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 Pharmacological and Psychological Interventions

Walter Glannon

in Bioethics and the Brain

Published in print:
2006
Published Online:
January 2007
ISBN:
9780195307788
eISBN:
9780199867431
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195307788.003.0004
Subject:
Philosophy, Moral Philosophy

This chapter assesses the potential benefits and harms of actual and possible uses of psychopharmacological agents for prevention, therapy, and enhancement. These include using drugs to prevent or ... More


Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Aaron S. Kesselheim and Michelle M. Mello

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0014
Subject:
Law, Medical Law

The FDA prevents prescription drug manufacturers from directly promoting their products for uses that the FDA has not validated (“off-label” uses), but in the recent case of United States v. Caronia, ... More


The FDCA as the Test for Truth of Promotional Claims

Christopher Robertson

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0015
Subject:
Law, Medical Law

Physicians often prescribe drugs and devices for “off-label” uses not reviewed or approved by the FDA, but the makers of those products are not allowed to promote those uses, as that would evince an ... More


Why FDA’s Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection

Coleen Klasmeier and Martin H. Redish

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0016
Subject:
Law, Medical Law

This chapter explains why, given the fact that off-label use of prescription drugs is itself a purely legal activity, the prohibition on off-label promotion contravenes core notions of free ... More


A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records

Andrew English, David Rosenberg, and Huaou Yan

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0034
Subject:
Law, Medical Law

This chapter proposes deploying electronic prescription technology as an interface connecting the FDA with physicians and patient records to enhance its regulation of medical product usage. Such an ... More


The Use of Evidence: Federal Regulation of Prescription Drugs and Medical Devices

Carol M. Ashton and Nelda P. Wray

in Comparative Effectiveness Research: Evidence, Medicine, and Policy

Published in print:
2013
Published Online:
September 2013
ISBN:
9780199968565
eISBN:
9780199346080
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199968565.003.0002
Subject:
Public Health and Epidemiology, Public Health

The U.S. Food and Drug Administration is statutorily responsible for ensuring that prescription drugs and medical devices meet evidential standards for safety and efficacy before they are approved ... More


Pharmaceutical Marketing

Stuart O. Schweitzer and Z. John Lu

in Pharmaceutical Economics and Policy: Perspectives, Promises, and Problems

Published in print:
2018
Published Online:
May 2018
ISBN:
9780190623784
eISBN:
9780190623814
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190623784.003.0011
Subject:
Economics and Finance, Financial Economics

The pharmaceutical industry has been heavily criticized for the amount it spends, as well as for the tactics it uses to promote drugs. This chapter begins by providing an overview of pharmaceutical ... More


The Right to Be Covered: Therapeutic Choice and Health Insurance

Lewis A. Grossman

in Choose Your Medicine: Freedom of Therapeutic Choice in America

Published in print:
2021
Published Online:
October 2021
ISBN:
9780190612757
eISBN:
9780197606582
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190612757.003.0011
Subject:
History, American History: 20th Century

This chapter explores the paradoxical assertion of freedom of therapeutic choice in the context of reimbursed health care. Cries of “rationing!” and “death panel!” are directed at every suggestion of ... More


Paternalism and Public Health

Jessica Flanigan

in Pharmaceutical Freedom: Why Patients Have a Right to Self Medicate

Published in print:
2017
Published Online:
August 2017
ISBN:
9780190684549
eISBN:
9780190684570
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190684549.003.0002
Subject:
Philosophy, Political Philosophy

Since medical paternalism is wrong in the clinical context, it should be rejected in public policy as well. But even if paternalistic public health policies were permissible, it is not clear that ... More


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