In this article by our pharmaceutical interpreters and GMP translators, you will learn exciting details about the history of the FDA, the Food and Drug Administration in the USA. How did the authority come about and what have been some of the milestones in its history since then? Read more in the following blog post.

The FDA, the Food and Drug Administration, is the US federal regulatory authority for food, drugs and other products and one of the oldest regulatory authorities in the world. Today, we take it for granted that food does not contain any toxic additives and that medicines only contain what is stated on the packaging. But this was by no means always the case. Read more about the history of the FDA in the blog post by our pharmaceutical interpreters and GMP translators.

The beginnings of the FDA – abuses in food and drug production

At the beginning of the 20th century, when there were still virtually no regulations for the production of food and medicines, many abuses were uncovered in the USA - partly by the Muckrakers, a group of journalists and writers. They drew the public's attention to harmful food additives such as toxic preservatives or colourings, hygiene problems and the harmfulness or at least ineffectiveness of so-called panaceas. One of the best known among them is probably Upton Sinclair, who published his book The Jungle in 1906, in which he denounced the appalling conditions in the slaughterhouses of the time. While Sinclair was mainly concerned with the social grievances and precarious working conditions, the general public found the disastrous hygienic conditions much more alarming. In the same year, the Meat Inspection Act is passed in the USA. This law makes it compulsory to inspect both live animals and slaughtered meat and to comply with certain hygiene standards. In addition, official inspections are introduced to monitor fulfilment of the requirements. On the same day, the Food and Drugs Act is also passed, prohibiting the trade in contaminated or mislabelled food and drugs between the states. Although there had already been similar endeavours during the 19th century, this law laid the foundation for the establishment and thus the history of the FDA. However, it took until 1930 for the Bureau of Chemistry, the predecessor agency, to become the Food and Drug Administration (FDA).

Toxic or ineffective drugs call the FDA into action

However, drug safety in the USA was still in its infancy in the late 1930s: in 1937, over a hundred people, many of them children, died after taking a drug containing a toxic solvent. This happened because proof of the safety of a medicinal product or even a marketing authorisation wasn’t yet required. This soon changed as a result of a law that had been under discussion for some time: In 1938, the US Congress passed a new federal law called the Federal Food, Drug, and Cosmetic (FDC) Act. It contained new, stricter regulations and replaced the now outdated Food and Drugs Act of 1906. For the first time ever, there now was a requirement for a type of marketing authorisation, in the course of which the safety of the medicinal product had to be proven. Due to drastic damage to the health of the population caused by mascara, among other things, the new law also covered cosmetics for the first time. Another new feature was that, in cases of false information in the labelling of medicinal products, it was no longer necessary to prove fraudulent intent in order to hold the manufacturer accountable. During this period, regulation by the authorities was urgently needed, particularly in the pharmaceutical sector. A good example of FDA intervention is the case of Harry M. Hoxsey, a miner who sold an ineffective cure for cancer and treated patients in a "clinic" for nearly 30 years starting in the mid-1920s. Many cancer patients died because they did not receive effective treatment, and some patients who did not even have cancer were harmed or at least deprived of their money. For example, skin cancer patients (or those who were thought to have skin cancer) were given a caustic paste containing arsenic as a supposed treatment. In the 1950s, the FDA was finally able to ban the sale of the "cure" and warned the population throughout the USA against the treatment. The warning ultimately lead to the closure of these "clinics".

Proof of efficacy and inspections become mandatory

At the beginning of the 1950s, the concept of prescription-only medicine was also introduced in the USA, which meant that certain medicines could only be taken if prescribed by a doctor, for example because the active ingredient was particularly potent or had serious side effects. The aim is to expose ineffective medicines and prevent drug abuse. The agency once again became the focus of public attention in the early 1960s when the thalidomide scandal was uncovered in West Germany. Taking this sleeping pill, which is currently used to treat conditions such as leprosy and multiple myeloma, causes malformations in newborn babies. Thanks to Frances Oldham Kelsey, who at the time worked at the FDA and did not grant approval due to her concerns about the safety of the drug, the American population is largely spared the teratogenic effects of the active ingredient. This event went down as another milestone in the history of the FDA and strengthened the position of the FDA, which thus demonstrated its value. As a result, new laws came into force in the USA in 1962, which now required proof of efficacy in addition to proof of safety in the application for authorisation - an important step towards the modern authorisation procedure, in which quality, efficacy and safety must be proven. The new law also laid the foundation for inspections of pharmaceutical companies by the FDA, essentially the precursor to GMP inspections.

From AIDS to the opioid crisis: The FDA over the last three decades

Criticism of the FDA becomes vocal at the beginning of the AIDS epidemic in the late 1980s. At that time, an HIV diagnosis was still tantamount to a death sentence, and effective and well-tolerated drugs did not yet exist. In October 1988, the politically active group ACT UP (AIDS Coalition to Unleash Power) protests in front of the FDA headquarters, demanding faster approval of new drugs for the treatment of fatal diseases and better access to participation in drug trials in order to at least have a realistic chance of survival. The protesters chanted "Fifty-two will die today / Seize control of the FDA!"   In doing so, they are drawing attention to the countless deaths caused by AIDS/HIV in the USA. In fact, the FDA relented and within a year fulfilled the demands of the protesters, involving patients more closely in the decision-making process. Today, HIV is readily treatable. A drug that cures HIV does not yet exist, but is increasingly within reach. However, the story of the FDA is far from over, as there will certainly be no shortage of challenges for the FDA in other areas as well: The Covid-19 pandemic has been contained, yet hundreds of people in the United States are still dying from the virus every week. The opioid crisis claims around 300 lives every day (!) in the United States. To combat this crisis, in March 2023, the FDA removed naloxone nasal sprays from the list of prescription-only medicines. New approvals of antibiotics and medicines for the treatment of oncological diseases are also highly relevant. Intensive research is being conducted in this field so that new mechanisms of action and effective yet well-tolerated active substances can be approved. One of the FDA's ongoing tasks is to inspect drug manufacturers in the United States and abroad. If your pharmaceutical company is facing a GMP inspection by the FDA or another drug regulatory authority, we will be happy to take care of the linguistic communication between your staff and the inspection team and also translate your pharmaceutical documents, such as SOPs, in advance of the inspection, e.g. from German into English.

Image: The U.S. Food and Drug Administration, www.flickr.com