Regulating pharmaceuticals S.88 Pure Food and Drug

Compelling Policy Question: What should be the goal of government policies related to the Pharmaceutical Industry?

Policy Case Study S.88:

S. 88 “for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein” (modified/link to original)

It shall be unlawful to manufacture or sell any food, drugs, medicines, or liquors which is adulterated or misbranded, or which contains any poisonous or harmful substance.

SEC. 4. That the examinations of foods, drugs, medicines, and liquors shall be made in the USDA Bureau of Chemistry.

SEC. 9. An article shall be deemed to be adulterated :

In case of drugs: First. If a drug differs from the standards of strength, quality, or purity, as determined by the Pharmacopoeia.

Second. If the label shall bear any false or misleading statement.

In the case of confectionery : If it contain terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug .

In the case of food: First. If any substance has or have been mixed and packed with it to affect its quality. Second. If any substance has been substituted. Third. If any valuable part has been removed. Fourth. It it contains any added poisonous or other dangerous ingredient. Fifth. If it consists of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, or if it is the product of a diseased animal.

An article of food is misbranded if: First. If it is sold under the name of another food. Second. If damage to the food is hidden to deceive the purchaser. Fourth. If the label has any false statements.

Violators of this act shall pay all the costs for the inspections.

SEC. 14. That this act shall not interfere with commerce wholly inside any State nor with the police powers of the States.

Historical Context: Timeline leading up to S.88

Between January 20, 1879, and June 30, 1906, 190 measures were presented in Congress related to protecting consumers of food and drugs. (eight became law, six passed the House but not the Senate, three passed the Senate but not the House, and 141 were never heard of after their introduction.)

During that time period , the increase in manufacturing, growth in cities, and rise in advertising led to an increase in the sale of "Patent Medicines" in the United States. Patent Medicines were products that the seller claimed had medical value (could cure a disease, etc.), but the contents of that medicine were often unknown and could be dangerous.

People sometimes refer to these patent medicines as "Snake Oils"

1820 Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first guide for standard drugs for the United States.

1848 Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.

1862 President Lincoln appoints a chemist, Charles M. Wetherill, to serve in the Bureau of Chemistry, a part of the new Department of Agriculture (USDA).

1880 Peter Collier, USDA chief chemist, recommends a national food and drug law, following his own food investigations. The bill was defeated.

1883 Dr. Harvey W. Wiley becomes chief chemist, expands the Bureau's food adulteration studies. Campaigning for a federal law, Dr. Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Bill."

1897 Tea Importation Act passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.

1898 Association of Official Agricultural Chemists (now AOAC International) establishes a Committee on Food Standards headed by Dr. Wiley. States begin incorporating these standards into their food statutes.

1902 The Biologics Control Act is passed to ensure the safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.

Congress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration.

December 14, 1905 - Senator Weldon Heyburn of Idaho introduces S. 88

Section #1 Guiding Question: Why do some people believe regulations should be the goal of government policies related to the pharmaceutical industry?

In 1906, the Republican Senator from Idaho Weldon Heyburn said in his speech introducing S. 88 to Congress...

(modified/link to original)

Heyburn's biography

Mr. President, this bill is one of very great interest to all the people of the country. The only question is does this bill accomplish what Congress desires to accomplish?

Is the bill fair to all of the people, those who manufacture, those who sell, and those who use the products? Committees have been working for years to create a bill that would accomplish this, and we hope that we have reached that point. The committee’s first consideration was to prevent the manufacture of harmful products, and products that would deceive and defraud the public.

As to the need for this legislation, I think it would be a waste of time to do more than suggest it. Nearly every State in the Union has a pure-food law. It is merely a question of will Congress extend a helping hand for the enforcement of the laws of the States in the interest of the people?

In some of the States more than 60% of all the drugs that are offered on the market are fraudulent. Not only do some drugs not possess the qualities for which the drug is sold, but many are adulterated to such an extent that they are dangerous to be used.

