Operationalizing FDA s New Consistent Communications Guidance Document

Transcription

1 Operationalizing FDA s New Consistent Communications Guidance Document FDLI Advertising & Promotion Conference 2017 Lisa Dwyer, King & Spalding Joshua Eizen, Actelion Pharmaceuticals Sheetal Patel, Johnson & Johnson Eric Rogers, Alcon Laboratories, Inc.

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenters and should not be attributed to their respective companies

3 Kefauver-Harris Amendments of 1962 Setting the Stage Effectively required S/E for each new intended use prior to marketing Intended Use Regulation (Feb. 1976) Speech/circumstances of persons responsible for the labeling of the article may be evidence of intended use Virginia State Bd. of Pharmacy v. Virginia Cit. Cons. Council (May 1976) Commercial speech not wholly outside of the First Amendment Statutory ban on advertising prescription drug prices violated First Amendment Ban not justified based on maintaining the professionalism of pharmacists 3

4 Considering the First Amendment WLF Guidance: Industry- Supported Scientific and Educational Activities Guidance: Good Reprint Practices Citizen Petition Guidance: Unsolicited Requests Notice: Scientific Exchange United States v. Caronia Citizen Petition

5 Considering the First Amendment Revised Draft Guidance: Reprints Granted Citizen Petitions Amarin v. FDA Pacira v. FDA U.S. v. Vascular Solutions U.S. v. Facteau/ Fabian Public Hearing & New Docket Memorandum Draft Guidance: Consistent Communications Draft Guidance: Communications with Payors 5

6 Consistent Communications Guidance Forgotten question: What is off-label speech? Guidance responds to industry interest in promoting information about the approved/cleared uses of products that is not contained in the products FDA-required labeling 6

7 Consistent Communications Guidance

8 Consistent Communications Guidance Describes how FDA intends to treat information, including promotional claims, that: is not contained in FDA-required labeling, but is consistent with FDA-required labeling Information will not alone be considered evidence of a new intended use 8

9 Conceptual Categories of Claims On-label Off-label Out-of-label Information expressly contained in FDA-required labeling Information that could trigger the need for a supplemental marketing application (or adequate labeling ) All other information about a medical product 9

10 The Three-Factor Test How does the out of label information compare to the FDArequired labeling? Indication Patient Population Limitations and Directions for Handling/Use Dosing/Administration Does the out of label information increase health risks relative to information in the FDA-required labeling? Does the FDA-required labeling enable the product to be used s/e under conditions suggested by the information? 10

11 Examples Consistent Communications Comparisons Information based on a comparison of the safety or efficacy of a medical product for its approved or cleared indication to another medical product s same approved or cleared indication Adverse Reactions Onset of Action Long-term safety and/or efficacy data Specific Patient Subgroups Patient-reported Effects Product Convenience Mechanism of Action 11

12 Substantiation: Evidentiary Standard Less than substantial evidence Scientifically appropriate and statistically sound Must be truthful and not misleading 12

13 CC Guidance: Effect on Devices? What is the impact of the guidance on devices? Does it change marketing strategies? Does it change submission strategies? What lessons learned by the device industry (e.g., navigating uncertainty) may be helpful to pharma? What are some examples where there is still uncertainty? 13

14 Does it CC Guidance: Opportunities change current promotional practices? evolve review processes, training and/or approach on overall execution? expand subject matter expertise involvement? evolve current internal policies and procedures? change designs of studies or target product profiles? 14

15 CC Guidance: Risks What are the risks here? How do we mitigate them? 15

16 Mitigate Risks for Consistent Communications 1. Ensure uniform internal review Standardize an analytical framework to review consistent communications 2. Appoint qualified decision-makers Select experienced employees with decision-making authority to approve consistent communications 16

17 Mitigate Risks for Consistent Communications 3. Utilize outside experts (scientific, regulatory, legal) to help evaluate consistent communications Risk-benefit profile of a product Context Truthful and not misleading 4. Document review and approval processes for consistent communications Flow through standard promotional review processes 17

18 What Will FDA Do Next? Informed speculation (finalization/revision) Eric Sheetal Josh Lisa 18

19 F O O D AND D R U G LAW I N S T I T U T E QUESTIONS?