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Oct 6, 2016

How Well Do You Know Your FDA History?

Efforts to promote safe, effective 
products go back 300 years! 

by Lisa Weeks

Marketing Communications

MasterControl


Editor’s note: This is part one of a two-part series.

Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start—new teachers, new clothes, new school supplies. I'm dating myself here, but was there anything better than a brand spanking new Trapper Keeper®?

For those of you who don’t know, the Trapper Keeper was THE 80s school supply must-have: an ultra-cool 3-ring binder with an outer shell (the “keeper”) that held glossy primary-colored folders (the “trappers”) and featured a fold-over Velcro closure to keep it shut.


I can still remember mine—a dazzling montage of clouds, rainbows, and hearts. Oh, the feel of it clasped against my chest as I walked to Mr. Ward’s seventh-grade history class, my favorite subject.

Sadly, my kids don’t share my love of school, or history, or Trapper Keepers, for that matter. “Why do we have to know this stuff? It happened so long ago. Who cares?” they moan. “Because it’s fun,” I say. They look at me like I’m weird. “Because it’s interesting,” I stress. They’re still not convinced. Finally, I quote the old saying, “Because those who don’t learn from the past are doomed to repeat it.” Maybe it was the word ‘doomed,’ but it got their attention. 

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As someone who reads and writes about quality and the life sciences, this old saying hits home. Our industry thrives on the concept of best practice, a technique or methodology that, through experience (history) and research has proven to reliably lead to a desired result—or avoid an undesired result.

In many ways, the FDA is the keeper of best practices and serves as a constant reminder of the importance of continuous improvement and learning from our mistakes. When we don’t, the repercussions are often dangerous and sometimes catastrophic.



The Origins of the FDA


Although not known by its present name until 1930, the FDA’s modern regulatory functions began with the passage of the Pure Food and Drugs Act on June 23, 1906. The law, a quarter-century in the making, prohibited interstate commerce in adulterated and misbranded food and drugs.(1)  Before this law, thousands of questionable remedies, many containing inert preparations and/or narcotic drugs and alcohol, were sold everywhere, to anyone, without restriction. Few remedies listed ingredients or misuse warnings on the label. Thus, the public was forced to acquire product information from the dispensing “pharmacist,” by word of mouth, or from bitter experience.

Credit for the establishment of the Pure Food and Drug Act, and consequently the FDA, goes to Theodore Roosevelt, the 26th President of the United States, and Harvey W. Wiley, the chief chemist of the Bureau of Chemistry in the Department of Agriculture.(2) Although some argue that President Abraham Lincoln and Charles Wetherill, Wiley's predecessor, sowed the seeds for modern day food and drug regulation in 1862. Both Roosevelt and Wiley were passionate about offering consumers a level of protection they had never known before.

On the same day, the Pure Food and Drugs Act went into effect, Roosevelt also signed the Federal Meat Inspection Act (FMIA), partly as a response to author Upton Sinclair’s book The Jungle, an expose of the Chicago meat packing industry. The law authorized the Secretary of Agriculture to inspect and prevent adulterated or misbranded meat and meat products from being sold as food and to ensure that meat and meat products are slaughtered and processed under sanitary conditions.(3)

While following the mandates outlined in the FMIA seems like a no-brainer, the law exposed just how appalling the conditions in U.S. factories were, as well as the fact that plant managers did not seem to care. Sadly, these abhorrent conditions and deceptive practices had been going for almost 300 years!

Some Early Food and Drug Regulations

  • First Colonial Law: 1646 Massachusetts Bread Law

Bread baking was the first commercial activity in the New World. It didn’t take long for the dishonest bakers to realize that profits would increase if they used cheap ingredients, such as chalk and ground beans, or short changed buyers on weight (hello, Whole Foods). This law set the price for a “loaf of bread” at one penny and decreed how much it should weigh. Inspectors could enter homes and seize “light” bread—they did not have “lite” bread back then.

Is this relevant today? You bet it is. In 2007, several pet food manufacturers in China were replacing protein with the coal derivative melamine, which can mimic protein in tests. Thousands of animals suffered kidney failure and died. Even more horrific, in 2008, a Chinese baby formula manufacturer was doing the same thing, resulting in at least six confirmed infant deaths and 300,000 confirmed reports of infant illness.(4)

  • First State Law: 1785 Massachusetts Unwholesome Provisions Law

This was the first state law that applied to foods in general, instead of a particular product, e.g., bread. If you think reading/understanding FDA regulations is tough, here is an excerpt from the 1785 law:

“…where some evilly disposed persons from motives of avarice and filthy lucre, have been induced to sell diseased, corrupted, contagious or unwholesome provisions to the great nuisance of public health and peace…”

Yikes! And forget 483s and warning letters, violators of this law were subjected to “standing in pillory.” The pillory was a wooden device erected on a post, with holes for securing the head and hands, used to humiliate the offender in a very public place for several hours.

  • First Federal Law: 1789 Act of Laying a Duty on Imported Goods, Wares, and Merchandise
This was a revenue-generating act with some quality provisions included to help control the quantity, and therefore the quality, of goods being imported into the U.S.


The preferred way to deal with food and drug violators back in the day.

