Susan Winckler Deck to Present 020717 Final
NDI Guidance III Roadmap to a Viable NDI Policy UNPA February 9, 2017 in Salt Lake City, UT
How the Trump Administration is Changing Washington, and What that Means for FDA Susan C. Winckler, RPh, Esq Chief Risk Management Officer
Our Agenda… The Trump Administration: The First 20 Days What It Means to FDA… FDA and its Supervisors FDA and its Peers FDA and its Agenda
©2016 LEAVITT PARTNERS
3
The Trump Administration: The First 20 Days
Administrations in Transition Planning
Deliverable 1: First 200 Days Plan
Deliverable 4: Contingency Plans
Handoff (First 100 Days)
Agency Reviews
Implementation
200 Days Plan
Task Forces Key White House Staff
Deliverable 2: Presidential Appointments Deliverable 3: Presidential Budget
Transition
Cabinet Positions Key Sub-Cabinet &SES Positions Other Appointments OMB/Agency FY14 Budget Planning President’s Economic Plan
Presidential Budget
Readiness Budget Planning
Lame Duck Period
Scenario Planning
Black Swan Events
Deliverable 5:
President – Elect Transition Functions
Deliverable 6: Relationship with Congress ©2016 LEAVITT PARTNERS
PE Transition Function Project
PE Transition Organization
Legislative Affairs Project Presidential Outreach
President-Elect Outreach Initial Outreach
September 2016
October 2016
November 2016
December 2016
January 2017
February 2017
March 2017
April 2017
5
By the Numbers… 28 Nominees Advanced
Tom Price (Secretary, HHS) Seema Verma (Administrator, CMS) Mick Mulvaney (Director, OMB) David Shulkin (Secretary, VA Affairs)
8 Confirmed by the Senate
0 from the health-related positions above
8 Executive Actions 12 Presidential Memoranda Lots of tweets… ©2016 LEAVITT PARTNERS
6
Two Actions Most Important to FDA Action
Date
Notes/Context
Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs
January 30th
• For every one new regulation issued, at least two prior regulations be identified for elimination • Cost offsets required; must also be listed on Unified Regulatory Agenda • Impact: if applied at an Agency level, could create real challenges for FDA • Requires planning, careful financial analysis, “counting” • NDI Guidance a ‘saver’ or a ‘cost’?
Presidential Memorandum: Hiring Freeze
January 23rd
• Non-military Federal employee hiring frozen except for “public safety” positions • “Public safety” has traditionally included inspectors/consumer safety officers; Commissioned Corps also exempt • Can yield situation with less-than-optimal management • At least 1,000 open positions 7
©2016 LEAVITT PARTNERS
FDA and its New Supervisors…
FDA…HHS…White House Within FDA, limited number of political appointees Commissioner, some Deputies, formerly the Chief Counsel More appointees in HHS Secretary, Assistant Secretaries, Counselors…
Most in White House Political leadership sets agenda and tone
©2016 LEAVITT PARTNERS
Policy Posture Priorities Generally does NOT include product decisions nor enforcement actions 9
FDA Organization Chart Women’s Health
Chief Scientist
Food & Veterinary Medicine
Resource Planning & Strategic Mgmt
Minority Health
Commissioner of Food & Drugs Stephen Ostroff, M.D. (acting)
Chief Counsel
Chief of Staff Thomas Kraus
Counselor to Commissioner
Medical Products and Tobacco
Operations
Global Regulatory Operations and Policy International Programs
Special Medical Programs Oncology Center of Excellence
Coordinated Outbreak Response & Eval.
Executive Secretariat External Affairs
Policy, Planning, Legislation, & Analysis (Vacant) Policy Leslie Kux
Equal Employment Opportunity
Finance, Budget, & Acquisitions
Human Resources
Facilities Engineering & Mission Support
Information Management & Technology
Safety, Security, & Crisis Mgmt
Planning Malcolm Bertoni Legislation (Vacant) Public Health Strategy & Analysis Peter Lurie
National Center for Toxicology Research
Center for Food Safety & Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
Cntr for Biologics Evaluation & Research
Center for Tobacco Products
Center for Drug Evaluation & Research
Center for Devices & Radiological Health
William Slikker
Susan Mayne
Steven Solomon
Melina Plaiser
Peter Marks
Mitchell Zeller
Janet Woodcock
Jeffrey Shuren
©2016 LEAVITT PARTNERS
10
New FDA Leadership?
