Photomedicine 2021-bashaw-revised-1a (nx power-lite copy)
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Presentation on the FDA Regulatory Landscape on Sunscreens presented at the 30th Annual Meeting of the Photodermatology Society-March 18th, 2021
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Photomedicine 2021-bashaw-revised-1a (nx power-lite copy)
- 1. 30th Annual Meeting of the Photodermatology Society-March 18th, 2021 FDA Regulatory Landscape on Sunscreens E. Dennis Bashaw, PharmD. Senior Science Advisor Office of Clinical Pharmacology Office of Translational Sciences US Food and Drug Administration
- 2. 2 Disclaimer • The presentation today should not be considered, in whole or in part, as statements of policy or recommendation by the US Food and Drug Administration. • Throughout the talk or the discussion/Q&A portion of the program representative examples of commercial products may be given to clarify or illustrate a point. No commercial endorsement is implied or intended.
- 3. 3 OUTLINE • 2020 • Landscape 2020-2021 –Science –Communication/Outreach –Policy/Regulations • Transitioning to the Future
- 4. 4 2020-THE YEAR OF GOOD VISION?
- 6. 6 The Current State of Dermal Absorption Assessment and Sunscreen Patient Factors Characterization Based Approaches Sunscreen Innovation Act Master MUsT Protocol Development Physiologically Based Pharmacokinetic Models
- 7. 7 COVID-19 Effect on FDA • FDA staff left the White Oak Campus on Friday 13th, 2020 – All conference rooms were sanitized and sealed – The buildings have been re-configured to promote social distancing • No date has been established for return to the facilities, although voluntary return to complete work that cannot be conducted at home has been authorized. • FDA has utilized a variety of methods to conduct business including ZOOM, WEBEX, and now deployment of MS-Teams • Resources and personnel have been re-deployed to assist in evaluation and review of COVID related projects on an as needed basis, while continuing to meet established deadlines.
- 8. 8 SCIENCE
- 10. Workshop 1 Materials: https://www.pharmacy.umaryland.edu/centers/cersievents/topical/ Workshop 2 Materials: https://cersi.umd.edu/july2020-topical-drug-development
- 11. 11 Second FDA MUsT on Sunscreen Absorption Published March 2020 “While the prior study was designed to represent maximal usage (ie, application at least every 2 hours), the current study was designed to provide additional data on the systemic exposure of the active ingredients following single application; residual skin amounts during the wash-out phase; plasma concentrations up to 17 days after the last application; and the systemic exposure to additional commonly used sunscreen ingredients, including octinoxate, homosalate, and octisalate. The systemic exposure of all the tested ingredients in all products exceeded 0.5 ng/mL on single application and remained above the threshold until 23 hours after application…” Discussion section of paper
- 12. 12 Representative Single Dose Absorption Data • One of the key findings of this study was that all of the tested sunscreen produced in vivo plasma levels following a single dose (2mg/cm2 applied to 75%BSA) Note: The identities and formulations of the test products are contained in the Supplemental Materials section, supplement 1 pages 39-40
- 13. 13 Advancing the Use/Standardization of In Vitro Permeation Testing (IVPT) • IVPT is a key element in formulation selection but has historically had some issues with acceptance due to issues of reproducibility. • Since the last workshop the FDA has published two articles on the use of IVPT in topical drug development and evaluation, primarily focusing on sunscreens. • The first article was focused as a “best practices strawman” for developing a consistent test that can be of regulatory use. • The second article was focused on the permeation of sunscreen and the data from that article will be discussed by the lead author Dr. Yang.
