Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?
Authors: Hussain S. Lalani, Aaron S. Kesselheim, Benjamin N. Rome
Journal: Annals of Internal Medicine (2022)

Ideas and OpinionsJune 2022Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?Hussain S. Lalani, MD, MPH, Aaron S. Kesselheim, MD, JD, MPH, and Benjamin N. Rome, MD, MPHHussain S. Lalani, MD, MPHProgram on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (H.S.L., A.S.K., B.N.R.)., Aaron S. Kesselheim, MD, JD, MPHProgram on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (H.S.L., A.S.K., B.N.R.)., and Benjamin N. Rome, MD, MPHProgram on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (H.S.L., A.S.K., B.N.R.).Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M22-0740 Annals Author Insight Video - Hussain S. Lalani, MD, MPH In this video, Hussain S. Lalani, MD, MPH, offers additional insight into the article, "Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?" (Duration 3:41) SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In January 2022, billionaire and Shark Tank investor Mark Cuban launched the Mark Cuban Cost Plus Drug Company (MCCPDC), selling more than 100 generic prescription drugs online, some at substantially lower than average market prices. While MCCPDC is not the first direct-to-consumer company trying to improve affordability of generic medications, its emergence highlights failures within the generic drug market that merit the attention of federal policymakers to ensure that all patients have access to low-cost generic drugs.Challenges in the Generic Drug MarketSince passage of the Hatch-Waxman Act in 1984, generic drugs have rapidly expanded in use and make ...References1. Generic Retail Drug Pricing and States. 2019. Accessed at www.ncsl.org/research/health/generic-retail-drug-pricing-and-states.aspx on 11 February 2022. Google Scholar2. Frank RG, Hicks A, Berndt ER. The price to consumers of generic pharmaceuticals: beyond the headlines. Med Care Res Rev. 2021;78:585-590. [PMID: 32468959] doi:10.1177/1077558720921100 CrossrefMedlineGoogle Scholar3. Patel AN, Kesselheim AS, Rome BN. Frequency of generic drug price spikes and impact on Medicaid spending. Health Aff (Millwood). 2021;40:779-785. [PMID: 33939520] doi:10.1377/hlthaff.2020.02020 CrossrefMedlineGoogle Scholar4. Generic Drugs Investigation Targets Anticompetitive Schemes. 2021. Accessed at www.justice.gov/atr/division-operations/division-update-spring-2021/generic-drugs-investigation-targets-anticompetitive-schemes on 9 February 2022. Google Scholar5. Sood N, Shih T, Nuys K, Goldman D. The Flow of Money Through the Pharmaceutical Distribution System. 2017. Accessed at https://healthpolicy.usc.edu/wp-content/uploads/2017/06/USC_Flow-of-MoneyWhitePaper_Final_Spreads.pdf on 11 February 2022. Google Scholar6. Trish E, Gascue L, Ribero R, et al. Comparison of spending on common generic drugs by Medicare vs Costco members. JAMA Intern Med. 2021;181:1414-1416. [PMID: 34228050] doi:10.1001/jamainternmed.2021.3366 CrossrefMedlineGoogle Scholar7. Brennan Z. Mark Cuban's new cost-plus-15% generic drug company is really a compounding pharmacy. Endpoints News. 2022. Accessed at https://endpts.com/mark-cubans-new-cost-plus-15-generic-drug-company-is-really-a-compounding-pharmacy/ on 9 February 2022. Google Scholar8. Food and Drug Administration. FDA Drug Competition Action Plan. Accessed at www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan on 4 February 2022. Google Scholar9. Food and Drug Administration. Competitive Generic Therapy Approvals. Accessed at www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals on 11 February 2022. Google Scholar10. Butler J. California Enacts Law to Produce Generic Prescription Drugs. The National Academy for State Health Policy. 2020. Accessed at www.nashp.org/california-enacts-law-to-produce-generic-prescription-drugs/ on 13 February 2022. Google Scholar Author, Article, and Disclosure InformationAffiliations: Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (H.S.L., A.S.K., B.N.R.).Financial Support: Dr. Kesselheim's and Dr. Rome's work is supported by Arnold Ventures.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-0740.Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, 1620 Tremont St., Suite 3030, Boston MA 02120; e-mail, [email protected]harvard.edu.Author Contributions: Conception and design: H.S. Lalani, A.S. Kesselheim, B.N. Rome.Analysis and interpretation of the data: H.S. Lalani, A.S. Kesselheim.Drafting of the article: H.S. Lalani.Critical revision for important intellectual content: H.S. Lalani, A.S. Kesselheim, B.N. Rome.Final approval of the article: H.S. Lalani, A.S. Kesselheim, B.N. Rome.Statistical expertise: H.S. Lalani, B.N. Rome.Obtaining of funding: A.S. Kesselheim.Administrative, technical, or logistic support: H.S. Lalani, B.N. Rome.Collection and assembly of data: H.S. Lalani.This article was published at Annals.org on 19 April 2022. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Hussain S. Lalani, MD, MPH In this video, Hussain S. Lalani, MD, MPH, offers additional insight into the article, "Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?" (Duration 3:41) FiguresReferencesRelatedDetails Metrics Cited byPrescription drug expenditures: An employer perspective June 2022Volume 175, Issue 6Page: 890-891KeywordsDrug policyDrug pricesDrugsFood and Drug Administration ePublished: 19 April 2022 Issue Published: June 2022 Copyright & PermissionsCopyright © 2022 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...