Medical Device Promotion
on Social Media:
Regulatory Considerations
and Best Practices
Jeffrey K. Shapiro
Hyman, Phelps & McNamara, P.C.
Washington, DC
[email protected]
www.hpm.com
www.fdalawblog.net
Tony Blank
Barton & Blank, LLC
Chelmsford, MA
[email protected]
www.bartonblank.com
October 21, 2014
1
In The Social Media Draft
Guidances…
 FDA has chosen to address two issues
 If promotion is on character space limited
platform (e.g., tweets – 140 characters),
how does a firm meet risk information
disclosure requirements? (Not easily)
 If user-generated content has
misinformation about a device in social
media, may the firm post corrective
information? (Yes)
2
Before we get to the guidances in
detail…
FDA has authority from FD&C Act over
device labeling (all types of devices)
FDA has authority over only “restricted
device” advertising
So, is social media labeling or
advertising?
A good question!
3
The Draft Guidances Fail to Say If Social
Media Is Labeling or Advertising!
 To try and figure it out for ourselves,
we’ll take a quick look at key definitions
 Labeling (including “promotional labeling”)
 Advertising
 Restricted devices
 We’ll also look at how intended use
factors in to FDA’s regulation of both
labeling and advertising
4
What is labeling?
 Labeling consists of “all labels and other
written, printed, or graphic matter” on or
“accompanying” a device – FD&C Act sec.
201(m)
 The material does not physically need to
accompany the device to be labeling
(Kordel v. US, 335 U.S. 345, 350 (1948))
5
What is labeling?
 “the FDA regulations and the case law make clear that
labeling under the FDCA is construed expansively, such that
it may encompass nearly every form of promotional activity,
including package inserts, pamphlets, mailing pieces, fax
bulletins, reprints of press releases, and all other literature
that supplements, explains, or is otherwise textually related
to the product”
 press releases disseminated to physicians, internal company
e-mails to sales representatives leading to oral
representations, blast faxes to physicians, and others by this
defendant satisfied the definition of labeling under the FDC
Act (U.S. v. Harkonen, 2009 WL 1578712 (N.D.Cal.) (June 4,
2009))
6
What is promotional labeling?
 Not a term that appears in the FD&C Act
or FDA’s regulations
 It is the agency’s informal term for
labeling that is not required (e.g.,
package insert) but is used to promote
the device (e.g., a brochure)
7
What is advertising?
 FD&C Act does not define
“advertisement,”
 FDA’s drug regulations provide examples
 Advertisements in published journals,
magazines, other periodicals and newspapers
 Advertisements broadcast through media such
as radio, television, and telephone
communication systems
(21 C.F.R. 202.1(l)(1))
8
Prescription Device
 Could be Class I or II 510(k)-cleared or
Class III PMA approved
 FDA deems it safe only if used under
supervision of licensed practitioner
 Labeling must have statement: “Caution:
Federal (U.S.) law restricts this device to sale by
or on the order of a physician.”
 Labeling must have date of latest revision
(21 C.F.R. 801.109(a), (b) & (e))
Restricted Devices
Prescription device +
Designated in PMA approval order
(or by regulation) as device whose
sale, distribution, and use is
restricted under FD&C sec. 520(e)
Restricted Devices
All restricted devices are either
Class III with PMA approval
Hearing aids OR
Analyte specific reagents (ASRs)
Basic legal requirements for
device labeling
 All labeling must be truthful and nonmisleading (FD&C Act secs. 502(a), 201(n))
 Failure to disclose material facts is misleading
 FDA says failure to provide reasonably equal
balance to benefit-risk is misleading
 All promotional labeling that makes claims
about a firm’s Rx device must include the
indicated use and the risks associated with use
(21 CFR 801.109(d))
12
Basic legal requirements for
device labeling
 Information required to appear on the
label or labeling must be placed
prominently thereon with such
conspicuousness and in such terms as to
render it likely to be read and understood
by the ordinary individual under
customary conditions of purchase and
use (FD&C Act sec. 502(c))
13
Basic legal requirements for
“restricted device” advertising
Must have a “brief statement of
intended uses” and relevant risk
(FD&C Act sec. 502(r))
Cannot be “false or misleading in
any particular” (FD&C Act sec.
502(q))
14
Basic legal requirements for
“restricted device” advertising
Advertising must include
true statement of device’s established
name, if any, printed prominently and
in type at least half as large as
trade/brand name
brief statement of intended uses,
relevant warnings, precautions, side
effects, and contraindications
Basic Rule for Labeling and
Advertising All Types of Devices
Must promote devices only for a
510(k) cleared or PMA approved
intended use
 Creating a new intended use misbrands or
adulterates the device in the absence of a new
clearance or approval (FDCA secs. 502(o), 501(f))
and adequate instructions for use (FDCA sec.
502(f))
16
How does FDA determine
intended use?
 Objective intent – company’s public
statements determine intended use
Based upon all labeling and
advertising, e.g., written, electronic or
oral statements, print advertising, etc.
21 C.F.R. § 801.4
17
Now let us circle back to the draft
guidances…
 Discussion of legal framework shows
that, if social media is considered
labeling, these draft guidances apply to
all devices
 On the other hand, if social media is
advertising, these draft guidances only
apply to restricted devices (primarily,
Class III, PMA approved)
18
Social Media: Labeling or
Advertising?
 A dictionary definition of an advertisement:
 A notice or announcement in a public
medium promoting a product, service, or event or
publicizing a job vacancy
 This fits with the examples of advertisements in
FDA’s drug regulation
 Print journal ad, TV or radio spot
 Labeling would be promotion via a private
medium (e.g., a brochure) rather than
appearing on a public platform
19
Social Media: Labeling or
Advertising?
