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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are contrary to or call into question the<br />
use at issue should accompany it. Id. at 8<br />
(suggesting that to the greatest extent possible<br />
firms should rely on “published peerreviewed<br />
articles, medical texts, or data<br />
derived from independent sources”). As<br />
mentioned, a firm response to a nonpublic<br />
request should originate with medical<br />
or scientific personnel as opposed to sales<br />
or marketing personnel, and the following<br />
information should accompany it: a copy<br />
of the approved FDA labeling, a statement<br />
that the FDA has not approved the drug for<br />
the off- label use, a statement detailing the<br />
FDA- approved uses of the drug, a statement<br />
listing all important safety information,<br />
and a complete list of all references for the<br />
information disseminated in the response.<br />
Id. at 9 (also imposing a responsibility on<br />
the manufacturer to maintain records,<br />
particularly of the nature of the request<br />
for information, the information provided<br />
responding to the request, and follow- up<br />
questions received from the requestor).<br />
<strong>The</strong> draft guidance makes a separate<br />
set of recommendations for responding to<br />
an unsolicited public request. Specifically,<br />
if the request for off- label information is<br />
made in a public forum, then a responding<br />
firm cannot respond in the same forum,<br />
which would then make the information<br />
available to the public and which the FDA<br />
would consider evidence of an intended offlabel<br />
use. Id. at 10. (citing dual concerns<br />
that publicly posted information “is likely<br />
to be available to a broad audience for an<br />
indefinite period of time” and about the<br />
“enduring nature of detailed public online<br />
responses to off- label questions because<br />
specific drug or device information may<br />
become outdated). Furthermore, the draft<br />
guidance directs that firms should not<br />
respond to any public inquiry unless the<br />
request specifically refers to a product by<br />
name, and if a firm decides to respond<br />
publicly to such a request, the response<br />
should be limited to providing the manufacturer’s<br />
contact information for the medical<br />
or science department and “should not<br />
include any off- label information.” Id. at 11<br />
(emphasis in original). Finally, anytime a<br />
representative of a manufacturer responds<br />
to an unsolicited request, the representative<br />
should disclose the involvement with<br />
the manufacturer and should refrain from<br />
adopting promotional tones. Id. at 12.<br />
<strong>The</strong> Shortcomings of the<br />
FDA Draft Guidance<br />
Unless the FDA makes major modifications<br />
before finalization, the guidance as<br />
it stands will potentially increase uncertainty<br />
for drug manufacturers. Right now<br />
it doesn’t achieve its stated purpose: to<br />
“clarif[y] [the] FDA’s policies on unsolicited<br />
requests for off- label information,<br />
including those that firms may encounter<br />
through emerging electronic media.”<br />
U.S. Food and Drug Admin., Unsolicited<br />
Requests, supra, at 1.<br />
<strong>For</strong> example, two means by which the<br />
draft guidance differentiates a solicited<br />
request from an unsolicited request are<br />
troublesome. This is especially true given<br />
that firms cannot respond to unsolicited<br />
requests, and making a mistake distinguishing<br />
between a solicited and an unsolicited<br />
request could elicit a violation. <strong>The</strong><br />
draft guidance twice emphasizes that the<br />
FDA considers a request solicited if it is<br />
“prompted in any way by a manufacturer or<br />
its representatives.” Id. at 4, 5. This distinction<br />
could potentially subject manufacturers<br />
to liability for a variety of innocent and<br />
widespread industry practices. <strong>For</strong> example,<br />
according to the broad language in the<br />
draft guidance, when a sales representative<br />
asks a group of physicians if the physicians<br />
have any questions and one or more<br />
of those physicians respond with questions<br />
about off- label use, the FDA would consider<br />
this a solicited request. Technically, the<br />
sales representative’s question “prompted”<br />
the physicians’ inquiries. Moreover, if the<br />
FDA categorizes these inquiries as solicited,<br />
then the FDA might consider any<br />
response at all—even to convey truthful<br />
information or to offer the manufacturer’s<br />
contact information—evidence of promoting<br />
an off- label use. See id. at 4–5.<br />
According to the draft guidance, the FDA<br />
will consider a request unsolicited only if it<br />
is “initiated by persons or entities that are<br />
completely independent of the [drug manufacturer].”<br />
Id. at 4. <strong>The</strong> FDA in the draft<br />
guidance does not clearly define “completely<br />
independent.” While the draft guidance<br />
lists some of the medical professionals<br />
that the FDA may consider independent,<br />
it does not acknowledge that exceedingly<br />
commonly a drug manufacturer will have<br />
interactions with physicians or health-care<br />
organizations or recommend how a drug<br />
Anytimea representative<br />
of a manufacturer responds<br />
to an unsolicited request,<br />
the representative should<br />
disclose the involvement<br />
with the manufacturer<br />
and should refrain from<br />
adopting promotional tones.<br />
manufacturer should interact with them.<br />
Id. <strong>For</strong> example, would the FDA view a physician<br />
or a health-care organization as relinquishing<br />
independence when they form<br />
purchasing or consulting agreements with<br />
a manufacturer Moreover, if that physician<br />
or organization suddenly becomes affiliated<br />
with a drug manufacturer, would<br />
any question they asked about off- label usage<br />
become solicited, subjecting the manufacturer<br />
to liability for responding<br />
<strong>The</strong>se ambiguities regarding the distinction<br />
between solicited and unsolicited<br />
requests can have a chilling effect<br />
on the dissemination of valuable medical<br />
information. If a drug manufacturer<br />
is found to have promoted an off- label use<br />
illegally, it would potentially incur billions<br />
of dollars in fines. <strong>For</strong> example, in<br />
July <strong>2012</strong>, GlaxoSmithKline agreed to pay<br />
$3 billion to settle claims it illegally promoted<br />
off- label uses for Paxil and Wellbutrin.<br />
Jesse J. Holland, GlaxoSmithKline<br />
to Pay $3 Billion for Health Fraud, S.F.<br />
Chron., July 2, <strong>2012</strong>, http://www.sfgate.com/<br />
news/article/ GlaxoSmithKline-to-pay-3-billion-forhealth-fraud-3678945.php<br />
(last visited Sept. 10,<br />
<strong>2012</strong>). Because drug manufacturers potentially<br />
face massive penalties for off- label<br />
drug-use marketing, they will understandably<br />
err on the side of caution with ambiguous<br />
guidance activities which migh expose<br />
firms to those penalties. Inevitably healthcare<br />
professionals will not have access to<br />
vital medical information that they should<br />
have access to, and their patients will not<br />
<strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong> ■ 25