Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs, Report to Congressional Requesters   [open pdf - 991KB]

"Generic versions of brand-name drugs provide substantial cost savings for patients and the U.S. health care system. FDA [Food and Drug Administration], an agency within the Department of Health and Human Services (HHS), has approved generic versions of NBCDs [nonbiological complex drugs]. Some industry stakeholders have asserted that, because it is difficult to assess equivalence for these complex drugs, there could be safety and efficacy problems that might not appear until after generic versions are on the market. GAO [Government Accountability Office] was asked to assess FDA's process for reviewing generic versions of NBCDs. Among other things, this report (1) identifies the scientific challenges the review of generic versions of NBCDs may present and (2) identifies and evaluates the steps FDA has taken that may help address the challenges related to the review of generic NBCDs. GAO studied the literature and examined FDA productspecific guidance. GAO reviewed information related to the five NBCDs for which FDA had approved a generic version prior to fiscal year 2017. GAO also interviewed FDA officials and a nongeneralizable selection of 19 stakeholders, including brand-name drug sponsors, sponsors of generic versions of NBCDs that have and have not received FDA approval, and external expert groups."

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Government Accountability Office: http://www.gao.gov/
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