Pharma, Social Media, & Mobile A Happy Ménage à Trois?
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The document discusses pharmaceutical companies' use of social media and mobile applications. It notes milestones and mistakes in pharma's adoption of these technologies. It also summarizes guidelines from regulatory agencies on topics like adverse event reporting, off-label promotion, and editing drug information online. Survey results show most agree self-regulation is needed for mobile medical apps. The document provides resources for assessing social media readiness and best practices in mobile health.
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Pharma, Social Media, & Mobile A Happy Ménage à Trois?
- 1. © 2013 Pharmaguy Pharma, Social Media, & Mobile A Happy Ménage à Trois? 3rd Annual Pharma eMarketing Congress 11- 13 Sept 2013 * Barcelona, Spain
- 2. © 2013 Pharmaguy Learn from Milestones & Mistakes Milestones – Important “firsts” have paved the way for cautious followers. Mistakes – Best way to learn & benefit from your competition’s errors. “Constant Effort and Frequent Mistakes are the Stepping Stones to Genius” Elbert Hubbard, American writer 2
- 3. © 2013 Pharmaguy 3 Pharmaguy Has Been There (at FDA), Done This Testified as Panel Member at 1996 FDA Hearing on Internet Co-Founded Internet Healthcare Coalition (1997) Co-Authored the eHealth Code of Ethics (2000) Blogged About Pharmaceutical Digital Marketing Practices Since 2005 Presented Survey Results at the 2009 FDA Hearing on Social Media
- 4. © 2013 Pharmaguy FDA Sends 14 Warning Letters FDA sends 14 letters on a single day to major pharmaceutical companies concerning their Google and Yahoo Rx paid search ads. Letters were dated 29 March 2009, but made public on 2 April 2009. April 2, 2009 4 1 April 2009: Pharmaguy posted fake “April Fools” press release announcing publication of FDA guidance on pharma’s use of social media.
- 5. © 2013 Pharmaguy 5 FDA Hosts Public Hearing November 12-13, 2009 “This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.” April 2, 2009: Pharmaguy issued first public call for FDA public hearing on social media. “We should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.”
- 6. © 2013 Pharmaguy 6 "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA) “Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.” FDA's "Social Media Guidance Cliff" New Deadline is July 2014 As of 30 May 2013, no “actions completed” reported in FDASIA-TRACK
- 7. © 2013 Pharmaguy Q: When is Pharma Accountable for Information on 3rd-Party Social Media Sites? For what online communications are manufacturers, packers, or distributors accountable? In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products? A. When marketer or agent sponsors the discussion (e.g., provides a specific grant to independent 3rd-party host such as a patient advocacy group to sponsor the discussion) B. When marketer or agent paid for the content (e.g., paid patients for testimonials or otherwise provided compensation) C. When marketer or agent paid for display ads to be run on specific discussion pages (e.g., only discussions related to the product advertised) 7
- 8. © 2013 Pharmaguy Accountability Survey Results 8
- 9. © 2013 Pharmaguy Accountability: Best Practices DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible. Half of survey respondents agree Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.] About two-thirds of survey respondents agree 9
- 10. © 2013 Pharmaguy Q: Should Pharma Edit Drug Articles on Wikipedia? 10 When is it appropriate for pharma companies to edit Wikipedia articles that include "misinformation" about their drugs? A. Never B. Always C. Depends
- 11. © 2013 Pharmaguy Appropriate Wikipedia Editing Practices 11
- 12. © 2013 Pharmaguy 12 What challenges are presented in handling adverse event information from social media sources? A. The amount of information from these sources is potentially too vast to be processed economically (lack of resources) B. Finding adverse event information from these sources is like finding a needle in a haystack (too daunting) C. The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable) D. There are many potential issues that won't fully be known until the practice of monitoring social media for AEs is more prevalent (unknown issues) Q: What Are the Challenges in Handling AEs?
