VTA Annual Meeting Kevin Altman September 17, 2019 Application - - PowerPoint PPT Presentation

VTA Annual Meeting Kevin Altman September 17, 2019

• Application must demonstrate

that new tobacco product is appropriate for the protection of the public health

• FDA must consider risks and

benefits to population as a whole, including users and non-users of tobacco products

• Currently Due May 11, 2020

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• FDA must also consider:

ØIncreased or decreased likelihood that existing users of tobacco products will stop using such products and ØIncreased or decreased likelihood that those who do not use tobacco products will start using such products

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• FDA may refer application to Tobacco

Products Scientific Advisory Committee (TPSAC)

• FDA must act within 180 days of receipt
• f complete application
• For now, up to one-year continuing

compliance period (for 8/8/2016 products with applications filed by 5/12/2020)

• Expect a change in compliance policy

later this month on flavored ENDS

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• “Submitted” = when complete application is

delivered and received by CTP’s DCC

• “Accepted” = when FDA completes a

preliminary review and determines that the application on its fact contains all required information

• “Filed” = when FDA completes a threshold

review and determines that a complete, substantive review is warranted (results in filing letter or refusal to file letter)

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• 1. Full reports of all investigations of

health risks of new tobacco product

• 2. Full statement of components,

ingredients, additives, properties, and principle(s) of operation of such tobacco product

• 3. Full description of methods, facilities,

and controls used in manufacture, processing, packing, and installation

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• 4. Explanation of how product complies

with any applicable tobacco product standards

• 5. Samples of product and components
• 6. Specimens of proposed labeling
• 7. Any other relevant info FDA may

require

• 8. Environmental assessment

PLUS possible inspection of manufacturing and/or research sites

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} Cover letter, executive summary,

table of contents

} May submit single submission for

multiple products: clearly identify what content pertains to each distinct product

} Identify trade secret/confidential

information by submitting one un- redacted version and one marked- for-redaction version

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} Full descriptive information for each product } Summary of all research findings, including

health risks of the product, the product’s effect

• n tobacco use behavior among current users

(including dual use), the product’s effect on tobacco use initiation among nonusers, and the product’s effect on the population as a whole

} Detailed explanation of how data and info

submitted supports APPH finding, including comparison of the health risks of the product to

• thers currently on the market

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} Full statement of components, ingredients,

additives, including intended function

} Description of properties, principles of

• peration

} Information about container closure system } Constituent testing that reflects the range of

• perating conditions, use patterns and types
• f products likely to be used with the product

} Final Guidance provides updated list of

constituents

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} Identify all manufacturing, packaging and

control sites

} Provide narrative description, list/summary

• f all SOPs and examples of forms for

production steps, employee training, supplier controls, validation steps, product release procedures, complaint handling and corrective/preventative actions

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} Full reports of investigations:

• That support and are adverse to your

application

• Both nonclinical and clinical

investigations assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure and consumer use profiles, novel components

• Conducted within and outside of U.S.

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} It may be possible to support an order

without conducting new nonclinical or clinical studies

• Literature reviews and meta-analyses
• Master files
• Bridging
• Instead of clinical studies, could use acute toxicological

endpoints or other clinical endpoints with bridging information, potentially in tandem with nonclinical in vitro assays assessing toxicity associated with long term use of a tobacco product

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} Thorough toxicological and pharmacological

evaluation of ingredients, mixtures of ingredients, and aerosols

} Strong scientific justification for potential

daily exposure levels of users to ENDS product aerosol

} In absence of tox data, may be able to use

computational modeling using surrogate chemical structures

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} Consumer perceptions } Likelihood of initiation and cessation by both

users and nonusers of tobacco products (including vulnerable populations)

} Product use patterns, user topography } Labeling comprehension, self-selection, and

actual use

} Human factors } Abuse liability } Biomarkers of harm and exposure? } Health Outcomes

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} E-Liquids

• Components, ingredients, additives
• Flavors – tox, development, consumer

perception and appeal (youth and adults)

