1. Hyman, Phelps & McNamara, P.C.
Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices
Jeffrey K. Shapiro
Hyman, Phelps & McNamara, P.C.
Washington, DC
Tony Blank
Barton & Blank, LLC
Chelmsford, MA
October 21, 2014

2. 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)

3. 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!

4. 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

5. 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

6. 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 (N.D.Cal.) (June 4, 2009)) 6

7. 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)

8. 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 (l)(1))

9. 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 (a), (b) & (e)) 9

10. 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) 10

11. All restricted devices are either
Class III with PMA approval
Hearing aids OR
Analyte specific reagents (ASRs) 11

12. Basic legal requirements for device labeling
All labeling must be truthful and non-misleading (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 (d))

13. 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))

14. 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))

15. 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 15

16. 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

17. 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

18. 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)

19. 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

20. 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

21. 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.

22. 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

23. 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.

24. 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.

25. 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

26. 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

27. 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.”

28. 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

29. 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?

30. 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

31. 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”.

32. 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?

33. 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?

34. 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.

35. Thank You!