4.2: The Food and Drug Administration (FDA)
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The FDA (www.fda.gov) is an administrative agency created to regulate food and drug supplies in the United States for the safety and health of its citizens. FDA is an agency within the Department of Health and Human Services. It should be noted that the FDA has traditionally focused on the US markets, however, with the global market growth (of imports and exports of products and raw materials) the FDA now manages over 2 trillion dollars of goods manufactured in over 150 nations worldwide (FDA, FDA Global engagement report, 2016).
International Harmonization Efforts
What happens when a biotechnology company based in the United States or any other country wants to expand to overseas marketplaces? Conflicting regulatory standards made trade difficult until an effort began in the 1990s to harmonize international standards so that important medical products could be bought and sold with less regulatory ‘red tape.' The FDA has been the leader in this effort both in the U.S. and around the globe. The FDA assists both foreign and domestic manufacturers in compliance with CGMP, CGP, GLP, Safe and Sanitary Processing, and other regulations. (http://www.fda.gov/ForIndustry/default.htm).
Organization
The FDA is vast and complex. A complete organizational chart (2017) is found on their website here.
The FDA, like most organizations, change with changing the economy, world harmonization, and emerging technologies and products. The current hierarchy consists of the Office of the Commissioner overseeing five offices and directorates. Those offices oversee eight centers.
Like the federal government, the FDA possesses the following powers:
- Legislative: The FDA has the authority to create and issue rules.
- Executive: The FDA has the power to conduct investigations.
- Judicial: The FDA has the jurisdiction to review the evidence and make judgments on a product.
The FDA has "product centers" headquartered, largely in the Washington, D.C. area, (the NCTR is in Jefferson, Arkansas). FDA "field offices" are located throughout the United States. The field offices are "the eyes and ears" of the FDA, and it is from these offices that operational personnel enforce the law.
Explore!
Visit the FDA website and select each tab at the top of the page. Each tab corresponds to each of the different types of products the FDA regulates. Briefly describe each.
| Product | Description |
|---|---|
| Drugs | A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The site includes drug approval, safety, availability, regulatory information, research and consumer information relating to drugs |
FDA Field Offices
Office of the Commissioner: Leadership of the agency's scientific activities, communication, legislative liaison, policy and planning, women's and minority health. (fda.gov). www.fda.gov/about-fda/fdaorganization/office-commissioner
Office of Medical Products and Tobacco: Provides advice and counsel to the Commissioner on all medical product and tobacco-related programs and issues. www.fda.gov/about-fda/office-medicalproducts-and-tobacco/patient-affairs-staff
- Center for Biologics Evaluation and Research
- Center for Devices and Radiological Health
- Center for Drug Evaluation and Research
- Center for Tobacco Products
Office of Foods and Veterinary Medicine: Leads a functionally unified FDA Foods Program that addresses food and feed safety, nutrition, and other critical areas to achieve public health goals.
- Office of Foods and Veterinary Medicine
- Center for Food Safety and Applied Nutrition
- Center for Veterinary Medicine
Office of Global Regulatory Operations and Policy: Provides leadership for FDA's domestic and international product quality and safety efforts. www.fda.gov/about-fda/fda-organization/officeglobal-regulatory-operations-and-policy
Office of Operations: Provides agency-wide services including information technology, financial management, procurement, library services, and freedom of information, FDA history, and facilities. www.fda.gov/about-fda/office-operations/office-ethics
FDA Product Centers
Now, let’s examine more closely the functions of several important product-oriented centers: CDER, CBER, CDRH, CVM, CTP, NCTR, and CFSAN.
Center for Drug Evaluation and Research (CDER): The CDER oversees the regulation of drugs. The official definition of a drug is "an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles designed to affect the structure or any function of the body of man or other animals." (FDA, 2016) CDER regulates over-the-counter and prescription drugs, including biological therapeutics (act as drugs), and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, and dandruff shampoos are all considered "drugs." Why? More on this in a later chapter!
