Center for Biologics Evaluation and Research

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The Center for Biologics Evaluation and Research (CBER) is one of the FDA’s six centers, which are part of the U.S. Department of Health and Human Services. The current director is Vinay Prasad, M.D., M.P.H. CBER works to ensure the safety, quality, and effectiveness of biologics and related products, including vaccines, probiotics, blood products, and cell, tissue, and gene therapies.

Not all biologics are regulated by CBER. Some products, like monoclonal antibodies and other therapeutic proteins, are regulated by the FDA’s Center for Drug Evaluation and Research (CDER).

CBER’s authority comes from laws like the Public Health Service Act and the Food, Drug, and Cosmetic Act. Section 351 requires licenses for biologics that move across state lines; CBER can deny licenses or suspend or cancel them if manufacturers don’t meet requirements. Section 361 allows the government to regulate the interstate spread of disease, a power the FDA carries out. Many CBER products are also considered drugs and follow the same drug rules as other FDA-regulated products.

Regulations are published in Title 21 of the Code of Federal Regulations. CBER-specific rules appear mainly in parts 600–680. Rules for human cells, tissues, and cellular therapy products are in part 1271. Blood for transfusion falls under other sections, and clinical trial rules are in part 50, among others. CBER also issues guidance documents to help industry, which are generally followed and may have regulatory effect when clarifying existing rules.

The FDA uses systems like the Vaccine Adverse Event Reporting System to track safety issues with vaccines and other biologics. CBER’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets regularly to discuss vaccines and, for example, helps determine the yearly influenza vaccine virus selection.

Historically, CBER’s work includes reviewing Biologics License Applications (BLAs). For example, in 2001, CBER reviewed 16 BLAs with a median review time of about 13.8 months and median approval time of about 20.3 months.

CBER’s origins go back to the Biologics Control Act of 1902, sparked by a vaccine-contamination scare involving a horse named Jim. It began as part of the NIH and was moved to the FDA in 1972, where it became the Bureau of Biologics, focusing on vaccines, allergy serums, and blood products. In 1982 it merged with the Bureau of Drugs to form the Center for Drugs and Biologics, and in 1987 it split into CBER and CDER. The split reflected different laws and approaches: CBER took a more public-health–oriented, collaborative style, while CDER handled drug regulation. In 1997, user fees were introduced, shifting some funding to manufacturers. In 2002, some biologics moved from CBER to CDER. CBER also regulates blood-related tests, software, and transfusion-related devices, though many device matters are handled by the Center for Devices and Radiological Health (CDRH). Federal law allows FDA advisory committees, and as of 2018 there were 31 such committees. During the COVID-19 pandemic in 2020, VRBPAC gained media attention for reviewing COVID-19 vaccines.