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  5. Center for Biologics Evaluation and Research (CBER) Responsibilities Questions and Answers
  1. Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER) Responsibilities Questions and Answers

What is the Center for Biologics Evaluation and Research (CBER)?

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

What products does CBER regulate?

CBER regulates an array of diverse and complex biological products, both investigational and licensed, including:

  • Allergenics
    Patch tests used to diagnose the causes of contact dermatitis. Extracts used to diagnose and treat rhinitis ("hay fever"), allergic sinusitis and conjunctivitis, and bee stings.
  • Blood
    Blood and blood components used for transfusion, such as red blood cells, plasma, and platelets. Pharmaceutical products made from blood, such as clotting factors and immunoglobuilns.
  • Devices
    Medical devices and tests used to safeguard blood, blood components, and cellular products from HIV, hepatitis, syphilis, and other infectious agents. Reagents used to type blood. Machines and related software used to collect blood and blood components.
  • Gene Therapy
    Gene therapy products that replace a person's faulty or missing genetic material. Gene therapy research could lead to new treatments for cancer cystic fibrosis, heart disease, hemophilia, diabetes, and infectious diseases such as AIDS.
  • Human Tissues and Cellular Products
    Human tissues for transplantation, such as skin, tendons, ligaments, and cartilage. Cellular products, such as human stem cells and pancreatic islets. Tissue and cellular products have the potential to treat cancer, Parkinson's disease, hemophilia, anemia, diabetes, and other serious conditions.
  • Vaccines
    Vaccines used for the prevention of infectious diseases, such as mumps, measles, chicken pox, diphtheria, tetanus, influenza, hepatitis, smallpox, and anthrax. Vaccines under development to treat HIV, and to treat or prevent non-infectious conditions, including various cancers.
  • Xenotransplantation Products
    Xenotransplantation products use live animal cells, tissues, or organs to treat human diseases such as liver failure and diabetes, where human materials are not always available.

What is the legal authority for regulating biological products?

Biological products are approved for marketing under provisions of the Public Health Service Act (PHS Act). However, because most biological products also meet the definition of "drugs" under the Federal Food, Drug, and Cosmetic Act (FD&C Act), they are also subject to regulation under FD&C Act provisions.

CBER has also been delegated authority to regulate certain drugs closely related to biologics, such as anticoagulants packaged in plastic blood collection containers. CBER regulates these as drugs under the FD&C Act. Similarly, some medical devices used in blood banks to produce biologics are regulated by CBER under the FD&C Act's Medical Device Amendments of 1976. Examples of such devices are automated cell separators, empty plastic containers and transfer sets, and blood storage refrigerators and freezers.

What are the advantages to the public for regulation of biologics under the PHS Act?

The PHS Act emphasizes the importance of manufacturing control for products that cannot be defined. This is extremely important for the safety of our blood supply, our vaccines, especially our live viral vaccines, e.g. varicella and polio. The consistency, safety, efficacy and stability of these products, especially vaccines, are dependent on clearly defining and adhering to the processes described in an application, because the important structural features of the final product cannot be defined and there is an increased risk of the introduction of adventitious agents.

The PHS Act provides the agency with a licensing mechanism to confer approval of biological products and provides additional assurance to people receiving blood products and the millions of children being immunized each year to protect from childhood diseases.

The PHS Act also provides authority to immediately suspend licenses in situations where there exists a danger to public health. This statute also allows us to prepare or procure products in the event of shortages and critical public health needs, and authorizes the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases in the US and/or between states. This law also provides important flexibility in regulation of biotechnology products, which facilitates the introduction and development of new medicines.

How are biological products approved?

The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by CBER. Biological products intended for veterinary use are regulated under a separate law, the Virus, Serum, and Toxin Act, which is administered by the U.S. Department of Agriculture.

Licensing of biologic products under the PHS Act is very similar to the new drug approval process for human drugs. Following initial laboratory and animal testing, a biological product is studied in clinical trials in humans under an investigational new drug application (IND). If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted to CBER as part of a biologics license application for review and approval for marketing.

After a license application is approved for a biological product, the product may also be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by CBER, the manufacturer submits samples of each lot of product to CBER together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer's tests performed on the lot. CBER may also perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, CBER conducts laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness of biological products.

What is CBER's role after a biological product is approved and in use?

CBER continues to monitor the safety and stability of biological products that have been approved. Manufacturers must report certain problems to FDA's Biological Product Deviation Reporting System. Manufacturers must also report and correct product problems within established timeframes. If a significant problem is detected, a manufacturer may need to recall a product or even stop manufacturing it.

CBER encourages health professionals and members of the public to report problems with biological products to FDA's MedWatch and, for vaccines, to the Vaccine Adverse Event Reporting System (VAERS).

Does CBER conduct inspections?

CBER inspects manufacturing plants before it approves products, and thereafter, on a regular basis. The purpose of these inspections is to assess whether biological products are made in compliance with appropriate laws and regulations, and to assist in identifying any changes needed to help ensure product quality.

CBER also may inspect clinical study sites to determine whether the studies are being carried out properly, and to ensure that accurate information is being submitted to the agency. CBER has a number of enforcement tools that may be used when a manufacturer or clinical researcher is in violation of FDA laws and regulations.

What is CBER's response to public health threats and bioterrorism?

CBER has a long history of responding quickly to public health threats. In the past, CBER's role in regulating vaccines against smallpox and polio contributed to the eradication of these dread diseases. Now, in response to the potential threat of a biological attack, CBER is facilitating the development of investigational vaccines against anthrax and smallpox. CBER also is overseeing clinical studies for new vaccines against HIV, hepatitis viruses, and West Nile Virus. In response to the new threats of West Nile virus, "Mad Cow Disease," and Severe Acute Respiratory Syndrome (SARS), CBER has taken strong measures to ensure that blood and tissue products continue to be safe.

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