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fever. I have here the statement of eight different theories on how it operates. There is no agreement between them. One says, "Lessens irritability of heat regulating center." Another says, “ Promotes heat dissipation by increasing sugar in the blood.” Another says, “ Dilatation of cutaneous vessels.” Another says, “ Action on metabolism."
Take the ordinary purgatives. There is no agreement between therapists as to which do and which do not act on the liver and stimulate bile production. What drugs are chologogues and what not.
Take the vitamins. No one can tell how they act. Yet “C” cures and prevents scurvy and “D” cures and prevents rickets, and another one prevents pellagra. How does cod-liver oil or lemon juice or other things act? What does iodine do in goiter to prevent or remedy it?
The anesthetics, ether and chloroform, how do they work? By the Meyer-Overton law or by the theory of Verworn, or oxygen deprivation, or by deficient nutrition of the brain, by anemia or how? When they do not know and when they cannot tell us what are we to do? I quote from Sollman, page 97, the 1926 edition:
A real science of therapeutics by which it would be possible to tell the exact results is largely a vision.
I again at this point revert to the indefinite and uncertain character found in what is attempted to be a legislative definition of a crime. Congress should not enter the realm of dream and make the violation of a vision a crime.
Attention is now called to paragraph (b) of section 9 under the heading of “False advertisement.” The purpose of this section is to prohibit the public advertisement of any drug for self-medication of a list of diseases named in the section. There is, however, a provision that if an advertisement is not otherwise in violation of the law it may be disseminated to the medical profession. If the representations are not true they may not be told to the doctors or the public. If the provisions of the act are otherwise complied with you can tell the doctor but you must not tell the patient. If the law is otherwise violated you mustn't tell either of them.
Thus, if a child is suffering from whooping cough you mustn't tell the mother, but you can tell the doctor.
The medical profession says that wooping cough is a self-limited disease which does not yield to drug treatment. The doctor is called not for the purpose of curing the whooping cough but to palliate and relieve the paroxysms. To do this he leaves a package of medicine. The manufacturer of such medicine, however, must not interfere with the practice of the doctor in such case by telling the mother of the child so suffering that she can get relief for her child if the doctor is not available.
This is the real purpose of the act, and why isn't it said in terms, that no representation of statement of any kind can be made, truthful or otherwise, concerning a palliative for any of the diseases mentioned unless you call your doctor in to treat them? That is just what it means. If that is intended why not say so!
Now I quite agree that there are some diseases in which the doctor should be called. Personally I would be the first one to call him.
It is unnecessary, however, that it be effected in this manner. Its purpose can be effectuated, so far as the public is concerned. by using in substance the following language:
No preparation may be advertised or recommended as a cure for any disease or condition which is generally recognized as incurable or incapable of palliation by the simple administration of drugs.
Such a provision is sufficient and will be sustained by the courts.. (See opinion of Mr. Justice Hughes in the last paragraph of Seven cases v. United States, 239 U.S. 510.)
Attention is now called to section 12, page 18, and section 13. These are the permit and inspection sections. It will be observed, however, that there is no limitation whatever placed upon the Secretary in determining whether permits should be issued or withheld.
This is equally true as to the provisions of section 13 relating to inspections. The only thing that would stop it with respect to the inspection would be the refusal of a court of equity to grant an injunction.
There is an amusing provision in section 13, and that is that inspection cannot be had until after there has been a request made to the owner for permission. Nothing is said as to the time or method of approach. It might be well, if this provision is to be written into the law, to establish in connection therewith a code of social ethics or conventions. It is suggested that these sections be deleted from the bill.
Attention is called to section 16, which provides for seizures of offending articles. This should be amended to provide that thereshould be no seizure of an article based upon a claim with respect to the curative effect of the drug unless and until there has been a hearing provided for, and that the seizures should not be made in numerous districts. This section provides that they may be seized wherever found.
The power of seizure under a similar provision in the present law has been ruthlessly exercised in numerous cases and there have been many seizures in widely separated and remote jurisdictions, and implicit in such seizures was the threat of additional seizures.
The attention of the committee, however, is invited to a comparatively recent decision, 1929, by the Court of Appeals of the District of Columbia, National Remedy Co. v. Jardin, in which that court unanimously held that:
If certification should be made to the district attorney in every district where a product might be found, the manufacturer would be crippled or ruined long before the final adjudication in the court could be had.
