FDA Will Not Submit Proposal To Congress To Seek Authority To Approve Generic Biotechnology Medications

Main Category: Biology / Biochemistry
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 07 Feb 2008 - 5:00 PDT

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FDA spokesperson Christopher Kelly on Tuesday 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 (Edney, CongressDaily, 2/6).

FDA Chief Operating Officer John Dyer on Monday said that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline (Kaiser Daily Health Policy Report, 2/5).

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" (CongressDaily, 2/6).

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