- 13. © 2013 Pharmaguy 13 Social Media Adverse Event Survey Results
- 14. © 2013 Pharmaguy “UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB‟s Vice President of Clinical Research Goal: Generate patient-reported outcomes that may help UCB better understand how patients live with epilepsy and help advance epilepsy care. Provides disease tracking tools Deployed a system for reporting adverse events to FDA 14 UCB Embraces Adverse Events on Sponsored PatientsLikeMe Epilepsy Discussion Board June 16, 2009
- 15. © 2013 Pharmaguy 15 13 June 2011: ABPI Pharmacovigilance Expert Network (PEN) published “Guidance Notes” on management of AEs on pharma owned/sponsored Websites; AEs should be collected and documented, regardless of seriousness of event and whether or not there is an identifiable reporter (http://bit.ly/BritAEguide) 1 April 2011: PMCPA issued “informal guidance” for applying its Code to social media; e.g., communication with physicians via Twitter, corrections to Wikipedia, appropriate use of metadata (http://bit.ly/PMBBritsvFDA) EU Online AE Reporting & Twitter Guidance
- 16. © 2013 Pharmaguy 16 December 27, 2011 Section VI addresses responding to unsolicited requests on public forums such as the Internet and "emerging electronic media” Cites cases on YouTube, blogs, and Twitter: Pharma should respond to unsolicited requests via private channels “FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information” FDA Off-Label Guidance & Social Media
- 17. © 2013 Pharmaguy Pharma is Overcoming Social Media Hurdles 17
- 18. © 2013 Pharmaguy Pharma is Overcoming Social Media Hurdles 18 Period I: 54% Period II: 30% Period I: 24% Period II: 42%
- 19. © 2013 Pharmaguy Sanofi-Aventis Vs. Patient on Facebook 19 March 15, 2010 The pharmaceutical industry’s worst fear was realized when a “disgruntled patient” posted multiple adverse event messages and photos on the wall of a Sanofi-Aventis Facebook page (VOICES). The page did not have comments turned off and did not include any terms of use.
- 20. © 2013 Pharmaguy Sanofi Didn’t Give Up on Facebook 20 August 11, 2011 “Likes” have grown from 522 in January 2011 to over 6,700 in June 2013. “Since we operate in a heavily regulated industry, we… must preview all messages.” “While some messages may not be posted, we are listening and encourage you to continue sharing.” Sanofi US Diabetes Won the 2012 Pharmaguy Social Media Pioneer Award
- 21. © 2013 Pharmaguy I called this tweet “Sleazy Twitter Spam” Challenge (US): How to fit benefits and fair balance in 140 characters or less? Challenge (Globally): How to make it meaningful for patients We’re Still Friends! 21 First (& Only?) Pharma Rx Branded Tweet! June 18, 2009
- 22. © 2013 Pharmaguy First Live Pharma TweetChat 22 February 16, 2011 AstraZeneca hosted a one-hour chat on Twitter to raise awareness about helping patients save money through prescription savings programs. Tony Jewell, AZ, won the 2011 Pharmaguy Social Media Pioneer Award
- 23. © 2013 Pharmaguy Pharma’s First Disease Condition TweetChats 23 September 2 and 9, 2013 Boehringer Ingelheim hosted a live #COPDChat TweetChat at the European Respiratory Society 2013 Congress to “discuss the latest 'hot topics' in #COPD with leading experts. We'll be chatting about the role of dual bronchodilation in COPD, discussing whether there is a need for new treatment options and whether digital COPD tools can improve patient care and disease outcomes. Non- US/UK participants only. BI also hosted #ChatAFib, a live TweetChat event which took place on 2 September 2013 during #ESCCongress2013. The participants discussed cardiovascular disease and thrombosis in women.
