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![Non-mandatory eCTD
Submissions
‣ It will be permissible to continue these
submissions in paper, even after the
guidance is finalized
‣ FDA “strongly encourage[s]” companies to
adopt eCTD even for these submissions
27](https://image.slidesharecdn.com/phillycookeectdforad-promosubmissions-151122145413-lva1-app6891/75/PhillyCooke-eCTD-Submissions-for-Ad-Promo-27-2048.jpg)
![Subpart H (& E) Approvals
“FDA may grant marketing approval for a new drug [or biological]
product on the basis of adequate and well-controlled trials
establishing that the drug [or biological] product has an effect on a
surrogate endpoint that is reasonably likely, based on
epidemiologic, therapeutic, pathophysiologic, or other evidence, to
predict clinical benefit or on the basis of an effect on a clinical
endpoint other than survival or irreversible morbidity.”
– Guidance for Industry Fast Track Drug Development Programs –
Designation, Development, and Application Review, FDA 2006, page 3
“The [subpart H or E approval] does not apply to a product alone,
but applies to a combination of the product and specific indication
for which it is being studied.”
– Guidance for Industry Fast Track Drug Development Programs –
Designation, Development, and Application Review, FDA 2006, page 3
32](https://image.slidesharecdn.com/phillycookeectdforad-promosubmissions-151122145413-lva1-app6891/75/PhillyCooke-eCTD-Submissions-for-Ad-Promo-32-2048.jpg)
Uploaded byDale Cooke
PhillyCooke eCTD Submissions for Ad-Promo
The document presents a detailed guide on the electronic submission of advertising and promotional materials for FDA-regulated products, emphasizing the transition to the eCTD format as mandated by the FDA. It outlines the requirements for mandatory and non-mandatory submissions, including guidelines for promotional materials, and highlights the importance of compliance with updated regulations. Additionally, it provides tips for organizations to improve their submission processes and prepare for future regulatory changes.
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PhillyCooke eCTD Submissions for Ad-Promo
- 1. Getting Ad-Promo on Board the eCTD Train Presented by: Dale Cooke PhillyCooke Consulting DCooke@PhillyCooke.com 19 November 2015
- 2. Disclosure: PhillyCooke Consultingis not a law firm, and nothing provided in this presentation should be construed as offering legal advice. Specific details of each company’s promotional efforts might require adjustments of the information provided in this presentation.
- 3. PhillyCooke Consulting helpscompanies communicate about FDA-regulated products using 21st century tools, while remaining compliant with regulations written in the 1960s. PhillyCooke Consulting services focus on 1. Review & Approval Process Improvement 2. Training 3. Promotional Review of Tactics 4. Policy Development 5. Agency Submission Preparation
- 4. Topics 1.Background 2.Guidance Requirements 3.Launch Submissions 4.PaperSubmissions 5.Material Types 6.Tips from FDA 7.Next Steps 4
- 5.
- 6. Move to ElectronicSubmissions ‣ As part of FDASIA, Congress authorized FDA to mandate that certain submissions to FDA be electronic, such as • NDAs • INDs • BLAs • ANDAs ‣ FDA has been releasing multiple guidances about different types of submissions 6 Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM333969.pdf
- 7. The CTD ofeCTD 7
- 8. eCTD Format ‣ AnXML file structure for submissions to regulatory authorities* ‣ Establishes a common table of contents for information ‣ Module 1 (of 5) is used as a catch-all ‣ Promotional submissions use Module 1 8 *For more on eCTD, see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm
- 9.
- 10. Submitting Ad/Promo Materials ‣CBER/APLB has been accepting electronic submissions via portal for years ‣ CDER/OPDP now accepts electronic submissions via portal, as of June 15, 2015 • Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs • Must use version 3.3 or higher of eCTD 10 OPDP Link: http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm090181.htm CBER/APLB Link: http://www.fda.gov/BiologicsBloodVaccines/Development ApprovalProcess/AdvertisingLabelingPromotionalMaterials/ucm118171.htm
- 11.
- 12. A Guidance LikeFew Others “FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this guidance because it is not an accurate description of all of the effects of this guidance. This guidance contains both binding and nonbinding provisions. Insofar as this guidance specifies the format for electronic submissions pursuant to section 745A(a) of the FD&C Act, it will have binding effect.” —page 3 12
- 13. Guidance Scope The guidancecovers ALL submissions of promotional materials to OPDP & APLB* Two types of submissions 1. Mandatory (final samples, subpart H & E) 2. Non-mandatory (DTC TV (for now), advisory comment, etc.) 13 * CDRH & CVM are not covered by this guidance. CDRH does not require promotional materials submissions.
