Social Media Working Group Comments to FDA

[JohnMack]

Source: Docket No. FDA-2009-N-0441 (Federal Register)

[Find analysis of this document here:
A Pharma "Social Media Working Group" Submits Comments to FDA (Pharma Marketing Blog)
and
Analyzing Pharma Social Media Working Group’s Response (PRforPharma)]


January 26, 2010
Division of Dockets Management (HFA-305) Food and Drug Administration
5630 Fishers Lane
Room 1061 Rockville, MD 20852

Re: Written Comments: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools

Dear Sir/Madam:

Healthcare professionals, patients, caregivers and other consumers are increasingly interacting within online communities in which health-related topics are discussed. However, this on-line health information is accompanied by serious concerns regarding source, quality, and credibility (Kunst, H., Groot, D., Latthe, P.M., Latthe, M., & Khan, K.S. (2002). Accuracy of information on apparently credible websites: Survey of five common health topics. 8MJ, 324, 581-582). Engaging in these online communities allows pharmaceutical manufacturers to interact with those healthcare professionals, caregivers, and consumers seeking health and product information when and where they are looking for it. As authoritative sources of medical product information and the conditions and diseases for which the products are used, it is appropriate that pharmaceutical manufacturers contribute to, and participate in, these communities in order to help ensure the accuracy and completeness of the information presented and discussed.

To that end, the Social Media Working Group (SMWG) is a voluntary working group of pharmaceutical industry representatives who have come together to facilitate discussions with the Division of Drug Marketing, Advertising and Communications, industry associations, and other pharmaceutical manufacturers on social media issues. The SMWG includes representatives from the following companies: Amgen, Inc.; AstraZeneca LP; Bristol-Myers Squibb; Millennium Pharmaceuticals, Inc.; and sanofi-aventis U.S.

The SMWG welcomes the opportunity to comment on the above-referenced notice of public hearing and request for comments entitled "Promotion of Food and Drug Administration Regulated Medical Products Using the Internet and Social Media Tools." Following are the SMWG's comments submitted in response to the request for comments for the FDA's consideration. Please note that each representative of the SMWG continues to remain free to have independent opinions on issues presented herein.

FDA Question 2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?

·How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?
·Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?

A. Company Sites, Microsites and Communities
Promotional content that mentions specific products must comply with applicable promotional regulations. Companies may meet these requirements, in the context of sites hosting online discussions, by prominently presenting a product's full indication, relevant important risk information, and a link to the product's full prescribing information as part of the hosting site's static elements.

In addition, if companies choose to monitor the site, they should consider establishing guidelines for anticipating, monitoring, and responding to unsolicited off-label comments and questions posted by third-party visitors within company-hosted online communities.

1. Anticipating and Monitoring of Off-Label Comments
Given the free-flowing nature of discussions that take place within online communities, and the likelihood that there will be posts that contain off-label information or potential adverse event reports, the FDA may recommend that company sites/online communities include clearly-stated Terms of Use with which community members are asked to agree to prior to participation. (Note: specific terms of use to be defined by individual companies.) In addition, the FDA could require that companies monitor such sites/communities on a regular basis (each business day, for example) to ensure compliance with the Terms of Use and take appropriate action when the Terms of Use are violated.

The following Terms of Use may be considered:

·Participation in this site requires that members adhere to the Terms of Use set forth.
·Comments will be reviewed and may be removed if they are deemed to violate the Terms of Use.
·Provisions for
§Removal of posts that violate the Terms of Use;
§Notifying individuals who have submitted violative statements; and
§Barring repeated violators from further participation.

For unbranded (non-promotional) sites, such as those devoted to disease
awareness, the following Term of Use should be considered:

·This site is not intended as a forum for discussing specific products or treatments. Posts discussing products are subject to removal. Product-related questions should be directed to the company's Customer Service or [other appropriate department for handling] at [toll-free number, fax, e-mail].

For product-related sites, the following Term of Use should be considered:

·This site is intended as a forum for discussing FDA-approved uses of [product x], which are [insert approved indications]. As such, postings containing product discussions that are not consistent with the FDA-approved prescribing information (include hypertext link to full prescribing information) are subject to removal. Product-related questions should be directed to Customer Service or [other appropriate department for handling] at [toll-free number, fax, email]. (Note: site will be appropriately balanced.)

