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3 - Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US

Published online by Cambridge University Press:  30 August 2023

Michael J. Malinowski
Affiliation:
Louisiana State University
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Summary

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

Keywords

direct-to-consumer marketingdirect-to-physician marketingFood and Drug Administration (FDA)prescription drug marketingpatent medicinesCouncil on Pharmacy and Chemistrycommercial speech doctrinepersonal genome medicinegenomic revolutionFood and Drug Modernization Act (FDAMA)Prescription Drug User Fee Act (PDUFA)user feesprescription drug television advertisements/adsphysician educationdrug spendingbiologicsgenomicsThe Pharmaceutical Research and Manufacturers of America (PhRMA)Code on Interactions with Health Care Professionalscorporate civil rights movementCentral Hudson Gas Co.Hudson testcontinuing medical education (CME)Accreditation Council for Continuing Medical Education (ACCME)enduring materialsWashington Legal FoundationFDA Guidance documentsmedical literatureoff-label usepeer reviewBlueprint to Lower Drug PricesPrice Ruledrug list pricesCongressional Budget Office (CBO)Federal Trade CommissionFDA regulatory letters/FDA lettersFDA enforcement actionsparticipatory health movementScott Gottlieb21st Century Cures Act23andMepersonalized genome medicinegenetic health risk testingdiscretion to practice medicinedoctor–patient relationshipdoctor–patient decision-makingHuman Genome ProjectDNA forensicsCOVID-19 vaccinesdisease awareness campaignsdisease mongeringcoronary-artery diseasesocial anxiety disorderpublic health powersprescription-onlyconsumer genetic testing servicesVirginia PharmacyKefauver–Harris AmendmentsMemorandum of Understanding Between FTC and the FDAVioxxSection 506(b)AvandiaActivaseOffice of Surveillance and EpidemiologyFood and Drug Administration Amendments Act (FDAAA)Medicare Part Dlifestyle drugsDurham–Humphrey Amendment
Type
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Information
Personal Genome Medicine
The Legal and Regulatory Transformation of US Medicine
, pp. 124 - 157
Publisher: Cambridge University Press
Print publication year: 2023

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