This month in pharma: June 1906, the formation of the US Food and Drug Administration
The pathway for drugs to reach market may be one of the most debated and lamented aspects of the pharma industry today, with both the cost and the effort to prove a drug’s safety and efficacy increasing, in addition to the meticulous art of labelling.
The US during the 19th century was a different matter entirely, however, with ill people just as likely to find opium or cocaine in a mysterious bottle bought freely at the end of a travelling circus show as they were to find any number of toxins intended to produce some form of physiological effect, if not necessarily the advertised or safest one.
For in this regulatory wilderness, whoever had the largest budget to buy the biggest posters and appear in the most popular newspapers and who gave the best sales pitch at the end of the most entertaining sideshow peppered with paid-off shills, was king, regardless of the side effects or the limitations of the products they offered.
With no legislation to deter or control such exploitation, these ‘patent medicines’ flourished, providing fortunes to such men as Benjamin Brandreth, whose Vegetable Universal Pill to cure impurity of the blood was marketed on a mass scale through the publication of pamphlets and whole books about medicine.
By the beginning of the 20th century, however, awareness was increasing about the harmful effects of these ‘medicines’ and demand was growing from the public to know exactly what they were getting when buying those bottles.
One of the main figures in this fight for the facts was Samuel Hopkins Adams, an investigative journalist from New York who championed drug reforms in his article ‘The Great American Fraud’ for the journal Collier’s Weekly in 1905.
The article describes ‘gullible America’ and its consumption of harmful products under the influence of ‘undiluted fraud’.
‘Acetanild will undoubtedly relieve headache of certain kinds,’ Adams wrote of one such product, ‘but acetanilid, as the basis of headache powders, is prone to remove the cause of the symptoms permanently by putting a complete stop to the heart action.’
Explaining their continued use, he theorised: ‘None of these ‘cures’ really does cure any serious affection, although a majority of their users recover. But a majority, and a very large majority, of the sick recover anyway. Were it not so - were one illness of fifty fatal - this earth would soon be depopulated.’
Adams’ campaign was one backed by Harvey Washington Wiley, head of the US government’s division of chemistry and a man with a strong background in science and agriculture who had ideas to improve both the drug industry and the safety of preservatives in food.
With support from Walter McNab Miller, president of the General Federation of Women’s Clubs, Dr Edward Ladd, a leader among the state food and drug officials, and Alice Lakey, of the National Consumers League, Wiley championed new legislation, and on June 30, 1906, President Theodore Roosevelt signed into law the Food and Drugs Act.
Now widely recognised as the day the US Food and Drug Administration (FDA) was born, the creation of this act was the US government’s attempt to put a stop to food adulteration and ‘quack’ remedies by requiring that certain drugs, such as alcohol, cocaine and morphine, be accurately labelled with contents and dosage, all enforced by the Bureau of Chemistry.
In its early days, legal procedures and the techniques of inspection began to be developed and then applied in hundreds of court cases, with the government winning a series of judicial decisions to strengthen the law and uncover areas where it needed to improve.
The Bureau of Chemistry continued to develop and enforce the 1906 law until 1927 when it was split into the Food, Drug, and Insecticide Administration, for regulatory function, and the Bureau of Chemistry and Soils, for research functions.
The Food, Drug, and Insecticide Administration was later renamed in 1931 to its current moniker, the Food and Drug Administration.
As well as its name, its functions changed, with revisions to the 1906 act signed in 1938 to include cosmetics and therapeutics, as well as several improvements to drug regulation, such as requiring new drugs to be shown as safe before marketing and to authorise factory inspections.
By 1962 the industry environment had changed again and new rules were passed to shift to a pre-market approval system requiring drugs to demonstrate effectiveness, before medical devices regulation was strengthened in 1976.
With further revisions along the way, the FDA has remained a largely positive force in US healthcare.
So, although that environment may have changed from the snake oil salesmen of the 1800s, the FDA’s remit is still close to its initial intention: to make sure people are aware of what is in the medicines they are receiving, and that they do what they are meant to do in the safest way possible.
Tom Meek, web editor at PMLiVE