Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support
Authors: Ameet Sarpatwari, Alison K. LaPidus, Aaron S. Kesselheim
Journal: Annals of Internal Medicine (2020)

Ideas and Opinions3 March 2020Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government SupportCorrection(s) for this article:CorrectionsJun 2021Correction: Revisiting the National Institutes of Health Fair Pricing ConditionFREEAmeet Sarpatwari, PhD, JD, Alison K. LaPidus, MPH, and Aaron S. Kesselheim, MD, JD, MPHAmeet Sarpatwari, PhD, JDBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S., A.K.L., A.S.K.), Alison K. LaPidus, MPHBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S., A.K.L., A.S.K.), and Aaron S. Kesselheim, MD, JD, MPHBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S., A.K.L., A.S.K.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-2576 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The federal government's substantial contribution to the development of many products has fueled controversy over the high cost of prescription drugs in the United States. A quarter of new drugs developed during the past decade had key, late-stage contributions from publicly funded research (1)—most commonly by the National Institutes of Health (NIH)—prompting concerns that Americans are "paying twice" for these expensive medications.Senators and other policymakers have proposed that the NIH should more actively work to ensure fair pricing of drugs developed with its support (2). In response, critics have noted that such an intervention was attempted. In 1989, the ...References1. Nayak RK, Avorn J, Kesselheim AS. Public sector financial support for late stage discovery of new drugs in the United States: cohort study. BMJ. 2019;367:l5766. [PMID: 31645328] doi:10.1136/bmj.l5766 CrossrefMedlineGoogle Scholar2. We Protect American Investment in Drugs Act, S. 2387, 116th Congress (2019). Google Scholar3. Langer E. Researcher Jerome P. Horwitz, 93, created AZT, the first approved treatment for HIV/AIDS. The Washington Post. 9 September 2012. Accessed at www.washingtonpost.com/national/health-science/researcher-jerome-p-horwitz-93-created-azt-the-first-approved-treatment-for-hivaids/2012/09/19/0c08c38a-0280-11e2-9b24-ff730c7f6312_story.html on 21 November 2019. Google Scholar4. Furstenberg MH. AZT the first AIDS drug. The Washington Post. 15 September 1987. Accessed at www.washingtonpost.com/archive/lifestyle/wellness/1987/09/15/azt-the-first-aids-drug/f38de60b-1332-4bb3-a49f-277036b1baf2 on 21 November 2019. Google Scholar5. National Institutes of Health. Reports of the NIH panels on cooperative research and developments agreements: perspectives, outlook, and policy development. Accessed at www.ott.nih.gov/sites/default/files/documents/pdfs/NIH_%20CRADA_Report_on_Reasonable-Pricing_Clause_1994.pdf on 21 November 2019. Google Scholar6. Department of Health and Human Services Office of Inspector General. Technology Transfer and the Public Interest: Cooperative Research Development Agreements at NIH. November 1993. Accessed at https://oig.hhs.gov/oei/reports/oei-01-92-01100.pdf on 1 March 2021. Google Scholar7. U.S. Government Accountability Office. Technology transfer: NIH-private sector partnership in the development of Taxol. Accessed at www.gao.gov/products/GAO-03-829 on 21 November 2019. Google Scholar8. Guston DH. Technology transfer and the use of CRADAs at the National Institutes of Health. In: Branscomb LM, Keller JH, eds. Investing in Innovation: Creating a Research and Innovation Policy That Works. Cambridge, MA: MIT Pr; 1999:221-50. Google Scholar9. Landhuis E. Outsourcing is in. Nature. 2018;556:263-5. [PMID: 29643487] doi:10.1038/d41586-018-04163-8 CrossrefMedlineGoogle Scholar10. National Academies of Sciences, Engineering, and Medicine. The role of NIH in drug development innovation and its impact on patient access: proceedings of a workshop. Accessed at http://nationalacademies.org/hmd/Reports/2019/role-of-NIH-in-drug-development-innovation-and-its-impact-on-patient-access-proceedings.aspx on 21 November 2019. Google Scholar Author, Article, and Disclosure InformationAffiliations: Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S., A.K.L., A.S.K.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-2576.Corresponding Author: Ameet Sarpatwari, PhD, JD, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, [email protected]harvard.edu.Correction: This article was corrected on 17 March 2021 to correct the citation in reference 6.Current Author Addresses: Drs. Sarpatwari and Kesselheim: Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120.Ms. LaPidus: 22 M Street Northeast, Washington, DC 20002.Author Contributions: Conception and design: A. Sarpatwari, A.S. Kesselheim.Analysis and interpretation of the data: A. Sarpatwari, A.K. LaPidus, A.S. Kesselheim.Drafting of the article: A. Sarpatwari, A.K. LaPidus.Critical revision of the article for important intellectual content: A. Sarpatwari, A.S. Kesselheim.Final approval of the article: A. Sarpatwari, A.K. LaPidus, A.S. Kesselheim.Statistical expertise: A. Sarpatwari.Obtaining of funding: A. Sarpatwari, A.S. Kesselheim.Administrative, technical, or logistic support: A. Sarpatwari, A.K. LaPidus.Collection and assembly of data: A. Sarpatwari, A.K. LaPidus.This article was published at Annals.org on 28 January 2020. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCorrection: Revisiting the National Institutes of Health Fair Pricing Condition Metrics Cited byThe Bayh-Dole Act at 40: Accomplishments, Challenges, and Possible ReformsCorrection: Revisiting the National Institutes of Health Fair Pricing ConditionPublic funding and the importance of reasonable pricing for buprenorphineBuprenorphine for opioid use disorder: The role of public funding in its developmentA Market Shaping Approach for the Biopharmaceutical Industry: Governing Innovation Towards the Public InterestL'innovation thérapeutique, à quel prix ?Development of a National Public Pharmaceutical Research and Development Institute 3 March 2020Volume 172, Issue 5Page: 348-350KeywordsCancer treatmentDisclosureDrug policyDrug pricesDrugsMotivationPerceptionPrevention, policy, and public healthRenal diseasesScientists ePublished: 28 January 2020 Issue Published: 3 March 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. 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