Download FDA Regulation of Mobile Medical Apps

All Hands Meeting - November 6-7, 2014
FDA UPDATE: Essential Knowledge
Pharmaceutical and Medical Device
Companies Need for 2015
Presenters:
Ellen Darling
+1.949.623.3540
[email protected]
© Copyright 2014 by K&L Gates LLP. All rights reserved.
Carol Pratt
+1.503.226.5762
[email protected]
Agenda
 FDA Guidance on Social Media/Advertisements
 New Preemption Implications
 Proposed Regulation of Software Used in
Healthcare IT
 Mobile medical applications, medical device
data systems, medical image
storage/communication devices
 Proposed Regulation of Laboratory Developed
Tests
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FDA Guidance on Social Media/Advertisements
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FDA Guidance on Social Media/Advertisements
Evolution of Direct-to-Consumer (“DTC”)
Advertising
Before 1906, there were no regulations relating to
the marketing of drugs.
A drug company, or really anyone, could concoct
crazy formulas, patent them and say anything they
wanted about their invention.
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Evolution of DTC Advertising
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Evolution of DTC Advertising
By the mid-1980’s, the FDA declared that it had
regulatory jurisdiction over DTC ads and required,
among other things:
 A fair and balanced account of risks and
benefits
 A summary of potential side effects
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Evolution of DTC Advertising
Meeting these requirements in print ads was
do-able, but accomplishing this in radio and TV ads
posed problems for the industry.
As a result, companies started relying more on
other types of ads as a way to get around the rules:
 Reminder Ad
 Help-Seeking Ad
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Evolution of DTC Advertising
Traditional DTC advertising is expensive. In
2007, industry spent $5 billion on DTC ads.
DTC advertising is controversial.
 Opponents argue:
 Leaves patients misinformed and sometimes
overwhelmed
 Overemphasizes the benefits of the drug
 Leads to over-utilization of drugs
 Short-circuits important discussions between a
patient and a physician
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Evolution of DTC Advertising
 Proponents argue:
 Helps educate patients about different medical
conditions and drug therapies
 Causes them to do more research about a
potential condition or drug option
 More likely to reach out to their doctors with
questions
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Evolution of DTC Advertising
Our research indicates that only two countries,
the U.S. and New Zealand, allow DTC advertising.
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DTC Ads Via Social Media
Our industry has been relatively slow to utilize
social media despite statistics about the number of:



People with multiple devices using social media
every day
Facebook comments every minute
Tweets generated weekly
This form of advertising is inexpensive compared
to traditional, DTC advertising.
So why the delay?
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DTC Ads Via Social Media
November 2009 - FDA held a hearing entitled
“Promotion of Food and Drug Administration Regulated Medical Products Using the Internet and
Social Media Tools” to discuss, among other things:



What online communications are manufacturers,
packers and distributors accountable for?
How can manufacturers, packers and/or
distributors fulfill regulatory requirements (e.g., fair
balance, disclosure information, and postmarketing submission requirements) in their
internet and social media promotion?
When is the use of links appropriate?
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DTC Ads Via Social Media
What happened after the FDA hearing in 2009?

The FDA initially received over 70 comments to
the docket

In 2009 alone, FDA issued over a dozen warning
letters relating to promotion on social media
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June 2014 Notice of Draft Guidance
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June 2014 Notice of Draft Guidance
The FDA states:
“This draft guidance is intended to describe FDA’s
current thinking about how manufacturers, packers, and
distributors . . . of prescription human and animal drugs . . .
and medical devices for human use . . . that choose to
present benefit information should present both benefit
and risk information within advertising and promotional
labeling . . . of their FDA-regulated medical products on
electronic/digital platforms that are associated with
character space limitations—specifically on the
Internet and through social media or other technological
venues (Internet/social media)….”
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June 2014 Notice of Draft Guidance
The FDA continues:
“..Examples of Internet/social media platforms
with character space limitations include online
microblog messaging (e.g., messages on Twitter or
“tweets,” which are currently limited to 140 character
spaces per tweet) and online paid search (e.g.,
“sponsored links” on search engines such as Google
and Yahoo, which have limited character spaces as
well as other platform-imposed considerations.”
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June 2014 Notice of Draft Guidance
The FDA stated that the general factors that
should be considered in communicating benefit
information on Internet/social media with character
space limitations are:
 “Benefit information should be accurate and
non-misleading and reveal material facts
within each individual character-space-limited
communication (e.g., each individual message
or tweet).”

