Regulatory Considerations in Mobile Programs


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This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms

This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here:

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  • “Ponder the individual impacts of the book, the newspaper, the telephone, the radio, the tape recorder, the camera, the video camera, the compass, the television, the VCR and the DVD, the personal computer, the cellphone, the video game and the iPod. The smartphone is all those things, and it fits in your pocket.” from New York Times, October 4, 2013
  • Adherence apps Refill remindersSymptom trackersDoctor discussion guidesPatient support connection/communicationDosage calculators
  • If app is an accessory to an already regulated mobile device (e.g., using an iPhone as a remote control for an MRI), then the app accessory has the same regulatory class and requirements as the device to which it is an accessory.
  • Regulatory Considerations in Mobile Programs

    1. 1. Regulatory Considerations in Mobile Programs Presented by Dale Cooke & Geoff McCleary 13 November 2013
    2. 2. Agenda > Rise & importance of mobile > FDA mobile apps guidance > An open question > Mobile medical device requirements > Promotional labeling in mobile tactics > Q&A 2
    3. 3. Rise & importance of mobile 3
    4. 4. Vatican, 2005
    5. 5. Vatican, 2013
    6. 6. Source: KPCB
    7. 7. 91% of smartphone owners have their phone within arm’s length most of the time. (60% all the time) 7
    8. 8. 8
    9. 9. of ALL children under two, 9 are using mobile
    10. 10. Mobile DRIVES % of all internet traffic 10
    12. 12. 9 out of 10 would “take” an app if a physician prescribed it.
    13. 13. Building a study to learn more… > Survey 2000+ consumers to find out how they use smartphones to access disease related health information and services now, and what they want to access in the future. > We asked patients and caregiver across 20 diseases in 5 categories • • • • • Allergy & Asthma Cardiologic Conditions Neurologic Conditions Diabetes Gastroenterological Conditions > Demographic profiles • Age, income, marital status, location, etc > Condition Profiles • Disease, impact, treatment type, activity at physician’s office > mHealth Use • use by disease category, device type, location, future needs
    14. 14. STUDY REPORT: Consumer Use of Smartphones for Condition Related Health Activities Prepared by 14
    15. 15. FDA mobile apps guidance 15
    16. 16. What is this thing? Advertising & Promotion 16 Medical Devices
    17. 17. FDA is here to help Released September 2013 ce/GuidanceDocuments/UCM263366.pdf See also, 17
    18. 18. MMA guidance Mobile Medical App (MMA) defined as: “a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device.” —FDA 18 Guidance for Industry: Mobile Medical Applications, page 7
    19. 19. Digitas Health is also here to help 19
    20. 20. CDRH will focus its regulatory efforts on apps that: > Are accessories to a regulated medical device > Transform the mobile device into a medical device > Perform patient-specific analysis and provide patientspecific treatment recommendations 20
    21. 21. 21
    22. 22. 22
    23. 23. CDRH will focus its regulatory efforts on apps that: > Are accessories to a regulated medical device > Transform the mobile device into a medical device > Perform patient-specific analysis and provide patientspecific treatment recommendations 23
    24. 24. “Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act)” —FDA Guidance for Industry: Mobile Medical Applications, page 4 24
    25. 25. Regulatory discretion FDA is asserting two things: 1. FDA has the legal authority to enforce legal and regulatory requirements in that area. 2. FDA will not use that authority. 25
    26. 26. Will FDA change its position? —FDA Mobile Apps Twitter Chat, September 26, 2013 26
    27. 27. • Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions; • Provide patients with simple tools to organize and track their health information; • Provide easy access to information related to patients’ health conditions or treatments; • Help patients document, show, or communicate potential medical conditions to health care providers; • Automate simple tasks for health care providers; or • Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems. —FDA Guidance for Industry: Mobile Medical Applications, page 16 27
    28. 28. 28
    29. 29. 29
    30. 30. 30
    31. 31. An open question 31
    32. 32. What about dosing apps? “apps that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy” ARE devices where FDA will require presubmission, etc. —FDA Guidance for Industry: Mobile Medical Applications, page 15 But… “Mobile apps that perform simple calculations routinely used in clinical practice” ARE devices where FDA will NOT require presubmission, etc. —FDA Guidance for Industry: Mobile Medical Applications, page 17 32
    33. 33. Some will not be subject to enforcement —FDA Mobile Apps Twitter Chat, September 26, 2013 33
    34. 34. Medical device requirements 34
    35. 35. Meeting medical device requirements > Medical device manufacturer registration > Class determination (I, II, or III) > Validated development environment and/or quality systems in place > Investigational Device Exemption filing requirements > 510(k) or PMA filing with FDA likely required > Postmarketing reporting requirements 35
    36. 36. Promotional labeling in mobile tactics 36
    37. 37. Mobile apps as promotional platforms Mobile apps can be advertising platforms (e.g., The New York Times app, Doximity) When the underlying app discusses health, the same rules apply > Is it a medical device? > Does regulatory discretion apply? > Is your paid placement an advertisement or part of the app’s core functionality? 37
    38. 38. Promotional labeling requirements Four Types of Communication Product Promotion Requirements > Reminder Ads > Product Name Usage > Product Promotions > Fair Balance > Disease Awareness Communications > Indication Statement > Redirecting Communications > Adequate Provision (Directions for Use) > MedWatch Statement > Beware turning your app into a regulated device via promotion! 38
    39. 39. But what about mobile promotion? Unique considerations for mobile promotion > Device size > Device variability > Screen rotation > Technology changes (Go away, Flash!) > Screen takeover > Touch screen interface > Integration with the rest of the device (GPS, calendar, reminders, accelerometer, etc.) 39
    40. 40. Questions? Dale Cooke Vice President/Group Director, Regulatory Review @PhillyCooke on Twitter
    41. 41. About the speaker: Dale Cooke, VP/Group Director, Regulatory Dale Cooke is the head of the regulatory department for Digitas Health. He has worked with more than 30 pharmaceutical and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, Boston, San Francisco, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), and the Food and Drug Law Institute (FDLI). Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. Dale earned his B.A. in Philosophy from Southern Methodist University and an M.A. in Analytical Philosophy from the University of Arizona and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health. 41
    42. 42. Geoff McCleary Vice President/Group Director, Mobile Innovations As group director of mobile innovation at Digitas Health, Geoff is responsible for all mobile channel strategy and oversight of mobile efforts globally for Digitas Health work across multiple offices for major pharmaceutical, healthcare, and biotech clients. Before joining the company in 2012, Geoff was head of strategy for mobile healthcare marketing agency Eveo. With responsibility for development of strategy, research and planning practices for an organization with over 40 healthcare apps in the app store. Prior to Eveo, Geoff was the VP Strategy for imc2 Health & Wellness, developing strategic vision and direction for the company’s east coast pharmaceutical clients. In addition, he was lead for the company’s Mobile Center of Excellence, providing mobile marketing consulting to major CPG brands as well as existing healthcare clients. More than 15 years of pharmaceutical and interactive marketing experience enables him to provide the most strategic mobile and technological insights to the world’s largest pharmaceutical clients. As a leading mobile marketing evangelist, Geoff has established himself as a proponent of using mobile tools, social media and emerging technologies to creative meaningful connections with patients, consumers and physicians. 42