- 24. © 2013 Pharmaguy 24 December 13, 2011 The Prescription Medicines Code of Practice Authority (PMCPA) ruled Allergan breached the Code on several counts after an employee accidentally tweeted publicly about Botox Employee violated Allergan’s "Global Social Media Policy” that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity." Should pharmacos make their SM policies public to be more transparent & accountable? Pharma Employee Tweet Problem
- 25. © 2013 Pharmaguy 25 A promise to visitors of SM sites you own or sponsor about how YOU will behave, not how you expect THEM to behave Think of it as serving a similar purpose as your privacy policy Includes: Your comment moderation policy; this requires more details than what has been seen to date Rules for participation by your employees (reflects the internal policy that your employees are trained on) Rules for participation by agents of your company (should be same as apply to your employees; trained on also) Other “rules of engagement”; e.g., correction of misinformation Thoughts on an Outward-Facing SM Policy
- 26. © 2013 Pharmaguy What's Your Social Media Implementation Plan? 26
- 27. © 2013 Pharmaguy End of Part 1 27 Any QUESTIONS?
- 28. © 2013 Pharmaguy Reigning in the “Wild West” of Mobile Health Apps 28 Inaccurate Health Apps Good App Privacy Practices Test and Document Certification of Mobile Health Apps Industry Self-Regulation
- 29. © 2013 Pharmaguy Is This the Typical Mobile Health App Developer Hired by Pharma? Easy entry into mHealth offers incredible opportunity for innovation in healthcare; however, the open market comes with certain concerns, namely, “how credible are the apps I am (or my patients are) using?” 29 Are developers knowledgeable about applicable regulations, laws, and pharma sensibilities?
- 30. © 2013 Pharmaguy FDA Mobile Medical Apps “Scope of Oversight” Pyramid 30
- 31. © 2013 Pharmaguy Q: Is This App an MMA Subject to FDA Regulation? 31 uChek Urine analyzer, which is intended for use with reagent strips (e.g., Bayer Diastix) for the qualitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity. A. Yes B. No C. I Don’t Know
- 32. © 2013 Pharmaguy Undocumented & Untested(?) Pharma MMAs 32 Psoriasis app by Janssen includes a “PASI” (Psoriasis Area and Severity Index) calculator No citation of source used to perform calculation – was it the equation above? No disclaimer such as "Persons using the data within for medical purposes should not rely solely on the accuracy of the data herein.” Was the app tested and certified by a third-party? Is this an “MMA” subject to FDA regulation?
- 33. © 2013 Pharmaguy The First Ever “Dear Doctor” Letter Regarding a Mobile Medical App Recall 33 Pfizer Rheumatology Calculator Most downloaded app tracked by POCKET.MD (5-Star user rating) Recalled via a “Dear Doctor” Letter in October 2011 because of "a bug in the app ... gives wrong results.”
- 34. © 2013 Pharmaguy More Mobile Health App Guidance from FDA for Pharma to Worry About 34 Standalone Clinical Decision Support (CDS)
- 35. © 2013 Pharmaguy Pharma Mobile Health App Best Practices Survey 35
- 36. © 2013 Pharmaguy Q: Will Mobile App Regulations Stifle Innovation? 36 How concerned are you that current draft FDA regulatory guidelines will inhibit pharma companies from developing mobile health apps for consumers and physicians? A. Concerned B. Not Concerned C. Neutral
- 37. © 2013 Pharmaguy More Survey Results 37 How concerned are you that current draft FDA regulatory guidelines will inhibit pharma companies from developing mobile health apps for consumers and physicians? 77% agree that it is in the drug industry's best interest to police itself and develop best practices or self- regulatory guidelines
- 38. © 2013 Pharmaguy Self- Regulation of Pharma Mobile Medical Apps 38 The pharmaceutical industry must police itself with regard to development of medical apps; e.g., Issue “Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry.” Some suggested guidelines, include: Apps should cite the source of the data used by the app and include contact information for reporting errors. Call this a “Mobile App Adverse Event Reporting & Tracking” system. Apps must be rigorously tested & certified by a third-party to ensure quality and accuracy. Apps should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.