Reveal material facts about the use of a
product, such as limitations to an indication or
the relevant patient population
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June 2014 Notice of Draft Guidance
“Benefit information should be accompanied by risk
information within each individual character-space-limited
communication.”
 A company must assess whether, once benefit
information is conveyed, there is enough room to
“adequately convey required risk information” and any
other required information
 Should communicate the most serious risks
 Provide a mechanism (i.e., a hyperlink) to allow direct and
exclusive access to a complete discussion of only the
risks of the product
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June 2014 Notice of Draft Guidance
What does the FDA say a company should do if it
cannot fit all of this information in 140 characters?
 Do not do it - consider some other mode of
advertising
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What Did Industry Think About The Draft
Guidance?
 FDA’s guidance is contrary to its own conduct
 Does not take into consideration certain search
engines, such as Google, that state that there is
no guarantee that links will be displayed
 Precludes, as written, manufacturers, etc… of
complex drugs with multiple indications and
serious risks, or certainly boxed warnings, from
using this form of advertising
 FDA should consider following a guideline
similar to the FTC’s social media guideline
 Violates the First Amendment
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September 2014 Notice of Draft Guidance
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DTC Ads Via Social Media – Risks and Benefits
Managing decisions relating to whether to
advertise via the Internet/social media
 Risks of advertising on social media:
 Warning letters
 Lack of control over re-tweets etc…
 Litigation with competitors
 Loss of control of messaging and brand image
 Costs associated with monitoring and other
regulatory issues
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DTC Ads Via Social Media – Risks and Benefits
 Potential benefits of advertising on social
media:





Statistics about social media’s effect on
buying/decision making
Increase market share?
Reminder ads are not as impactful as product
claim ads
Sheer increase in the number of your potential
audience
Less expensive than traditional DTC ads
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New Preemption Implications
Impact of Preemption Decisions and the FDA’s
2013 Proposal
Wyeth v. Levine, 555 U.S. 555 (2009)
A state-law failure to warn tort action against a
brand name drug manufacturer is not preempted.
PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011)
FDA’s regulations preventing generic drug
manufacturers from changing their labeling except to
mirror the label of the brand-name manufacturer preempt
state-law failure-to-warn claims against generic drug
manufacturers because it is impossible for generic drug
manufacturers to comply with both federal and state duties
to warn.
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Impact of Preemption Decisions and the FDA’s
2013 Proposal
Mutual Pharm. Co., Inc. v. Barlett, 133 S. Ct. 2466
(2013)
State-law design defect claims that turn on the
adequacy of a drug’s warnings are preempted by the
FDC Act and under Mensing.
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Impact of Preemption Decisions and the FDA’s
2013 Proposal
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Impact of Preemption Decisions and the FDA’s
2013 Proposal
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FDA’s Proposal – The Aftermath
FDA’s proposal spawned numerous comments and
criticisms:
 Several Republican members of Congress expressed “grave
concerns” in a letter to FDA Commissioner Hamburg, M.D.:
 Proposal conflicts directly with the statute
 Thwarts the law’s purpose and objectives
 Imposes significant costs on the drug industry and
consumers
 Generic Pharmaceutical Association’s concerns:
 The proposal is unjustified and unwarranted
 The proposal, if allowed, would result in an estimated
$4 billion in U.S. health care costs annually
 Unintended consequences affecting patient’s access to
drug therapies
FDA’s response to the criticism
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FDA’s Proposal – The Aftermath
Views of the supporters of the proposal:
 Will allow the public to be informed as soon as
possible when new safety information becomes
available
 Assure labeling for a prescription drug remains
up-to-date when the branded drug is no longer
being marketed
 Helps incentivize generic drug manufacturers
concerns about tort liability
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The Dolin Decision
Can a brand manufacturer be held liable to a
plaintiff for injuries and/or death allegedly caused by
ingestion of a drug manufactured and sold by a
generic company. Yes.
Dolin v. Smithkline Beecham Corp., 2013 U.S. Dist.
LEXIS 3211 | 2013 WL 120279




