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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Drug and Medical Device<br />
receive the most innovative treatments<br />
available for their medical conditions.<br />
In addition to having a chilling effect, if<br />
adopted as it stands the FDA guidance also<br />
may unduly burden permissible exchanges<br />
of medical information. <strong>For</strong> example, irrespective<br />
of the forum, a firm can only<br />
respond to a question about off- label information<br />
directly “to the individual making<br />
Unless the FDAmakes<br />
major modifications before<br />
finalization, the guidance<br />
as it stands will potentially<br />
increase uncertainty for<br />
drug manufacturers.<br />
the request… as a private, one-on-one communication.”<br />
U.S. Food and Drug Admin.,<br />
Unsolicited Requests, supra, at 7. This example<br />
in the draft guidance illustrates the<br />
misguided nature of the policy regarding<br />
public requests for information: the FDA<br />
will classify a request as a public request<br />
when someone asks a manufacturer’s representative<br />
a question about an off- label use<br />
during a live presentation to multiple people.<br />
According to the draft guidance, any<br />
response must be “limited to providing the<br />
firm’s contact information and should not<br />
include any off- label information.” Id. at 11<br />
(emphasis in original). Notably, this same<br />
scenario applies to most requests submitted<br />
through social media. If an individual posts<br />
a question about an off- label use in a public<br />
Internet forum, a response can only consist<br />
of the firm’s contact information. This policy<br />
is counterproductive. By not responding<br />
to a direct question with a direct answer it<br />
appears that a firm has something to hide,<br />
and the inquiring health care professional<br />
cannot receive a prompt answer to a legitimate<br />
medical question.<br />
26 ■ <strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong><br />
Off-Label Marketing and<br />
the First Amendment<br />
Clearly some of the policies proposed by the<br />
FDA in the draft guidance regarding unsolicited<br />
requests for off- label use information<br />
do not advance public health, but the<br />
general FDA policy on off- label marketing<br />
also may violate the First Amendment. Historically,<br />
commercial speech was not considered<br />
protected speech, but over the past<br />
40 years commercial speech increasingly<br />
has garnered First Amendment protection.<br />
This trend began in 1976 with the Supreme<br />
Court decision that a Virginia law prohibiting<br />
advertising prescription drug prices<br />
violated the First Amendment. Va. State<br />
Bd. of Pharmacy v. Va. Citizens Consumer<br />
Council, Inc., 425 U.S. 748 (1976). Four<br />
years later, in Central Hudson Gas & Electric<br />
Corp. v. Pub. Serv. Comm’n, the Court<br />
established a four-prong test for determining<br />
whether particular commercial<br />
speech deserves First Amendment protection<br />
from government regulation. 447 U.S.<br />
557 (1980).<br />
<strong>The</strong> test espoused in Central Hudson—<br />
still the controlling standard—first evaluates<br />
whether the speech promotes illegal<br />
activity or misleads. If so, the speech would<br />
not warrant protection. If the speech promotes<br />
legal activity and is truthful, then the<br />
second question a court asks is whether the<br />
restriction advances a substantial government<br />
interest. If a court determines that the<br />
restriction advances a substantial government<br />
interest, then a court would next ask<br />
whether “the regulation directly advances<br />
the government interest asserted.” Finally,<br />
the last prong asks “whether [the regulation]<br />
is not more extensive than is necessary<br />
to serve that interest.” Id. at 566. <strong>The</strong><br />
government bears the burden of persuasion<br />
for the final three prongs, and if the<br />
government does not meet the burden for<br />
all three, a court generally will find the regulation<br />
unconstitutional. Coleen Klasmeir<br />
& Martin H. Redish, Off- Label Prescription<br />
Advertising, the FDA and the First Amendment:<br />
A Study in the Values of Commercial<br />
Speech Protection, 37 Am. J. L. and Med.<br />
315, 338 (2011).<br />
Under the Central Hudson framework,<br />
commercial speech has received expanding<br />
First Amendment protection. See, e.g.,<br />
Sorrell v. IMS Health Inc., 131 S. Ct. 2653<br />
(2011); Thompson v. W. States Med. Ctr.,<br />
535 U.S. 357 (2002); Lorillard Tobacco Co.<br />
v. Reilly, 533 U.S. 525 (2001). <strong>The</strong> case law<br />
under the Central Hudson framework may<br />
support the proposition that the federal<br />
ban on off- label drug-use marketing may<br />
be unconstitutional.<br />
Under the first prong of the Central<br />
Hudson test, the commercial speech must<br />
promote lawful activity and be truthful<br />
to warrant First Amendment protection.<br />
Courts have held that off- label marketing<br />
satisfies this prong as long as the information<br />
disseminated is not inherently misleading<br />
because the underlying activity<br />
being promoted—off- label use of an FDAapproved<br />
drug—is lawful. United States v.<br />
Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y.<br />
2008) (citing Wash. Legal Found. v. Friedman,<br />
13 F. Supp. 2d 51, 66–67 (D.D.C. 1998)<br />
(defining inherently misleading as “more<br />
likely to deceive the public than inform it”);<br />
United States v. Caputo, 288 F. Supp. 2d 912,<br />
920–21 (N.D. Ill. 2003). Advertising is not<br />
inherently misleading because it promotes<br />
a particular point of view. <strong>The</strong> Supreme<br />
Court has stated that it is unlawful to ban<br />
truthful advertising that does not mislead<br />
simply because it has an effective sales<br />
pitch. See Sorrell, 131 S. Ct. at 2671; Liquormart,<br />
Inc., 517 U.S. at 503 (“Bans on truthful,<br />
nonmisleading commercial speech…<br />
usually rest on the offensive assumption<br />
that the public will respond irrationally to<br />
the truth”). See also U.S. Food and Drug<br />
Admin., Unsolicited Requests, supra, at<br />
10 (acknowledging that manufacturers<br />
are capable of responding to requests for<br />
off- label information in a “truthful, nonmisleading,<br />
and accurate manner”).<br />
Once a manufacturer demonstrates that<br />
the disseminated information is truthful,<br />
as mentioned the burden shifts to the government<br />
to justify the commercial speech<br />
regulation. <strong>The</strong> first part of this burden, the<br />
second prong discussed in Central Hudson,<br />
requires the government to show that the<br />
regulation restricting commercial speech<br />
advances a substantial government interest.<br />
This is a relatively easy burden for the<br />
agency to satisfy, and courts have held<br />
that the FDA position that the ban encourages<br />
manufacturers to participate fully in<br />
the FDA regulatory process is sufficient.<br />
Thompson, 535 U.S. at 369–70 (holding that<br />
the government has a substantial government<br />
interest preserving the FDA new drug<br />
approval process). But cf. Friedman, 13 F.<br />
Supp. 2d at 69–71 (ensuring that physicians<br />
receive accurate and unbiased information<br />
does not qualify as a substantial gov-