Most have heard of the FDA (Federal Drug Administration), but its origins are rarely known. In today’s economic and political climate, many regulations are being questioned, rethought, and even repealed in favor of swifter approval and increased financial gains.
So, what exactly prompted the creation of an entire organization to regulate what we eat, what we inject to heal and treat our ailments, and what products we can put on our skin or take for our beauty? Turns out, these regulations didn’t initially come from one organization, but rather rose out from urgency of many.
Before the Creation of the FDA
It might be surprising to know that the FDA took decades to build and was only created to administer the laws enacted before it was devised.
The fringe beginnings of the FDA can be traced back to the year 1848, with the creation of the Agricultural Division in the Patent Office. It became a federal consumer protection agency in 1906, with the passage of the Pure Food and Drugs Act- a culmination of approximately 100 bills written over a quarter of a century. All the bills were created to stem the abuses in the marketplace and protect from the harmful effects of negligence and greed.
However, it wasn’t until 1930 that the FDA established itself officially and with real authority. Of course, this was met with much interference and opposition, as with all regulation.
The Revolution of Upton Sinclair
There was a great deal of effort by many entities, doctors, and worried consumers to push for regulation. However, one man stands out as the strongest proponent of these changes. The American Medical Association had been pushing for regulation for decades. Then there was a study published on labor and production conditions in the meat-packing facility in 1904, which sparked Upton Sinclair to write “The Jungle.” At the same time, Samuel Hopkins also picked up the study and promptly published a 12-part series on fraud in the patent-medicine industry.
The outrage created by both pieces even caught President Theodore Roosevelt, who quickly signed the 1906 Pure Food and Drugs Act.
In turn, this novel was picked up by Harvey Washington Wiley, chief chemist for the Bureau of Chemistry of the U.S. Department of Agriculture. Wiley’s passion is said to have been making food and medicine safe for the public, and drove him to tap into his network, including the General Federation of Women’s Clubs (led by activist Alice Lakey), national associations of pharmacists as well as physicians, and the AMA. Together they changed public opinion and lobbied for more regulations.
While they were granted more support and regulation power, and more laws were written, they still faced challenges including mild support from President Roosevelt and continued lobbying from the corporations they sought to regulate. They still face many of these same challenges today. Still, the recognition prevails, that these regulations are needed, if only to protect the public.
How The Industrial Revolution Urged Regulation
The Industrial Revolution gave rise to several companies, turning them from local producers to national enterprises. Suddenly products could be shipped across the country and stored for months, and even years at a time due to the revolution of canning.
Catalogs began to promote and sell medicines. Marketing became strategic, artful, and easily broadcast due to television. Slogans and jingles made them trendy, allowing companies to sell far more than they ever had.
Manufacturers began to see more opportunities and ways of making money, began cutting corners, and devising ways to save money from the start. They added spices, additives, and other non-ingredients to keep their products fresher for longer and mask the obvious signs of expiration. Consumers were none the wiser.
Producers of medicine also saw ways to prolong their profits by giving consumers morphine and cocaine, mere distractions and relievers, instead of treatments.
While regulations were being drawn during these times due to push from the AMA and other advocates, there was still little being done to enact these restrictions and the FDA had minor authority.
This changed after 100 people died from a “wonder drug” pushed by the cosmetics industry. These deaths brought about the Food, Drug, and Cosmetic Act of 1938, which gave the FDA injunction power, allowed them to set food standards, and included the cosmetics industry in regulations for the first time.
Past & Present Opposition to FDA Regulations
The arguments of the past often echo into the future, and that applies heavily to the creation and continuation of the FDA.
During the initial stages of the formation of the FDA, and immediately following, many businesses (particularly dairy and meat farmers) grew concerned about the increase in regulations. Regulations slow down production, constrict their margins, create paperwork, hassles, and even restrict when and what they can sell.
Their arguments were vocalized right from the start, in 1904, with the publishing of the study of the conditions inside the meat packing facilities, which inspired the controversial Sinclair novel, “The Jungle”. Since this study was funded by the Socialist Party, many claimed that it was “socialist interference”, though the American Medical Association had been calling for this kind of reform for decades.
Opposition continued throughout the decades, as the FDAs regulatory power grew. One major criticism that still stands was one claimed by Milton Friedman in the late fifties, that the regulatory process is inherently biased. He believed that banning a helpful drug had adverse effects, but they were largely undetectable, while approving a harmful drug would be highly publicized. Therefore, the FDA would take the path of least resistance. One that would result in the least amount of criticism of their organization.
This, however, is slightly negated by instances such as the thalidomide birth defects crisis, in which approximately 10,000 babies were born with defects as a result of the drug. This became an argument for more regulation and led to the creation of the Kefauver Harris Amendment in 1962, which required proof of efficacy and safety approval.
This only created more criticism, with critics claiming that this added considerable costs to drug creation and approval (costs which are passed on to the consumer), as well as delays, which costs lives. The claim is backed by the fact that prior to the amendment it took only seven months to approve a drug, and more than seven years for approval by the late nineties. During the AIDS and HIV crises, these criticisms grew to a head with large protests, prompting the FDA to introduce expedited approval for drugs that treat life-threatening diseases.
Criticisms of the organization continue on and are widespread. The supplement industry, for one, claims that the pharmaceutical industry has their hand too far in the organization, making it impossible for dietary supplements to be marketed for their true benefits. They believe the money earned from pharmaceuticals creates extraordinary bias from the organization. Other critics of the FDA follow this claim by stating that the organization is far too slow in repealing drugs from the market once they are proven unsafe, and often overlook safety concerns during initial approval.
Their claims of overlooking safety concerns extend further, into the meat and dairy industries and their use of carbon monoxide to prevent discoloration of meat (hiding signs of spoilage), and the use of rBGH in cows and antibiotics in farm animals. There has been a growth in concern in the latter claim, as humans and bacteria become more resistant to antibiotics. The FDA is said to be increasing their disapproval for these treatments.
Back and forth this process goes, a balancing act of criticism and response that is entirely necessary for the health of the public. Drugs must be approved for the treatment of ailments, and regulations must be in place to ensure the public isn’t being taken advantage of. However, there is still a long way to go before we reach a true balance, when the cost of drugs is low and the quality and safety is high, when our food is safe and healthy, but profits can still be made. It’s likely that there will always be criticisms of the FDA, but regardless of them, we now know the reasons the FDA was created, and why it will continue to exist.
To learn more about regulatory affairs in the present day, contact Treximo today.
