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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ernment interest); Klasmeir, supra, at 346.<br />
Consequently, a successful First Amendment<br />
challenge to the FDA ban on off- label<br />
drug-use marketing will likely have to<br />
demonstrate that the FDA has failed to satisfy<br />
the third or fourth prongs of the Central<br />
Hudson test or both prongs.<br />
<strong>The</strong> third prong requires the FDA to<br />
show that the ban on off- label marketing<br />
directly advances the government interest<br />
asserted. Whether the FDA can satisfy this<br />
burden regarding off- label drug-use marketing<br />
is questionable even though current<br />
case law holds that an off- label marketing<br />
ban does directly advance a substantial<br />
government interest in preserving the<br />
integrity of the FDA approval process. See<br />
Thompson, 535 U.S. at 371(finding that prohibiting<br />
advertising for products that have<br />
not undergone FDA screening may encourage<br />
manufacturers to submit their products<br />
to the testing process); Friedman, 13<br />
F. Supp. 2d at 72 (determining that “one of<br />
the few mechanisms available to the FDA to<br />
compel manufacturers behavior is to constrain<br />
their marketing options; i.e., control<br />
the labeling, advertising and marketing”).<br />
Accord Caronia, 576 F. Supp. 2d at 401.<br />
However, as the third prong analyzes<br />
the asserted government interest, if the<br />
asserted interest encompasses the stated<br />
interest of protecting the public health, then<br />
the current FDA policy does not directly<br />
advance that interest. See U.S. Food and<br />
Drug Admin., Unsolicited Requests, supra,<br />
at 3. <strong>The</strong> FDA draft guidance acknowledges<br />
that “off- label uses or treatment regimens<br />
may be important therapeutic options and<br />
may even constitute a medically recognized<br />
standard of care” and that manufacturers<br />
often have the most complete information<br />
about a drug’s off- label use. See id. at<br />
2. Consequently, a persuasive argument<br />
exists that current FDA policy has a detrimental<br />
effect on the public health because<br />
firms cannot inform physicians about therapeutic<br />
off- label uses. Due to the FDA policies<br />
limiting dissemination of information,<br />
patients may not receive the most innovative<br />
therapies for their conditions. See Klasmeir,<br />
supra, at 346. Accordingly, depending<br />
on the level of generality used to characterize<br />
its justification, the FDA draft guidance<br />
policies arguably does not satisfy the<br />
Central Hudson third prong because the<br />
policies prevent the dissemination of valuable<br />
information, which negatively affects<br />
the availability of helpful medical treatments.<br />
That the proposed policies articulated<br />
in the FDA draft guidance includes<br />
forbidding firms from publicly correcting<br />
untrue or misleading information about<br />
off- label drug uses further undermines that<br />
FDA-stated purpose to make helpful medical<br />
treatments available. See U.S. Food and<br />
Drug Admin., Unsolicited Requests, supra,<br />
at 10–12.<br />
<strong>The</strong> government must also satisfy the<br />
fourth prong of the Central Hudson test,<br />
whether a regulation is more restrictive<br />
than necessary to promote a substantial<br />
government interest. <strong>The</strong> government<br />
might have problems with this prong<br />
because current case law suggests that the<br />
prohibition on off- label drug-use marketing<br />
may not satisfy that burden. In Wash. Legal<br />
Found. v. Friedman, the court held that<br />
prohibiting the distribution of independent<br />
textbook excerpts and article reprints from<br />
medical and scientific journals concerning<br />
off- label drug uses was unconstitutional<br />
because the regulation was more extensive<br />
than was necessary to advance the substantial<br />
government interest in encouraging<br />
manufacturers to submit all drug uses<br />
to the FDA for approval. 13 F. Supp. 2d<br />
51, 54–55 (D.D.C. 1998) vacating as moot,<br />
Wash. Legal Found. V. Henney, 202 F.3d<br />
331 (D.C. Cir. 2000) (vacating the district<br />
court judgment after the FDA adopted the<br />
position that the Food and Drug Administration<br />
Modernization Act and the guidance<br />
at issue did not confer authority to<br />
the FDA to prohibit or to sanction speech).<br />
Importantly, the district court held that the<br />
FDA had less restrictive means available to<br />
achieve the substantial government interest<br />
of encouraging manufacturers to submit<br />
all drug uses to the FDA for approval<br />
that would not burden commercial speech;<br />
namely, the “full complete, and unambiguous<br />
disclosure by the manufacturer,” including<br />
a disclaimer that the FDA had not<br />
approved the off- label use. Id. at 72–73. But<br />
see United States v. Caronia, 576 F. Supp. 2d<br />
385, 397 (E.D.N.Y. 2008) (holding that the<br />
off- label marketing ban was constitutional<br />
partly because the court could not “identify<br />
non-speech restrictions that would<br />
likely constrain in any effective way manufacturers<br />
from circumventing the approval<br />
process”). Despite the different reasoning<br />
articulated by the court in Caronia,<br />
576 F. Supp. 2d at 397, the Friedman court<br />
instructively reasoned that full disclosure<br />
rather than regulation “comports with the<br />
Supreme Court’s preference for combating<br />
potentially problematic speech with more<br />
speech.” 13 F. Supp. 2d at 73.<br />
Subsequently, the Supreme Court has<br />
indicated a strong reluctance to condone<br />
regulations that burden commercial speech<br />
when the government has other means of<br />
regulation available. In Thompson v. W.<br />
States Med. Ctr., the Supreme Court held<br />
that a law that prohibited pharmacies from<br />
advertising compounded drugs was unconstitutional.<br />
535 U.S. 357 (2002). <strong>The</strong> Court<br />
determined that the law did not satisfy<br />
the forth prong of the Central Hudson test<br />
because “the Government… failed to demonstrate<br />
that the speech restrictions [were]<br />
not more extensive than [was] necessary to<br />
serve those interests.” Id. at 371 (internal<br />
citations omitted). Specifically, the Court<br />
suggested that the government could adopt<br />
acceptable alternatives to a commercial<br />
speech restriction such as limiting the volume<br />
of compounded drugs that a pharmacy<br />
could sell or limiting the percentage<br />
of total revenue that compounded drug<br />
sales could account for. Id. at 372. <strong>The</strong> FDA<br />
potentially could also adopt these measures<br />
as less restrictive alternatives to the current<br />
FDA ban on off- label drug-use marketing.<br />
In Sorrell v. IMS Health, the U.S. Supreme<br />
Court determined that the First Amendment<br />
is hostile toward any regulation that<br />
places restrictions on commercial speech<br />
in the name of the public good. Sorrell held<br />
that a Vermont law that prevented pharmacies<br />
from selling prescription information<br />
to pharmaceutical companies for marketing<br />
purposes violated the First Amendment<br />
because it did not directly advance the state<br />
interest in protecting medical privacy and<br />
reducing health-care costs. Sorrell, 131<br />
S. Ct. at 2668. <strong>The</strong> Court declared that<br />
“[s]peech in aid of pharmaceutical marketing…<br />
is a form of expression protected by<br />
the Free Speech Clause of the First Amendment.”<br />
Id. at 2659. Specifically the Court<br />
wrote that “[t]he First Amendment directs<br />
us to be especially skeptical of regulations<br />
that seek to keep people in the dark for<br />
what the government perceives to be their<br />
own good.” Id. at 2670. (finding fault addi-<br />
Off-Label, continued on page 81<br />
<strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong> ■ 27