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is a field for conflict and dispute, should property be destroyed and manufacturers and others sent to the penitentiary because some doctors have in their own minds an opinion on it, or because the impossible is required?

It is unfortunate that this is a state in which medical knowledge of therapy finds itself. The difficulty is in the fact that it is in such a state. The Supreme Court of the United States has recognized this situation. A former Congress of the United States, after more than a year of consideration, recognized it. They deliberately excluded the matter of medical opinion from the act and enacted the so-called "Sherley ar.endment" to that act, which reads:

Third. if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent, I suggest, therefore, that the language used in the second sentence of paragraph (a) be deleted and the language of the Sherley amendment, which has stood the test of more than 20 years, be substituted therefor.

Your attention is now called to paragraph (d) of section 8. I don't know whether this paragraph is astutely and cleverly drawn or otherwise. If cleverly drawn its real meaning and effect is hidden. It provides that an article is misbranded if any word, statement, or other information required on the label to avoid adul teration is misbranding under any provision of the act is not prominently placed thereon in such a manner as to be easily seen, and in such terms as to be readily intelligible.

The bill contains provisions which specifically require certain statements to appear. I can understand these, and, insofar as the provision relates to definite requirements, it would be unobjectionable. Such statements, which the Congress in its wisdom requires. to be disclosed, should be stated in a plain and conspicuous manner.

This provision, however, must be read in connection with section 22, which grants authority to the Secretary to make regulations for the efficient enforcement of the act. Except as this grant is modified by the provisions relating to the power to be exercised by a committee of public health, the Secretary is without limit. This is particularly true where the language used is ambiguous or not clear. Under the terms of paragraph (a) he may require a world of information that is wholly unnecessary for the protection of the public, upon the theory that, in his opinion, such information is necessary to avoid adulteration or misbranding.

I submit that this provision should be deleted, and that if a law is enacted, it state in clear, unmistakable terms the requirements as to such matters as in the opinion of Congress should be declared. The language used in section 8, paragraph (a), page 10, clating to misbranding of drugs, and section 9, paragraph (b) relating to advertising, are the same, and therefore can be treated together.

This is a requirement that when a drug is not offered as a specific cure but is a palliative, it must declare first that the drug is a palliative, and again, how the palliative, and again, how the palliation is effected.

I am informed that there are but few diseases for which it is even claimed that specific cures have been found. There are thousands

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of drugs found in materia medica. Doctors prescribe hundreds of different drugs. With the exception of the very few, practically all drugs are palliatives, and to require such a stateinent upon all but a few of the drugs used does not appeal to me as being particularly wise. The statement would soon become so conunon that it would either be meaningless or attain a secondary significance.

It would be wiser if, instead of requiring a statement that a drug is a palliative, the Congress would name the list of diseases for which specific cures have been found, and require a statement that drugs offered for their treatment are in fact specific cures. In the event it would be proven that they are not such specific cures, then the statement would be a misbranding.

Of course the Congress should, if it should so provide, protect the manufacturer or distributor of the drug who does make the statement if tomorrow medical opinion would be changed upon the subject.

The serious situation presented, however, is found in the requirement that there shall be a declaration of how the palliation is effected. It would be interesting to note exactly what is in the mind of the author of the bill in making this statement. Certainly it does no mean that the label requirement will be satisfied if it is stated that the palliation is effected by the taking of so many doses of the drug. If it means that the label must carry a statement concerning the physiological and pharmacological effect of the drug upon the pathological conditions, it is impossible of performance. If this information could be obtained from the medical and pharmacological professions it would be a different thing, but it cannot be so obtained, because they don't know, except in very few instances. How can a manufacturer know how palliation is affected if the doctors can't tell him? It can neither be declared upon the basis of substantial medical opinion nor by demonstrable scientific fact, first, because there is no substantial medical agreement as to the great majority of diseases, which are palliated, and no facts by which they can be appropriately demonstrated.

When the doctors can tell us just why the stomach does not digest itself; when they have come to an agreement as to the cause of a · common cold, whether it is based upon the hypothesis that it is due to a filterable virus, or, as is claimed by another group, due to a mild form of acidosis.

Permit me to refer to just a few: Take the analgesics-aspirin, amid opyrine, quinine, salicylates. Here are a few of the theories as to how they act to relieve pain.

United States dispensary: "We are entirely ignorant."

Sollman: "Mechanism obscure-may consist in change of meningeal," those around the brain.

Cushny: "May be assumed to be an action on a synapse on the path conveying pain."

Bastedo: "Action on synapse or result of action in regulating balance between heat production and heat lost."

Solis Cohen: "Partly central, partly peripheral."

Now, where are we when we get a demonstrable scientific fact! That is the medical opinion as to how aspirin is going to relieve pain. Now take the theories regarding how antipyretics reduce

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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.

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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 pallia tion 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 madeto 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

The action and proposed action of the Department would 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

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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.

In the enforcement under the old law, until stopped by the decision 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 Department 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

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