Patient only ingested generic version
Negligence causes of action allowed to stand
Causes of action that could not stand
Court’s reasoning
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Impact on the Generic and Brand Industry
 Safety department’s evolving role
 Monitoring adverse events of other companies
 Management of new labeling issues
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Proposed Regulation of Software Used in Healthcare IT
Congressional Mandate to FDA
Explosion of Health IT
 Lack of coherent FDA regulatory framework 
uncertainty in industry (interferes with innovation)
Food and Drug Administration Safety and Innovation Act
(FDASIA) of 2012

Required FDA to develop and post on its website a
proposed strategy and recommendations on:
 An appropriate, risk-based regulatory framework
for healthcare information technology that:



Promotes innovation
Protects patient safety, and
Avoids regulatory duplication
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Congressional Mandate - FDASIA
FDA required to develop strategy and
recommendations with federal partners:
 Office of the National Coordinator for Health
Information Technology (ONC)
 Federal Communications Commission (FCC)
April 2014 – FDASIA Health IT Report
 “Proposed Strategy and Recommendations
for a Risk-Based Framework”
 Authored by FDA, ONC and FCC
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April 2014 – FDASIA Health IT Report
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FDASIA Health IT Report – April 2014
Three Categories of Health IT Functionality
1. Administrative Health IT

Billing, claims processing, scheduling, etc.
2. Health Management Health IT

Health information and data management, data
capture and encounter documentation, electronic
access to clinical results, most clinical decision
support software
3. Health IT with Medical Device Functionality

An instrument, apparatus, implement, machine …
including any component, part, or accessory, which is
… intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation, treatment,
or prevention of disease”
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FDASIA Health IT Report – April 2014
Health IT with Medical Device Functionality
 Current focus of FDA oversight
 Regulate under FDA’s current regulatory
framework for medical devices
 If Health IT meets statutory definition of a
“medical device,” then subject to FDA
oversight
 No need for new statutory category or
regulations – can regulated under existing
medical device framework
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FDASIA Health IT Report – April 2014
Principles for Regulatory Framework
 Narrowly tailored approach to FDA regulation of
Health IT

Recognizes limited FDA resources
 Oversight driven by patient risk
 Employ a risk-based approach to appropriately
mitigate patient safety risks while avoiding
unnecessary regulatory oversight

Medical devices: Class I, II, III
 Leverage industry standards and best practices
 Facilitate innovation
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September 2013 Notice of Draft Guidance
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What’s New? FDA Regulation of Healthcare IT
Mobile Medical Applications – DRAFT
Guidance (6/25/13)
 “Mobile application”
 Software that runs on a mobile platform, or
 Web-based software executed on a server
but tailored to a mobile platform
 FDA will focus regulatory oversight on mobile
medical apps that
 are “medical devices” and
 could pose risk to patient safety if the mobile
app did not function as intended
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FDA Regulation of Medical Devices
 Class I devices: General Controls
 Establishment registration and medical device
listing
 Quality System (QS) regulation
 Labeling requirements
 Medical Device Reporting
 Premarket notification - 510(k) (unless exempt)
 Reporting Corrections and Removals
 Class II devices: General Controls + Special Controls
+ (usually) Premarket Notification (510(k))
 Class III devices: General Controls + Premarket
Approval (PMA)
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FDA Regulation of Mobile Medical Apps
FDA intends to exercise enforcement discretion
on low risk software intended to:

Help patients 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

Enable patients or providers to interact with Personal
Health Record (PHR) or Electronic Health Record
(EHR) systems.
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FDA Regulation of Mobile Medical Apps
Examples of apps for which FDA intends to exercise
Enforcement Discretion



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Allow asthmatics to track inhaler usage, asthma attacks,
location of user at the time of an attack, or environmental
triggers of attacks
Provide periodic educational information, reminders, or
motivational guidance to smokers trying to quit, patients
recovering from addiction, or pregnant women
Enable a patient or caregiver to create and send an alert or
general emergency notification to first responders
Allow a user to collect (electronically or manually entered)
blood pressure data and share this data through e-mail,
track and trend it, or upload it to a personal or electronic
health record
Allow user to log, record, track, evaluate, or make decisions
or behavioral suggestions related to developing or
maintaining general fitness, health or wellness
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FDA Regulation of Mobile Medical Apps
FDA will enforce compliance on mobile medical apps that:
 Connect to one or more medical devices for the
purpose of controlling the device(s) or
displaying, storing, analyzing, or transmitting
patient-specific medical device data
 Transform the mobile platform (hand held) into a
regulated medical device by using attachments,
display screens, or sensors or by including
functionalities similar to those of currently
regulated medical devices