2. Responding to Unsolicited Off-Label Questions
When responding directly to unsolicited product inquiries from individual HCPs or consumers about unapproved uses of approved products, or investigational agents, such inquiries should be handled by company medical professionals trained in responding to such requests. In responding to an unsolicited request for off-label information, a company may respond in the following manner:

·Inform the community that the question pertains to off-label use and forward the question to the appropriate company function (e.g., Medical Information), or when possible, directly provide the requestor with contact information with which they can contact Medical Information at their discretion; and
·Retain the off-label request posting, along with the company acknowledgment, to ensure the community is informed of its off-label nature. This avoids the risk ofan off-label question being viewed without clarification.

3. Following Up on Posted Off-Label Statements
When addressing visitor postings that contain off-label statements, consideration should be given to the avoidance of undue censorship of the online discussion. Preservation of the patient-HCP relationship should also be considered when responding to the consumer population. With this in mind, when addressing a visitor's off-label statement, a company may:

·Notify the community that a visitor's comment includes off-label information;
·Include a link to the product's prescribing information, web site, or Medical Information, as applicable.

And for the consumer population:

·Direct the visitor and broader community to their HCPs for additional information.

The company would remove the off-label posting/statement within a reasonable time to ensure availability of this information is limited. Companies should also determine criteria for type of information to be addressed/corrected and length of time information would remain online.

B. Third-Party Sites
When a company proactively posts product-related information within a third-party site, such information would be considered promotional and should comply with applicable promotional regulations. The following sections provide recommendations for joining and responding to social media discussions.

Joining or Responding to Discussions
When joining or responding to existing online discussions, it is important to evaluate whether a company post is product-specific. In the case of a proactive posting by the company, the posting should comply with applicable promotional regulations. It is recommended that companies refrain from joining off-label product discussions.

A company response to an on-label product question on a third party site should be balanced and include a link to the product's full prescribing information. When responding to a community member's unsolicited request for off-label information, posed directly to the company (once company has joined the discussion), and as previously described for company sites, it is recommended that such responses be delivered by a company's medical staff directly to the person posting the question.

The following are considerations for a company response to an off-label question:

·Inform the community that the question pertains to off-label use and forward the question to the appropriate company function (e.g., Medical Information), or provide the requestor with contact information with which they can contact Medical Information at their discretion; and
·Retain the off-label request posting, along with the company acknowledgment, to ensure the community is informed of its off-label nature. This avoids the risk of an off-label question being viewed without clarification.

When a community member posts off-label statements, consideration should be given to the avoidance of undue censorship of the online discussion. Preservation of the patient-HCP relationship should also be considered when responding to the consumer population. With this in mind, when addressing a HCP member's off-label statement, a company may:

·Notify the community that a member's comment includes off-label information; and
·Include a link to the product's prescribing information, web site, or Medical Information, as applicable.

And for the consumer population:
·Direct the member and broader community to their Heps for additional information.

·How should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable (see, e.g., Sec. 314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii), 601.12(1)(4),601.45, and 601.94)?

Form FDA 2253 Submission

The postmarketing commitment to submit all promotional materials at the time of initial dissemination is particularly challenging for social media, which involve real-time dialogue among community members. It is not possible for a company to submit promotional postings at time of first use and still maintain the open dialogue that characterizes social media.

In order to address this dilemma, for promotional company sites, or company pages on third-party sites, the following items could be submitted on Form 2253:

·Static elements (graphics, indication, important safety infonnation, package insert link, etc.)
·Proactive promotional company postings such as those intended to introduce a topic for discussion
·The site's URL, which would constitute a submission of the online discussion by reference

An alternative to the time of first use submission is to batch and submit discussion threads occurring within company-hosted discussions. These could be captured and submitted on a weekly or monthly basis.

In the context of company participation in entirely independent third-party communities, Form 2253 submissions would be limited to only those promotional postings proactively made by a company.

FDA Question 5. Questions specific to Internet adverse event reporting

·How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
·How is adverse event information from these sources being received, reviewed, and processed?
·What challenges are presented in handling adverse event information from these sources?
·What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?

Adverse Event Reporting
In the event potential adverse event reports are posted on a company-sponsored community, it is recommended that such postings be handled according to the company's established procedures for handling and reporting spontaneous adverse event reports, including appropriate follow-up to obtain the necessary elements needed to report an adverse event.