Center for Biologics Evaluation and Research (CBER): The CBER oversees the regulation of biologics. The official definition of a biological product is ‘any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product’ (FDA, 2016). More information on a biologic in the following video. Note, therapeutic biologics are biologics that act like drugs and therefore are overseen by CDER instead. More on this in a later chapter!
Center for Devices and Radiological Health (CDRH): Oversees the regulation of medical devices and radiation-emitting products, and also includes biotechnology products used in diagnostics, such as HIV or pregnancy tests. You will be surprised to learn about some unusual products that are considered medical devices. https://www.fda.gov/AboutFDA/Centers...dTobacco/CDRH/
Center for Veterinary Medicine, and (CVM): The CVM is a product center, which oversees the regulation of food, food additives, drugs and biologics for animals. They also conduct research that helps the FDA ensure the safety of animal drugs, food for animals, and food products made from animals. However, they do not oversee pre-clinical animal studies. Those fall under the purview of the product center of the product the pre-clinical studies are for. Here is a video on the CVM put out by the FDA.
Center for Food Safety and Applied Nutrition (CFSAN): CFSAN oversees food safety and purity. It has the power to regulate all domestic and imported food except for meat, poultry, and eggs (USDA regulates those). They oversee the safety of food ingredients developed through biotechnology, dietary supplements, food additives, and proper labeling of food. CFSAN is also concerned with food contamination, such as biological pathogens and naturally occurring toxins.
Center for Tobacco Products (CTP): The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified-risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. (fda.gov)
National Center for Toxicological Research (NCTR): FDA's research center conducts peer-reviewed research and develops new scientific tools for FDA to improve public health. This research produces innovative tools to assist in solving complex health issues, anticipated toxicological problems, and enhances the science of regulatory decision-making at the FDA. The NCTR publishes an annual report outlining their projects and can be found here.
Test Your Knowledge!
Go to this website for a tutorial about the Food and Drug Administration.
Scroll down and press on the sound icon to hear videos. At the very bottom of the page is a self-quiz. Briefly summarize the mission of the FDA and outline the primary duty of each of the following FDA offices:
| Center or Office | Summary of Main Duties |
|---|---|
| CFSAN | |
| CDER | |
| CBER | |
| CDRH | |
| CVM | |
| NCTR | |
| ORA | |
| CTP |
Rulemaking, Adjudication, Guidelines, and Points to Consider
The primary administrative activities of the FDA are rulemaking and adjudication.
- Rulemaking affects both the public and the drug and device manufacturers. When new rules are proposed, the FDA publishes them electronically in the code of federal regulations (CFR), which is available to the public at www.ecfr.gov.
- Adjudication is the term used to describe how the FDA responds to requests for approval to investigate or market a product. The FDA reviews each submission as a separate case even if each submission refers to the same product. Upon conclusion of its review, the FDA responds with its disposition or order.
Federal regulations are first published in the Federal Register (FR) by the executive departments and agencies of the Federal Government published every business day by the National Archives and Records Administration (NARA).
The Federal Register is a legal newspaper where the public is given notice of proposed new rules and intended actions, allowing time for comment. When the FDA finalizes a rule, it publishes its response to public comments in a preamble to the rule.
This bureaucratic process is quite time-consuming and, therefore, the FDA employs two additional methods of transmitting information to the public and industry: Guidelines and Points to Consider, which are published on the FDA website. Neither the Guidelines nor the “Points to Consider” represent any legal regulation and may be challenged by scientific or other types of evidence.
- Guidelines represent the FDA’s formal position on long-standing issues. Guidelines also communicate procedures or standards of general applicability that are acceptable to the FDA.
- Points to Consider are intended to disclose the FDA's current position on any area considered new or rapidly changing, such as some parts of the biotechnology industry. In other words, the FDA has not formulated a formal stance.