In June 2014, the Food and Drug Administration issued two draft guidance documents regarding product promotion and social media: (1) “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”; and (2) “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”1
While the draft guidances are not legally binding, they offer insight into FDA’s expectations and issues for industry to consider as it continues to develop social media campaigns.
The documents are the latest installments in a series of guidance documents the agency has promised to provide industry, in an effort to clarify the parameters and the agency’s enforcement interpretation on promotional messaging using ever-changing social media.2 FDA has requested comments by September 16, 2014. It recognizes the issues are daunting and need industry input. This Bulletin summarizes some key points of the guidances and offers AGG observations. For purposes of brevity, we will not describe all of the examples presented by FDA in the guidances.
Correcting Independent Third-Party Misinformation
■Aswehaveadvisedclientspreviousl, control of themessageiscentraltoFDs determinationof whethertheproductownerhasregulatoryobligationstocomplywith labelingandadvertisingrequirements.
■The agencymakes clear that any correctionis voluntaryand not requiredby the agenc.
FDA’s intent is to provide guidance for “if they [firms such as manufacturers, distributors, or packers] choose to respond . . . to misinformation created or disseminated by independent third parties.” (emphasis added)
■The new draft guidancedoes not apply when the firm is responsible for the product-specific communication (i.e., “owned, controlled, created, or influenced, or affirmatively adopted or endorsed, b, or on behalf of, the firm”).
■FDAdefines “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. FDA has determined it may benefit the public health for firms to correct misinformation about their products (including, for example, situations in which a firm is aware of misinformation that may be dangerous or harmful to the public health).
- See Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM401079.pdf and Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf.
- See AGG Bulletin: http://www.agg.com/FDA-Stops-Being-Antisocial--Recent-Social-Media-Guidance-Breaks-the- Silence-01-21-2014/
■The draft guidance explains that the agency does not intend to take enforcement action against a firm that correctsmisinformationinatruthfulandnon-misleadingmanner(withintheparametersoutlinedintheguidance), evenwithoutmeetinganyotherapplicablelabelingandadvertisingrequirements.Again,thisrelatesto misinformationdistributed by independent third parties, where the company is not responsible for the product- related communications.Thecompanymustcomplywithapplicablerequirementsrelatingtoproductinformation whereit controlsthemessage.
■Theagencyrecognizesthat it ispossibleacompanymighthostadiscussionforumaboutits productbutnot participateinthediscussion.FDArecommendsthatthecompany“includeanoverarchingclearandconspicuous statement that the firm did not create or control the UGC [user-generated content].” In other words, the company canmakeclearitisnotendorsingorsupportingthestatement.
How to Correct Misinformation
■Ratherthanprovidingthecorrectiveinformationonthethird-partyforum, acompanymaychooseinsteadto providea“reputablesource”asthecontactpersonat thecompanywherecorrectinformationcanbeobtained (e.g.,providing thecontact information forthe firms MedicalAfairsDepartment).
□ relevant and responsive to the misinformation;
□limitedand tailoredto the misinformation;
□non-promotionalin nature, tone, and presentation;
□consistent with the FDA-requiredlabelingfor the product;
□supported by sufficient evidence, including substantial evidence, when appropriate, for prescription
□either posted by the companyin conjunctionwith the misinformationin the same area, o, if provided to the author of the misinformation,referencethe misinformationwith the intent that the correctionbe posted in conjunctionwith the misinformation;and
□ disclose that the person providing the corrective information is affiliated with the firm that manufactures,
packs, or distributes the product.
■ThecompanyshouldprovidetheFDA-requiredlabeling,suchasinalinkthatgoesdirectlyto thelabelingoralink that opens a PDF file of the labeling in a new windo. FDAadvises against links to a promotional website or a promotionaladdress.
□ebelieveFDAiscomfortablewithcorrectingmisinformationto properlyeducate,butit doesnotwant suchcorrectionsto becomepromotionalopportunities.
□Firmsarecautionednotto provideinformationthatgoesbeyondcorrectingthemisinformationand crosses into proactive promotion. For example, if a company fixes information specific to one indication, it shouldnotdiscussotherapprovedindications.
■Companiesare not expectedto correct all misinformationin a forum; howeve, if a companychoosesto correct misinformationin one portion, it shouldcorrect all of the misinformation in that clearly defined portion of a forum on the Internet or socialmedia.The companycannot chooseto respondonly to negativemisinformationin the
forum (whether in one defined area or over several postings) or correct overstatement of risks while ignoring other information that overstates a product’s benefit (i.e., be careful about selective correction).
■If a companyprovidescorrective informationto the independentthird part, FDAwillnot holdthe company responsiblefor the third partys subsequentactions (or lack thereof).
■Companies are not required to submit corrections to FDA.Howeve, the agency suggests that firms maintain records in case the agencyhas questions,such as the nature or content of the misinformation,whereit appeared, the date it appeared,and the content and date of the corrective information.
■While FDAdoes not specifically identify Wikipedia by name, it refers to an “Internet-based, interactive, collaborativelyeditedencyclopedia.”The agencyrecommendsthat, if there is misinformation,the companymight contact the webpageauthor and providecorrective informationto the autho.
Character Space Limitations – Presenting Risk and Benefit Information
■The agency clarifies that this guidance applies to character-limited forums, such aswitter and internet search engine“sponsoredlinks.”Networkingplatforms(e.g., Facebook)andbanneradvertisementsareexcluded,asthe agencybelievestheydonothavethesamecharacterspacerestrictions.