- 14. 14 In Vitro Permeation Testing (IVPT) https://doi.org/10.1177/2168479019875338 • Topics covered include – System selection • Static vs Flow-Thru – Skin selection for use • Donor • Skin site • Skin Integrity • Thickness • Preparation and storage – Receptor fluid • Temperature • Agitation • Duration – Study Design • Duration • Sampling time intervals • Replicates
- 15. 15 https://doi.org/10.1016/j.jid.2020.04.009 In Vitro Permeation Testing (IVPT)
- 17. 17 External Outreach • Complicated by COVID-19 • In early 2020 a series of talks were given at the New York Society for Cosmetic Chemists meeting at the end of January speakers included: – Myself – Dr. Raney (FDA/OGD) – Dr. Stinchcomb (Univ. of MD) – Dr. Yi (FDA/OCP) • Presentations cancelled (selected) – AAD – The Photodermatology Society Annual Mtg. – 9th International Symposia on Microdialysis
- 18. 18 External Outreach • In 2021 the FDA hopes to again be able to engage with the scientific community in person rather than via webex, zoom, or emails. • For this reason, your feedback about this workshop, its pluses and minuses from an educational and scientific content delivery standpoint is very important.
- 19. 19 FDA Pilot Guidance Snapshot • Explanation of why the guidance document is important • Highlights from the guidance document • Educational background about the guidance topic • Link to the full guidance document • Drug development timeline for when to apply the guidance recommendations • Guidance Recap Podcast that describes highlights and background the guidance document explained directly from the authors • Twitter hashtags to create a platform for discussing views on the guidance • Link to the FDA docket for providing official comments to the Agency (for applicable draft guidances) https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance documents. During the Pilot, Guidance Snapshots will contain a subset of the following key features:
- 20. 20 MUsT Snapshot • In comparison, in the actual Guidance document, the MUsT Study Elements and Consideration section is over 5 pages and has specific verbiage on these elements and how to address them. • The snapshot provides a concise overview of the issues and why it is an element to be evaluated. • Each page of the snapshot also contains the weblink to the actual guidance
- 22. 22 OTC Monograph Reform • On March 27, 2020, the President signed into law H.R. 748, the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) • The CARES Act includes an important legislative initiative that reforms and modernizes the way OTC monograph drugs are regulated in the United States
- 23. 23 https://www.govinfo.gov/content/pkg/BILLS-116hr748enr/pdf/BILLS-116hr748enr.pdf The “CARES ACT” 335 Pages Long OTC Drug Review Pages 155-188
- 24. OTC Monograph Rulemaking Process Under OTC Drug Review Prior to CARES Act
- 25. OTC Monograph Drug Regulation Before and After CARES Act
- 26. 26 What Will Not Be Covered Today • A discussion of the impact of the CARES Act on topical product development for the OTC space is beyond the scope of this workshop. • The FDA Small Business Industry Assistance (SBIA) Program has posted a video overview of the CARES Act as it relates to monograph reform online (6/1/2020): https://www.youtube.com/watch?v=88gZr0RDoww
- 27. Addresses the Sunscreen Innovation Act (SIA)
- 28. 28 TRANSITIONING TO THE FUTURE
- 29. 29 The FDA’s and CDER’s “DUAL” Role FDA Regulations Science Conservative Innovation
- 30. 30 Transitioning to a Post-COVID World • COVID-19 has disrupted the traditional FDA workload and communication strategies – Eliminated the opportunity for face-to-face meetings (internal & external) – Disrupted normal processes and caused the development of new methods and tools – A return to how “things were” is unlikely and the echo of 2020 will reverberate for years to come • The CARES Act contained a re-programming of the OTC review space and has a direct impact on sunscreen evaluation and the SIA • The need for generation of data in the sunscreen absorption space remains and the FDA is looking towards Industry, Academia, and Clinicians to help fill in the gaps
- 31. 31 The Goal Clinical Pharmacology Pharmaco- genomics Biomarkers in drug development Biomarker Qualification Big data Rare diseases IVPT/ IVRT Targeted therapies Open Flow Microperfusion Microdialysis Patient Factors Translational medicine Characterization Based Approaches DPK CARES ACT Sunscreen Innovation Act Master MUsT Protocol Development Biomarker Qualification Collaboration Physiologically Based Pharmacokinetic Models Translational Medicine Science Based Regulatory Policy
- 32. 32 The Goal Clinical Pharmacology Pharmaco- genomics Biomarkers in drug development Biomarker Qualification Big data Rare diseases IVPT/ IVRT Targeted therapies Open Flow Microperfusion Microdialysis Patient Factors Translational medicine Characterization Based Approaches DPK CARES ACT Sunscreen Innovation Act Master MUsT Protocol Development Biomarker Qualification Collaboration Physiologically Based Pharmacokinetic Models Translational Medicine Science Based Regulatory Policy Collaboration is the KEY To success
- 33. 33 Contact Info E. Dennis Bashaw, PharmD. Senior Science Advisor Office of Clinical Pharmacology Office of Translational Sciences US Food and Drug Administration Edward.bashaw@fda.hhs.gov LinkedIn
Notas do Editor
- As previously mentioned, this presentation shouldn’t be considered statements of policy or recommendation by the US FDA.
