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

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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).

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.

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