Forces influencing generic drug development in the United States: a narrative review.
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.


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.
Johns Hopkins University Bloomberg School of Public Health, Center for Drug Safety and Effectiveness, 624 N. Broadway, Room 644, Baltimore, MD 21205 USA.
Chia-Ying
CY
Lee
Johns Hopkins University Bloomberg School of Public Health, Center for Drug Safety and Effectiveness, 624 N. Broadway, Room 644, Baltimore, MD 21205 USA.
Xiaohan
X
Chen
Palo Alto Medical Foundation Research Institute, Palo Alto, CA USA.
Robert J
RJ
Romanelli
Johns Hopkins University Bloomberg School of Public Health, Center for Drug Safety and Effectiveness, 624 N. Broadway, Room 644, Baltimore, MD 21205 USA ; Division of General Internal Medicine, Johns Hopkins University School of Medicine, 624 N. Broadway, Room 644, Baltimore, MD 21205 USA.
Jodi B
JB
Segal
Generic drug; Incentives; U.S. Food and Drug Administration
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