Mobile Medical Applications

FDA and FTC Advertising and Promotion Issues

Agenda• Overview and Introduction

– Vernessa Pollard, Arnold & Porter LLP

• Segment One: FDA Regulatory Landscape– Bradley Merrill Thompson, Epstein Becker & Green

• Segment Two: Labeling, Advertising, and Promotion – Michele L. Buenafe, Morgan Lewis & Bockius LLP

• Segment Three: FTC Enforcement and Civil Liability– Jeffrey N. Gibbs, Hyman, Phelps & McNamara, PC

• Segment Four: FTC Enforcement Perspective and Trends

– Karen Mandel, Division of Advertising Practices, FTC

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Overview• The convergence of wireless and medical

technologies is changing the way consumers and healthcare providers manage health and treat disease.

• Technology developers are beginning to offer mobile health products and solutions that provide greater flexibility, connectivity, and information to consumers and healthcare providers.

• Many of these products and solutions are regulated by FDA, FTC, and others; therefore, they present new advertising and promotional challenges for developers and regulators.

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Regulatory Landscape

Medical &

Healthcare Apps

CMS

Industry

Groups

FTC

Competitors

FDA

Plaintiffs’ Bar

States

ONC

The Company: ABC Tech, Inc.

• ABC has developed the Comm4Kids app, which it plans to market as providing augmentative and alternative communication for children with autism.

• ABC understands that the app will be regulated, but it’s not sure what regulations apply or what marketing and promotional issues it should consider.

• Our panel of experts will attempt to guide ABC by providing multiple perspectives to help the company understand the regulatory framework, risks, and potential solutions associated with marketing its product.

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Comm4Kids

Revolutionizing Autism

Treatment and Outcomes

Join the Revolution

Get the latest news, connect with others, ask questions, share your

story.

The Product: Comm4Kids

• The Comm4Kids app is a communication app that teaches children how to convey their everyday needs through sentences, symbols, and pictures.

• It also has a text-to-speech function,

word prediction, and a customizable vocabulary and interface.

• The company believes that daily use of the app will improve speech, communication, and engagement among children diagnosed with Autism.

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Comm4Kids transforms an Android device into an

affordable augmentative and alternative

communication device for autistic children

Comm4Kids :

speaks.

Prompts.

Predicts.

Teaches.

Reacts.

Rating: 5 Stars from 50 Reviews

Downloads: Between 10,000-50,000

Price: $1.99

Purchase upgrades in App. See Ads and insights

from our sponsors.

Comm4Kids

FDA REGULATORY LANDSCAPE

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Bradley Merrill Thompson

Is Comm4Kids a Medical Device?

The Law is Not Always Clear

Ihatepeas.com

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2015 Final MMA Guidance: What gets regulated?

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1. Accessories to a medical device

Mobile apps that are an “extension” to a medical device by connecting to the device in order to:

a. Control the device;

b. Use in active patient monitoring; or

c. Analyze medical device data.

2. Functionalities similar to currently regulated medical devices

a. Using special medical attachments;

b. Using generic attachments; and

c. Using no attachments.

3. Clinical Decision Support Software

a. Performing patient-specific analysis; and

b. Providing patient-specific diagnosis, or treatment recommendations.

Mobile Medical Apps

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Unregulated Mobile Apps and Enforcement Discretion Mobile Apps

5 Categories

1. Electronic copies of medical textbooks

2. Educational tools

3. Facilitate patient access to information

4. Business operations in healthcare settings (accounting, billing)

5. Generic aid (e.g. magnifying glass)

Enforcement Discretion Examples

1. Patient motivators

2. Patient day-timers

3. Access to contextually relevant information

4. Certain telemedicine products

5. Simple professional calculators

6. Connections to EHR’s

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• Overarching Scope: Healthy Lifestyle• Permitted Association with Chronic Disease

‒ “Reduce the risk of certain chronic diseases or conditions;” or

‒ Help us live “well with certain chronic diseases or conditions.”

• Well-Understood and Accepted Association• Permitted Functionality

‒ “Promote, track, and/or encourage choice(s)….”• Low Risk

Wellness Apps (2015 Draft Guidance)

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“Augmentative and alternative communication for children with autism”

1. Disease or wellnessa. Autism is a diseaseb. But is this just living healthy with disease?

2. Functionality a. More like education (unregulated)b. Not a treatment or diagnosticc. Maybe more like prosthetic?

3. What is the risk?a. Compare to prosthetics

4. What is existing practice? a. Proloquo2Go (a top app of 2009)b. Grace Appc. iCommunicate

Is Comm4Kids Regulated?

