FDA Regulation of Internet Pharmaceutical Communications: Strategies for Improvement
![handle is hein.journals/foodlj55 and id is 295 raw text is: FDA Regulation of Internet Pharmaceutical
Communications: Strategies for Improvement
EMILt L. LOZA *
Great technological advances are leading us to redefine and expand the ways in which laws
apply to us as individuals and as a Nation .... Laws must be applied as vigorously on Main
Street as on the information superhighway'
I. INTRODUCTION
The Internet propels prescription drug marketing into the 21 st century.2 The Food
and'Drug Administration (FDA), however, has yet to establish effective regulation
over this new medium. By maintaining that its current regulations sufficiently ad-
dress the Internet, FDA arguably compromises public health and limits consumer
access to empowering health information. FDA should act promptly to improve its
position on the Internet.
This article begins with a contextual discussion of the roles that consumers, pro-
viders and managed care organizations, and pharmaceutical manufacturers play in
healthcare and how the Internet affects the interplay among these roles. The article
then details FDA's current regulatory position with respect to Internet drug communi-
cations. A brief survey of representative Internet drug sites follows, introducing mod-
els by which to compare the sites' fair balance'4 and information accessibility.' Within
this context, the article demonstrates the significant legal and informational problems
that arise due to the insufficiency of FDA's approach to the Internet issue. Next, the
article analyzes the application of FDA's current regulations to the Internet, revealing
flaws in the regulations' binary advertising or labeling classification system and
the legal and informational problems that result from compartmentalizing Internet
* Ms. Loza is a third-year law student at The George Washington University Law School and recent Law
Clerk to the Honorable Sheila F. Anthony, Commissioner, Federal Trade Commission, Washington, D.C. This
article is an updated version of Ms. Loza's submission for the 1997-1998 H. Thomas Austern Memorial
Writing Competition. Ms. Loza wishes to acknowledge with deep appreciation the sponsorship of Teresa
Moran Schwartz, Deputy Director, Bureau of Consumer Protection, Federal Trade Commission and Maurice
C. Shapiro Professor Emeritus, Public Interest Law, The George Washington University Law School. The
views expressed herein do not necessarily reflect the views of the Federal Trade Commission or any individual
Commissioner.
[Editor's Note: The author's survey of Internet sites was conducted as a point-in-time review at
the time of the original submission; thus individual company promotions and Internet sites neces-
sarily will have changed and will be more or less accessible to readers conducting research from
this article. Where possible, the Editor has confirmed cited Internet addresses, but any assertions
made about the content of specific sites are the author's and do not reflect the views of FDLI or any
members of its editorial staff. Any such assertions by the author may be better understood as
retrospective commentary.]
I Proclamation No. 6792, 60 Fed. Reg. 21,423 (1995) (statement by William Jefferson Clinton on the
occasion of Law Day 1995).
2Unless otherwise noted, the terms drugs, prescription drugs, and pharmaceutical products synonymously
refer to prescription drugs for human use.
3 The term consumer(s) refers to patients and others not in health professional roles.
4 Fair balance is the regulatory requirement that drug advertisements equivalently apprise consumers of
positive (i.e., uses, safety, and effectiveness) and negative (i.e., side effects and contraindications) drug product
information. 21 C.F.R. § 201(e)(5) (1998).
I This term refers to the degree to which language is comprehensible to consumers.](ViewImageLocal?handle=hein.journals/foodlj55&div=31&collection=journals&method=preview&ext=.png&size=3)
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FDA Regulation of Internet Pharmaceutical Communications: Strategies for Improvement
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