Promotional Practices Social Media in Medical Devices

7/31/2019 Promotional Practices Social Media in Medical Devices

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Promotional Practices:

Social Media

Rights, Rewards, Responsibilities, and Risks

Edward M. Basile

+1 (202) 626-2903

[email protected]


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What types of social media mightCompanies consider using?


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FACEBOOKBayer Healthcare

UsingFacebook to

develop an

online

community


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TWITTERBoehringer Ingelheim

Using Twitter

interactively, to

facilitate

conversations with

patients, HCPs and

other third-parties


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BLOGSGSKFocusing on corporate

and other healthcare

related news, chronicdiseases, corp. social

responsibility, GSK

people and musings on

healthcare reform


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CHAT ROOMJ&J

Online community for

parents, children,

adults and families todiscuss living with

type 1 diabetes


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ONLINE COMMUNITYGenentech

Genentechs

Herceptin HER Story

Community helps

connect women with

breast cancer


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YOUTUBE & WEBCASTSMedtronic

Using YouTube

to demonstrate

product use


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Discussion Question

What FDA laws and regulations should theCompany be aware of when developing astrategy for social media?


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INFORMATION ON THE INTERNET

FDA does not regulate the medium, FDA regulatesthe message. (Podcast with Dr. Jean Ah Kang, Special Assistant to Tom Abramsat DDMAC, in charge of Web 2.0 policy development)

Therefore, in general, FDA applies traditionaladvertising and promotion rules to information

distributed on the internet. FDA is monitoring internet websites and social media

for promotion violations.

Unique aspects of the internet and social media (andlittle affirmative guidance from FDA) makecompliance with FDA advertising and promotionrules especially challenging.


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KEY FDA REQUIREMENTS

On-Label Discussions Only. Social media postings shouldnot include discussion of off-label use of Company productsor use of any unapproved or pending Company products orcompounds in the pipeline.

Postings should not be created with the intent to induce orgenerate responses or questions that discuss off-label use.

Fair-Balance. Any postings discussing specific Companyproducts must include a fair balance between informationrelating to risks and benefits.

Truthful and not misleading. Social media postings shouldbe truthful and not misleading. A false or misleadingstatement is one that is not supported by substantial evidenceor that fails to present all relevant data and context.


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FDA GUIDANCE ON SOCIAL MEDIA

Originally scheduled for December 2010. Delayed until Q1, 2011.At the end of March, FDA postponed the release without a projectednew date.

FDAs Guidance document will focus on 6 areas: Responding to unsolicited requests,

Fulfilling regulatory requirements within space limitations, Fulfilling postmarketing submission requirements, Online communications for which companies should be held

responsible,

Hyperlinks, and Correcting misinformation.

There will be guidance on some specific matters, but there will beno new regulations or new standards. (Tom Abrams, DDMAC, atDIAs annual meeting, February 22, 2011)


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DRAFT GUIDANCE ON UNSOLICITEDREQUESTS FOR OFF-LABEL

INFORMATION

Draft guidance issued on December 30, 2011 Comment period closed on March 29

Guidance clarified FDAs policies on the following: Defining unsolicited requests for off-label information Public and non-public requests for information How to respond to public and non-public unsolicited

requests


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DRAFT GUIDANCE ON UNSOLICITED REQUESTSFOR OFF-LABEL INFORMATION contd

Unsolicited Requests Initiated by those who are completely independent of

the manufacturer or distributor

No financial relationships with or prompts from the firm Private call to medical information staff Question posed during a presentation about off-label

uses

Question posted on the firms website


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DRAFT GUIDANCE ON UNSOLICITED REQUESTSFOR OFF-LABEL INFORMATION contd

All response to off-label questions must be: Truthful BalancedNon-MisleadingNon-Promotional Scientific or medical in nature


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Hypothetical

You are VP of Compliance at ACME MedicalProducts, a manufacturer of pharmaceuticals andmedical devices. Your boss, the CEO, is quitetechnologically savvy and is eager for the Company to

get ahead of the competition in using social media topromote the Companys marketed products. He alsohopes to use social media to educate HCPs aboutproducts under clinical development and to addressfrequently received questions from HCPs about certain

unapproved uses of the Companys products.


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Hypothetical

The CEO has asked you to prepare an internalpolicy SOP to ensure that the Companys socialmedia activities comply with FDA requirements.Specifically, he asked that the following issues be

addressed:


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Discussion Questions

How should the Company monitor its use of social media? What regulatory responsibilities might be included in the monitoring?

Who in the Company should be permitted to participate insocial media sites sponsored by the Company?

