September 16, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

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1 September 16, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD Re: Docket No. FDA 2014-D-0447: Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. GENERAL COMMENTS: In general, the Draft Guidance provides comprehensive information about FDA s proposed recommendations for companies seeking to correct misinformation on the Internet and social media platforms generated by independent third parties. There are, however, several points on which BIO requests further consideration or elaboration. We appreciate FDA s recognition that public health may benefit when firms correct misinformation about their products. Indeed, conversations purporting to contain accurate information about biopharmaceutical products are already happening and prevalent on social media platforms. BIO members seek assurance of FDA s flexibility regarding manufacturer participation in these already-existing conversations, in order to provide balanced, researched, and accurate information regarding their products. Without flexibility, the alternative is a potential continuation of the chilling effect on manufacturer participation, despite the fact that firms likely have the most accurate and up-to-date information and resources for the public at large. It is in the best interest of the public for FDA to assure firms of flexibility, given the realities of the platforms on which these conversations are already taking place.

2 We further note that, as BIO has commented previously, 1 the provision by a manufacturer of truthful and not misleading information about a manufacturer s products has constitutional protection under the First Amendment. 2 A manufacturer s participation in the scientific and medical dialogue, by communicating truthful and not misleading corrective content about its products, is entitled to broad protection even if the content or distribution method may be inconsistent with this Draft Guidance. Nonetheless, we also appreciate the recommendations provided in this guidance for firms to exercise this right to voluntarily correct misinformation created or disseminated by independent third parties. Detailed comments are provided below. 1. Influence This Draft Guidance does not clearly specify the considerations FDA uses in determining when product communications using interactive technologies are subject to control, involvement, or influence of firms that market the product. As was noted by numerous comments to the January Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics FDA has adopted without explanation a broader interpretation of the concept of influence or control than it had previously in this context, and the lack of specificity about the threshold triggers for influence or control creates ambiguity about the content for which a company will be held responsible. Despite FDA s response to the Medical Information Working Group (MIWG) citizen petitions that We recognize the evolving legal landscape in the area of the First Amendment, and we are reviewing and analyzing the Agency s policies, guidance, and regulations in this area more broadly, 3 FDA has provided little clarity to address the ambiguous influence or control concepts it published in the January Draft Guidance, and has not explained why such a broad interpretation remains appropriate. As BIO has commented previously, we have concerns with FDA s recommendation that manufacturers be viewed as accountable for content with which the manufacturer may have had mere involvement, or influence over (as broadly defined by FDA) a product-related communication. 4 There is no regulatory basis to hold a firm responsible 1 BIO Comments on Revised Draft Guidance for Industry on Distributing Scientific Medical Publications on Unapproved New Uses- Recommended Practices. See ype=pdf. 2 Sorrell v. IMS Health, Inc. 113 S.Ct. 2653, 2659 (2011) ( [s]peech in aid of pharmaceutical marketing... is a form of expression protected by the Free Speech Clause of the First Amendment ). 3 Citizen Petition Approval Response from FDA CDER to Ropes and Gray LLP and Sidley Austin LLP. See pe=pdf. 4 Bio Comments on Postmarketing Submissions of Interactive Promotional Media Docket FDA-2013-N-1430, April 11, See Type=pdf. BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 2 of 8