Perform patient-specific analysis and providing
patient-specific diagnosis, or treatment
recommendations
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Examples of Mobile Medical Apps That Must
Meet Regulatory Requirements
Mobile medical apps that connect to existing
medical devices to control the device(s) or display,
store, analyze, or transmit patient-specific, including
apps that:
 alter the function/settings of an infusion pump

control or change settings of an implantable
neuromuscular stimulator

calibrate, control, or change settings of a
cochlear implant

act as wireless remote controls or
synchronization devices for computed
tomography (CT) or X-Ray machines
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Examples of Mobile Medical Apps That Must
Meet Regulatory Requirements
Mobile medical apps that transform a mobile
platform into a medical device, including apps that:



use a sensor or lead connected to a mobile
platform to measure and display the electrical
signal produced by the heart (electrocardiograph
or ECG) or blood glucose levels
use tools within the mobile platform (e.g., speaker)
to produce controlled levels of test tones and
signals intended for use in conducting diagnostic
hearing evaluations
use an attachment to the mobile platform (e.g.,
light source, laser) to treat acne, reduce wrinkles,
or remove hair
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Examples of Mobile Medical Apps That Must
Meet Regulatory Requirements
Mobile medical apps that perform patient-specific
analysis and providing patient-specific diagnosis, or
treatment recommendations, including apps that:



connect to a nursing central station and display
medical device data to a physician’s mobile platform
for review (e.g., a medical device data system)
connect to a perinatal monitoring system and
transfer uterine contraction and fetal heart rate data
to another display to allow for remote monitoring of
labor progress
connect to bedside (or cardiac) monitors and
transfer the data to a central viewing station for
display and active patient monitoring
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June 2014 – FDA Expands Enforcement
Discretion of Health IT
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June 2014 DRAFT Guidance
FDA expanded scope of Health IT devices
subject to FDA’s enforcement discretion
 Three categories of medical devices
 Medical device data systems (MDDS) [21
CFR 880.6310]
 Medical image storage device [21 CFR
892.2010]
 Medical image communications device [21
CFR 892.2020]
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Medical Image Devices
Medical image storage device
 Provides electronic storage and retrieval
functions for medical images
Medical image communications device
 Provides electronic transfer of medical image
data between medical devices
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Medical Device Data Systems (MDDS)
MDDS are:
 Hardware or software products
 That transfer, store, convert formats, and
display medical device data
 Do not modify the data
 Do not control the functions or parameters of
any connected medical device
 Are not intended to be used in connection with
active patient monitoring
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Medical Device Data Systems (MDDS)
 February 2011 – FDA down-classified from
class III (PMA) to class I (general controls)
 June 2014 – FDA does not intend to enforce
any regulatory requirements


“This means that for [these] devices …, the
FDA does not intend to enforce compliance
with the regulatory controls, including
registration and listing, premarket review,
postmarket reporting and quality system
regulation for manufacturers of these types of
devices.”
Applies also to mobile medical apps that are
MDDS
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FDA Regulation of Health IT – Practice Tips



Know whether your software is/is not a medical device

Subject to FDA’s enforcement discretion?

Subject to FDA’s medical device requirements?
Set limits on functionality

Even class I medical devices require more time
and $$ to develop

Monitor upgrades & improvements
Ensure marketing claims/strategy are consistent with
intended regulatory category


Monitor ‘claims creep’
Watch for FDA to finalize guidances
 FDA is regulating by guidances, not formal
rulemaking
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Proposed Regulation of Laboratory Developed Tests
Proposed Regulation of Laboratory Developed
Tests (LDTs)
What is an LDT?
 An in vitro diagnostic (IVD) that is intended for
clinical use and designed, manufactured and
used within a single laboratory

