appeals, being "constitutional courts," would be subject to the same disability in this respect as the Supreme Court.

The legislative history of the present act reveals that Congress was confronted with a similar problem as to the scope of review of administrative regulations and rejected the solution now proposed. As reported out with an amendment by

1 In any event, the use of the word "trial" in the bill is in itself a misnomer. In all probability the drafters intended to have a review on the record and not a trial de novo.

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the House Committee on Interstate and Foreign Commerce after passage by the Senate, S. 5, Seventy-fifth Congress, contained a special review provision in section 701 (f) permitting anyone appealing from a regulation to adduce additional evidence before a district court, and further providing that the court might take such further action as "justice may require.'' House Report No. 2139, Seventyfifth Congress, third session, pages 11-12. The Supreme Court, in Federal Security Administrator v. Quaker Oats Co. (318 U. S. 218 (1943)) explained the elimination of this provision:

before enactment, the conference committee substituted for these provisions those which became section 701 (f) of the act. While under that section the Administrator's regulations must be supported by findings based upon

substantial evidence' adduced at the hearing, the Administrator's findings as to the facts if based on substantial evidence are conclusive. In explaining these changes the chairman of the House conferees stated on the floor of the House that 'there is no purpose that the court shall exercise the functions that belong to the executive or the legislative branches' (83 Congressional Record, p. 9096)."

The conference committee further noted, with respect to the review provided in section 701 (f) (S. Rept. No. 2716, 75th Cong., 3d sess.):

“The type of judicial review provided in the agreement is as broad as the Constitution permits in the case of review by a constitutional court. It is to be noted that the function of the Secretary in making regulations and orders to carry them out is legislative in character.

Judicial review of the Secretary's action to determine if there was substantial evidence to support the finding, and of course, upon constitutional questions, may be had.”

To permit a review by trial de novo at the level of the court of appeals would not only impede and hamper the enforcement program with respect to the most dangerous drugs, but would burden these courts with a legislative function which, it appears likely, they may not constitutionally be called upon to perform.

This bill also authorizes oral prescriptions which are reduced to writing and filed by the pharmacist. It does not require that the physician confirm or agree to confirm the prescription in writing. In this, it departs from the bill which we previously endorsed. We believe that at the very least the physician should agree to confirm his oral prescriptions in writing within 72 hours, and that he should not be entirely freed from his responsibility to confirm because the pharmacist reduced the telephone order to writing.

We therefore recommend that the bill, with the above-suggested amendment, with the deletion of the excepting provision in lines 12-14 on page 4, and with certain clarifications and technical amendments which we should like to suggest at the appropriate time, be enacted by the Congress.

The Bureau of the Budget advises that there is no objection to the submission of this report to your committee. Sincerely yours,

Oscar R. EWING, Administrator.

*

DEPARTMENT OF JUSTICE,
OFFICE OF THE DEPUTY ATTORNEY GENERAL,

Washington, April 30, 1951.
Hon. ROBERT CROSSER,
Chairman, Committee on Interstate and Foreign Commerce,

House of Representatives, Washington, D. C. MY DEAR MR. CHAIRMAN: This is in response to your request for the views of the Department of Justice concerning the bill (H. R. 3298) to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act.

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 352) sets forth the various circumstances under which drugs and devices will be deemed to be misbranded. Section 503 (b) (21 U. S. C. 353 (b)) specifies certain exemptions with respect to drugs dispensed on written prescriptions.

The bill would amend section 503 (b) so as to provide that a drug dispensed by filling or refilling a written or oral prescription shall be exempt from the requirements of section 502, except with respect to certain packaging requirements and those provisions of the section which provide that a drug shall be deemed to be misbranded if its labeling is false or misleading in any particular or if it is an imitation of another drug or if it is offered for sale under the name of another drug, and except with respect to the provisions of the Act dealing with insulin and the various antibiotics covered by the statute. The measure provides, tion."

however, that such exemption shall prevail only if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in the prescription.

Separate provision is made if the drug is intended for use by man, and is (1) a habit-forming drug subject to the regulations prescribed under section 502 (d) (21 U. S. C. 352 (d)); or (2) has been found by the Federal Security Administrator to be unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law; or (3) if an effective new drug application under section 505 (21 U.S. C. 355) limits it to use under the professional supervision of a licensed practitioner. In such event the exemption is to apply only if the drug is dispensed upon a written prescription or upon an oral prescription which is reduced to writing and filed by the pharmacist, or is dispensed by refilling a prescription if such refilling is authorized by the prescriber in the original prescription or the oral order and such order is reduced to writing and filed by the pharmacist. A drug which falls within the three categories mentioned immediately above will be misbranded if at any time prior to its being dispensed its label fails to bear the statement “Caution: Federal law prohibits sale or dispensing without prescrip

The bill also provides that the act of dispensing the drug contrary to the provisions of the bill shall be deemed to be an act which results in the drug's being misbranded while held for sale. This would insert into the Federal Food, Drug, and Cosmetic Act the theory, based on regulations, pursuant to which the Food and Drug Administration has recommended prosecution of druggists who sell, without prescriptions, drugs bearing the so-called prescription legend and which have not been removed from the immediate containers in which they were shipped in interstate commerce. Such a sale by a druggist would be in violation of section 301 (k) (21 U. S. C. 331 (k)).