What, if any, restrictions should be placed on employeesregarding their participation in sites notsponsored by theCompany, but that may contain information about theCompanys products or compounds in the pipeline?

What about employees personal use of social media?


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How can the Company use HCP consultants toparticipate in its social media sites? What, if any, restrictions should be placed on the

consultants when participating in Company-sponsored social media?

What, if any, restrictions should be placed on theconsultants participating in non-Company-sponsoredsites?

If discussing off-label use of the Companys products? If discussing the investigational use of a compound under

development for a new indication?


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Should the Company permit third parties to postcomments on Company-sponsored social media sites? If yes, what should the Companys policy be

regarding comments?

Review in advance? Decline to post some comments?Which ones?

Who should be responsible for reviewing comments?


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How should the Company respond to negativecomments regarding the Company or the Companysproducts?

On Company-sponsored social media sites? On non-Company-sponsored social media sites?

Is there any recourse if the Company believes someoneis using social media to disparage the Company or itsproducts?


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The CEO is already thinking of ways to use specific social mediasites and has mentioned the following ideas. What are yourthoughts?

Twitter - The CEO is interested in tweeting about Companyproducts. Because of the character limitations of Twitter,there is not enough space to mention risks. Do you have anyconcerns?

Patient Advocacy Site - The CEO would like to fund patientadvocacy and physician education sites that will not becontrolled by the Company. There may be some off-labeldiscussion of Company products on these sites. Do you have

any concerns?

Can the Company link to these sites?


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Chat Room - The CEO want to launch a Company-sponsored chatroom where HCPs can freely discuss the Companys products. Hebelieves that because the Company will have no involvement in therunning of the site, HCPs will be able to discuss off-label uses underthe practice of medicine exception. Do you have any concerns?

YouTube Video - An investigator in one of the Companys clinicaltrials for an investigational product was interviewed by local media.The CEO would like to post the video on the Companys YouTube

page. Do you have any concerns?

Company-sponsored blog - The CEO would like to use aCompany-sponsored blog, controlled by Medical Affairs, to list

peer-reviewed journal articles on unapproved uses of the Companysproducts. Do you have any concerns?


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FACEBOOK WIDGETUntitled Letter, July 2010

This website contains a Facebook Share socialmedia widget that generates [Company]-createdinformation for [Drug]that can be shared with

Facebook users (i.e., shared content). The sharedcontent is misleading because it makes

representations about the efficacy of [Drug] but failsto communicate any risk information associated

with the use of this drug. In addition, the sharedcontent inadequately communicates [Drugs] FDA-approved indication and implies superiority over

other products.

We also note multiple [Drug] web pages containwidgets that allow users to share content via other

social media applications offered via the ShareThis tool (http://sharethis.com). Some of thecontent available to share through these othersocial media applications raise similar issues to

those discussed in this letter.


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FAIR BALANCE AND THE INTERNET -SPONSORED LINKS

In April, 2009, FDA sent Untitled Letters to 14 pharmacompanies stating that the use of sponsored links on internetsearch engines such as Google.com are misleading because theydo not include product risk information.

The sponsored links, however, fail to

communicate any risk information, and their

casual approach to [Drug] treatment isextraordinary in light of the potentially

lethal risks of the drug and the stringent

controls over its distribution . . . By omitting

the most serious and frequently occurring

risks associated with the drug, the sponsored

links misleadingly suggest that [Drug] is

safer than it is known to be. We note thattheses sponsored links contain a link to the

products website . . .However, this does

not mitigate the misleading omission of risk

information from these promotional

materials.


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YOUTUBEUntitled Letter, May 2011

60-second video posted by a drug sales rep under direction of districtmanager.

Video featured off-camera voice of a sales rep speaking to a staffperson in a physicians office. The rep makes claims about theosteoporosisdrugs dosing benefits (e.g., can eat and drink with

[the drug] in the morning). FDA objected to the following: Promotional claims without any risk or indication information; Misleading suggestion that there were no dosing considerations

or restrictions -- the drugs PI stated that it should be taken in the

morning immediately after breakfast due to significantly higherincidence of abdominal pain when administered under fastingconditions; and

Failing to submit the video at the time of dissemination onFDA-2253.


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Recommendations for ACME Medical

Develop social media policy Companys objectives, e.g., marketing, customer service,

research, outreach, etc.

Consider both company-sponsored and third-party content Topics that will be encouraged vs. prohibited Disclaimers/notices that explain companys monitoring andeditorial policy Handling adverse events Guidelines for employee participation, e.g., management

approval, training, disclosures, etc.

Monitor social media outlets and audit mechanism Communicate government scrutiny Robust enforcement of the policy

Documents

Promotional Practices Social Media in Medical Devices