Presentation to the DIA Regulatory Affairs Community AdPromo Working Group webinar on July 25, 2018 on FDA's Regulation of Scientific Exchange

1. Web Meeting
July 25, 2018
Your WG Co-Chairs: Kimberly Belsky (Mallinckrodt) and Dolores Shank-Samiec (Merck)
DIA Regulatory Affairs Community
AdPromo Working Group
“Scientific Exchange – New Interpretations??”
Guest Presenter Michael A. Swit, Esq.

2. Disclaimer
Page 2
The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and should not be
attributed to DIA, its directors, officers, employees, volunteers,
members, chapters, councils, Communities or affiliates, or any
organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the
individual presenter and are protected under the copyright laws of
the United States of America and other countries. Used by
permission. All rights reserved. DIA and the DIA logo are
registered trademarks or trademarks of Drug Information
Association Inc. All other trademarks are the property of their
respective owners.

3. Standard Disclaimers
Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
This presentation supports an oral briefing and should
not be relied upon solely on its own to support any
conclusion of law or fact.
These slides are intended to provide general
educational information and are not intended to
convey legal advice.
Page 3

4. A Glimpse at my last slide …
FDA and its views on scientific exchange have not
changed markedly in the past 20 years.
But, need to keep a keen eye on First Amendment
developments to see how they might in the future…so
stay tuned
In the interim, a few thoughts follow on
developments/issues impacting scientific exchange…
Page 4

5. Page 5
What Does Scott* Say?
*Scott Gottlieb, MD, 23rd Commissioner of FDA

6. Scott in 2006 …
“The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just
because the wheels of my government institution and its meticulous work may take longer to turn than
the wheels of clinical science? Some people believe that patients should be treated only according to the
clinical evidence included in a drug's approved indications. Yet this evidence may be two or maybe
three years old, especially in a fast-changing field like cancer, where off label use of medicines
provide important opportunities for patients to get access to the latest clinical practice and for
doctors to tailor their patients' treatment plans based on medical need and personal
preferences.” …
Efforts to limit prescription and scientific exchange to indications only specified on a label
could retard the most important advances in 21'st century medicine. The development and
deployment of drugs is becoming more and more closely linked to understanding of mechanism of
action, which means that physicians can use drugs in more sophisticated ways that cannot all be
anticipated on a label, or easily or quickly studied in prospective studies. Once again, this is
especially true in diseases where the underlying damage results from an often clearly identifiable
molecular mistake, diseases like cancer.
[Emphasis added]
• Remarks by Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, FDA, December 5, 2006, at the
Windhover FDA/CMS Summit
• source: http://wayback.archive-it.org/7993/20170722084218/https://www.fda.gov/NewsEvents/Speeches/ucm051792.htm
Page 6

7. More Scott …
2008
Those who pursue a rigid adherence to restrictions on the exchange of off-label
information, and who fail to recognize that the sharing of scientific evidence can
sometimes have important public health benefits, are guilty of pursuing a rigid
standard that does not take measure of the consequences.”
[Bold in the original]
– http://www.aei.org/publication/from-fda-a-good-framework-for-distributing-
information-on-off-label-uses/print/
2012
“A core principle of America’s constitutional speech protections is that the government
should not establish what is orthodox, especially when it comes to politics, the arts,
religion, and science. The founders recognized that these matters are by their nature
iterative, and that it would be dangerous in a democratic society for the government to
use its resources to pick a side in these debates. Matters that are subject to their own
evolution—a core feature of how new science unfolds—are better addressed by
adding voices to the debate, not suppressing them.”
[Emphasis added.]
https://www.aei.org/publication/the-us-department-of-justices-targeting-of-
medical-speech-and-its-public-health-impacts/
Page 7

8. Page 8
And, what does Becky* say?
*Rebecca K. Wood, Esq., FDA Chief Counsel (resigned in June 2018).

9. Wood at FDLI Annual Conference
“FDA has previously announced a number of anticipated guidance
documents that articulate FDA’s current thinking on manufacturer
communications about their products. There has been great interest, for
example, in the parameters of a firm’s communications about health care
economic information (so-called HCEI) with payors, formulary committees,
and similar entities. What effect does Section 114 of FDAMA, the
amendments under the 21st Century Cures Act, and the overlay of recent
First Amendment jurisprudence have on Section 502(a) of the FD&C Act?
What is FDA’s recommendation about how firms should communicate HCEI
with payors, formulary committees, and the like regarding prescription
drugs—particularly in light of the sophistication and built-in skepticism of
that audience? We anticipate having more to say on this important
matter.” [Final guidances came out last month]
[Emphasis added]
Source: https://www.fda.gov/NewsEvents/Speeches/ucm606622.htm
Page 9

