For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Drug and Medical Device<br />
While the FDCA serves nearly to ban<br />
off- label marketing absolutely, a physician<br />
has limitless ability to prescribe a medication<br />
for an off- label use. Physicians have the<br />
absolute discretion to prescribe a medication<br />
for any purpose that they deem medically<br />
appropriate, regardless of whether<br />
the FDA has approved the drug for that<br />
indication. Incongruity aside, this policy<br />
As the Internet and social<br />
media have expanded<br />
and facilitated the spread<br />
of information, the FDA<br />
policy on off- label use<br />
marketing has become<br />
increasingly unrealistic.<br />
acknowledges that completely banning<br />
off- label drug use is untenable because in<br />
many instances—particularly in pediatrics<br />
and oncology—such off- label uses represent<br />
novel and cutting- edge treatment for<br />
certain medical conditions. See Osborn,<br />
supra, at 303–04. It is widely accepted that<br />
the time- consuming and costly nature of<br />
the FDA approval process means that it is<br />
often economically unfeasible for a manufacturer<br />
to test all potential off- label usages<br />
for a drug. See Anna B. Laakmann, Collapsing<br />
the Distinction Between Experimentation<br />
and Treatment in the Regulation<br />
of New Drugs, 62 Ala. L. Rev. 305, 317–<br />
18 (2011). <strong>The</strong>refore, an outright ban on<br />
off- label usage would invade the province<br />
of the practice of medicine and in many<br />
instances prevent patients from receiving<br />
the best or only drug available for treating<br />
a medical condition.<br />
Ostensibly, the FDA off- label use marketing<br />
ban seeks to prevent manufacturers<br />
from promoting off- label uses that have<br />
not endured the rigorous FDA screening<br />
process. Belying this justification, however,<br />
the FDA has failed to distinguish<br />
between “truthful” and “misleading” offlabel<br />
use marketing or to take into account<br />
24 ■ <strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong><br />
the unfettered discretion that physicians<br />
have to prescribe medication for off- label<br />
uses. Furthermore, as the Internet and<br />
social media have expanded and facilitated<br />
the spread of information, the FDA policy<br />
on off- label use marketing has become<br />
increasingly unrealistic. It ignores that<br />
the public has wide access to information<br />
about off- label uses and widely seeks<br />
this information. See Susannah Fox, <strong>The</strong><br />
Social Life of Health Information, Pew<br />
Internet & American Life Project 2 (May,<br />
12 2011), http://pewinternet.org/~/media//files/<br />
reports/2011/pip_social_life_of_health_info.<br />
pdf. Accordingly, this policy is unsustainable,<br />
as the recently released FDA guidance<br />
highlights in advising firms how to<br />
respond to unsolicited requests for information<br />
about off- label uses.<br />
<strong>The</strong> FDA Draft Guidance<br />
On December 23, 2011, the FDA released a<br />
draft guidance document directed to the<br />
industry entitled, “Responding to Unsolicited<br />
Requests for Off- Label Information<br />
about Prescription Drugs and Medical<br />
Devices.” <strong>The</strong> FDA sought through the<br />
draft guidance “to describe the [FDA’s]<br />
current thinking about how manufacturers<br />
and distributors… can respond to<br />
unsolicited requests for information about<br />
unapproved or uncleared indications or<br />
conditions of use.” U.S. Food and Drug<br />
Admin., Guidance for Industry Responding<br />
to Unsolicited Requests for Off- Label<br />
Information about Prescription Drugs and<br />
Medical Devices, Draft Guidance, 1 (Dec.<br />
2011), http://www.fda.gov/downloads/drugs/ guid<br />
ancecomplianceregulatoryinformation/guidances/<br />
ucm285145.pdf. Specifically, the draft guidance<br />
explains how the FDA differentiates<br />
a solicited request for information from an<br />
unsolicited request and the proper procedures<br />
for responding to public and private<br />
unsolicited requests about off- label uses.<br />
Solicited requests are those “requests for<br />
off- label information that are prompted in<br />
any way by a manufacturer or its representatives.”<br />
U.S. Food and Drug Admin.,<br />
Unsolicited Requests, supra, at 5. A firm<br />
cannot solicit requests for information for<br />
off- label use, and the FDA may consider<br />
this evidence that the firm sought to market<br />
a medication for a new intended use<br />
in violation of the FDCA. See id. <strong>The</strong> draft<br />
guidance provides numerous examples of<br />
solicited requests. <strong>For</strong> instance, the FDA<br />
would view a manufacturer’s sales representative<br />
mentioning an off- label use<br />
and inviting a health-care professional to<br />
request more information about the use<br />
as a solicited request. On the other hand,<br />
an unsolicited request is one “initiated<br />
by persons or entities that are completely<br />
independent of the relevant firm.” Id. at 4.<br />
Stated succinctly, a request for information<br />
is unsolicited when it was not “prompted in<br />
any way by [the] manufacturer or its representatives.”<br />
Id.<br />
<strong>The</strong> draft guidance further subdivides<br />
unsolicited requests into public and nonpublic<br />
requests and defines each. According<br />
to the draft guidance, “[a] non- public<br />
unsolicited request is an unsolicited request<br />
that is directed privately to a firm using a<br />
one-on-one communication approach.” Id.<br />
(mentioning an e-mail from an individual<br />
directed to the medical information staff<br />
of a manufacturer about an off- label use as<br />
an example of a private communication).<br />
A public unsolicited request is one “made<br />
in a public forum, whether directed to a<br />
firm specifically or to a forum at large.” Id.<br />
(mentioning posting a question about an<br />
off- label use of a specific product on a firmcontrolled<br />
website or third-party forum<br />
accessible to a broad audience as an example<br />
of a public forum). <strong>The</strong> draft guidance<br />
then delineates the proper way to respond<br />
to each type of request.<br />
<strong>The</strong> draft guidance lists the information<br />
that firms should include in all responses<br />
to non- public unsolicited requests about<br />
off- label uses. <strong>The</strong> FDA directs firms to<br />
answer unsolicited requests with “truthful,<br />
balanced, non- misleading, and<br />
non- promotional scientific or medical<br />
information that is responsive to the specific<br />
request.” Id. at 6–7. Moreover, when<br />
a firm responds to a nonpublic request,<br />
the firm should distribute the information<br />
only to the person making the request “as<br />
a private, one-on-one communication,”<br />
and the information “should be tailored to<br />
answer only the specific question(s) asked.”<br />
Id. at 7 (indicating that if a firm receives a<br />
broad request the firm should narrow the<br />
response as much as possible). Furthermore,<br />
information in a response should be<br />
“truthful” and “scientific in nature,” independent<br />
medical or scientific personnel<br />
should generate it, and publications that