- 39. © 2013 Pharmaguy Social Media Pharma Marketing Readiness Self-Assessment -- http://bit.ly/SMreadiness Pharma Mobile Health App Best Practices Survey -- http://bit.ly/MobileBPsurvey Overcoming Space Limitations in Social Media; http://bit.ly/fdasmSpace Use code „FDA397‟ to get it FREE! Accountability for Pharma Content on Social Media Sites; http://bit.ly/fdasmAcct Use code „FDA497‟ to get it FREE! Solving the Social Media Adverse Event Reporting Problem; http://bit.ly/fdasmAE Use code „AE495‟ to get it FREE! Pharma is Overcoming Social Media Hurdles: Assessing the Three Biggest Obstacles to Success; http://bit.ly/SMhurdles Use code „SMhurdleFREE‟ to get it FREE! Resources 39
- 40. © 2013 Pharmaguy Thank You! 40
Editor's Notes
- I’ll start with social media and the difficult road the drug industry has traveled in its attempt to master social media and integrate it into its marketing communications strategy. FDA’s famous 14 letters alerted pharma to the fact that the agency is now looking carefully at how the industry promotes its products via the Internet. I pushed this issue in December 2006 when I blogged that “FDA should be taking a closer look at drug promotion via the Internet.” And the timing of my 2009 April Fools’ joke was perfect – many pharma people were primed to believe the FDA actually came out with digital guidance and several were angry at me for playing such a cruel joke!
- I’d like to believe that my call for public hearings back in April 2009, motivated the FDA to act. Unfortunately, however, the hearings were hastily organized and as a result, they did not include ALL stakeholders as I urged. Consumer advocates were missing and agencies and industry service providers dominated the speaker roster. Relative to the 1996 hearing, few pharma companies made presentations at the 2009 hearing.This shirt appeared in my presentation to the FDA at the November hearings! It was my way of predicting the outcome.
- Congress put some language in recent legislation that requires the FDA to issue social media guidance by July 2014. Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.I call this FDA's "Social Media Guidance Cliff.”FDA’s (FDASIA)-TRACK must include the deliverables with statutory dates, as well as other tasks required to implement the FDA Safety and Innovation Act.To date, no completed tasks for SM guidance have been entered in the database, which indicates to me that the FDA will not soon deliver any draft guidance but will wait until the very last minute.Why the delay? For one thing, the industry is pushing for legally binding regulations, not guidance and threatening a First Amendment challenge to any guidance drafted by the FDA. Pfizer, for example, said in comments to the FDA that the proposed social media guidance “raises First Amendment concerns.” Guidance, said Pfizer, is too vague and engenders “extensive [First Amendment] litigation.”
- FDA had questions about pharma correcting misinformation about drugs on third-party sites. One important 3rd-party site where misinformation about drugs may be found is Wikipedia.“If you want your customers to access information about your products from the quality perspective and in the simplest way, you have to deal with using Wikipedia,” said Dr. Bertalan Meskó (@Berci).Berci, however, did not mean that pharma companies should secretly and selectively alter information as in this example: In July of 2007, employees of Abbott Laboratories altered entries to Wikipedia to eliminate information about a Mayo Clinic study that revealed that patients taking the arthritis drug Humira faced triple the risk of developing certain kinds of cancers and twice the risk of developing serious infections.
- Another one of my surveys specifically asked respondents under what circumstances should pharma edit drug articles on Wikipedia. The best practice is to appoint an “official” Wikipedia editor as recommended by Berciand ensure that editors reveal ties to companies. Although a substantial minority of respondents feel that FDA should regulate pharma edits to Wikipedia drug articles, in comments submitted to the FDA docket, PhRMA suggested that manufacturers would welcome correcting misinformation about their products posted to 3rd-party sites such as Wikipedia IF these corrections were NOT subject to FDA regulation.
