FDA’S CENTER FOR BIOLOGICS COMMEMORATES 100 YEARS OF BIOLOGICS REGULATION

Today, the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) opened a two-day symposium, “Science and the Regulation of Biological Products: From a Rich History to a Challenging Future.” The symposium commemorates 100 years of achievements in biologics regulation. In 1902, Congress passed the Biologics Control Act (the Act), after 13 children died from a diphtheria vaccine contaminated with tetanus.

Since then, Congress expanded the Act and gave what is now known as CBER the authority to regulate biological products, such as vaccines, blood and blood derivatives, toxin/antitoxins, therapeutic serums, allergenic products and similar biologics. The symposium honors the past contributions of CBER scientists and regulators, underscores the role of biologics in modern medicine, and provides a glimpse into the exciting future of biologic innovations and CBER’s role in shepherding these products to market.

The symposium, being held at the National Institutes of Health’s Masur Auditorium, features top officials from the U.S. Department of Health and Human Services (HHS) and FDA-Claude A. Allen, Deputy Secretary, HHS; Lester Crawford, DVM, PhD, Deputy Commissioner, FDA: Kathryn C. Zoon, PhD, Director, CBER; and Paul Parkman, MD, past director of CBER and co-developer of the first rubella virus vaccine-and other renowned scientists.

"We have made major strides over the last 100 years in advancing the public health by approving new and better medical products, and protecting U.S. citizens from unsafe biological products. It's a legacy of accomplishment that we can be proud of, and a reminder of the importance of our continued efforts to promote Americans' health and safety", said HHS Deputy Secretary Claude Allen.

"This is an occasion to not only salute the 57th Congress for having adopted this exceptional legislation, but also to pay homage to the many scientists of great talent and dedication who have instilled the Act's provisions with real life and meaning, and to pledge to keep their tradition alive," said FDA Deputy Commissioner Lester Crawford. Dr. Crawford also praised the present Center leadership -- especially the Director, Dr. Kathryn Zoon.

Among the many significant scientific and regulatory contributions made by CBER staff, are:

• pioneering research on vaccines, including development and licensing of the first Rubella (German measles) vaccine and the first licensed bacterial conjugate vaccine for Haemophilus influenzae.
• groundbreaking research on Hepatitis B, viral transmission and viral inactivation, leading to new regulatory requirements to protect recipients of blood and blood plasma, and licensing of diagnostic tests for Hepatitis B;
• licensing of the first HIV test kit to protect the blood supply, as well as new-generation tests for HIV, including nucleic-acid based tests;
• use of state-of-the-art DNA microarray technology to study genes (genomics), research that could lead to a better understanding of infectious diseases, to better standardization of biologics, and to new, improved medicines and vaccines; and
• collaboration with NIH on proteomics research-the study of all proteins in living cells-which potentially could revolutionize cancer detection and care.
• licensure of many new biotechnology-derived products for severe and life-threatening illnesses.

Predicts Zoon, "The next century will be very exciting and very challenging. We can expect new vaccines, including an AIDS vaccine, a safer blood supply, safer tissue products, bio-engineered cellular replacement parts, and new treatments for cancer, Alzheimer’s, and other devastating diseases. Proteomics and genomics research will lead to customized medicines. CBER is poised and well-prepared to respond to the public health challenges of the next century. We welcome the future and look forward to continuing to fulfill our mission to protect and enhance the public health."

As part of the commemorative activities, CBER also is sponsoring an exhibit at the National Museum of American History, that opened September 20, and has produced a video and book that trace the Center’s history and highlight its contributions to advancements in public health.

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