The FDCA replaced and expanded on the protections of the Pure Food and Drug Act of 1906. In 1938, under the newly implemented law, drug developers had to submit an application for approval to the Food and Drug Administration (FDA) for the first time, along with substantial evidence that their product was safe before marketing it. Substantial evidence meant adequate and well-controlled studies based on sound scientific principles and judgment with full reports of these investigations. Samples of the drug could also be requested.
What was commerce like before 1938?
Prior to the FDCA, there was less assurance when products went on the market. If a health hazard related to a drug was detected, the government had the burden to show its harm before it could remove it from interstate commerce. Most often, if successful, it was at a point when it was too late.
As a precursor, before the FDCA was put in place, a devastating event occurred where 107 people died from a poisonous ingredient, diethylene glycol, in a sulfanilamide elixir. This product was also improperly labeled. Unfortunately, this was just one of many.
To underscore the numerous dangerous and deceptive products that the FDA did not have authority to remove from the market during that period, they formed a traveling exhibit in 1933. This was later adapted into a book in 1936.
The evolution of the FDCA
Since its enactment, there have been at least 30 amendments to the FDCA, including:
- the Durham-Humphrey Amendment of 1951 requiring classification of certain drugs as prescription only, and
- the Kefauver-Harris Amendment of 1962 requiring drug manufacturers to provide proof of drug efficacy before marketing approval as well as addressing drug advertising and generic drugs.
More recent amendments include the Orphan Drug Act of 1983, Prescription Drug Amendments of 1992, FDA Modernization Act of 1997, and FDA Amendments Act of 2007 (FDAAA). Under the FDAAA, to add to existing post market safety assessment tools, the FDA launched the Sentinel Initiative – a national system using existing electronic health databases to more quickly identify potential safety issues of approved products.
The FDCA can be found in the United States Code (USC) under Title 21, Chapter 9, covering Drugs and Devices in Subchapter 5, Part A, with details on New Drugs in Section 355. The official statutes corresponding to the FDCA have been made administrative law by the FDA in the Code of Federal Regulations as published in the Federal Register.
Applicable to food (including chewing gum and bottled water), drugs, medical devices, and cosmetics, the FDCA also regulates tobacco products. Oversight of dietary supplements and herbal medicines is limited primarily to manufacturing practices except for homeopathics that are listed in the United States Pharmacopoeia, a quality standard publication recognized since 1820.
In the years to come
Much of the work within the pharmaceutical industry and in clinical research organizations (CROs) stems from the FDCA in order to meet the requirements of providing substantial evidence to the FDA through strong science. This has been seen through a dedication to carrying out rigorous, decade-spanning programs in order to sufficiently test drug products.
The vast amount of data collected during pre-clinical and clinical development, continuing through post market monitoring, are reported in accordance with regulatory guidance to make the facts and that commitment clear. For the next 80 years, this obligation will be just as clear for the simple fact that all pharmaceuticals need to be deemed safe and effective for their intended use.
Undoubtedly, the FDCA is still relevant and keeping pace with our more sophisticated digital society of today. It will continue to play a major role in protecting public health and shaping the pharmaceutical industry by upholding high scientific standards to maintain confidence in the medicines that are made available in the US and around the world.
by Christine Tervo, MS
About the author
Christine Tervo, MS, is a senior medical writer at MMS, with more than 15 years of regulatory writing experience in the pharmaceutical industry across a wide range of therapeutic areas. She has presented on regulatory advisory actions at the Drug Information Association (DIA) annual meeting and has volunteered with the Alzheimer’s Association to write for a campaign to increase research funding.