- Over the 2011 Christmas holidays, while most of us were still on vacation, the FDA quietly issued without fanfare "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet. While this may not be the "social media" guidance many people were expecting, it does include guidelines for responding to unsolicited requests for off-label information encountered through "emerging electronic media.”The primary take-away is that such requests NOT be handled by sales or marketing people and that responses should be via private channels not via open forums such as on Youtube, blogs, and Twitter.
- Despite the lack of FDA guidance, pharmaceutical marketers have come a long way in integrating social media into their overall marketing strategy.These are data from the Social Media Readiness survey tool I have been running since December, 2007. Over 300 marketers working for drug or device companies have taken the survey. The survey asks questions to evaluate readiness in three categories: regulatory (e.g., aversion of risk), culture (e.g., sensitivity to criticism), and personal experience. Scores are calculated. This compares scores prior to July, 2009, with scores afterward.Not every pharma company, however, is at the same point in the adoption curve. Some are more willing to take "risks," some are more savvy about applicable FDA regulations, and some are more knowledgeable about social media in general.
- Let’s look at more detail regarding how pharma employees rate their companies’ readiness to deal with social media readiness issues.You can see that in the early period prior to July 2009, the majority of respondents thought their companies had a “very cautious” regulatory climate with only 24% saying the climate was “very aggressive.” Theses days, it seems from these results, pharma companies are seen as much less cautious and more aggressive.I guess that is due to the lack of significant FDA “warning” letters being sent that involve social media. In other words, the “received wisdom” is that pharma companies are negotiating the social media regulatory challenges without specific guidance from the FDA.Be careful though! The FDA hammer may fall again just as it did the day after April Fools’ Day in 2009.
- Of course, there is good reason why pharma companies fear comments on Facebook as this case demonstrates.However, this could have been prevented:Problem #1: No one at S-A was monitoring this site or seemed to be responsible for it.Problem #2: There was no policy in place for what constitutes acceptable comments and how comments would be moderated or deleted.Problem #3: There was no social media “crisis management plan” other than “remove all comments!”
- Sanofi learned from its mistakes and even spoke about them in a public forum; i.e., my Pharma Marketing Talk show titled: “What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now.” In that show I interviewed Dennis Urbaniak, VP U.S. Diabetes. Listen to the podcast: http://bit.ly/PMT098The Sanofi US Diabetes team won the third (2012) Pharmaguy Social Media Pioneer Award.
- There are several non-regulatory reasons why pharma companies have not hosted more chats:Pharma companies are concerned about being overwhelmed by adverse events that may pop up in tweets during a chat session that they host and/or moderate.Pharma companies are concerned about "off-label" promotion that may be made by chat participants.Organizing and moderating a chat requires too much effort and is too risky.Once you start a chat, it's very hard to control the message.Consumers don't really want to chat with pharma companies (but physicians would be interested in chats featuring experts discussing the latest research).Despite dire predictions of "PR failure," the chat was a great success and proof that a pharmaceutical company can indeed host meaningful Twitter chats.There were a few attempts by two or three "malcontents" to "hijack" the conversation. These people made the most tweets that included the #rxsave hash tag, but despite their attempts to ask "the tough questions" about off-label promotion of drugs and Seroquel side effects, everyone completely ignored the hijackers and the conversation continued as if these people were not even there.Tony Jewell (@tonyjewell), Senior Director of External Communications at AstraZeneca US, received the 2nd Pharmaguy Social Media Pioneer award for his pioneering use of Twitter.
- I first suggested that BI host a #COPDChat back in November, 2010: "It appears to me that a pharma-hosted Twitter chat about a disease condition would be of high interest to consumers and patients [and physicians]. BoehringerIngelhiem, for example, could host a COPD Twitter chat in conjunction with its DRIVE4COPD campaign (eg, #COPDChat).” The #COPDChat is intended for physicians and the news media. It is NOT intended for patients and consumers, although there is no way that the general public can be excluded. Therefore, it seems to me that BI has to assume consumers will be at least "lurking" and may also be posting. The self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI) specifically prohibits Twitter chats even when "intended" for physicians only. The code states:"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code. Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."BI is a member of the ABPI, hence the reason for its disclaimer that #COPDChat is not intended for a UK audience. It remains to be seen, however, if such disclaimers carry weight with the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees ABPI's self-regulatory code.
