For The Defense, November 2012 - DRI Today

ance advises how firms such as manufacturers
and distributors of pharmaceuticals
and medical devices should respond to requests
for information about unapproved
or “off- label” uses for FDA- approved drugs
and medical devices. The impetus for the
guidance has been the continuing expansion
and prevalence of the Internet and
social media, and the industry’s resulting
uncertainty regarding how to respond to
information posted publicly and questions
about off- label uses in light of the strict FDA
ban on marketing for off- label indications.
Though the FDA has not yet finalized the
guidance, in its current form it will do little
to resolve uncertainties. First, the guidance
doesn’t clearly distinguish between solicited
and unsolicited requests for off- label information
and will chill the dissemination of
valuable information about off- label uses.
Second, the guidance unduly limits the permitted
exchanges of valuable medical information
that may adversely affect the public
health. Finally, the guidance does not take
into consideration the burgeoning case law,
particularly the recent Supreme Court decision
Sorrell v. IMS Health, which strongly
suggests that the FDA ban on truthful marketing
of off- label uses is an unconstitutional
restriction of commercial speech.
Background
The Food, Drug and Cosmetic Act (FDCA)
prohibits manufacturers from marketing
or promoting off- label drug uses. The FDA
had interpreted a combination of provisions
as effectively having made it illegal for
manufacturers to disseminate information
regarding indications for use that the FDA
has not approved. The FDCA makes it illegal
for a manufacturer to introduce a drug
into interstate commerce unless the product
has undergone clinical trials demonstrating
safety and efficacy for its intended
uses. See 21 U.S.C. §355(a), (b) (2006). Furthermore,
the FDA must approve the labeling
of a new product for all of its intended
uses; namely, the product’s directions for
use, its indications, and its side effects. 21
U.S.C. §352(f) (2006). Moreover, the FDA
interprets a manufacturer’s intended use
by examining “labeling claims, advertising
matter, or oral or written statements
by such persons or their representatives.”
21 C.F.R. §201 (2012).
Accordingly, if a manufacturer markets
an approved drug for an indication not yet
approved by the FDA, it “becomes an unapproved
new drug with respect to that use.”
65 Fed. Reg. 14,286 (2000). An unapproved
new drug by definition would have insufficient
labeling and inadequate use directions.
See 21 U.S.C. §352(f) (2006); Wash.
Legal Found. v. Friedman, 13 F. Supp. 2d
51, 54–55 (D.D.C. 1998). Consequently, a
manufacturer must seek and obtain FDA
approval for any new indication; otherwise
any marketing of that off- label use is
considered misbranding and violates the
FDCA labeling mandates, regardless of
the truthfulness of the information. See 21
U.S.C. §352 (2006); John E. Osborn, Can I
Tell you the Truth A Comparative Perspective
on Regulating Off- Label Scientific and
Medical Information, Yale J. Health Pol’y &
Ethics 299, 329 (2010). Violating the FDCA
misbranding provisions also potentially
subject violators to treble damages and qui
tam actions under the False Claims Act
(FCA) for “knowingly mak[ing], us[ing], or
caus[ing] to be made or used, a false record
or statement material to a false or fraudulent
claim.” 31 U.S.C. §3729(a)(1)(B) (2006);
Osborn, supra, at 310–11. Furthermore,
any person convicted of illegally marketing
a drug is guilty of a misdemeanor. See
21 U.S.C. §331 (2006).
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