Gottlieb: FDA unprepared for follow-on biologics

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Former FDA deputy commissioner for medical and scientific affairs Scott Gottlieb, now a senior fellow at the American Enterprise Institute, has expressed serious concern that his former agency may be unprepared to conduct regulatory reviews of generic or follow-on biologics, when and if Congress passes legislation establishing a regulatory pathway for such products.

Speaking in November before a Food & Drug Law Institute-sponsored conference on generic biologics, Gottlieb said he did not believe the FDA has “thought through” who, and which organizational elements, should assume responsibility for regulatory reviews for biosimilars. Unless this issue is carefully considered, he predicted there could be significant delays in approvals.

Gottlieb said his concern is based on impressions, gained during his tenure with the agency, on what he now views as the cause for many delays in approvals. “Many people believe that delays in generic drug approvals can be attributed mainly to citizen petitions, or delaying tactics engaged in by innovator companies,” he said.

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