Such a result we think was not contemplated by Congress, except possibly in unusual cases where drastic action would be necessary for the immediate protection of the public.
The court further said:
in effect deprive appellant of its property through the destruction of its business before the issue involved could be determined by the court. The result, therefore would be little different than as though no provision had been made for judicial review. Such a course of conduct on the part of the Department amounts to arbitrary exercise of power and is a deprivation of due process of law.
It is quite apparent that the sponsors of the present legislation desire a reenactment of the provision that articles may be seized
wherever found, and to point out in suits hereafter that by such reenactment the commencement of a large number of seizures was in fact “contemplated by Congress.”
I still submit, however, that the question of the taking of property without due process of law can be properly invoked. Therefore, this provision should be rewritten; first, to provide that in case the claim is made upon the basis of representations concerning the curative effect of an article, that the proceedings in libel for condemnation should be had in but a single jurisdiction, giving, however, to the Government the right to ask injunctive relief to prevent repetitious introduction in interstate commerce pending such adjudication.
În the enforcement under the old law, until stopped by the deci. sion to which I have just referred, the methods used with respect to multiple seizures were ruthless. If, therefore, the provision expressly stating the purpose of Congress to continue this is contained, it should be safeguarded in such a way that there would be no violation of the due process of law clause of the Constitution of the United States.
Provision is made in section 21 for publicity. This provision is not only for the notices of judgment, such as are published under the present law, but grants to the Secretary the power to disseminate other information upon the ground that it may be necessary to protect the public health from danger or fraud.
There is a provision, however, that no such information will be disseminated regarding any product by name before rendition of final judgment in proceedings against it. This sounds all right. It must be borne in mind, however, that it has been the practice in the Department for a good many years in many instances to cause seizures to be made without a first notice. Sometimes the first information that a manufacturer has that goods have been seized has been perhaps a telephone call from a jobber.
Manufacturers have uniformly tried to cooperate with the Department. I know this, because I have represented manufacturers in literally hundreds of cases, wherein we have asked the help of the Der tment to assist in writing our labels, not only to comply with the law but to conform to the views of the Drug Administration with respect to the law.
In case seizures have been made manufacturers have always been met with a refusal to even discuss the matter unless and until a promise is made that there will be no contest of the pending matter. Upon receiving such assurance, the Department then indicates the manner in which labels should be changed. The result is that there have been hundreds of notices of judgment following decrees where no claimant appears.
This publicity provision should be amended by adding, on page 33, in line 19, after the words “ final judgment”, the words and after a trial has been had.” This will prevent the Department from building up another misleading “chamber of horrors” and exploiting itself with respect to articles which have been handled in this manner.
In this behalf I should also like to suggest that no adequate provision is made in the law for administrative hearings. Thousands
of manufacturers would be happy to sit down with the Department and adjust their minor differences.
Just one more matter to which I want to call the attention of the committee. Section 23 pretends, and I use the word “pretends advisedly, to grant a court of review of regulations. It will be observed, however, that there are peculiar words of inclusion—the words“ unreasonable, arbitrary, or capricious.” Such words of inclusion really amount to words of exclusion.
There is no remedy granted in section 23 that is not now open in courts of equity. “ Unreasonable, arbitrary, or capricious duct upon the part of officials may always be challenged, and the question as to whether or not any regulation is invalid may also be challenged in a court of equity. Therefore, section 23 is wholly meaningless as an effort to gain court relief. If it is intended to grant by statute a court review, it should specifically provide that the court may enter such order as the law and facts in the case warrant and not be limited to the question of whether or not the actions of the officials in promulgating the regulations are capricious, unreasonable, and arbitrary.
There are other provisions of the bill which need most careful attention and study. Doubtless the committee will give careful consideration to the provision of 2800, section 16, containing a grant of power to a petty officer of the drug administration to cause seizures upon the basis of his own whim or guess; that the committee will determine whether or not_minor matters of labeling may not be administratively settled. In other words, whether it should not require the drug administration to discuss with manufacturers the labeling of products when such manufacturers in good faith apply to the Department for that purpose, in order that they may not only conform to the law but to determine if possible by conference the Department's construction of the law and its interpretation of labels.