10. Page 10
Intended Use and Off-Label Dissemination

11. “Intended Use” Rule –
Proposed regulation – September 2015 – 80 Fed. Reg.
57756 [Hot Link]
• aimed at tobacco issues
• changes to medical products regulations on “intended uses” deleted
focus on “knowledge” of off-label uses in:
• 21 CFR 201.128
• 21 CFR 801.4
Final regulation – January 9, 2017 – 82 Fed. Reg. 2193
• still primarily aimed at tobacco issues
• implemented changes to 201.128 and 801.4 – adding in a “totality of the
evidence” standard (see slide 19)
• Reaction
• 15 comments on changes to “intended use” rule – many objecting to (a) lack of
notice of “totality” standard and (b) that it was substantively improper
Page 11

12. Changing Intents … Indefinitely Delayed
January 16, 2018 – 83 Fed. Reg. 2092
• Effective date of changes to 201.128 and 801.4 indefinitely delayed
• FDA – substantive concerns of the comments on 2017 Final Rule
included:
• ‘‘totality of the evidence’’ standard
– should be narrowed to only those things that are explicitly stated in
promotions and advertising or other external claims
– Note: FDA – in 2017 final rule had said that, in determining intended
use, it could., under appropriate case law, look to “any relevant source
of evidence” – 82 Fed. Reg. at 2206.
• comments – also included calls to specifically exclude from “evidence”
– scientific exchange
– other truthful, non-misleading info
– reliance on “knowledge” of off-label use
Page 12

13. Changing “intents” …
Page 13

14. Page 14
FDA Memo on First Amendment
January 2017

15. The First Amendment Memo
January 18, 2017 -- Announced at same time as draft guidances on
(a) communications consistent with labeling and (b)
communications with payors
• https://www.regulations.gov/document?D=FDA-2016-N-1149-0040
Key FDA points by FDA
• Off-label promotion is dangerous
• majority of off-label uses lack adequate evidence of effectiveness (M-11)
• risk of adverse events higher in off-label use (M-12)
• Requiring approval supports good promotion
“The requirements of the FDA Authorities, including the evidence generation
requirements and the prohibitions on distributing products for unapproved uses, help
protect the integrity and reliability of the promotional information in the medical
marketplace by helping to ensure that the uses for which medical products are marketed
are ones for which they have been shown to be safe and effective, and that these products
have labeling that provides appropriate directions for these uses. In this way, the FDA
Authorities serve to promote the flow of truthful, non-misleading, and scientifically valid
promotional information.” (M-13-14)
Page 15

16. The First Amendment Memo …
How communications on off-label uses can help the public
health
• supports informed decision making for patient treatment, particularly for
special populations (e.g., pediatric, rare disease, refractory patients)
• advances scientific understanding and research – and may spur research
Balancing FDA’s role and the benefits of off-label
communications:
• “FDA, in implementing the FDA Authorities, has sought to strike a
careful balance, supporting medical decision-making for patients in the
absence of better options, but doing so without undermining the
measures designed to incentivize the development and
approval/clearance of medical products that would reduce the need to
rely on unapproved use, in light of its risks.” (M-20)
Page 16

17. First Amendment Memo …
FDA on scientific exchange:
• “FDA has also described how industry may support scientific or
educational activities (such as Continuing Medical Education
programs) without being subject to FDA regulation.”
• “In addition, it has long been FDA policy not to consider a firm’s
presentation of truthful and non-misleading scientific information
about unapproved uses at medical or scientific conferences to be
evidence of intended use when the presentation is made in non-
promotional settings and not accompanied by promotional
materials.” (M-21)
Page 17

18. Page 18
Lurking Legislation

19. H.R. 1703 – Medical Products
Communications Act of 2017
Sponsor: H. Morgan Griffith (R-Va);
• https://www.congress.gov/bill/115th-congress/house-bill/1703
Intended Uses of Drugs & Devices
• determined by “objective intent” of manufacturer/sponsor or
persons acting on their behalf “as demonstrated by statements
contained in labeling, advertising, or analogous oral statements; and
• NOT determined by:
• actual or constructive knowledge by mfr./sponsor of off-label use ; or by
• “scientific exchange” – as defined in 201A(b) of the Act (as amended by
1703)
Page 19

20. H.R. 1703 – Medical Products
Communications Act of 2017 …
Scientific Exchange – 201A(b)
• (1) shall not constitute labeling, advertising, or evidence of a new
intended use
• (2) Scientific Exchange (“SciEx”) communication must:
• be supported by “scientifically appropriate and statistically sound data,
studies, or analyses”
• bear a “conspicuous and prominent” statement that the product or use has
not been approved or is not in the labeling (e.g., for an OTC monograph
drug or exempt device)
• sponsor makes no claims the product or use has been demonstrated to be
safe or effective
… continued …
Page 20