In its guidance on postmarketing adverse reporting, the FDA states that "Before considering any clinical incident for submission to the FDA in an expedited or periodic safety report, applicants, manufacturers, and licensed manufacturers should have knowledge of the following four data elements:

• An identifiable patient;
• An identifiable reporter;
• A suspect drug or biological product; and
• An adverse event or fatal outcome.

In the absence of one or more of the aforementioned elements, companies will have to determine if additional follow-up is necessary or possible, in order to obtain the information. However, consistent with the international standard FDA has adopted as part of the International Conference on Harmonisation (lCH), companies "are not expected to screen external websites for ADR information. However, if [a company] becomes aware of an adverse reaction on a website that it does not manage, the [company] should review the adverse reaction and determine whether it should be reported." Companies should regularly screen their websites for potential ADR case reports (ICH E2D Post-Approval Safety Data management: Note for Guidance on Definitions and Standards For Expedited
Reporting. November 2003).

In order to appropriately manage adverse event reports from online community members, the following Term of Use may be considered:

·This site is not intended for the reporting of side effects associated with the use of prescription drugs. If you, or someone you know, has possibly experienced a side effect while taking [company's product], please contact our Drug Safety/Pharmacovigilance department at [toll-free telephone number, fax number, email address}. You are also encouraged to report negative side effects of prescription drugs to the FDA. To do so, visit www.fda.gov/medwatch or call1-800-FDA-I088.

Summary
In recognition of the need to enable responsible industry engagement in social media consistent with our legal obligations and commitment to good business practices, this document has outlined a number of potential approaches that enable industry engagement in social media. To date, industry participation in social media has been extremely limited. Because of this, opportunities are being missed to engage in meaningful discussions with relevant audiences in the media they increasingly turn to for health information. It is hoped that this document may help foster new ways for companies to sponsor or participate in online communities to allow for two-way interactions in a compliant, yet unrestrictive, manner.

Sincerely,

The Social Media Working Group:

• Craig M. Audet, Vice President, U.S. Regulatory Affairs Marketed Products, sanofi-aventis U.S. LLC
• Mark Gaydos, Sr. Director, U.S. Regulatory Affairs Marketed Products, sanofi-aventis U.S. LLC
• Leah Palmer, Executive Director, Global Regulatory Affairs, Amgen, Inc.
• Cynthia Phillips, Senior Director, Regulatory Labeling and Promotional Compliance,
• Millennium Pharmaceuticals, Inc.
• Preeti Pinto, Executive Director, Promotional Regulatory Affairs, AstraZeneca LP
• Stacy Reese, Associate Director, Promotional Regulatory Affairs, AstraZeneca LP
• Paul Savidge, Vice President, Promotion Compliance, Bristol-Myers Squibb
• Sara Stults, Group Director, Promotion Compliance, Bristol-Myers Squibb

Submitted in Duplicate Attachment

ATTACHMENT 1 DEFINITIONS

Company Site: Web site, with a social media component, created and maintained by or on behalf ofa pharmaceutical company.
Third-Party Site: Web site, with a social media component, created and maintained by a third party, independent of a pharmaceutical company.
Chat Room: A Web site in which users can engage in real time discussions, generally related to a specific topic (Adapted from chat room. (n.d.) WordNet 3.0, Farlex clipartcollection. (2003-2008). Retrieved June 4, 2009, from http://www.thefreed ictionary.comJchat+room)
Microsite: A small Web site or a part of a Web site dedicated to a subject. Also known as a "minisite” (Definition of: microsite. (n.d.). PC Magazine Encyclopedia. Retrieved January 12,2010, from http://www.pcmag.comJencyclopedia_term/0,2542,t=microsite&i=46964,OO.asp)
Off-label: Product information or use that is not consistent with the FDAapproved full prescribing information. It includes, but is not limited to, unapproved indications, dosing regimens (including combinations), patient populations, or safety and efficacy data.
Online Communities: Social networks, blogs, microblogs, chat Tooms, video-sharing sites, and other forums in which people are engaged in discussions, or otherwise share information, about diseases, treatments, and other health-or medical practice-related matters.
Posting: An openly viewable message on the internet, generally intended to be viewed by members of online communities.