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Forces influencing generic drug development in the United States: a narrative review - PubMed Skip to main page content
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Review
. 2016 Sep 22:9:26.
doi: 10.1186/s40545-016-0079-1. eCollection 2016.

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

Chia-Ying Lee  1 , Xiaohan Chen  1 , Robert J Romanelli  2 , Jodi B Segal  3
Affiliations
Review

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

Chia-Ying Lee et al. J Pharm Policy Pract. .

Abstract

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.

Keywords: Generic drug; Incentives; U.S. Food and Drug Administration.

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References

    1. U.S. Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation . ASPE issue brief. Expanding the use of generic drugs. 2010.
    1. Anonymous, Generic Pharmaceutical Association . Generic drug savings in the U.S.: Seventh annual edition: 2015. 2015.
    1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations. 2003.
    1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs — general considerations. 2014.
    1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. 2013.

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