Abstract
BackgroundGeneric drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process.Methods and FindingsA survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians’ perceptions of the FDA’s generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA’s process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13–26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues.ConclusionsPhysicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.
Highlights
Low-cost generic drugs generate major cost savings for the nation’s health care system, providing more than $931 billion in savings in the last decade.[1]
Physicians hold largely positive views of the Food and Drug Administration (FDA)’s generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brandname drugs
In a 2013 grant announcement, the FDA Office of Generic Drugs published a list of six generic products approved between 2008 and 2012 using product-specific methods for assessing equivalence[21]: acarbose tablet (Precose, Bayer), vancomycin capsule (Vancocin, ViroPharma), sodium ferric gluconate injection (Ferrlecit, Sanofi-Aventis), enoxaparin injection (Lovenox, Sanofi-Aventis), calcitonin salmon nasal spray (Miacalcin, Novartis), and venlafaxine ER tablet (Effexor XR, Wyeth)
Summary
Low-cost generic drugs generate major cost savings for the nation’s health care system, providing more than $931 billion in savings in the last decade.[1]. The Food and Drug Administration (FDA) approves generic drugs on the basis of comparisons with the brand-name version that show pharmaceutical equivalence and bioequivalence. Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians’ perceptions of generic drugs and the generic drug approval process
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