- 14. Mandatory Submissions For mandatorysubmissions, some (but not all) aspects of this guidance will become binding two years from the date of issuance of the final version of the guidance Binding aspects ‣ File formats ‣ File nomenclature Non-binding aspects ‣ Particular recommendations about FDA’s preferences 14
- 15. Non-mandatory Submissions ‣ Fornon-mandatory submissions, all parts of this guidance will be non-binding ‣ It is highly recommended that companies adopt these practices ‣ These practices should NEVER be used for competitor promotion complaints 15
- 16. All Promo Submissions Requirements 1.Include NDA, ANDA, or BLA number of product(s) being promoted 2. Specific material type from 2253 list 3. Separate HCP and consumer material submissions 4. Separate different submission types (e.g., final samples vs. advisory comments) 5. Submit ads and promo labeling separately from other submissions (e.g., NDAs, postmarketing reports) 16
- 17. Mandatory Submissions All submissionsmandated by 505(b), (i), or (j) of FDCA & 351(a) or (k) of PHS 1. Final samples (2253 submissions) 2. Subpart H (& E) preapproval submissions 3. Subpart H (& E) 30-day submissions 17
- 18. Overview of 1.15Organization 18
- 19. OPDP vs. APLBDiscrepancies ‣ Because APLB has been accepting gateway submissions for years, can use older versions of eCTD ‣ Both OPDP & APLB can accept version 3.3 or higher of us-regional-backbone file ‣ For OPDP, Form 2253 ONLY accompanies final samples ‣ For APLB, Form 2253 accompanies both draft & final samples ‣ Consequently, must fill out box 14 for APLB submissions, but not for OPDP 19
- 20.
- 21.
- 22. Final Samples Suggestion “Firmsare also encouraged to submit annotated versions of the promotional material(s) cross-referenced to the product labeling and references, if applicable.” —Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format— Promotional Labeling and Advertising Materials for Human Prescription Drugs FDA 2015, page 6 22 Though the submission of the 2253 final samples via eCTD is mandatory, this change is not.
- 23. TV Prereview ‣ FDApermitted to mandate 45-day predissemination submission under 503C of FDCA ‣ Not subject to mandatory eCTD submission ‣ 2012 predissemination guidance NOT implemented ‣ 2015 promo submissions guidance directs to that 2012 guidance 23
- 24. Prereview of TelevisionAds ‣ FDAAA authorizes FDA to mandate submission of the FINAL TV spot 45 days prior to use (in addition to 2253 filing) ‣ FDA draft guidance on implementation released • Draft guidance should NOT be followed • Draft did not require ALL TV spots be submitted • Prioritized first TV spots, products with enforcement actions 24 http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm090159.htm
- 25. PhRMA Guidelines onPrereview Although FDAAA 45-day requirement has NOT been implemented, PhRMA Guidelines state: “Principle 8: Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.” Q&A on Principle 8: “…Under Principle 8, while not intending to place additional burdens on FDA, companies commit to submitting new DTC television advertisements to FDA earlier than currently required and a reasonable time in advance of first use to give FDA the opportunity to comment, consistent with its priorities and resources…” 25
- 26. Non-mandatory eCTD Submissions 1. Requestsfor advisory comments a. Launch b. Non-launch 2. Follow-up to advisory comments a. Resubmissions b. General correspondence c. Amendments d. Withdrawal requests e. References (previously missing) 3. Response to FDA action a. Untitled and warning letters b. Requests for information 26
- 27. Non-mandatory eCTD Submissions ‣ Itwill be permissible to continue these submissions in paper, even after the guidance is finalized ‣ FDA “strongly encourage[s]” companies to adopt eCTD even for these submissions 27
- 28. Complaints Do NOT submit complaints about competitor’s promotion via eCTD 28
- 29.
- 30. NDA Filed NDA Accepted Establishes PDUFA Date PDUFA Date 10(or 6) months after NDA acceptance Standard Drug Approval Timeline Day of Approval (DOA) FDA Advisory Comments Submission FDA Advisory Comments Received (~45 days later) Signify Voluntary Events
- 31. FDA Guidance onLaunch Comments Core launch materials defined as 1. One HCP promo (e.g., vis aid) 12 pages or less 2. One HCP advertisement (e.g., journal ad) 4 pages or less (excluding brief summary) 3. One DTC promo (e.g., patient brochure) 12 pages or less 4. One DTC advertisement (e.g., print ad) 4 pages or less (excluding brief summary) 5. HCP and/or DTC website 12 pages or less (each) Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format— Promotional Labeling and Advertising Materials for Human Prescription Drugs FDA 2015, pages 8-9 31
- 32. Subpart H (&E) Approvals “FDA may grant marketing approval for a new drug [or biological] product on the basis of adequate and well-controlled trials establishing that the drug [or biological] product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.” – Guidance for Industry Fast Track Drug Development Programs – Designation, Development, and Application Review, FDA 2006, page 3 “The [subpart H or E approval] does not apply to a product alone, but applies to a combination of the product and specific indication for which it is being studied.” – Guidance for Industry Fast Track Drug Development Programs – Designation, Development, and Application Review, FDA 2006, page 3 32
- 33. NDA Filed NDA Accepted Establishes PDUFA Date PDUFA Date 10(or 6) months after NDA acceptance Subpart H (or E) Drug Approval Timeline Day of Approval (DOA) FDA Advisory Comments Received Signify Voluntary Events FDA Advisory Comments Submission (Mandatory) 90 Days Post Approval (Begin 30-day submissions) Initial 120- Marketing Period Ends Subpart H Restrictions Lifted
- 34.