 Could argue that public internet platforms
like Facebook, Twitter, chat room are the
digital equivalent of a public square or
newspaper or magazine advertising
 If so – draft guidances are not applicable
to almost all Class I and II devices
20
Social Media: Labeling or
Advertising?
 An important legal/regulatory question – but…
 Neither Labeling nor Advertising may be false or
misleading
 FDC Act
 Lanham Act
 Failing to provide a balance of risk and benefit
information about the medical device in social media
promotion may be considered misleading under
either or both Statutes.
21
Two DRAFT Guidance Documents
 Internet/Social Media Platforms with Character
Space Limitations— Presenting Risk and Benefit
Information for Prescription Drugs and Medical
Devices
 Internet/Social Media Platforms: Correcting
Independent Third-Party Misinformation About
Prescription Drugs and Medical Devices
22
Guidance: Presenting Risk and
Benefit Information
 If a firm chooses to make a benefit claim,
then the firm should incorporate risk
information in the same character-space
limited communication.
 The firm should provide a mechanism for
accessing a complete discussion of the
risks associated with the product.
23
Guidance: Presenting Risk and
Benefit Information
 Factors for consideration…
 Whether claims are accurate and not misleading;
 Prominence and readability of risk information
relative to benefit information
 Recommendations…
 Risk and Benefit information presented together;
 At minimum, include most serious risks;
 Provide a mechanism (e.g., link) to access complete
information.
24
Guidance: Correcting
Misinformation
 Applies to information created / communicated
by independent third parties;
 Provides how companies should respond (if
they choose) to misinformation…
 Accurate
 Non-promotional
 Directed toward misinformation
 Provide access to labeling
 Disclose affiliation with company
25
Guidance: Correcting
Misinformation
 Firms are not expected to submit corrections to
Agency
 Firms should maintain records of all such
corrections…
 Content of misinformation;
 Where it appeared;
 Date of appearance or identification;
 Corrective information provided; and
 Date corrective information was provided
26
Guidance: Correcting
Misinformation
 Clear definition of when a firm is responsible for the product
communication…
“..communications that are owned, controlled, created, or
influenced, or affirmatively adopted or endorsed, by, or on behalf
of, the firm. The firm is thus responsible for communications on
the Internet and Internet-based platforms, such as social media,
made by its employees or any agents acting on behalf of the firm.
Additionally, if a firm writes, collaborates on, or exerts control or
influence on product-specific content provided by a third party, to
the extent that responsibility for the development is imputable to
the firm, the recommendations set forth in this guidance do not
apply. Accordingly, as a general matter, the firm must comply
with all applicable regulatory requirements related to labeling or
advertising for that content.”
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Putting it into Practice…
 Firms should institute policy on Social Media
communications
 The basics…
 Clear definition of which communications are covered by the
policy;
 Define when risk information must be included with
communications;
 Establish processes for monitoring sponsored communications;
 Establish standards for monitoring independent
communications;
 Clear definition of employee roles/responsibilities
28
Real world scenario…
 An employee of a firm that manufactures wearable
insulin pumps posts a picture (on their personal
Facebook page) of their son/daughter wearing the
device along with the caption… “So proud of my
company! This pump is amazing! We’re all sleeping
through the night!”
 Should the company policy address posts like these on an
employee’s personal social media channel?
 If so, what about risk information?
29
Real world scenario…
 Your firm manufactures a coronary stent called the “SuperStent”.
At a recent cardiology meeting (TCT), results from an independent
clinical trial comparing the SuperStent to its arch-rival, the
“Ostent” concluded there was a significant safety advantage with
the SuperStent. The title of the talk was “SuperStent superior to
Ostent in all safety measures”. Marketing proposes sending one of
the following tweets to its followers…
 Real world data confirms it: SuperStent is safer than Ostent! Click
here for all the details. #SuperStent
 Did you hear about the data presented at TCT? SuperStent vs Ostent
trial results. Read more. #SuperStentSafer
30
Real world scenario…
 Your company manufactures a variety of orthopedic implants
(including knee and hip replacements). T. Bolen, former running
back for the Florida Possums writes a blog about his experiences
in the NFL. During his storied football career, he had both knees
replaced with your company’s products. The company has paid
him $250,000 to blog about his personal experiences with the
implants.
 During review of his latest blog post, regulatory and legal have
specified that important product information (including risks) need
to be included in the post. T. Bolen objects – he believes the
readers will be offended because the blog post will “look like a
commercial”.
31
Real world scenario…
 Your firm manufactures lasers used in aesthetic
procedures. Your marketing campaign incorporates
Tweets, Facebook and Instagram posts. Marketing has
received requests from clinics to be provided with the
same creative material that they may then use to send
through their own social media channels.
 Policy considerations?
 Monitoring plan?
32
Real world scenario…
 Your firm manufactures ablation catheters, currently
indicated for treatment of sustained or recurrent, Type
One atrial flutter. A physician group recently posted
the results of their experiences using the ablation
catheter to treat atrial fibrillation. Marketing realizes
they cannot promote off-label, although the
administrator of the company’s FaceBook page has
already “Liked” the post.
 Is this a problem?
33
Key Takeaways
 Regulation of medical device promotion on social media
does not fit neatly into existing paradigms;
 Best practice is to establish policy to drive acceptable
standards and criteria within your organization;
 Social media introduces significant opportunities to
engage with customers/patients – thus the volume of
material provided through social media channels will be
much higher than traditional brochures and sell sheets;
and
 Implementing best practices within an organization will
introduce new complexities and challenges.
34
Thank You!
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