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

Armen Hareyan's picture

Biotechnology Medications

FDA spokesperson Christopher Kelly on Tuesday saidthat, despite comments from an agency official on Monday, the agency will notsubmit to Congress a legislative proposal to seek authority to approve genericversions of biotechnology medications, CongressDaily reports(Edney, CongressDaily, 2/6).

FDA Chief Operating Officer John Dyer on Monday said that the agency had begunto draft language for such a proposal. In addition, a congressional aide saidthat FDA informed the House Energy andCommerce Committeeabout 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. Fiscalyear 2009 budget documents refer to a legislative proposal that will providerecommendations on an FDA approval process for generic versions of biotechmedications. Kelly said that the reference to such a proposal was an"expression by FDA of our interest in moving this forward, not an actualproposal" (CongressDaily, 2/6).

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