- 35.
- 36.
- 37.
- 38. eCTD Elements Section VIof guidance provides directions for specific submission eCTD procedures for all submission types, including ‣ File structures • Where to include product label • Where to include the annotated file (when applicable) ‣ File naming conventions ‣ Attributes ‣ How to submit multiple materials together ‣ Leaf titles and how to make them informative for reviewers 38
- 39. Presentation of Materials SectionVII of guidance provides directions and examples for specific types of promotional materials Overarching considerations include ‣ Legibility ‣ Comprehensibility • Annotate as needed to explain what it is, actual sizes, functionality, etc. ‣ Comprehensive • Fully functioning websites requested (“whenever possible”) • All possible permutations and views (e.g., all possible two- page spreads of a three-page brochure) 39
- 40. Special Considerations ‣ Materialsrequiring manipulation ‣ Multi-page spreads ‣ Kits 40
- 41. Electronic Materials ‣ Submissionshould represent “how the promotional piece will look and convey messages to the end user” —page 30 ‣ FDA requests that the materials be fully interactive, just like the original ‣ FDA suggests submitting a video as an alternative 41
- 42.
- 43. eCTD Submissions Happening ‣New M1 was released June 15, 2015 ‣ Some companies have already begun submitting to OPDP in eCTD ‣ At Food & Drug Law Institute Advertising & Promotion conference, FDA presented on lessons learned so far 43
- 44. Tip 1: Useversion 3.3+ of eCTD ‣ OPDP can ONLY accept submissions in version 3.3 or higher ‣ APLB can accept older versions of eCTD ‣ APLB will STOP accepting older versions 24 months after guidance is finalized 44
- 45. Tip 2: Ad-PromoCorrespondence ‣ Do NOT include correspondence related to ad- promo in other sections (e.g., Section 1.2) ‣ Section 1.15.1 is dedicated solely to ad-promo correspondence 45
- 46. Tip 3: UseCorrect Date Format ‣ The date format to be used is yyyymmdd (four- digit year, two-digit month, and two-digit day) E.g., 20151119 46
- 47. Tip 4: AnnotatedVersions Optional ‣ For final sample submissions, annotated versions are helpful, but not required ‣ Required elements for final samples • Clean version (Section 1.15.2.1.1) • Current label (Section 1.14.6) • Completed Form 2253 (Section 1.1) For multiple products, include leaf with Form 2253 47
- 48. Tip 5: HandlingJV Relationships When there is a joint venture partnership, license holder should send general correspondence explaining the partnership ‣ Subsequent submissions should note that partnership (e.g., in comments on Form 2253) ‣ Both companies should use the same version of eCTD ‣ Coordinate numbering sequencing among the companies to avoid duplicate submissions 48
- 49. Tip 6: UseCorrect 2253 Version ‣ Use of older versions of Form 2253 can delay processing ‣ Current version of Form 2253 always available from FDA forms website: http://www.fda.gov/AboutFDA/ ReportsManualsForms/Forms/default.htm 49
- 50.
- 51. Timeline Guidance is draft Commentperiod closed July 21, 2015 ‣ Comments can always be submitted on any guidance (draft or final), but comments received prior to close of comment period are guaranteed to be considered in subsequent versions of guidance ‣ Six comments were filed and can be viewed at: http://www.regulations.gov/#! docketBrowser;rpp=25;po=0;dct=PS;D=FDA-2015- D-1163;refD=FDA-2015-D-1163-0001 Two years (24 months) from issuance of final guidance, SOME aspects of this guidance will be mandatory 51
- 52. In the Meantime… ‣Review your existing submissions standards against the standards proposed in the guidance ‣ Determine the feasibility of adopting FDA’s recommendations ‣ Talk with vendors (e.g., review systems) and internal operations about adopting eCTD ‣ Develop and implement transitional measures (e.g., adopting file naming conventions) ‣ File comments with FDA ‣ Train marketing ops personnel on eCTD 52
- 53. Questions? Dale Cooke PhillyCooke Consulting DCooke@PhillyCooke.com @PhillyCookeon Twitter PhillyCooke.com www.Scribd.com/Dale_Cooke www.slideshare.net/PhillyCooke 53
- 54. Speaker Bio: DaleCooke Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and training to companies about developing compliant promotional materials for FDA-regulated products. Dale has worked with more than 30 pharmaceutical and medical device clients around the world. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the University of California San Francisco’s American Course in Drug Development and Regulatory Sciences program. Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of FDLI’s primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and life sciences use of social media. Previously, Dale served as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare Communications Group. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall University’s School of Law. 54