} Apparatus

• Design factors and parameters for batteries,

atomizers and software

• Materials
• Power supply, charging source, electrical

safety

• Schematics

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} Applicants may propose specific sales and

distribution restrictions to support a showing that the marketing of product would be APPH

} For example, a restriction that decreases the

likelihood that non-users of tobacco products will start using the new product

} FDA may then consider the product in that

context and include the proposed restrictions as mandatory conditions for marketing upon authorization

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} Insufficient listing of ingredients,

additives, and properties

} Insufficient manufacturing

information and labeling specimens

} Lack of statement regarding

compliance with product standards

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ØBy working Together ØSharing Questions and Information ØSharing certain compliance costs (Tox work, literature review and behavioral science) ØBuilding an alliance with common interests ØBuild a CITMA Model within VTA

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} Competing companies working together in

• ne organization with a common goal

} Using retained professionals to inform you of

all FDA compliance issues by developing

Ø Write-ups on new rules and guidance so you understand the issues and how they affect your company Ø Communicating your concerns directly to the FDA while protecting company’s identity Ø Commenting to or meeting with the FDA, OIRA, SBA and OMB on all proposed rules or guidance Ø Strategies to comply with regulations Ø Templates to help you file information with the FDA Ø Guidelines as to how to perform various responsibilities

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} Members see the value in sharing ideas and

the costs associated with FDA compliance

} More people working on an issue is better

than a few

} More feedback from the FDA due to constant

communication with the FDA by legal counsel

} Develop a valuable relationship with the FDA } FDA is a “Contact Sport” } VTA will become the prominent information

base for E-Products

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} Providing FDA compliance information to

members is critical to members success

} VTA would Still provide Legislative services on

the ever under attack vapor segment

} Pilot program in place for a common PMTA

approach

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} Working with member manufacturers and

• thers to develop “model PMTA”

} Meet the Minimal PMTA Standard by May 11,

2020

} “Appropriate for the protection of public

health” filter

} Pass/Fail Model } Establish scientifically valid, lowest possible

cost protocols

} Standardize filings across industry

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} Address Statutory Obligations

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• Product Characterizations
• Manufacturing Description
• HPHC
• Stability
• Environmental Assessment
• Literature Review

Also: Define and implement plans, protocols and implementation strategies regarding the Guidance recommendations, including: Behavioral Testing –(Consumer use, label comprehension and youth access and appeal) PK studies Biomarkers?

} Chemical Testing, which is based on the

composition of the e-liquids, i.e. the recipe

• Pro

Product chara racteri rization*

• De

Descripti tion of f th the manufa factu turing g process*

• Ha

Hazardo dous a s and P d Potentially Ha Hazardo dous C s Const stituents s (H (HPHCs) ) – in in the liq liquid id and the aeros

• sol
• l
• Pro

Product stability y

• En

Environmental Assessment*

• Rev

Review ew of the e available e toxi xicological liter erature e based ed on yo your i ingredients

} Be

Behavio ioral l Te Testin ing, whic ich is is based on the co cons nsume umer respons nse to the he product uct and nd labeling ng

• Pha

Pharmacoki kine netic (PK PK) stud udies

• Pr

Prevalenc nce stud udies

• Pr

Produc uct perception n stud udies

• Ob

Observationa nal stud udies

• La

Label co comp mprehension studies

} Behav

Behavioral al T Test esting ng

• Gr

Grou

• up si

simi milar ty type pes s of pr produ ducts ts to to redu duce numbe mber

• f
• f tests
• De

Define la labeling ling s stra rategy f for p r pro roduct ucts

– Simp Simple le vs

• vs. complex lab

labels ls

• Ma

Maximize ze mo modeling g and bridgi ging g on Be Behavioral St Stud udie ies

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} Pass/Fail model } Statutory Requirements filed by May 11,2020 } Working together to streamline costs and

cost sharing (tox, behavioral protocols, literature review etc.)

} Consistent Unified Approach } Identification of Organizations that can

perform the various tasks of a PMTA

} Feedback from professional and FDA can be

shared to strengthen your PMTA application

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Questions?

Contact Information Kevin Altman Aka8015@msn.com 804-370-1443

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