Modern Food and Drug Regulations


While the Pure Food and Drug and Act did much to improve the safety and efficacy of food and drug preparation in the early 1900s, the country still had a long way to go. To circumvent legislation, hucksters simply changed advertising tactics and continued to sell their questionable drug products, not as patent medicines but as “prescriptions” to have “filled” at the nearest drugstore. The most popular of these fake prescriptions was (and continues to be) diet products.

Health fraud scams were rampant because the 1906 law did not require any drug information to be submitted to the FDA before marketing, only that drugs meet standards of strength and purity. In other words, it was perfectly legal to market a “wonder drug,” such as Johnson’s Mild Combination Treatment for Cancer, with little therapeutic evidence to back up its claims. In the U.S. v. Johnson, the Supreme Court ruled that the product’s efficacy claims were outside the scope of the 1906 act.(5) 


  • Sherley Amendment of 1912
In response to the U.S. v. Johnson ruling, Congress enacted the Sherley Amendment, which prohibited labeling medicines with false therapeutic claims. Sherley was a step in the right direction but far from ideal. The burden of proof was still on the government to show that the drug’s labeling was false and/or misleading. This often proved difficult. When a misbranded diabetes medicine called Banbar, which was made from the extract of horsetail weed, resulted in several deaths, the jury ruled in the drug maker’s favor—despite the fact that the government could produce the death certificates of diabetes sufferers who had taken the drug, as well as the fact that the drug maker was a former shirt salesman!(6) Clearly, the first 28 food and drug inspectors, who were chosen in 1907 out of a pool of more than 2,000 applicants, had their work cut out for them.

  • 1914 Harrison Narcotic Act
One of the worst patent medicine abuses was the addiction of babies given “soothing syrups” to stop their crying. These “soothers” as they came to be known contained varying amounts of morphine, heroin, opium, or laudanum (a mixture of alcohol and opium). The 1906 law required only that the name of the narcotic and the dose be declared on the label. This enabled druggist to sell the syrups with powerful, addictive narcotics over the counter. Driven by the combined anti-opiate efforts of the American Medical Association and national magazines, the Harrison Narcotic Act of 1914 was passed, prohibiting retail druggist from selling syrups containing narcotics over the counter.(7)

  • The Food, Drug, and Cosmetic Act of 1938
Real change came as a result of public outcry after the S.E. Massengill Company made and sold an elixir (sulfanilamide) using diethylene glycol, derived as a co-product with ethylene glycol (antifreeze) and trimethylene glycol. The elixir caused mass poisoning and the agonizing deaths of 100 people, many of whom were children. The public was outraged, and the chemist who created the drug committed suicide.

One grief-stricken mother wrote a heartbreaking letter to President Franklin D. Roosevelt describing her six-year-old daughter’s death:

“…the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane…It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind…(8)

The sulfanilamide tragedy of 1937 made it clear that a complete overhaul of the 1906 law was needed. It came with the passing of the Food, Drug, and Cosmetic Act (aka FD&C Act and FFDCA), signed into law by FDR on June 25, 1938. For the first time, manufacturers were required to prove a drug’s safety before they could market it to consumers. The 1938 act replaced the 1906 Pure Food and Drug Act. It also eliminated the Sherley Amendment, set safe tolerances for unavoidable poisonous substances, and authorized factory inspections.(9)

What’s Ahead? Stay Tuned for Part Two

Although the FD&C Act has been amended many times, it is still remains the cornerstone of food and drug safety legislation in the U.S. In part two, we’ll look at the most significant amendments to the FD&C Act, as well as the events that prompted them. Part Two will also include an entertaining quiz, so you can test your FDA knowledge. See, told you history was fun!

The author would like to thank MasterControl’s Quality Manager, Lillian Erickson, for her invaluable contributions to this post.



Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.

References:


(1)   Brochure: The History of Drug Regulation in the United States, http://www.fda.gov/AboutFDA/WhatWeDo/History/FOrgsHistory/CDER/CenterforDrugEval (accessed September 23, 2016).http://www.fda.gov/AboutFDA/WhatWeDo/History/default.ht


(2)   History - U S Food and Drug Administration Home Page, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm (accessed September 23, 2016).


(3)   Federal Meat Inspection Act - Wikipedia, the free encyclopedia, https://en.wikipedia.org/wiki/Meat_Inspection_Act (accessed September 23, 2016).


(4)   PowerPoint - Lillian’s slide presentation, History of Food and Drug Regulations, (accessed September 23, 2016).


(5)   Promoting Safe and Effective Drugs for 100 Years - U S Food and Drug Administration “About the FDA” Page, http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/CentennialEditionofFDAConsumer/ucm093787.htm (accessed September 23, 2016).


(6)   Ibid.

(7)   Pure Food and Drugs - National Institutes of Health, https://www.nlm.nih.gov/exhibition/phs_history/foodanddrugs.html (accessed September 23, 2016).

(8)   Elixir sulfanilamide - Wikipedia, the free encyclopedia, https://en.wikipedia.org/wiki/Elixir_Sulfanilamide_disaster (accessed September 23, 2016).

(9)   Promoting Safe and Effective Drugs for 100 Years - U S Food and Drug Administration “About the FDA” Page, http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/CentennialEditionofFDAConsumer/ucm093787.htm (accessed September 23, 2016).




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