What is Biotechnology?  

The National Center for Biotechnology Information Medical Subject Headings (MeSH) database defines “biotechnology” as a “body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., genetic engineering) is a central focus; laboratory methods used include transfection and cloning technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction."[1]

Key biotech organizations, according to the National Library of Medicine include:

Which Government Agencies Are Concerned About Biotechnology?

Government agencies and organizations such as the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the US Department of Energy (DOE), and the US Department of Agriculture (USDA) are all supporting efforts related to biotechnology.

Within the National Institutes of Health Office of Science Policy, there is a Biosafety, Biosecurity, and Emerging Biotechnology Policy Division that focuses on the development of policies that support the responsible oversight of life science research. This division supports NIH guidelines for research concerning the use of recombinant or synthetic nucleic acid molecules, dual use research of concern (DURC), and the NIH Stem Cell Registry. Programs overseen by this division include the Biosafety Recombinant DNA Policy Program, the Biosecurity Policy Program, and the Emerging Biotechnology Policy Program.[4]

The National Institutes of Health also oversees the National Center for Biotechnology Information (NCBI). The NCBI provides access to biomedical and genomic information. As a national source for molecular biology information, the NCBI develops new information technologies to further the understanding of fundamental molecular and genetic processes that control health and disease. The organization creates automated systems for storing and analyzing knowledge pertaining to molecular biology, biochemistry, and genetics. The NCBI also facilitates the use of its databases and software, providing support to the medical and research communities.[5]

The Centers for Disease Control and Prevention (CDC) Division of Scientific Resources encompasses the Biotechnology Core Facility Branch (BCFB). The BCFB is comprised of six laboratories, which focus on biotechnology areas such as genomic sequencing, proteomics and protein chemistry, scientific computing and bioinformatics, DNA synthesis, peptide synthesis, and molecular assay development. The BCFB provides biopolymer reagents and advanced analytical methodology to the CDC community. This branch provides services and reagents to researchers responding to public health and/or bioterrorism emergencies.[6]

The US Food and Drug Administration (FDA) is responsible for the regulation of both food (crops and animals/animal products) and drugs (pharmaceuticals, biologics, etc.) produced using biotechnology. The following FDA websites and documents may be helpful to those seeking FDA guidance on biotechnology related topics: 

Agencies such as the Department of Energy (DOE), Environmental Protection Agency (EPA), and the Department of Agriculture (USDA) also provide guidance for the biotechnology segment; however, these agencies do not provide guidance on biotechnology within the context of healthcare and medicine.  

Why is Federal Oversight of Biotechnology Important? 

The federal government seeks regulatory approaches that protect human and animal health and the environment, while also reducing regulatory burdens, unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers. According to the National Strategy for Modernizing the Regulatory System for Biotechnology Products, federal agencies that regulate biotechnology products should aim to continuously improve predictability, increase efficiency, and reduce uncertainty in regulatory processes and requirements. The federal government maintains high standards based on “best available science” that provide adequate and appropriate health and environmental protection. Agencies “establish transparent, coordinated, predictable, and efficient regulatory practices across agencies with overlapping jurisdiction.”[7] In addition, the oversight of biotechnology-based products through clear and transparent public engagement increases public confidence in biotechnology products and processes.[7]

FDA Office of Biotechnology Products 

The FDA plays a role when it comes to the regulation of biotechnology products related to the medical and pharmaceutical industries. Within the FDA, there is an Office of Biotechnology Products. The Office of Biotechnology Products is situated within the Office of Pharmaceutical Quality, which is part of the Center for Drug Evaluation and Research (CDER).[8] The mission of the Office of Biotechnology Products is to protect public health by assuring the quality, safety, efficacy, and security of therapeutic protein and monoclonal antibody products. Contact information for this FDA office is included here. 

US Food & Drug Administration
Center for Drug Evaluation and Research
Office of Pharmaceutical Quality
Office of Biotechnology Products
White Oak Building 51, Room 4184
10903 New Hampshire Avenue
Silver Spring, MD 20993
(301) 796-4200 

FDA Protocol for Using Independent Consultants for Biotechnology Clinical Trials 

Companies, organizations, or researchers looking to bring a drug that is biotechnology-derived to the clinical trial stage can submit a request to the FDA for the agency to engage an independent consultant to participate in the review of their protocol for a clinical study that is intended to serve as the primary basis for their claim of efficacy.[9] More information about this program is available here.

Updated by Theresa Pipher, October 2020