--- title: "Forces influencing generic drug development in U.S. | Sutter Health" description: "Review of influences on, and strategies to incentivize, generic drug development in the U.S." url: "https://www.sutterhealth.org/research/publications/influences-generic-drug-developmt-us-1055312519" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Research publications](https://www.sutterhealth.org/research/publications) / 4. Forces influencing generic drug development in U.S. # Forces influencing generic drug development in the United States: a narrative review. Lee CY, Chen X, Romanelli RJ, & Segal JB. _J Pharm Policy Pract. 9:26. doi: 10.1186/s40545-016-0079-1. eCollection 2016._ 2016-09-22 ## 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. [PubMed abstract](https://www.ncbi.nlm.nih.gov/pubmed/27688886) ## Research topics - [Health Policy](https://www.sutterhealth.org/research-search-results?query=%22%5C%22Health+Policy%5C%22%22) ## Related publications [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) - Publication ### [An economic analysis of payment for health care services: the United States and Switzerland compared.](https://www.sutterhealth.org/research/publications/econ-analysis-healthcare-svce-paymt-1055312540) Zweifel P, Tai-Seale M. Int J Health Care Finance Econ. 9(2):197-210. doi: 10.1007/s10754-009-9061-7. Epub 2009 Apr 9. 2009 Jun 01 - Publication ### [Enhancing Medicare's hospital-acquired conditions policy to encompass readmissions.](https://www.sutterhealth.org/research/publications/medicare-hosp-acquired-conds-policy-readmissions-1055312903) McNair PD, Luft HS. 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Forum for Health Economics and Policy. 16(2):57–86. 2013 Sep 01 [View all publications](https://www.sutterhealth.org/research-search-results?verticalKey=research_publication) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/publications/influences-generic-drug-developmt-us-1055312519#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Research publications","item":"https://www.sutterhealth.org/research/publications"},{"@type":"ListItem","position":4,"name":"Forces influencing generic drug development in U.S."}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalScholarlyArticle","@id":"https://www.sutterhealth.org/research/publications/influences-generic-drug-developmt-us-1055312519#medicalscholarlyarticle","name":"Forces influencing generic drug development in the United States: a narrative review.","headline":"Forces influencing generic drug development in U.S.","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. 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