21. H.R. 1703 – Medical Products
Communications Act of 2017 …
Scientific Exchange – 201A(b)
• (3) – may include:
• dissemination of scientific findings in scientific or lay media;
• publication or results of scientific studies;
• letters to editor in defense of public challenges;
• communications at scientific or medical conferences or meetings;
• dissemination of medical or scientific publications, reference texts, clinical
practice guidelines
• proactive or reactive communication on R&D efforts;
• proactive or reactive communication of scientific, technical, or medical
information by personnel in scientific, medical, or clinical depts. at mfr.
• proactive or reactive communication of health care economic and health
outcomes information to individuals or groups responsible for decisions
related to health resource utilization, including selecting medical products or a
population of patients.
… continued … Page 21

22. H.R. 1703 – Medical Products
Communications Act of 2017 …
Scientific Exchange – 201A(b)
• (4) Rule of Construction – Nothing in this subsection shall be
construed –
• ‘‘(A) to authorize the Secretary to require that a manufacturer or
sponsor submit an application, certification, or other such submission,
or to seek the Secretary’s review or approval, before, during, or
subsequent to engaging in scientific exchange; or
• ‘‘(B) to limit the ability of manufacturers or sponsors to engage in
communications or activities that properly constitute scientific
exchange as that term is described in paragraph (2) but that are not
specified in paragraph (3).’’
Page 22

23. H.R. 2026 – Pharmaceutical Information
Exchange (PIE) Act
Sponsor: Brett Guthrie (R-Ky)
https://www.congress.gov/bill/115th-congress/house-
bill/2026?q=%7B%22search%22%3A%5B%22Hr+2026%22%5D%7D&r=1
Health care economic or scientific information
provided to payor, formulary, or similar entity is not
misbranded or unapproved if:
• based on “competent and reliable scientific information”;
• relates to an investigational drug or investigational use of approved
drug; and
• NDA supplement submitted or studies completed with intent to
submit
Page 23

24. Page 24
Duty to Correct on Social Media – or “Non-
Scientific Exchange”??

25. June 2014 – Draft Guidance: Correcting
Third Party Posts
Internet/Social Media Platforms: Correcting
Independent Third-Party Misinformation About
Prescription Drugs and Medical Devices [Hot Link]
No duty to correct -- if on your SM page. However, DG
applies only to prescription drugs and prescription
medical devices.
• Why? Not articulated
• My guess – the “learned intermediary” due to need for Rx
Page25

26. ➢ UGC = User Generated Content
➢ General rule – not responsible for 3P UGC; but what does this
mean in the DG?
➢ Key policies in the DG
– correcting is voluntary
– if you correct in a truthful and non-misleading way, FDA does not
intend to object if appropriate corrective info does not
otherwise meet regulatory requirements.
6/14 – DG on Correcting 3P SM Misinfo …
Page 26

27. ➢ “Appropriate Corrective” Information
– Be relevant and responsive to the misinformation
– Be limited and tailored to the misinformation
– Be non-promotional in nature, tone, and presentation
– Be accurate
– Be consistent with the FDA-required labeling for the product
– Be supported by sufficient evidence, including substantial
evidence, when appropriate, for prescription drugs
continued …
6/14 – DG on Correcting 3P SM Misinfo …
Page 27

28. ➢ “Appropriate Corrective” Information …
– Either be posted in conjunction with the misinformation in the
same area or forum (if posted directly to the forum by the firm),
or should reference the misinformation and be intended to be
posted in conjunction with the misinformation (if provided to
the forum operator or author)
– Disclose that the person providing the corrective information is
affiliated with the firm that manufactures, packs, or distributes
the product.
➢ FDA required labeling should either be included or provided in a
non-promotional link that goes directly to the labeling
6/14 – DG on Correcting 3P SM Misinfo …
Page 28

29. ➢ Forums
– FDA – don’t have to correct ALL misinformation
• agency recognized that these are very difficult to
monitor
– But, company doing a correction should make clear
what part it is correcting – a “clearly defined portion” –
• should date the correction
• but must correct all misinformation in that “clearly
defined portion”
➢ Don’t have to submit corrections to FDA
6/14 – DG on Correcting 3P SM Misinfo …
Page 29

30. Questions After the Webinar?
➢ Call, e-mail or write:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California 92130
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
Page 30

31. About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30 years. Before
returning to his private law practice in late 2017, he served for 3 years as the chief regulatory counsel at
Illumina, Inc., the world’s leading developer of gene sequencing technologies. Prior to that, Swit was a
special counsel in the FDA Law Practice 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, therapeutic
biotech products, medical devices, and IVDs.
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, where he helped spearhead the company’s emergence from the Generic Drug
Scandal. 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. A member of the
California Bar, Mr. Swit also has been admitted in Virginia and the District of Columbia, but is not currently
active in those jurisdictions.
Page 31