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FDA Regulation of Promotion & Advertising-- Part 6A: Draft Guidance on Medical Product Communications Consistent with Labeling


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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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FDA Regulation of Promotion & Advertising-- Part 6A: Draft Guidance on Medical Product Communications Consistent with Labeling

  1. 1. ©2010 Copyright © 2015 ComplianceOnline This training session is sponsored by 1 FDA Regulation of Promotion & Advertising Part 6A: Draft Guidance on Medical Product Communications Consistent with Labeling • Michael A. Swit, Esq.
  2. 2. ©2017 Copyright  Medical Products Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers [Hot Link] – Draft Guidance, January 2017  Purpose – to state how FDA evaluates “medical product” communications that present information not contained in the FDA-required labeling to determine if that info is consistent with the required labeling Medical Products Communications – Draft Guidance -- Q&A 2
  3. 3. ©2017 Copyright  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 3
  4. 4. ©2017 Copyright  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 4
  5. 5. ©2017 Copyright  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 5
  6. 6. ©2017 Copyright  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 6
  7. 7. ©2017 Copyright  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 7
  8. 8. ©2017 Copyright  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 … 8
  9. 9. ©2017 Copyright  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 9
  10. 10. ©2017 Copyright  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 … 10
  11. 11. ©2015 Copyright End of Part 6A 11
  12. 12. ©2017 Copyright Questions?  Call or e-mail: Michael A. Swit, Esq. LAW OFFICES OF MICHAEL A. SWIT San Diego, California m: 760-815-4762 e: web:  Follow me on: – LinkedIn: – Twitter:
  13. 13. ©2017 Copyright 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, 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.