3 for statements that are not made by or on behalf of the firm. 5 Indeed, recognition that firms should not be responsible for content that is not actually made on behalf of the firm would be consistent with Section 230 of the Communications Decency Act. 6 Therefore, the definitions should be consistent with the existing legal framework otherwise the Draft Guidance could appear inappropriately to broaden the accountability for content that is not actually made or distributed by or on behalf of the firm. In the examples provided in the Draft Guidance, firms are clearly responsible for a post provided by the firm s marketing department as part of a promotional campaign (Example 1). A firm also exerts control over user-generated content (UGC) when it removes unfavorable posts about its products and adds favorable posts on a firm-hosted discussion group (Example 2). However, a firm is not responsible for UGC when the blogger generating the discussion does not have a relationship with the firm (Example 3) or when a firm monitors for profanity and obscenity but does not participate in the discussion on a firm-hosted discussion forum (Example 4). Given these examples, it is unclear whether FDA considers a firm s moderation of a forum by way of posting topics for discussion or asking survey questions would constitute prompting or even influence by the firm. BIO posits it should not. UGC resulting from a 2-way dialogue with an independent user, even if on a firmcontrolled or firm-owned forum in which a firm posts topics for discussion or open-ended survey questions, should not be considered prompted or solicited UGC or UGC influenced by the firm, provided the firm includes a clear and conspicuous statement that the firm did not create or control the UGC. In this instance, the firm should not be responsible for the content from the independent user and should be allowed, if it so chooses, correct instances of misinformation that may occur in the dialogue. 2. Corrective Communications We believe that FDA s failure to address if corrective information is subject to regulatory requirements creates ambiguity and that corrective communications cannot appropriately be considered advertising or labeling. In FDA s July 10, 2014 webinar the Agency stated that this means that if companies choose to correct misinformation and do so as set forth per the specific recommendations in this draft guidance, FDA does not intend to object if the company s voluntary correction of misinformation does not meet otherwise applicable regulatory requirements, if any. 7 The Agency implies that any corrective communication that is truthful and non-misleading but does not fully comply with the Draft Guidance may be considered labeling or advertising, without acknowledging that there are communications where such a classification would not be 5 See, e.g., 21 CFR (d), which describes the requirements for any labeling distributed by or on behalf of the manufacturer, packer or distributor of the drug (emphasis added) U.S.C. 230 (c) (1) (2000) ( No provider of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider. ). 7 FDA Social Media Draft Guidance Webinar Q&A s (July 10, 2014). See 84.pdf. BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 3 of 8

4 appropriate. For example, if a firm responded to a tweet in which a user suggests a potentially dangerous off-label use is appropriate by inviting the user to call the company s call center for more information about appropriate use of the product, but fails to follow recordkeeping or other technical requirements of the Draft Guidance, that tweet should not be considered labeling or advertising. 3. Correcting Misinformation in a Clearly Defined Portion In the Federal Register notice announcing the availability of this Draft Guidance, FDA asked for comments on its recommendation that a firm identify the misinformation or define the portion of the forum it is correcting and correct all the misinformation that appears in that clearly defined portion. Commenters were asked to discuss whether this is an appropriate and effective way for firms to correct misinformation without correcting all misinformation that might appear in a forum. BIO does not believe this is an effective way for firms to correct misinformation that may appear in a forum, since a clearly defined portion is a subjective determination. Although we acknowledge that firms should avoid cherry-picking pieces of misinformation to correct, we recommend that firms should not be held responsible for correcting each piece of misinformation by the location of the misinformation. Instead, firms should be permitted to disclose the specific information they are correcting (by including the date, time, and other identifiers) and to correct that misinformation in a truthful and nonmisleading manner. 4. Scientific Exchange BIO suggests FDA confirm in any final guidance that the recommendations in this Draft Guidance are not intended to inhibit legitimate scientific exchange principles generally, and certainly concerning FDA-approved products in cases where misinformation may affect public health. In such cases, we suggest that FDA provide firms the flexibility to correct misinformation or provide a reputable source from which to obtain the correct information, such as the firm s medical affairs department. For example, legitimate scientific exchange to correct misinformation could include the discussion of a post hoc analysis of a clinical trial or the unapproved use of an FDA-approved product. Because such legitimate scientific exchange would not otherwise constitute advertising or labeling, BIO believes that such interchanges fall outside the scope of the guidance but are permissible under the already applicable principles governing scientific exchange. 5. Discussion Forums Example 4 (page 5) of the guidance states, A firm hosts a discussion forum about its drug s or device s FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by independent third parties and can, if it so chooses, correct misinformation according to this guidance. BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 4 of 8

