"Scientific Exchange -- New Interpretations??"
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The document is a summary of a web meeting held on July 25, 2018, focused on the topic of scientific exchange and its evolving interpretations, featuring guest presenter Michael A. Swit, Esq. It discusses the FDA's stance on off-label communications, regulatory challenges, and proposed legislative changes aimed at improving the exchange of scientific information while balancing patient safety and public health needs. The document also highlights key quotes from FDA officials and outlines legislative efforts like H.R. 1703 to clarify scientific exchange without it being considered misleading or misbranded.
![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](https://image.slidesharecdn.com/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523/85/Scientific-Exchange-New-Interpretations-6-320.jpg)
![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](https://image.slidesharecdn.com/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523/85/Scientific-Exchange-New-Interpretations-7-320.jpg)
![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](https://image.slidesharecdn.com/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523/85/Scientific-Exchange-New-Interpretations-9-320.jpg)
![“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](https://image.slidesharecdn.com/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523/85/Scientific-Exchange-New-Interpretations-11-320.jpg)
![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](https://image.slidesharecdn.com/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523/85/Scientific-Exchange-New-Interpretations-25-320.jpg)
"Scientific Exchange -- New Interpretations??"
- 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
- 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