- On March 27, 2020, the President signed into law H.R. 748, “the Coronavirus Aid, Relief, and Economic Security Act” or the “CARES Act”. The CARES Act includes an important legislative initiative that reforms and modernizes the way OTC monograph drugs are regulated in the United States. For simplicity, we will refer to the regulatory framework under the CARES Act as OTC Monograph Reform, throughout this presentation.
- The rule-making process to develop the OTC monographs was a three-phase public process in which each phase required FDA to publish in the Federal Register. The end result of rulemaking established the requirements for an OTC therapeutic class-otherwise known as the monograph. In the first phase, an advisory panel evaluated the safety and effectiveness of Active Pharmaceutical Ingredients (API) under certain conditions of use in OTC drugs along with their claims. The advisory panel’s conclusions about the safety and effectiveness of the ingredients were then published by the FDA in the form of an Advanced Notice of Proposed Rulemaking (or ANPR) for public comment. The second phase involved FDA reviewing the public comments and any new data that may have become available after the initial review. Then, FDA published a Tentative Final Monograph (or TFM) in a Notice of Proposed Rulemaking which was again open for public comment. In the third and last phase, FDA reviewed the public comments and issued a final OTC drug monograph in the form of a final monograph published in the Code of Federal Regulations. All drugs that were not GRASE and did not fall under a monograph required premarket approval through an NDA
- As we talked about, there were positives with the previous OTC drug review system which will remain as we move to the new process. So what stays the same under OTC Monograph Reform? First, the OTC monograph process will remain an ingredient based review system where active ingredients are grouped by therapeutic category and FDA evaluates active ingredients under specified conditions of use. GRASE determination will remain the same . Drugs complying with their OTC monograph and other applicable requirements may be marketed without FDA approval just as in the past. As in the monograph system pre-CARE, manufacturers may make limited changes to drugs as permitted by the monograph and other applicable requirements, e.g. changes to inactive ingredients Finally, the process under OTC Monograph Reform will remain a Public process, with a Public comment period before a Final order But OTC Monograph Reform also reforms and modernizes the OTC Drug Review. For example, - Rulemaking is changed to an administrative order process. -OTC Monograph Reform puts in place an OTC monograph order request (OMOR) system. -The status of existing monograph drugs is clarified, including not only drugs that were subject to final monographs, but also drugs that were previously subject to TFMs and ANPRs. -A process will be set up for minor changes in dosage form. -OTC Monograph Reform sets out a period of exclusivity for certain monograph drugs. -FDA will receive user fees to fund OTC monograph drug activities. -Finally, industry will be able to have formal development meetings with FDA.
- OTC Monograph Reform includes certain provisions that impact matters addressed previously under the Sunscreen Innovation Act (or SIA) and implements a number of changes to how FDA regulates OTC sunscreen drugs. OTC Monograph Reform provides for an automatic repeal of the SIA which sunsets –or ceases to be effective-- on September 30, 2022. However, while SIA remains in effect, OTC monograph Reform adds a provision to enable exclusivity under SIA for final orders that permit a sunscreen to contain a sunscreen active ingredient not previously incorporated in sunscreens that could be marketed without approved NDAs. Any final sunscreen order that issues under SIA will also be deemed a final order under 505G (or OTC monograph reform) In addition, OTC Monograph Reform requires FDA to issue a proposed sunscreen order no later than 18 months after enactment of OTC Monograph Reform