Rejecting PhRMA's Request, US FDA Sticks With Size Over Function In Defining Biologic

The Pharmaceutical Research and Manufacturers of America failed to convince the US Food and Drug Administration to define "protein" based on function, principally its method of manufacture, rather than the size of its amino acid sequence.

PhRMA made the request in comments to FDA on its proposed rule to amend the definition of "biological product" in the Public Health Service Act and its interpretation of what...