Made and used by the same lab

Device is not sold; test results are sold
 Also known as “home brew” assays or devices
 IVDs are included in the FDA definition of
medical device
 FDA has exercised enforcement discretion for
LDTs since 1976
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Proposed Regulation of LDTs


LDTs have been regulated by CLIA since 1988
 CLIA requirements focus on testing process –
ability to perform test in an accurate and
reliable manner
FDA has been asserting the need for more FDA
regulation of LDTs for several years

LDTs have evolved from “traditional” LDTs
 Typically manufactured in small volumes by
local labs
 Used commercially available components,
legally marketed for clinical use
 Were interpreted by physicians and
pathologists at treating facility
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Proposed Regulation of LDTs
Modern LDTs are:
 manufactured with components that are not legally
marketed for clinical use and/or not made by the
testing lab
 offered beyond local populations and manufactured
in high volume



used widely to screen for common diseases rather
than rare diseases
used to direct critical treatment decisions (e.g.,
prediction of drug response)
highly complex (e.g., automated interpretation, multisignal devices, use of non-transparent algorithms
and/or complex software to generate device results)
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October 3, 2014
FDA Proposed Regulation of LDTs
2 Draft Guidances
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LDT Framework Guidance
Rationale for FDA regulation of LDTs
 FDA regulation of safety and efficacy needed to fill
gaps in CLIA oversight

Clinical validity
 Accuracy of test to measure or detect the
clinical condition for which it is intended

Analytical validity
 Analytical specificity and sensitivity,
accuracy and precision
 Not evaluated by CLIA before test is used

Post-market surveillance
 Adverse event reporting
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LDT Framework Guidance – Proposed
Regulation
 Continued full enforcement discretion
 LDTs for forensic use
 LDTs used in CLIA-certified, highcomplexity histocompatibility laboratories
for organ, stem cell, and tissue
transplantation
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LDT Framework Guidance – Proposed
Regulation

Partial enforcement discretion
 Regulatory requirements



Yes - General controls, registration &
listing, AE reporting
No - premarket review, QS
Applies to:
 Low-risk (class I) LDTs
 LDTs for rare diseases
 “Traditional” LDTs
 LDTs for Unmet Needs” when no FDAapproved or cleared equivalent device is
available
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LDT Framework Guidance – Proposed
Regulation
 No enforcement discretion
 Requirements: premarket review, QS,
registration & listing, AE reporting
 Moderate risk (class II) LDTs
 510(k)

FDA aims to use third party review for
premarket review
 High risk (class III) LDTs

PMA

FDA will do premarket review
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LDT Framework Guidance – Proposed
Regulation
Classification of LDTs
 Risk based
 FDA will use expert advisory panels
 Factors (not exclusive list)
 Level of risk of disease/condition or patient
population
 Screening or diagnosis use
 Nature of the clinical decision based on the test result
 Other data available to MD (in addition to the LDT
result),
 Potential consequences/impact of erroneous results
 FDA will issue draft guidance within 18 months of finalizing
Framework Guidance
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LDT Framework Guidance – Timelines
Requirement
Registration &
Listing
Premarket
Review
Class
After Final Guidance
All
6 months
(except
exempt)
III
Begin - 12 months
Complete - within 5 years
II
Begin – 5 years (after
completion of class III reviews)
Complete - within 9 years
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LDT Notification Guidance
Notification to FDA

Who: manufacturer of any LDT – no exceptions

What: must notify FDA and provide basic information
about LDT
 Data will be used to classify LDTs
 Will be made publically available on FDA
website
 Enforcement discretion depends on notification

When:
 Within 6 months of final Framework Guidance
 Prior to significant changes to notified LDTs
How: FDA website

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Proposed Regulation of LDTs – Practice Tips


Increased FDA regulation of LDTs is coming
Question is when and how much



Comment period on draft guidances ends
1/30/15
Will take FDA time to review and address
comments
In 2015, prepare for:
 Notification to FDA
 Registration and listing (unless exempt)


Look for draft classification guidance
In 2016, prepare for:
 Premarket review of prioritized class III LDTs
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Questions?
Ellen L. Darling
Carol Pratt
Orange County Office
Portland Office
+1.949.623.3540
+1.503.226.5762
[email protected]
[email protected]
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