Center for Biologics Evaluation and Research
Encyclopedia
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration
(FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics
(such as vaccine
s, blood product
s, and monoclonal antibodies
) and related products.
and in various sections of the Food, Drug and Cosmetic Act.
Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce
in the United States
. CBER may deny licensure or suspend or cancel a current license if a manufacturer does not comply with requirements. Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.
Section 361 of the same act allows the Surgeon General
to make and enforce regulations to control the interstate spread of communicable disease. This broad authority has been delegated to the FDA through a Memorandum of Understanding. Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act.
From these legal authorities, CBER publishes regulations which are included in the first chapter title 21 of the Code of Federal Regulations
. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for transfusion
, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.
In addition to these laws and guidances, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry. Licensed manufacturers are expected to adopt either the guidance or an equivalent process. In some cases, the guidance documents have the force of regulation because they are written to clarify existing rules.
. The FDA uses this software to analyze data on adverse reactions to vaccines and other biologicals in order to improve regulation.
of 1902. Originally, CBER was part of what became the National Institutes of Health
, rather than the FDA. Its mission included a mandate to foster the development of new vaccines.
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products.
Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. It was merged with the FDA's Bureau of Drugs to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. This reorganization similarly merged the bureaus responsible for medical devices and radiation control into the Center for Devices and Radiological Health
.
In 1987, under Commissioner Frank Young
, CBER and the Center for Drug Evaluation and Research
(CDER) were split into their present form. The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences. CBER took a more collaborative, public-health driven approach to working with the industry, and in the 1980s was quicker to approve products than their drugs counterparts. The growing crisis around HIV
testing and treatment, and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator
), led to the split. CBER was declared the primary agency for HIV/AIDS-related products, since HIV had been spread significantly by blood transfusion and related products.
In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers. CBER's research work has diminished dramatically since then.
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics
Biologics
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases...
(such as vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s, blood product
Blood product
A blood product is any component of the blood which is collected from a donor for use in a blood transfusion. Whole blood is uncommonly used in transfusion medicine at present; most blood products consist of specific processed components such as red blood cells, blood plasma, or platelets.-Relation...
s, and monoclonal antibodies
Monoclonal antibodies
Monoclonal antibodies are monospecific antibodies that are the same because they are made by identical immune cells that are all clones of a unique parent cell....
) and related products.
Scope
- BloodBloodBlood is a specialized bodily fluid in animals that delivers necessary substances such as nutrients and oxygen to the cells and transports metabolic waste products away from those same cells....
for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities. - Plasma derivatives, including immunoglobulinsIntravenous immunoglobulinIntravenous immunoglobulin is a blood product administered intravenously. It contains the pooled IgG extracted from the plasma of over one thousand blood donors. IVIG's effects last between 2 weeks and 3 months...
, hyperimmuneHyperimmune globulinHyperimmune globulin is similar to Intravenous Immunoglobulin except that it is prepared from the plasma of donors with high titers of antibody against a specific organism or antigen. Some agents against which hyperimmune globulins are available include hepatitis B, rabies, tetanus toxin,...
products, and antitoxinAntitoxinAn antitoxin is an antibody with the ability to neutralize a specific toxin. Antitoxins are produced by certain animals, plants, and bacteria. Although they are most effective in neutralizing toxins, they can kill bacteria and other microorganisms. Antitoxins are made within organisms, but can be...
s. - Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels.
- VaccineVaccineA vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s for use in humans. - Allergenic extracts.
- Some medical devices, specifically test kits for HIVHIVHuman immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
, tests used to screen blood donations, blood bank collection machines and equipment, and blood bank computer software. - XenotransplantationXenotransplantationXenotransplantation , is the transplantation of living cells, tissues or organs from one species to another. Such cells, tissues or organs are called xenografts or xenotransplants...
. - Gene therapyGene therapyGene therapy is the insertion, alteration, or removal of genes within an individual's cells and biological tissues to treat disease. It is a technique for correcting defective genes that are responsible for disease development...
and Human CloningHuman cloningHuman cloning is the creation of a genetically identical copy of a human. It does not usually refer to monozygotic multiple births nor the reproduction of human cells or tissue. The ethics of cloning is an extremely controversial issue...