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LABELING, ADVERTISING, AND PROMOTION

Michele L. Buenafe

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How Should ABC Label and Market Comm4Kids?

• Based on Brad’s advice, ABC is pursuing a three-track approach to product development: ‒ FDA medical device track: performing CDS functions.‒ Consumer product track: tracking symptoms and giving

educational messages.‒ Unbranded disease awareness: ABC will license its app to

pharmaceutical companies in a particular therapeutic area as an unbranded autism awareness tool and provide user data and advertising placement to pharmaceutical companies for a fee.

• ABC asks how it should label its app if the app is regulated as a medical device or a consumer product.

• ABC also wants to know how or whether it can market the App to pharmaceutical and drug companies for unbranded disease awareness.

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Medical Device Labeling and Promotion

FDA Requirements:• Identity, Quantity, Business name on package label (21

C.F.R. Part 801)

• Intended Use statements that comply with device classification regulation, 510(k), de novo, or PMA (as applicable)

• Adequate directions for use (including warnings) (21 C.F.R. § 801.5)

• Truthful, not misleading, and adequately substantiated

• Fair balance

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Medical Device Labeling and Promotion

How Applied to Mobile Medical Apps?• Physical package where applicable but could also consider

statements and descriptions in online retail platforms (e.g., “App Store” or “Google Play”)

• Start menu, home screens, settings, options, instructions, Pop-ups, ratings, and user-generated content on website and social media platforms?

• Static warnings, disclaimers, links to detailed risk information, and limited access for certain user populations (e.g., HCP certification or verification required, age verification for adult-only applications)

• End User License Agreements (EULA), privacy disclosure policies, or other policies requiring user click-through to accept terms and conditions?

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Consumer Product Labeling and Promotion

• FTC Act prohibits unfair and deceptive trade practices ‒ Applicable to mobile apps marketed as

consumer products and those marketed as devices

• “Claim creep” could trigger FDA requirements

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20http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm353513.htm

“It has come to our attention that you are currently marketing

the uChek Urine analyzer, which is intended for use with

[specific] … reagent strips for the qualitative and semi-

quantitative determination of urine analytes including glucose,

urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite,

leukocyte, and specific gravity. 

“The uChek Urine analyzer appears to meet the definition of a

device as that term is defined in section 201(h) of the Federal

Food Drug and Cosmetic Act. Please note that though the types

of urinalysis dipsticks you reference for use with your

application are cleared, they are only cleared when interpreted

by direct visual reading.  Since your app allows a mobile phone

to analyze the dipsticks, the phone and device as a whole

functions as an automated strip reader.  When these dipsticks

are read by an automated strip reader, the dipsticks require new

clearance as part of the test system.”

Intended Use Doctrine

Disease Awareness Claims

• App itself is not an FDA-regulated product• Must be mindful of requirements

applicable to pharmaceutical clients:‒ Links to pharmaceutical websites‒ Embedded pharmaceutical ads‒ Referencing articles discussing use of

specific drug products

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FDA ENFORCEMENT AND CIVIL LIABILITY

Jeffrey N. Gibbs

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FDA Enforcement

• FDA has afforded substantial regulatory flexibility to mobile medical applications.

• Flexibility is not unlimited, and “enforcement discretion” does not preclude enforcement action.

• Lines of permissible conduct are not clearly drawn.

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FDA Enforcement Factors

• Company’s intent• Consumer impact

‒ Safety risks‒ Actual harm: FDA’s response changes dramatically if

there is consumer injury

• False/misleading claims• Prior conduct, e.g., been warned in the past• If the media shines a spotlight on company or the

company shines a spotlight on itself• FDA seeking broader deterrent effect

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FDA Enforcement Tools

• Untitled Letters• Warning Letters• Seizure?• Injunction• Prosecution• Civil Penalties• Recall?• Publicity

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Civil Liability

• Many ingenious theories by plaintiff’s attorneys• Class action suit ubiquitous and can be filed

almost instantaneously‒ See e.g., VW

• Claims and theories will be based on state laws

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Civil Liability (cont’d)

• Civil Liability – Risk Factors:‒ Aggressive claims in order to be heard in a crowded

marketplace (>3,000 apps for mental health)‒ Promise more than can deliver‒ Minimize risks‒ Inadequate disclaimers‒ Lack of control over all promotional materials,

including links or testimonials‒ Inadequate validation‒ Inadequate understanding of how consumers will

use product‒ Confidentiality breaches

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How Should ABC Respond to FDA Enforcement?