- In closing this section devoted to social media, I would like to emphasize that to implement a strategy for using social media as part of your marketing campaigns, it is important to have a plan. But what are the action items of your implementation plan? This survey asked respondents to indicate how important it is to include the following action items as part of a social media implementation plan:#1: Get everyone - including marketing, regulatory people, corporate communications, C-level execs - on board#2: Become a dialogue company - learn how to listen and respond, not just push messages out#3: Have a sustained vision/goal#4: Train people who will be interacting directly with consumersCreate a social media Tsar position to oversee all the company's SM projects to assure compliance with guidelinesDevelop a moderation strategyDevelop guideposts, internal and external standard operating proceduresMarshall necessary resources - use the best tools availableUnblock corporate access to social media so employees can monitor and use applications such as Facebook while at work
- That’s the end of the first part of my presentation. I am open to answering any questions you may have before proceeding to talk about mobile health app challenges.
- These are some of the issues relating to mobile health apps developed by pharmaceutical companies that go beyond whether or not they are “mobile medical apps” (MMAs) subject to regulation by the FDA.
- Behind every mobile app is a developer – someone hired by pharma to develop apps. In testimony before the U.S. House of Representatives Energy and Commerce Committee Subcommittee on Communications & Technology, several expert witnesses alluded to "garage entrepreneurs" as the driving force behind the "trajectory of innovation" in the development of mobile health apps. They worry that such "small" enterprises do not have the money or knowledge to deal with FDA regulation, especially when it is uncertain which mobile health apps the FDA will or will not deem to be medical devices subject to regulation!
- FDA is attempting to ally fears about which types of health apps they may decide to regulate as MMAs. The top of FDA’s “Scope of Oversight” pyramid includes “mobile medical apps” (MMAs) that are traditional medical devices or a part or an extension of a traditional medical device. These are clearly within the scope of FDA’s oversight. The middle section includes patient self-management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by FDA's Center for Devices and Radiological Health , for enforcement discretion.The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.FDA has reserved the term "Mobile Medical App" (MMA) to mean a medical app that meets its medical "device" definition. When talking about mobile apps that clearly are NOT medical devices, I will use the phrase “Mobile Health Apps.”FDA is does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."
- At a March 20, 2013, U.S. House Energy and Commerce Subcommittee on Communications and Technology hearing, Bradley Merrill Thompson, General Counsel to the mHealth Regulatory Coalition, cited a urine analysis smartphone app that was clearly a medical device subject to FDA regulation. He didn’t name the app, but it surely was the uChek Urine Analyzer app.At first, the app’s disclaimer declared that the app was NOT a medical device. "If only it were that simple," said Thompson.Company received “It Has Come to Our Attention” letter from the FDA requesting a “clearance number.The currently-available version of uChek declares that it is a medical device: "The uChek system consisting of the uChek color mat, the Cuboid together with the uChek mobile application is a medical device that simplifies urine analysis."
- Many pharmaceutical marketers are developing mobile Apps for consumers and physicians that may or may not be considered MMAs by the FDA. An example is Janssen's "Psoriasis" app for the iPhone and iPad.The physician version -- which any non-physician can easily access -- includes a "PASI calculator." PASI stands for "Psoriasis Area and Severity Index," which is a tool for the measurement of severity of psoriasis. The equation above comes from Wikipedia. Is this how the Janssen app calculates PASI? We don’t know because the app does not indicate the source of the PASI calculation.Is this app a medical device that needs to be approved by the FDA? I think that's a valid question to ask since the App encourages physicians to use it while examining patients to help make a diagnosis.