I will not take the further time of this committee, but it does occur to me that this bill has been drawn with complete indifference to legitimate business, a disregard of actualities and unfamiliarity with law.
The CHAIRMAN. We have a letter from the District of Columbia Pharmaceutical Association and it has been asked that it be inserted in the record.
(The letter referred to is as follows:)
THE DISTRICT OF COLUMBIA PHARMACEUTICAL ASSOCIATION,
Washington, D.C., February 28, 1934.. Hon. HUBERT D. STEPHENS, Chairman, Committee on Commerce, United States Senate,
Washington, D.C. DEAR MR. CHAIRMAN: The following brief is respectfully submitted on behalf of the Washington Wholesale Drug Exchange and its stockholders and members, including practically all of the retail druggists of the District of Columbia, in opposition to S. 2800, the revised Tugwell bill, who urge the enactment as a substitute therefor either S. 2355, the bill introduced by the distinguished Chairman of the Senate Committee on Commerce, or the identical bill, H.R. 6376, introduced by the distinguished member from New York, Mr. Black.
Any law which has stood the test of 28 years' enforcement and accomplished as much as the Federal Food and Drugs Act of 1906 should not be repealed. Comparatively few cases of serious injury to the public health or welfare have been reported during the long period of the administration of the present law, particularly in recent years. This accounts for the fact that there is no public demand for the proposed legislation. Where necessary the present law should be amended. The Stephens and Black bills provide for this. The amendments have been carefully prepared by the National Drug Trade Conference, representing all branches of pharmacy and the drug trade, including State boards of pharmacy and colleges of pharmacy, best qualified by scientific knowledge and experience to draft amendments to the Federal Food and Drugs Act.
Your petitioner objects to the revised Tugwell bill on the following grounds:
1. Because it provides that “any representation concerning any effect of a drug shall be deemed to be false under this paragraph if that representation is not supported by substantial medical opinion or by demonstrable scientific facts." Representations by retail druggists to their customers, or by traveling salesmen to their customers, not supported by substantial medical opinion or by demonstrable scientific facts would violate the proposed law. The Secretary of Agriculture would decide what authorities should determine scientific facts, or substantial medical opinion. The findings of fact by the Secretary are made conclusive by the bill.
2. The definition of the term “drug” includes "devices." The term “drug" would include ear trumpets and artificial aids to hearing; artificial teeth and limbs; gymnasium equipment; dog muzzles; check reins, blinkers, and interference pads for horses; shoulder braces; fountain syringes, suspensory and obesity bandages; trusses; etc., all of these being related to the “mitigation or prevention of disease, or intended to affect the functions of the body of man or other animals."
3. The term “ labeling” as defined in the bill is too broad. It not only includes the principal label or labels upon the immediate container of any food, drug, or cosmetic, but all labels “and other written, printed, and graphic matter, in any form whatsoever."
4. The bil substitutes government by regulation for government by law. This is dangerous to the industries affected and establishes a precedent dangerous to all other industries and to our form of Government. The aides provided for the Secretary of Agriculture in drafting regulations are all appointed by the administration and responsible to the administration and in no wise safeguard the industries concerned and the public served by them against one-man government.
5. The administration of the proposed law unquestionably would restrict the manufacture, advertising, and sale of food, drugs, and cosmetics which should not be restricted. This would reduce the volume of production and distribution in the industries affected. This would decrease employment, lower wages, and retard business recovery, which Congress and the administration are endeavoring to promote through the enforcement of the National Industrial Recovery Act. Very respectfully,
President. A$A V. BURDINE,
Secretary E. C. BROKMEYER,
General Counsel. The CHAIRMAN. We will now hear from Mr. Hugo Mock, 10 East: Fortieth Street, New York City, representing the Associated Manufacturers of Toilet Articles.
STATEMENT OF HUGO MOCK, NEW YORK CITY, REPRESENTING
THE ASSOCIATED MANUFACTURERS OF TOILET ARTICLES
Mr. Chairman and members of the committee: I had the honor of representing this association upon the occasion of the previous hearing. A brief on behalf of the association was filed at that time. There were about six particulars in that brief in which we asked that Senate bill 1944 be amended. I am pleased to inform this com