Follow-On Science Ready, But Regulatory Pathway Not, Crawford Says

Acting FDA Commissioner Lester Crawford believes the science is available for the FDA to move forward on follow-on biologic products, but he told a recent industry conference that the FDA still has many kinks to work out on the regulatory front.

"We now have the science to fashion a generic biologics program, but we need to figure out how to do it," Crawford said during a session at the Generic Pharmaceutical Association's Annual Meeting in Boca Raton, Fla. "It's not as easy as the public thinks. Everyone who's a stakeholder needs to be a part of that process."

One hurdle that is holding the FDA back, said Crawford, is the bioequivalence issue. He noted that the agency still hasn't come up with a way to adequately compare biologic products.

"FDA has access to all data on drug development," Crawford said. "FDA needs to share as much of this information as we can. We want to use the information we have and bring in everyone who's interested in pharmaceutical development. A bad public health policy is one that delays the entry of generics."

Regarding the agency's long-awaited draft guidances and white papers on follow-on biologics, Crawford promised that the documents are being prepared, but he didn't indicate when they would be released.