FDA Regulation of Tobacco

Washington, DC

October 21, 2015

Interacting with the Agency

Jeams E. Dillard III, Senior Vice President, Regulatory Affairs and Chief Innovation Officer, Altria Client Services LLC

Ella Yeargin, Ombudsman, CTP, FDA

Moderated by Azim Chowdhury, Partner, Keller and Heckman LLP

Ella YearginCTP Ombudsman

FDLI, October 2015

| FDLI | October, 2015

OVERVIEW OF TODAY’S PRESENTATION

• Role of the Ombudsman

• When to Contact the CTP Ombudsman

• Frequent Topics: Inquiries, Complaints, Disputes

• Q&A

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The United States Ombudsman’s Association (USOA) defines a governmental Ombudsman as “an independent, impartial public official with authority and responsibility to receive, investigate, or informally address complains about governmental actions, and, when appropriate, make findings and recommendations, and publish reports.”

I receive and investigate complaints (in an informal manner) about CTP and seek to mediate, or otherwise resolve, disputes between CTP and entities outside CTP.

I follow a code of ethics and operating procedures drawn from those established by the Coalition of Federal Ombudsman, the USOA, and the International Ombudsman Association. These include neutrality, impartiality, objectivity, and confidentiality.

Ombudsman Principles

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Am I the First Person You Should Call?

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Probably Not. Start with Your Point of Contact.

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General InformationFor general inquiries, contact AskCTP@fda.hhs.gov or 1-877-287-1373 (9am EST-4pm EST).

All written correspondence, including regulatory correspondence, should be sent to the following address:

Center for Tobacco ProductsAttn: Document Control CenterBuilding 71, Room G33510903 New Hampshire AvenueSilver Spring, MD 20993-0002

Center Email AddressesTobacco Industry Questions: TobaccoIndustryQuestions@fda.hhs.govSmall Business Industry Questions: smallbiz.tobacco@fda.hhs.govFormal Correspondence and Speech and Meeting Requests: ctpexecsec@fda.hhs.gov. Also submit a proposed agenda and attendee list.To contact the Ombudsman with inquiries, complaints and disputes, please email ctpombudsman@fda.hhs.gov or call 301-796-3095.

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When To Call Me

• Try, if possible, to first resolve any complaint or dispute with your

POC in the CTP office involved

• I am here to listen to anyone who contacts my office.

• If I’m not the right resource, I’ll try to find it.

• Cannot get involved in matters that are in litigation

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What To Expect from Me

• To listen, ask questions (including about desired outcome), and review possible options

• To get involved informally at any stage in the Center’s decision-making process by request • Telecon, meeting, informal emails or conversations• No retaliation for contacting Ombudsman• May keep their identity confidential for some or all of

the process (unless threats to self/others made)• I’m available to provide informal advice on appeal processes

• Informally provide options• No retaliation for filing an appeal

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Informal, efficient, saving resources

Improve communications and working relationships

Deep understanding of Center operations

Adept at interacting with FDA staff

Unbiased sounding board, recognizing that I am a CTP employee

Why External Parties Contact Ombudsman

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• You haven’t heard back from your POC• You’ve raised a concern with a CTP office, but it still has not been

resolved• You have an issue to discuss, but you’re not sure who to request a

meeting with• You have feedback to give about CTP’s processes• There’s a topic you’d like to discuss anonymously• Before filing a formal appeal under 21 CFR 10.75• General inquiries

Remember: any party may ask me to sit in at any stage of the process without retaliation

What Types of Concerns Do I Hear About

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• Confidential• Impartial, independent, informal, external-focused• Listen, assess difficult situations, identify options • Receive and investigate complaints • Informally look into complaints • Facilitate de-escalation of conflicts between CTP and outside parties

• Respond to simple inquiries• Discuss informal dispute resolution options• Oversee formal appeal process (21 CFR 10.75)

• Resolve disputes at early stage through “shuttle diplomacy”

When You Call, I Listen

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How Do I Maintain Confidentiality?

Communications with the CTP Ombudsman are kept confidential by request except in rare instances such as risk

of injury to self or others.

Keep in mind, it may be difficult to move forward with a complaint if you request that your identity be kept in

confidence. In such cases, I may request permission to disclose identifying details about you.

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I’m also interested in hearing about the effectiveness of CTP’s programs and about problems that may be getting in the way of carrying out the Center’s regulatory responsibilities.

I welcome this input because it helps CTP to continually assess and improve the work that it does.

Part of my role is to promote good government, fairness, transparency, and accountability.

What’s the Issue?

|April, 2015

Who Contacted Me in 2014?

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You can find my 2014 Annual Report on the CTP website by searching for Ombudsman Annual Report or clicking here.

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Topics & Types of Contacts in 2014

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I cannot:

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• Become anyone’s personal advocate

• Violate trust (of FDA employees or external parties)

• Overturn a decision or action or force anyone to do so

• Work on a dispute when case is pending in legal process

• Violate the Ombudsman ethics and operating principles

• Become involved in cases in litigation

What I Can’t Do

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Stay in the Know

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CTP Website • Sign up for regular updates• Webinars, trainings, publications, tweets• Warning letters, SE/NSE decisions, etc.• Guidance, regulations, opportunities to comment

CTP Ombudsman Website• Read my annual reports

Freedom of Information (FOIA) Website• Familiarize yourself with what the Federal

Government can/can’t share and why• Read FAQs• Learn how to make a FOIA request

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CTPOmbudsman@FDA.hhs.gov

301-796-3095

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Questions?

FDLITobacco ConferenceOctober 21, 2015

19Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l

Jim DillardSr. Vice President, Regulatory AffairsChief Innovation Officer

Engagement Principles Be the most:

• Informative• Scientific and evidence-based• Balanced• Instructive and, therefore, most

persuasive

Provide the best advocacy for our positions

Advocate for accurate and non-misleading product communications to adult tobacco consumers

Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l 20

FDA Engagements

Biomarkers of Tobacco Exposure

Statistics

Electronic Cigarettes & the Public Health

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Scientific & Policy Organizations

Regulatory Filings

Site Tours Face-to-face Meetings

Altria Client Services l SVP, Regulatory Affairs & Chief Innovation Officer l October 21, 2015 l FINAL l 21 Third party trademarks and images are the property of their respective owners and are used for illustrative purposes only.