TY - JOUR
T1 - Forces influencing generic drug development in the United States
T2 - A narrative review
AU - Lee, Chia Ying
AU - Chen, Xiaohan
AU - Romanelli, Robert J.
AU - Segal, Jodi B.
N1 - Funding Information:
Dr. Jodi Segal, Dr. Robert Romanelli, and Ms. Lee were funded by the Food and Drug Administration through grant U01FD005267. Ms. Chen was not funded for her work on this project.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/9/22
Y1 - 2016/9/22
N2 - Background: The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing. Main results: Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics. Conclusions: We present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. We also review proposed strategies that regulators may use to incentivize generic drug development.
AB - Background: The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing. Main results: Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics. Conclusions: We present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. We also review proposed strategies that regulators may use to incentivize generic drug development.
KW - Generic drug
KW - Incentives
KW - U.S. Food and Drug Administration
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U2 - 10.1186/s40545-016-0079-1
DO - 10.1186/s40545-016-0079-1
M3 - Review article
AN - SCOPUS:84995665624
SN - 2052-3211
VL - 9
JO - Journal of Pharmaceutical Policy and Practice
JF - Journal of Pharmaceutical Policy and Practice
IS - 1
M1 - 26
ER -