BIO Calls on FDA To Conduct Open, Public Discussion on Follow-on Biologics

WASHINGTON, D.C. (April 24, 2003) --- In a citizen petition submitted to the Food and Drug Administration (FDA), the Biotechnology Industry Organization (BIO) urged the agency to conduct open and meaningful debate on the scientific, legal and policy issues concerning "follow-on" biotechnology products if the FDA is considering creating an approval mechanism for them.

The BIO citizen petition is available on the BIO Web site at

In a letter sent to FDA Commissioner Mark B. McClellan prior to the submission of the citizen petition, BIO President Carl B. Feldbaum urged the agency leader to "actively solicit public participation" if the FDA is considering a regulatory change related to biotechnology products.

"We strongly believe that any changes in a policy so significant to the biotechnology industry should involve a process that is transparent, public and open to all those interested in helping develop science-based regulations for biotechnology medicines," Feldbaum wrote. "Such openness has been a long-standing FDA tradition and serves the best interests of patients, the public and manufacturers.

"We ask that the FDA actively solicit public participation so that all parties − government, the scientific community, the biotechnology industry, our patients and others − may express their views," Feldbaum added.

Currently, most biotechnology products are licensed under the Public Health Service Act as biological products. However, certain biotech products, such as insulin and human growth hormone, were, for historical reasons, approved by the FDA as new drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act). The FD&C Act allows for abbreviated approvals for generic drugs that are proven by their manufacturers to be equivalent to the innovator drug, but it does not specifically address biotechnology medicines. However, in recent statements made by FDA officials, the agency has indicated its willingness to establish a follow-on pathway for some biotechnology products.

(For the policy explanation as to why public participation is essential for the FDA to move forward on any regulatory decision related to follow-on biotechnology medicines, see page 29 of the BIO citizen petition.)

BIO believes that FDA approval of any follow-on biotechnology medicine must be based on a full complement of original non-clinical and clinical data because of the unique scientific nature of biotechnology products. Without this information, the follow-on products could pose an unnecessary and potentially serious risk to patients.

Biotechnology medicines generally are highly complex and feature large molecular mixtures derived from living organisms. In contrast, chemical drugs typically consist of smaller, synthesized and chemically-defined molecules. Where the safety and effectiveness of a chemical drug can be established by the specification of its active ingredient, the safety and effectiveness of a biotech product is determined by the manner in which it is made, as well as by detailed in-process and final characterization. (See page 40 of the BIO citizen petition for details as to why existing science does not support a regulatory change for biotechnology medicines.)

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.