For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
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ance advises how firms such as manufacturers<br />
and distributors of pharmaceuticals<br />
and medical devices should respond to requests<br />
for information about unapproved<br />
or “off- label” uses for FDA- approved drugs<br />
and medical devices. <strong>The</strong> impetus for the<br />
guidance has been the continuing expansion<br />
and prevalence of the Internet and<br />
social media, and the industry’s resulting<br />
uncertainty regarding how to respond to<br />
information posted publicly and questions<br />
about off- label uses in light of the strict FDA<br />
ban on marketing for off- label indications.<br />
Though the FDA has not yet finalized the<br />
guidance, in its current form it will do little<br />
to resolve uncertainties. First, the guidance<br />
doesn’t clearly distinguish between solicited<br />
and unsolicited requests for off- label information<br />
and will chill the dissemination of<br />
valuable information about off- label uses.<br />
Second, the guidance unduly limits the permitted<br />
exchanges of valuable medical information<br />
that may adversely affect the public<br />
health. Finally, the guidance does not take<br />
into consideration the burgeoning case law,<br />
particularly the recent Supreme Court decision<br />
Sorrell v. IMS Health, which strongly<br />
suggests that the FDA ban on truthful marketing<br />
of off- label uses is an unconstitutional<br />
restriction of commercial speech.<br />
Background<br />
<strong>The</strong> Food, Drug and Cosmetic Act (FDCA)<br />
prohibits manufacturers from marketing<br />
or promoting off- label drug uses. <strong>The</strong> FDA<br />
had interpreted a combination of provisions<br />
as effectively having made it illegal for<br />
manufacturers to disseminate information<br />
regarding indications for use that the FDA<br />
has not approved. <strong>The</strong> FDCA makes it illegal<br />
for a manufacturer to introduce a drug<br />
into interstate commerce unless the product<br />
has undergone clinical trials demonstrating<br />
safety and efficacy for its intended<br />
uses. See 21 U.S.C. §355(a), (b) (2006). Furthermore,<br />
the FDA must approve the labeling<br />
of a new product for all of its intended<br />
uses; namely, the product’s directions for<br />
use, its indications, and its side effects. 21<br />
U.S.C. §352(f) (2006). Moreover, the FDA<br />
interprets a manufacturer’s intended use<br />
by examining “labeling claims, advertising<br />
matter, or oral or written statements<br />
by such persons or their representatives.”<br />
21 C.F.R. §201 (<strong>2012</strong>).<br />
Accordingly, if a manufacturer markets<br />
an approved drug for an indication not yet<br />
approved by the FDA, it “becomes an unapproved<br />
new drug with respect to that use.”<br />
65 Fed. Reg. 14,286 (2000). An unapproved<br />
new drug by definition would have insufficient<br />
labeling and inadequate use directions.<br />
See 21 U.S.C. §352(f) (2006); Wash.<br />
Legal Found. v. Friedman, 13 F. Supp. 2d<br />
51, 54–55 (D.D.C. 1998). Consequently, a<br />
manufacturer must seek and obtain FDA<br />
approval for any new indication; otherwise<br />
any marketing of that off- label use is<br />
considered misbranding and violates the<br />
FDCA labeling mandates, regardless of<br />
the truthfulness of the information. See 21<br />
U.S.C. §352 (2006); John E. Osborn, Can I<br />
Tell you the Truth A Comparative Perspective<br />
on Regulating Off- Label Scientific and<br />
Medical Information, Yale J. Health Pol’y &<br />
Ethics 299, 329 (2010). Violating the FDCA<br />
misbranding provisions also potentially<br />
subject violators to treble damages and qui<br />
tam actions under the False Claims Act<br />
(FCA) for “knowingly mak[ing], us[ing], or<br />
caus[ing] to be made or used, a false record<br />
or statement material to a false or fraudulent<br />
claim.” 31 U.S.C. §3729(a)(1)(B) (2006);<br />
Osborn, supra, at 310–11. Furthermore,<br />
any person convicted of illegally marketing<br />
a drug is guilty of a misdemeanor. See<br />
21 U.S.C. §331 (2006).<br />
<strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong> ■ 23