FDA is not ready to pursue authority to approve follow-on biologics

WASHINGTON Food and Drug Administration spokesperson Christopher Kelly recently said that, despite comments from an agency official on Monday, the agency will not submit to Congress a legislative proposal to seek authority to approve generic versions of biotechnology medications, CongressDaily reports.

FDA chief operating officer John Dyer had said on Monday that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that the FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline.

Kelly said that the comments from Dyer resulted from a misunderstanding. Fiscal year 2009 budget documents refer to a legislative proposal that will provide recommendations on an FDA approval process for generic versions of biotech medications. Kelly said that the reference to such a proposal was an “expression by FDA of our interest in moving this forward, not an actual proposal.”