The Evolution of Drug Regulation: The First FDA Approved Drug

The history of drug regulation in the United States is marked with significant milestones, one of which is the first drug approved by the U.S. Food and Drug Administration (FDA). Before we explore the first drug approved under the current FDA framework, it is essential to understand the historical context and the regulatory environment.

Origins of FDA Regulation

The root of modern drug regulation dates back to 1927, when the Food Drug and Insecticide Administration (FDIA) was established. Initially, the primary focus was on banning unsafe chemicals rather than approving drugs. The FDIA remained passive, allowing treatments like the monkey gland treatment in the 1920s to continue unchallenged. This method involved implanting monkey testicles into human patients, regardless of the lack of verifiable benefits and the unethical nature of the procedure.

The early FDA, much like its predecessor, tolerated these practices as long as they did not lead to a critical number of fatalities. These treatments were performed not only in the United States but also in Europe, leading to a form of informal approval.

The Modern FDA and the Food Drug and Cosmetics Act (FDCA)

The current FDA was established as a government authority in 1938 with the signing of the Food Drug and Cosmetics Act (FDCA). This landmark legislation not only clarified the FDA's role in regulating drugs but also introduced a more rigorous evaluation process. The act specified a formal application process for new drug approvals, marking a significant shift from the earlier laissez-faire approach.

As a result of the FDCA, the first drugs were approved in mass quantities. In 1940, there were approximately 2700 applications, with almost 1800 of them resulting in approvals. However, the first drug in line and the criteria for prioritizing these applications are not well-documented in readily available lists. Historically, the regulation of drug prescriptions and labeling was heavily reliant on the formulary list of drugs maintained by the United States Pharmacopeia (USP), a non-profit organization established in 1820.

The Current Landscape of Drug Approval

Today, the process for approving new prescription drugs is much more stringent. A new Rx drug requires positive FDA approval, which encompasses extensive clinical trials and rigorous testing. The FDA scrutinizes these applications meticulously to ensure the safety and efficacy of the drugs.

However, despite these measures, the adverse reactions caused by prescription drugs remain a significant public health concern. According to recent data, prescription drugs are responsible for over 81 million adverse reactions annually and cause more than 2400 fatalities every week. In fact, these medication-related harms contribute to prescription drugs being the fourth leading cause of death in the United States.

These statistics underscore the ongoing challenges in drug regulation and the need for continuous improvement in the approval and monitoring processes.

Conclusion

The first drug approved by the modern FDA in 1940 marked a significant milestone in the history of drug regulation. This event, along with subsequent legislative and procedural changes, reflects the evolving approach to ensuring the safety and efficacy of prescription drugs. As the landscape of pharmaceuticals continues to evolve, the role of the FDA in protecting public health remains crucial.