To the editor:

Your November 2004 editorial “Overdue process” misrepresents the Biotechnology Industry Organization's (BIO, Washington, DC, USA) position on follow-on protein products.

BIO was, in fact, the first organization to call for public debate on safety issues through its Citizen Petition submitted to the US Food and Drug Administration (FDA, Rockville, MD, USA) in April 2003—hardly a delaying tactic.

Also, you claim BIO charges that generic manufacturers are incapable of producing protein copies. For the record, we believe that any review and approval process for such products must require data adequate to show safety and effectiveness to protect patients. Given all the recent publicity about the safety of drugs, prudence, especially with complex biologics, should demand high priority.

Unlike most traditional small-molecule or chemically synthesized drugs, protein products are more complex and fragile. Protein products are typically made in living systems, which have inherent variability. Minor changes made in the manufacturing process can lead to significant changes in the product that can be assessed only in clinical trials.

BIO has worked with the FDA throughout this process and looks forward to participating with the agency in its scientific workshop scheduled for February 2005 where stakeholders will have the opportunity to present what I expect will be a variety of views. BIO's twin guideposts in this discussion are science and patient safety.