5 We recommend inserting and moderate after monitor, in any final guidance, as the expectation would be to remove or respond to certain posts, including for example, those that contain profanity or obscenity. Indeed, firms may wish to moderate more than profanity or obscenity, and at a minimum, any discussion forum would contain other necessary terms of use requirements that could result in content removal like trademark or copyright violations. Further, some companies may even wish to remove posts containing information on unapproved uses of approved products. Such reasonable, appropriate, and common moderator discretion should not be restricted if the firm is not influencing the content of the postings in the first instance. BIO believes that within the bounds of a clearly defined monitoring and moderation plan, the firm should not be viewed as influencing the user-generated content that is independent of the firm, when removing or responding to posts that violate the rules of engagement. CONCLUSION: BIO appreciates this opportunity to comment on the Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Specific, detailed additional comments are included in the following chart. We would be pleased to provide further input or clarification of our comments, as needed. Respectfully submitted, /s/ Jeffrey S. Peters Deputy General Counsel, Health Biotechnology Industry Organization BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 5 of 8

6 SPECIFIC COMMENTS SECTION ISSUE PROPOSED CHANGE I. INTRODUCTION II. Lines 76-79: BACKGROUND The Draft Guidance defines misinformation as positive or negative incorrect representations or implications about a firm s product created or disseminated by independent third parties who are not under the firm s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular. As written, this definition of misinformation is broad and could be subject to misinterpretation. Furthermore, it is unclear whether a firm s ability to correct misinformation is limited to instances in which the information may be harmful to public health. FDA should recommend that manufacturers may determine what is considered misinformation, as long as a manufacturer s response includes appropriate corrective information. III. DETERMINING WHETHER THIS DRAFT GUIDANCE APPLIES Lines : IV. The Draft Guidance states the applicability of the Guidance as when a firm is not responsible for a product-related communication that appears on the firm s own forum, an independent third-party website, or through social media, and the firm chooses to correct misinformation about its own product contained in that communication. We ask FDA to please clarify whether this Guidance applies only to interactive media or to any information created by third parties that appears on digital media, regardless of whether it is interactive or static. We recommend that firms be given the option to correct misinformation on any static or interactive independent third-party site. RECOMMENDATIONS FOR THE CORRECTION OF MISINFORMATION ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES A. APPROPRIATE CORRECTIVE INFORMATION Lines and The Draft Guidance describes providing a reputable source from which to obtain If a firm provides a general , phone number, or URL as a reputable source from which to obtain the correct BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 6 of 8

7 Footnote 8: correct information. information and then refers questions to the firm s medical communications department, this should not be interpreted as soliciting off-label questions or topics. Lines : The Draft Guidance states that a firm s communication should Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs. We request that FDA define or give examples of what constitutes sufficient evidence and clarify whether citations are necessary in the correction. For example, FDA should clarify whether a post hoc analysis that does not rise to the level of substantial evidence would constitute sufficient evidence for purposes of this Draft Guidance. B. CORRECTING A CLEARLY DEFINED PORTION OF A FORUM Lines and : The two examples (examples 8 and 9) give varied definitions of clearly defined portion. We believe the Draft Guidance is variable in its definition of a clearly defined portion of a forum (section IV, lines 222 to 224). For example, example 9 states, the firm does not address exaggerated efficacy claims in favor of the firm s product in other postings that appear to readers between the postings it is correcting. Even if the firm corrects the misinformation in the limited posts it chose, the firm s actions are not in accord with this guidance, which appears to contradict the text in example 8, which states, The firm is not expected to correct misinformation that appears in other comments. We ask the Agency to clarify the definition of a clearly defined portion to explain this apparent contradiction. C. APPROACHES TO CORRECTING MISINFORMATION Lines : The Draft Guidance states that A firm finds a webpage about its product that is written by an independent third party on an Internet-based, interactive, Many collaboratively edited encyclopedias, such as Wikipedia, do not have a single author associated with the content to which a firm can provide corrective information. In these cases, we believe the best way to correct BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 7 of 8

8 collaboratively edited encyclopedia. The firm may choose to contact the author of the webpage and provide corrective information to the author. D. COMMUNICATIONS THAT FALL OUTSIDE THE SCOPE OF THIS GUIDANCE E. THE CONSEQUENCES OF CORRECTING MISINFORMATION misinformation is to edit it directly. However, we would like to note that a firm may not have the ability to disclose its affiliation on the same screen as the correction of misinformation, due to the way the site functions. BIO Comments on Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices FDA Docket: FDA D-0447, September 16, 2014, Page 8 of 8