CBER's past names | ||
1880 — – 1890 — – 1900 — – 1910 — – 1920 — – 1930 — – 1940 — – 1950 — – 1960 — – 1970 — – 1980 — – 1990 — – 2000 — – 2010 — | Laboratory of Hygiene founded Renamed Hygienic Laboratory Became part of the newly formed Public Health and Marine Hospital Service RenamedNational Institute of Health (NIH) Division of Biologics Control formed within NIH Renamed Laboratory of Biologics Control Incorporated intoNational Microbiological Institute (NIH) Renamed Division of Biologics Standards Transferred to theFDA; renamed Bureau of Biologics Merged to form Center for Drugs and Biologics Split to form the Center for Biologics Evaluation and Research | |
The present center can trace its history back to the original American public health service, which later became the NIH.[1] | ||
TheCenter for Biologics Evaluation and Research (CBER) is one of six main centers for theU.S. Food and Drug Administration (FDA), which is a part of theU.S. Department of Health and Human Services. The current Director of CBER isVinay Prasad, M.D., M.P.H. CBER is responsible for assuring the safety, purity, potency, and effectiveness ofbiologics and related products (such asvaccines, live biotherapeutics (probiotics),blood products, andcell, tissue, andgene therapies). Not all biologics are regulated by CBER.Monoclonal antibodies and other therapeutic proteins are regulated by the FDACenter for Drug Evaluation and Research (CDER).
As of July 2006 CBER's authority resides in sections 351 and 361 of thePublic Health Service Act and in various sections of theFood, Drug and Cosmetic Act.[3]
Section 351 of the Public Health Service Act requires licensure of biological products that travel ininterstate commerce in theUnited 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.[citation needed]
Section 361 of the same act allows theSurgeon 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.[citation needed]
From these legal authorities, CBER publishes regulations which are included in the first chapterTitle 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 fortransfusion, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply.[citation needed]
In addition to these laws and guidelines, 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.[citation needed]
As of 2003, theVaccine Adverse Event Reporting System was based on a data integration platform fromInformatica. The FDA uses this software to analyze data on adverse reactions to vaccines and other biological, in order to improve regulation.[4]
CBER's Vaccines and Related Biological Products Advisory Committee meets annually for a discussion and vote concerning the next year'sinfluenza vaccine virus selection.[5][6]
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.[7]
CBER's history began witha horse named Jim, a vaccine-contamination scandal that prompted theBiologics Control Act of 1902. Originally, CBER was part of what became theNational Institutes of Health, rather than the FDA.[8] Its mission included a mandate to foster the development of new vaccines.[8]
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamedBureau of Biologics and focused on vaccines, serums forallergy shots, and blood products.[8]
Ten years later, with the beginning of thebiotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred.[8] It was merged with the FDA's Bureau of Drugs to form theCenter for Drugs and Biologics during an agency-wide reorganization under CommissionerArthur Hayes.[8] This reorganization similarly merged the bureaus responsible for medical devices and radiation control into theCenter for Devices and Radiological Health.
In 1987, under CommissionerFrank Young, CBER and theCenter for Drug Evaluation and Research (CDER) were split into their present form.[8] The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences.[8] 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.[8] The growing crisis aroundHIV 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.[8]
In 1997, Congress re-authorized user fees, and research previously done at taxpayer expense began to be charged to manufacturers.[8] CBER's research work has diminished dramatically since then.[8]
In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.[8] 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.[8]
Federal law and DHS policy define the procedures for the CBER to establish advisory committees,[13] which may further be divided into panels and must be renewed every two years.[14] As of 2018[update] the FDA has 31 advisory committees.
During theCOVID-19 pandemic in 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) received media attention as it reviewedCOVID-19 vaccines before their approval.[citation needed]
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