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1. Mandatory Disclaimers On Dietary Supplements Do Not Reliably Communicate The Intended Issues...... 1
Mandatory Disclaimers On Dietary Supplements Do Not Reliably Communicate The Intended Issues
Author: Kesselheim, Aaron S; Connolly, John; Rogers, James; Avorn, Jerry
Abstract:
Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have
recently been found unconstitutional under the First Amendment, which has been interpreted to protect
commercial as well as personal speech. As an alternative means of protecting patients from unreliable
marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to
promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of
studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform
consumers' health choices. A few small studies reported a modest impact of disclaimers on consumers'
attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many
consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The
available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially
ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs,
and it risks returning the United States to a previous era when inappropriate marketing claims about prescription
drugs proliferated and contributed to the inappropriate use of those products.
Full text:
Headnote
ABSTRACT Some efforts by the government to regulate the promotional statements of pharmaceutical
manufacturers have recently been found unconstitutional under the First Amendment, which has been
interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients
from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add
disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic
review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers
inform consumers' health choices. A few small studies reported a modest impact of disclaimers on consumers'
attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many
consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The
available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially
ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs,
and it risks returning the United States to a previous era when inappropriate marketing claims about prescription
drugs proliferated and contributed to the inappropriate use of those products.
Brand-name prescription drugs are heavily marketed to physicians and consumers in the United States. One
recent analysis estimated that manufacturers spend $30-$60 billion per year on such marketing,1 including over
$4 billion directed at consumers.2 For decades, the Food and Drug Administration (FDA) has restricted
manufacturers' promotion of prescription drugs in several important ways, including preventing manufacturers
from promoting their products to treat conditions for which the FDA has not determined adequate efficacy or
safety ("off-label uses"). Off-label prescribing activities by physicians are legal and may sometimes be evidence
based or clinically reasonable. However, most off-label uses are not supported by data.3
Off-label drug prescribing has led to poor efficacy or harm in many instances in recent years, such as the use of
nesiritide (Natrecor) for stable congestive heart failure,4 paroxetine (Paxil) for depression in children,5
Subject: Studies; Pharmaceutical industry; Dietary supplements; Marketing; Disclaimers; First Amendment-US;
Consumer protection;
Classification: 9190: United States; 9130: Experiment/theoretical treatment; 8641: Pharmaceuticals industry;
7000: Marketing; 4310: Regulation
Issue: 3
Pages: 438-446
Number of pages: 9
ISSN: 02782715
DOI: http://dx.doi.org/10.1377/hlthaff.2014.0515
Copyright: Copyright The People to People Health Foundation, Inc., Project HOPE Mar 2015
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