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
2
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
4
The Company: ABC Tech, Inc.
Comm4Kids
Revolutionizing Autism
Treatment and Outcomes
Join the Revolution
Get the latest news, connect with
others, ask questions, share your story.
• 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.
5
The Product: Comm4Kids
• The Comm4Kids app is a
communication app that teaches
children how to convey their everyday
needs through sentences, symbols, and
pictures.
Comm4Kids transforms an Android device
into an affordable augmentative and
• It also has a text-to-speech function,
word prediction, and a customizable
vocabulary and interface.
Rating: 5 Stars from 50 Reviews
Downloads: Between 10,000-50,000
Price: $1.99
• The company believes that daily use of
the app will improve speech,
communication, and engagement
among children diagnosed with Autism.
alternative communication device for
autistic children
Comm4Kids :
speaks.
Prompts.
Predicts.
Teaches.
Reacts.
Purchase upgrades in App.
See Ads and insights from
our sponsors.
Comm4Kids
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FDA REGULATORY
LANDSCAPE
Bradley Merrill Thompson
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Is Comm4Kids a Medical Device?
The Law is Not Always Clear
Ihatepeas.com
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9
2015 Final MMA Guidance: What gets regulated?
Regulated
Enforcement
Discretion
Unregulated
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Mobile Medical Apps
1.
2.
3.
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.
Functionalities similar to currently regulated medical devices
a. Using special medical attachments;
b. Using generic attachments; and
c. Using no attachments.
Clinical Decision Support Software
a. Performing patient-specific analysis; and
b. Providing patient-specific diagnosis, or treatment recommendations.
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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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Wellness Apps (2015 Draft Guidance)
• 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
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Is Comm4Kids Regulated?
“Augmentative and alternative communication for
children with autism”
1. Disease or wellness
a.
b.
Autism is a disease
But is this just living healthy with disease?
2. Functionality
a.
b.
c.
More like education (unregulated)
Not a treatment or diagnostic
Maybe more like prosthetic?
3. What is the risk?
a.
Compare to prosthetics
4. What is existing practice?
a.
b.
c.
Proloquo2Go (a top app of 2009)
Grace App
iCommunicate
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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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Intended Use Doctrine
“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.”
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm353513.htm
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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
32
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?
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