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 and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
Scope
- Blood 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 immunoglobulins, hyperimmune products, and antitoxins.
- Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels.
- Vaccines for use in humans.
- Diagnostic and therapeutic allergenic extracts.
- Live biotherapeutics (probiotics).
- Some medical devices, specifically test kits for HIV, tests used to screen blood donations, blood bank collection machines and equipment, and blood bank computer software.
- Xenotransplantation.
- Gene therapy and Human Cloning.
- 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 Act 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.
Vaccine Adverse Event Reporting System
As of 2003, the Vaccine Adverse Event Reporting System was based on a data integration platform from Informatica. 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 Act 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.
Leadership
- Kathryn Zoon, Director, 1992 to 2002
References
External links
- CBER home page
- 100 Years of Biologics Regulation Centennial anniversary reports
0 komentar :
Posting Komentar