• ABC ignores Brad and Michele’s advice. Specifically, ABC issues a press release about Comm4Kids, claiming the app is “revolutionizing the treatment and outcomes for autistic children.”

• The press release cites various observations studies and consumer satisfaction surveys conducted by ABC’s marketing department.

• ABC claims that the app improves autistic children’s communication skills at a faster rate than most traditional augmentative and alternative communication resources.

• Soon thereafter, FDA contacts ABC, stating that the app is an unapproved medical device. ABC contacts Jeff.

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Will The FTC Also Take Action Against ABC?

• Will the FTC bring an enforcement action against ABC for deceptively claiming that Comm4Kids improves communication skills?

• Karen will identify FTC regulatory issues for ABC.

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FTC ENFORCEMENT PERSPECTIVE AND TRENDS

Karen Mandel

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Disclaimer

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FTC Enforcement Authority

• FTC Act (15 U.S.C. §§ 41-58)– Section 5 prohibits unfair or deceptive

acts or practices; and– Section 12 prohibits false advertising

likely to induce the purchase of foods, drugs, devices, services, or cosmetics.• Apps are “devices” if intended to diagnose,

cure, mitigate, treat, or prevent disease, or affect the structure or function of the body

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Basic Advertising Principles

• Advertising must be truthful and not misleading.• Claims must be substantiated before being

made.– Express, implied, comparative, efficacy,

safety, “scientifically-proven”• Advertisements cannot be unfair (harm to

consumers outweighs overall benefit).• Qualifying information must be disclosed when

required to avoid misleading consumers.

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What is Substantiation?• Advertising claims require a “reasonable basis.”

– Pfizer Factors (1972): • Type and specificity of claim;• Type of product;• Consequences of a false claim and benefits of a truthful

claim;• Degree of consumer reliance; and• Type and accessibility of evidence.

– Advertising Substantiation Policy Statement (1983):• “Reasonable basis” standard is flexible; and• Depends on number of factors relevant to benefits and costs.

• A “reasonable basis” for health and safety claims is “competent and reliable scientific evidence.”

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Competent and Reliable Scientific Evidence

• Tests, analyses, research, or studies that are:– Conducted and evaluated in an objective manner by

qualified persons; – Generally accepted in the profession to yield

accurate and reliable results; and– Sufficient in quality and quantity to substantiate that

the representation is true:• When based on standards generally accepted in

the relevant scientific fields; and• Considered in light of the entire body of relevant

and reliable scientific evidence.

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Speaking of FDA. . .• FTC and FDA work together under a long-standing

liaison agreement.– FDA regulates product labeling, packaging, inserts,

and promotional materials distributed at point of sale. – FTC regulates claims in advertising, including print

and broadcast ads, infomercials, catalogs, Internet, and other marketing materials.

• FTC frequently consults with FDA when issues overlap and carefully considers their assessment of the science.

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Health Apps: Key FTC Issues

• Substantiation for health claims• Disclosures must be clear and

conspicuous• Endorsements subject to truth in

advertising requirements• Privacy and data security of consumer

health info

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FTC Health App Cases• Acne App Cases: AcneApp and Acne Pwner

– Alleged deceptions:• Lacked reasonable basis to claim that app effectively treats acne; and• Falsely claimed a study proves AcneApp effectively treats acne.

• Melanoma App Cases: MelApp and Mole Detective – Alleged deceptions:

• Lacked reasonable basis to claim that apps could diagnose melanoma; and

• Falsely represented MelApp was scientifically proven to be effective.• UltimEyes Vision App (in public comment period)

– Alleged deceptions in proposed complaint: • Lacked reasonable basis to claim that the app improves vision

substantially, in all users, or by specific measures, and treats or prevents presbyopia; and

• Falsely represented app was scientifically proven to be effective.

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Thank You!

Questions?