. - Historically, CBER was responsible for some therapeutic proteins, such as monoclonal antibodies. Control of these has been transferred to CDER. Some other drugs, such as certain anticoagulants and plasma volume expanders remain under the control of CBER.
Authority
As of July 2006 CBER's authority resides in sections 351 and 361 of the Public Health Service ActPublic Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....
and in various sections of the Food, Drug and Cosmetic Act.
Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce
Commerce Clause
The Commerce Clause is an enumerated power listed in the United States Constitution . The clause states that the United States Congress shall have power "To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes." Courts and commentators have tended to...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. CBER may deny licensure or suspend or cancel a current license if a manufacturer does not comply with requirements. Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.
Section 361 of the same act allows the Surgeon General
Surgeon General of the United States
The Surgeon General of the United States is the operational head of the Public Health Service Commissioned Corps and thus the leading spokesperson on matters of public health in the federal government...
to make and enforce regulations to control the interstate spread of communicable disease. This broad authority has been delegated to the FDA through a Memorandum of Understanding. Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act.
From these legal authorities, CBER publishes regulations which are included in the first chapter title 21 of the Code of Federal Regulations
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
. Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for transfusion
Blood transfusion
Blood transfusion is the process of receiving blood products into one's circulation intravenously. Transfusions are used in a variety of medical conditions to replace lost components of the blood...
, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.
In addition to these laws and guidances, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry. Licensed manufacturers are expected to adopt either the guidance or an equivalent process. In some cases, the guidance documents have the force of regulation because they are written to clarify existing rules.
Vaccine Event Adverse Reporting System
As of 2003, the Vaccine Adverse Event Reporting System was based on a data integration platform from InformaticaInformatica
Informatica Corporation is a NASDAQ listed company with ticker INFA. Founded in 1993, its headquarters is in Redwood City, California. Founded by Diaz Nesamoney and Gaurav Dhillon...
. The FDA uses this software to analyze data on adverse reactions to vaccines and other biologicals in order to improve regulation.
Flu vaccines
CBER's Vaccines and Related Biological Products Advisory Committee meets annually for a discussion and vote concerning the next year's influenza vaccine virus selection.Review and approval times
According to numbers from the FDA, in 2001 the CBER reviewed 16 Biologics License Applications (BLAs) with a median review time of 13.8 months and a median approval time of 20.3 months.History
CBER's history began with a horse named Jim, a vaccine-contamination scandal that prompted the Biologics Control ActBiologics Control Act
The Biologics Control Act was passed in the United States on July 1, 1902 after two incidents involving the deaths of children caused by contaminated vaccines. The first involved the horse named Jim whose tetanus-contaminated serum was used to produce a diphtheria antitoxin that caused the deaths...
of 1902. Originally, CBER was part of what became the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
, rather than the FDA. Its mission included a mandate to foster the development of new vaccines.
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products.
Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. It was merged with the FDA's Bureau of Drugs to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. This reorganization similarly merged the bureaus responsible for medical devices and radiation control into the Center for Devices and Radiological Health
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
.
In 1987, under Commissioner Frank Young
Frank Edward Young
Frank Edward Young was a U.S. administrator and physician. He served as commissioner of Food and Drug Administration between 1984 and 1989. Dr. Young is now a senior partner at The Cosmos Alliance, a Maryland-based venture capital firm....
, CBER and the Center for Drug Evaluation and Research
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and...
(CDER) were split into their present form. The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences. CBER took a more collaborative, public-health driven approach to working with the industry, and in the 1980s was quicker to approve products than their drugs counterparts. The growing crisis around HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
testing and treatment, and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator
Tissue plasminogen activator
Tissue plasminogen activator is a protein involved in the breakdown of blood clots. It is a serine protease found on endothelial cells, the cells that line the blood vessels. As an enzyme, it catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown...
), led to the split. CBER was declared the primary agency for HIV/AIDS-related products, since HIV had been spread significantly by blood transfusion and related products.
In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers. CBER's research work has diminished dramatically since then.
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological Health.
External links
- CBER home page
- 100 Years of Biologics Regulation Centennial anniversary reports