The bill also provides a procedure whereby any interested person may file a petition with the Federal Security Administrator proposing the addition to or deletion from the list of drugs found to be unsafe or ineffective for use in accordance with clause (2) of section 503 (b). Upon the filing of such a petition, the Administrator is required to give public notice of the proposal and a hearing thereon, and as soon as practicable thereafter shall make public his action upon such proposal. Any interested person may file objections to such action and request a public hearing upon such objections. The Administrator shall thereupon, after due notice, hold such public hearing and as soon as practicable thereafter by order make public his action on such objections. The order of the Administrator may, within 90 days after its issuance, be appealed to the court of appeals in accordance with the provisions prescribed in section 701 (f) and (g) of the act (21 U. S. C. 371 (f) and (g)), except that such appeal shall be in the nature of a trial de novo without presumptions in favor of either party to such appeal.

The bill also provides that its provisions shall not apply to drugs now included or which may hereafter be included within the classification stated in section 3220 of the Internal Revenue Code or to marijuana as defined in section 3238 (b) thereof. ·

Whether the bill should be enacted involves a question of policy concerning which this Department prefers not to make any recommendation. There are certain features of the measure, however, concerning which the committee may wish to give further consideration.

The bill provides for two public hearings in connection with a proposal for the addition to or deletion from the list of drugs found to be unsafe in accordance with the provisions of clause 2. A public hearing is provided for on the original proposal, and again provided for in connection with objections to the action of the Administrator upon the proposal. It would seem that the one public hearing on the original proposal would be sufficient.

The bill also provides for an appeal from the order of the Administrator. It is assumed that the order referred to is that made after the public hearing on the objections to the previous action of the Administrator. The review proceeding is to be in accordance with the provisions of section 701 (f) and (g) of the act, except that the appeal shall be in the nature of a trial de novo. It will be noted, however, that the review proceedings in section 701 are confined to questions of law. The court is given jurisdiction to affirm the order complained of or to set it aside in whole or in part. If the order refuses to issue, amend, or repeal a regulation and such order is not in accordance with law, the court shall by its judgment order the Administrator to take action with respect to the matter, in accordance

with law. In a de novo proceeding the court ordinarily has the power and function to make its own findings and judgment. Such a trial contemplates not only the record before the Administrator but the testimony of additional witnesses if desired. No such procedure is contemplated under section 701. The provision for a trial de novo would be incompatible with the review procedure provided for and leaves an ambiguity and doubt as to what the function of the appellate court would be. In addition, such a proceeding would appear to make the appellate court a revising agency and its action in the nature of an administrative decision. A question arises as to whether such a function is within the judicial power conferred upon Federal courts by the Constitution. Compare Radio Commission v. General Electric Co. (281 U. S. 464).

It might be desirable to consider the question of review in connection with the action of the Administrator in designating unsafe drugs under clause (2). It is believed that a review from such a determination in accordance with the procedure in section 701, would fully protect the rights of any person adversely affected since the Supreme Court has recently held that in considering the question of whether an order of this nature is supported by substantial evidence, the appellate court shall review the whole record.

The Director of the Bureau of the Budget has advised that there is no objection to the submission of this report. Yours sincerely,

PEYTON FORD, Deputy Attorney General.

ADMINISTRATIVE OFFICE OF THE UNITED STATES COURTS,

Washington, D. C., March 29, 1951. Hon. ROBERT CROSSER,

House Office Building, Washington, D. C. DEAR CONGRESSMAN CROSSER: I have compared the bill about which you have written me on March 22, 1951, to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act (H. R. 3298) with the present provision of the statute. The statute deals with the exemption from the requirements of the Federal Food, Drug, and Cosmetic Act in relation to the labeling of drugs handled in interstate commerce of drugs that are dispensed on a written prescription of a licensed physician, dentist, or veterinarian. The bill would make more detailed and specific the safeguards against abuse of the exemption from the provisions of the general statute.

The only feature of the bill that my office may qualify me to discuss is the provision in the next to the last paragraph of subsection (b) of section 503 of the statute as proposed to be amended (p. 4, lines 8 to 14) and especially the last clause on lines 11 to 14 of the printed bill. This section provides for appeals from orders of the Federal Security Administrator adding to or deleting from the list of drugs promulgated by him as "unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law” (clause 2, p. 2, lines 12 to 16 of the printed bill). It defines the procedure on appeal in general by reference to section 701 (f) (g) of the statute (21 U. S. C. 371 (f) (g)). These subsections provide that appeals from the orders of the Administrator may be filed in the United States court of appeals for the circuit in which the person taking the appeal resides or has his principal place of business. The pending bill would not change the court which would have jurisdiction to review orders of the Administrator in reference to the subject matter affected. That court would continue to be the court of appeals for the circuit.

The exception at the end of the paragraph would, however, make an important change from the present statute in respect of the procedure on review. Sections 701 (f) (g) of the present statute (21 U. S. C. 371 (f) (g)) prescribe that when a review is taken the review shall be had upon a transcript of the record and proceedings before the Administrator. "The findings of the Administrator as to the facts, if supported by substantial evidence, shall be conclusive.” The paragraph referred to of the pending bill would change the practice and make the appeal "in the nature of a trial de novo, without presumptions in favor of either party to such appeal.”

The Judicial Conference of the United States under which I act has not considered the particular bill and, therefore, I am not in a position to express an official opinion in regard to it, although the Conference is on record in opposition to the procedure of a trial de novo by a three-judge court for review of the orders of administrative agencies. I would point out that the provision that appeals

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