November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.

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This training session is sponsored by
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FDA Regulation of Promotion & Advertising
Part 6A: Draft Guidance on Medical Product
Communications Consistent with Labeling
• Michael A. Swit, Esq.

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 Medical Products Communications That Are
Consistent with the FDA-Required Labeling –
Questions and Answers [Hot Link]
– Draft Guidance, January 2017
 Purpose – to state how FDA evaluates “medical
product” communications that present information
not contained in the FDA-required labeling to
determine if that info is consistent with the required
labeling
Medical Products Communications –
Draft Guidance -- Q&A
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 Medical Products covered by DG
– Drugs
– Biologics
– Medical Devices
– Animal Drugs
 FDA Labeling
– Approved or cleared labeling
– Exempt products – that which is relied upon to provide
adequate directions for use and other required information
 Bottom line – if your communications are
consistent with the labeling, fact that not in the
labeling “not alone considered evidence of a new
intended use”
Basics
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 1. How Information Compares to Labeling; if answer
“yes” to any of these questions, NOT consistent:
– Indication – Do statements in the communication relate to a
different indication than the one(s) reflected in labeling?
– Patient Population – Are patient population statements in the
communication outside the approved/cleared patient population
in the labeling?
– Limitations and Directions for Handling/Use – Do
statements conflict with use limitations, or directions for
handling, preparing, and/or using the product, in the labeling?
– Dosing/Administration – Do representations/suggestions
about the product conflict with the recommended dosage or use
regimen, route of administration, or strength(s) (if applicable) in
labeling?
3 Factors FDA Uses To Decide if Consistent
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 2. Whether statements in the communication increase
potential for harm to health relative to FDA labeling –
– If a communication alters the benefit-risk profile of a product in
a way that may result in increased harm to health, the
communication is not consistent with the FDA-required labeling.
– Example:
• If a firm’s communication claims that its drug has superior effectiveness
compared to another drug, but its drug is reserved for third-line use due to
severe risks associated with its use while the comparator drug is approved
for first-line use as a result of its more favorable overall benefit-risk
profile, such a communication has the potential to increase harm to the
health of patients by suggesting use in a broader patient population (e.g.,
all patients with the disease/condition instead of just patients for whom
first- and second-line therapies are not suitable) than the drug’s benefit-risk
profile justifies.
3 Factors FDA Uses To Decide if Consistent
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 3. Whether the directions for use in the FDA-required
labeling enable the product to be safely and effectively used
under the conditions represented/suggested in the
communication —
 If the answer to #3 is “no,” the communication is not
consistent with the FDA-required labeling.
– Note: no examples given in the DG
 If you are consistent, the DG also says that FDA will not
regard the fact that the labeling does not match the
approved labeling as evidence of the lack of adequate
directions for use
 Devil is in the details – analyses are very fact-specific
3 Factors FDA Uses To Decide if Consistent
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 Comparisons of safety or efficacy of a product for
its labeled use vs. another product with same labeled
use. For example, from a head-to-head study.
 Information that provide additional context about
adverse reactions.
– Example – nausea is a labeled adverse reaction.
Communication informs how taking product with food might
reduce nausea
 Information about long-term safety or efficacy of
products with chronic use labeling
– Example – firm provides postmarketing info showing 18
months efficacy when approval was based on 24 weeks.
Examples of Communications Consistent
with Labeling
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 Info on patient subgroups that are consistent with
the overall patient population in labeling
– Example – info provided on number of women studied in the
pivotal clinical studies and the treatment effects in women
 Patient-reported outcomes from the labeled uses
– Example – report on patients’ perceptions of product’s impact
(while used for labeled indication) on their daily activities
 Information on additional context about the
mechanism of action
– Example – labeling states product works by binding on a
receptor and the information provides info on why the product
selects for that receptor
Examples of Communications Consistent
with Labeling …
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 Information about use of a product to treat/diagnose
a disease not in labeling
– Yes, that is an example …
 Information for use in patients not covered by
labeling
– Example – animal drug is OK’d for feedlot cattle; information
discusses use in dairy cattle
 Information for use in a different stage, severity, or
manifestation of disease than in labeling
– Example – drug for mild asthma; communication if about severe
asthma
Inconsistent Communications Examples
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 Information about use as monotherapy when product
approved only in conjunction with another product
 Information about different route of administration
 Information about different dosage, strength, or use
regimen
– Example: labeling is for B.I.D. dosing; communication covers
once a day
 Information about different dosage form
– Example – drug is capsule; communication is about an oral
solution.
Inconsistent Communications Examples …
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End of Part 6A
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Questions?
 Call or e-mail:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
 Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel

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About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues
since 1984. Before returning to his private law practice in late 2017, he served for 3
years at Illumina, Inc. as Senior Director, Legal, Regulatory. Prior to that, Swit was a
special counsel at the global law firm of Duane Morris LLP in its San Diego
office. Before joining Duane Morris in March 2012, Swit served for seven years as a
vice president at The Weinberg Group Inc., a preeminent scientific and regulatory
consulting firm in the Life Sciences. His expertise includes product development,
compliance and enforcement, recalls and crisis management, submissions and
related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for all types of life sciences companies, with a particular emphasis
on drugs, biologics and therapeutic biotech products. His FDA legal and regulatory
work also has included tenures in private practice with McKenna & Cuneo and
Heller Ehrman, and as vice president, general counsel and secretary of Par
Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994
to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and
other specialty information products for FDA-regulated firms. He has taught and
written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board.
He earned his A.B., magna cum laude, with high honors in history, at Bowdoin
College, and his law degree at Emory University.