- When I wrote the Pharma Marketing News article "Some Unregulated Physician Smartphone Apps May Be Buggy" back in January 2012, I reported that Pfizer "recalled" its Rheumatology Calculator app because of "a bug in the app ... gives wrong results.”Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD at the time, there must be many many users (physicians) out there who still have the app on their phones. At the time, I asked "Did Pfizer send these physicians a 'Dear Doctor' letter informing them of the problem and advising them to remove the app from their phones?" My best guesstimate answer at was: "Probably not.”It turns out, however, that Pfizer UK DID send out a "Dear Doctor" letter in October 2011, warning doctors that:“the Apple iPhone application gives on average a 15-20% higher score for DAS28-ESR compared to a score calculated using the published DAS28-ESR formula (with higher or lower incorrect scores in certain cases). It gives on average a 10-15% lower score for DAS28-CRP compared to a score calculated using the published DAS28-CRP formula2. Incorrect values are also obtained for the ASDAS-CRP score (scores are on average 15-25% lower) and for the PASI score (scores are up to 50% lower). There may also be minor errors in the Framingham scores.”
- The more I dig into FDA regulation of mobile health/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA's crosshairs.At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA “will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices.” Then I interviewed Bradley Merrill Thompson, General Counsel to the mHealth Regulatory Coalition, who mentioned ANOTHER FDA mobile guidance that the drug industry should be concerned about: new guidelines regarding FDA's regulation of clinical decision support (CDS) software.What is CDS? Here's FDA's definition:Uses an individual’s information from various sources (electronically or manually entered) Converts this information into new information that is intended to support a clinical decision Could be a mobile application, web-based service or desk top application#2 could apply to the use of algorithms or formulas such as the Janssen's PASI calculator and other pharma apps.Examples of CDS include mobile apps that remind users to take their medication; e.g. apps that give “reminders for tests, consults or medications.”FDA says its regulation of CDS apps depends on the clinical impact of medical decisions made on the basis of such apps (see chart).
- I ran a survey of readers to get their opinions on these issues. This survey asked if respondents agreed or disagreed with the following statements:Apps must include full disclosure regarding the company that has created the app or the sponsoring pharma company. This includes contact information. BRANDED apps MUST include ISI (important safety information) up front in an easily accessible manner (e.g., on start-up screen).Apps that are BRANDED (i.e., mention drug brand names) must be available ONLY from the appropriate U.S. app site (e.g., Apple App Store) even if all the FDA-required ISI (important safety information) is included.Apps intended to be used by healthcare professionals in the U.S. must be HIPAA compliant.If an app collects personal information, it should include a privacy policy that explains how such data is protected (security), who owns the data, how users can access the data, where data is stored (on device or on remote web site) and instructions for opting out of data collection.The pharmaceutical industry has to police itself with regard to development of all health apps regardless of what regulations FDA may impose.The app should include appropriate disclaimers and terms of use that the user MUST agree to before the app will run.All health/medical apps should be certified by third parties such as Happtique.If an app relies on algorithms or formulas, it must be validated through rigorous testing and documentation to ensure it works properly (i.e.,. calculations are correct).
- Other survey results suggest that the industry needs to regulate itself to put itself in the best possible position to limit overzealous FDA regulation of health apps.You can the survey and give YOUR opinions here: http://bit.ly/MobileBPsurvey
- At the moment, the drug industry is vigorously opposing FDA regulations, suggesting that the FDA is casting too "wide a net" over MMAs. PhRMAopenly expressed fears that overzealous FDA regulations will quash the development of innovative mobile health apps Another way for the pharmaceutical industry to prevent “overzealous” FDA regulations is by differentiating itself from the "wild west" breed of mobile health app developers. The industry should pro-actively issue “Guidelines for Mobile Health Apps Developed by the Pharmaceutical Industry” in much the same manner as it developed other self-regulatory guidelines such as PhRMA's “Code on Interactions With Healthcare Professionals” and International Federation of Pharmaceutical Manufacturers Association's Code of Conduct.These are a few of my personal views regarding issues that voluntary guidelines should address.