I will submit for this time the bill to the consideration of the Senate.

The artist E.W. Kemble drew a piece of art for Collier's Weekly magazine titled "Death’s Laboratory" in 1905

Caption: Patent medicines are poisoning people throughout America to-day. Babies who cry are fed laudanum under the name of syrup. Women are led to injure themselves for life by reading in the papers about the meaning of backache. Young men and boys are robbed and contaminated by vicious criminals who lure them to their dens through seductive advertisements.

Louis Dalrymple, The age of drugs, Puck, 1900

Library of Congress Summary:

Illustration shows the interior of a drugstore with an elderly man, the pharmacist, dispensing a "Bracer" to a crowd of eager consumers, while a young girl secures a bottle of "Soothing Syrup." On the counter are bottles and packets of "Arsenic, Strychnine, Antipyrin, Nerve Stimulant, Opium, Cocaine" and "The Needle." Signs on the wall state "The Killem' Quick Pharmacy," "Open all night," and "Prescriptions carefully compounded." The saloon keeper leans against a column and laments that he cannot "begin to compete with" the drug trade.

Udo J. Keppler, Partners in t[he] bogie business, Puck, 1900

Library of Congress Summary

Illustration showing two men, "Prof. Scarem" presenting his latest findings on microbes to a crowd of frightened onlookers, and "Dr. Fakem" selling the latest protection against microbes to a crowd of eager consumers. "Scarem" and "Fakem" are a pair of quacks working together to take advantage of a gullible public.

Frederick Burr Opper, Look before you eat, Puck, 1884

Library of Congress Summary: a man standing at a dining room table, using various chemical apparatus, such as a "Milk Tester" with "High Water Mark", a "Sand Extractor" over a "Sugar" bowl, and a "Butter Tester", as well as a microscope and a retort, to analyze food products before sitting down to eat. He has a book titled "Chemistry" in his coat pocket.

Section #2 Guiding Question: Why do some people believe regulations should not be the goal of government policies related to the pharmaceutical industry?

During an earlier debate over a Pure Drug Bill, a Republican from Rhode Island named Nelson Aldrich said in a speech to Congress...

The earlier bill was H. R. 6295

(modified/link to original) Aldrich's biography

Is there anything in the existing condition of affairs that makes it the duty of Congress to put the liberty of all the people of the United States in jeopardy because some man thinks that at some time some product contains substances which should not to be there?

Are we to pass laws that will prevent people all over the United States from using or selling products which, in the opinion of some of the people of North Dakota, may be bad for their health?

Are we going to decide that question here? Are we going to take up the question as to what a man shall eat and what a man shall drink, and penalize him if he is eating or drinking something different from what the chemists of the Agricultural Department think it is good for him to eat or drink?

Is that the purpose of Congress?

Caption: Ponce de Leon: They laugh at me, but they still keep it up!

Library of Congress Summary: Illustration shows an old man reaching for a bottle of "Glycero-Phosphate of Sodium," a patent medicine that apparently restores youthfulness to aged people. The spirit of Juan Ponce de León stands in the background, laughing.

What were the results of the debate?

After some amendments were made to the bill, it was passed and became known as the "Pure Food and Drug Act", as well as the "Wiley Act" (in honor of the scientist Dr. Harvey W. Wiley who campaigned for a pure food and drug law for decades).

While the Bureau of Chemistry was created in the 1860's, before the passing of the Pure Food and Drug Act, there were no laws related to regulating the medicines the Bureau would research. Through the use of labeling regulations, PFDA gave the government a way to regulate the pharmaceutical industry.

In 1927, the Bureau of Chemistry became part of the new Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. Another act changed the name of the FDIA to the FDA in 1930."

In 1938 the Pure Food and Drug Act was more or less replaced by a new law called the Federal Food, Drug, and Cosmetic Act of 1938. This law had stronger regulations, and better enforcement than the PFDA.