□Theexclusionof banneradvertisementsseemsto showtheagencys focusoncharacter space restrictions,ascomparedtooverallspacerestrictions.
■The agency acknowledges that for some products with complex indications or extensive serious risks, the firm should reconsider using character-limited platforms if an accurate and balanced presentation of risk and benefit information,inadditionto otherrequiredinformation,isnotfeasible.In suchcases,theagencynotesthata “reminder”promotionmaybeusedinstead(assumingtheproductdoesnotcarryablackboxedwarning).
■Benefits and risks should be presented in a comparably prominent manne.
■Benefit information should be accurate, non-misleading, and reveal material facts (e.g., limitationsof use or the indicatedpopulation).For prescriptiondrugs whoseprescribinginformationcontaina Highlightssection, the “Indicationsand Usage”portioncan serve as a referencefor what materialfacts shouldbe disclosed.
■In determining whether the risk information is appropriately comparable to the benefit information, the agency will consider: (1) whether the risk information qualifies any representations made about the product, and (2) whether the risk information is presented with a prominence and readability comparable to the benefit claims.
■Risk informationincluding,at a minimum, the most seriousrisks associatedwith the product shouldbe presented
together with benefit information within the character-space-limited communication.
□For prescriptiondrugs,FDArecommendsincludingallriskconceptsfrom aboxedwarning(inbolded text),allrisksthatareknowntobefatalorlife-threatening,andallcontraindications.If theproducthas none of these, the most significant warnings or precautions should be communicated.For animal drugs, risksincludingpotentialinjurytohumanhandlers/animalpatientsandriskof drugresiduesenteringthe humanfoodchainshouldbeincluded.
□For medical devices, if a risk is associated with a particular identifiable use or population, each of those
risks should be included.
■FDArecommendsincludinga direct hyperlinkto awebpageprovidingriskinformation(e.g., awebsitedevotedto providingcomprehensiveproductriskinformation,aparticularpagewithinawebsitedevotedto riskinformation, or a PDF file providing comprehensive risk information).Ahyperlink to the home page of the products promotional website alone would not be sufficient.
□URLshortening services may be used, but the agency recommends a URLthat identifies the page as providingriskinformation(e.g.,ww.product.com/risk).TheURLaddressshouldnotbepromotionalin tone.
■Firmsshouldincludeboththetrade/brandnameandestablishedname(genericname)of theproduct.The establishednameshouldbelisteddirectlytotherightof, ordirectlybelo, thebrandname.
■The landingpagefor each hyperlinkprovidedshouldincludeboth the brandand establishedname for the product.Additionall, for prescriptiondrugs, at least one dosageform and quantitativeingredientinformation shouldbe displayedin direct conjunctionwith the brandand establishednames.
■Commonabbreviations,punctuation,and other symbols may be used to helpprovidethe requiredinformation withinthe character limitations(e.g., ampersands(&), dashes, and chemicalingredientabbreviationsmay be used).
■Control,control,control.ThetwolatestFDAdraftguidancescontinueFDs themethat acompanys controlof themessageisanimportantfactor whenevaluatingwhetherthecompanyhasregulatoryobligations.Companies thatcontrolthemessagemustcomplywithapplicablelabelingandpromotionalregulatoryrequirements.A company that wants the commercial benefits of social media must also recognize it assumes the potential regulatoryandliabilityrisks.
■In all socialmediaguidances,one of FDs goalsis to educate the consume.Whether respondingto requests for of-label information, correcting third-party misinformation, or addressing risk and benefit information where there are character-spacelimitations,FDAseeks to ensurethat truthful, complete, and prominentinformationis provided(e.g., link or reputablesource).The agencydiscouragesusingeducationalopportunitiesas excuses for promotionalmessaging.
■FDArecognizesthe challengeswith socialmedia(e.g., character space limitations,the volumeof information
on the Internet, and the use of third parties to generate material). The agency is attempting to find a balance between the company’s regulatory obligations concerning product promotion versus the inevitable inability for the company to monitor and control other independent parties’ messages. The fact that, for example, the agency will not require correction of misinformation on an independent third-party site or a company can correct some, but not all, misinformation that might exist in cyberspace indicate an agency acceptance of certain limitations.
■While FDAappreciates the potential benefits of social media in product promotion and information dissemination, it willnot suspendits regulatoryexpectationsfor compliance.There is no requirementthat companiesuse social media; if they do, they must considerthe regulatoryand liabilityconsequences.
■Practically speaking, it seems very difficult for companies to send out tweets, particularly on the pharmaceutical side, that can provide the required fair balance and full risk-benefit information.
■It is possiblethat FDAmight issue more guidancein the future, but it appearsthat, from an advertising/ promotionalperspective,it may feel it is done, at least for no.
■The draft guidancesfocus on FDs interpretationand expectations.Companiesmust also considerpotential liabilityand commercialexposure.Therefore, any socialmediaplanningrequiresthe input of diferent groupsof a compan, includingcommercial,medical,regulator, legaland potentiallyqualityassuranceand compliance, depending on the specific postings. Furthermore, companies might want to revisit existing standard operating proceduresand evaluatewhetherrevisionsand subsequenttrainingare needed.
AGG Complimentary Webinar
Join us on Monday, July 14, 2014 from 11:30 am – 1:00 pm EST as FDA attorneys Alan Minsk and Kelley Nduom, explain the new guidances, make recommendations and take questions from the audience. Register Here.3
Authors and Contributors
Alan G. Minsk Partner, Atlanta Office 404.873.8690
Kelley Coleman Nduom Associate, Atlanta Office 404.870.5797