Former FDA Official Calls on Generic Industry to Support User Fees

Federal policymakers should ensure the FDA has adequate resources in order to review and approve follow-on biologics in a timely and effective manner, according to American Enterprise Institute (AEI) Research Fellow Scott Gottlieb.

Gottlieb, the former FDA deputy commissioner for medical and scientific affairs, urged agency officials to make the case before lawmakers that reviewing and approving applications for follow-on biologics would be a "resource-intensive" undertaking, and legislation toward that end should include the necessary funds to accomplish that objective.

"I think too often the agency is willing to accept increased authorities in new areas where it has an interest in being involved, without making sure it has the resources to do the work," Gottlieb said. "I think this is another case where the agency is going to get a lot of work without the resources to do it."

Approving applications for follow-on biologics can be more resource intensive than a new drug application (NDA) review as the review process for follow-on biologics involves a much wider, broader scope of applications, according to Gottlieb. "There is probably a narrower margin for how simple or complex an NDA can be, relative to a follow-on biologic application."

In a column posted on the AEI website, Gottlieb called on the generic drug industry to support the approximately $15.7 million generic drug user fee proposal. He said the FDA hopes the plan would help speed up the review process for generic drugs in new areas such as liposomal drugs, dermatological creams and inhaled drugs.