Nominee coming “soon”
Expected to focus on streamlining drug/device approval “We’re going to streamline FDA; we have a fantastic person.”
Senate confirmation process follows...
Frequently involves navigation of many issues on a variety of topics Can create a “low-profile” preference Safety issues don’t listen
©2016 LEAVITT PARTNERS
11
2017 Congressional Agenda (That Other FDA Supervisor…)
Congressional Agenda
Inauguration (Jan. 20)
Supreme Court Nomination (Jan. 31) Reconciliation for Possible ACA and Entitlement Reforms (Repeal and Replace?) (Feb-April)
Jan. 2017
Expiring Policies
UFAs (March-Sept.)
Cabinet Nominations (Jan/Feb.)
©2016 LEAVITT PARTNERS
Feb. 2017
FY18 Congressional Budget and Reconciliation Instructions (April)
March 2017
Tax Reconciliation Vehicle (April-Oct.)
FY18 Appropriations Bills (April-Sept.)
FY18 POTUS Budget (April)
April 2017
May 2017
June 2017
July 2017 Aug. 2017 September 2017 FY 17 Appropriations Expire Sept.
Debt Ceiling Reached (Can be extended with extraordinary measures) (March)
Continuing Resolution Expiration (April 28)
UFA Pink slips sent (July)
CHIP Expires Sept.
UFAs Expire Sept.
Oct. – Dec. 2017
Medicare, Medicaid, Public Health Extenders Expire Sept.12or Dec.
FDA and its Peers…
FDA…CMS…NIH Within ‘OpDivs’, limited number of political appointees Typically top leader and deputies
Most peer interaction is at political or top leadership level
Peer interaction will wait; top priority for new politicals is getting their own house in order
Dynamic may change if EO 13771 (2-for-1) applied at a Departmental level Who has ‘cost savers’?
©2016 LEAVITT PARTNERS
14
The FDA Agenda… Or at least what they think it will be.
Emerging User Fee Agreements: The UFAs. Reauthorization Due 9/30/17
PDUFA VI (Prescription Drugs)
MDUFA IV (Medical Devices) ©2016 LEAVITT PARTNERS
GDUFA II (Generic Drugs)
BsUFA II (Biosimilars) 16
Much on the horizon…
• Posture of FDA/Industry Interaction
• Supported? Discouraged? Just scrutinized?
• Commercial Speech and recent court cases • Foundation of food and drug law
• Interest in Food Safety? • Where Does Dietary Supplement Policy Fit? • Inspections Continue, Enforcement Action Continues • Safety • Contamination with drugs
©2016 LEAVITT PARTNERS
17
Smart on Value www.leavittpartners.com
How the Trump Administration is Changing Washington, and What that Means for FDA Susan C. Winckler, RPh, Esq Chief Risk Management Officer
Our Agenda… The Trump Administration: The First 20 Days What It Means to FDA… FDA and its Supervisors FDA and its Peers FDA and its Agenda
©2016 LEAVITT PARTNERS
3
The Trump Administration: The First 20 Days
Administrations in Transition Planning
Deliverable 1: First 200 Days Plan
Deliverable 4: Contingency Plans
Handoff (First 100 Days)
Agency Reviews
Implementation
200 Days Plan
Task Forces Key White House Staff
Deliverable 2: Presidential Appointments Deliverable 3: Presidential Budget
Transition
Cabinet Positions Key Sub-Cabinet &SES Positions Other Appointments OMB/Agency FY14 Budget Planning President’s Economic Plan
Presidential Budget
Readiness Budget Planning
Lame Duck Period
Scenario Planning
Black Swan Events
Deliverable 5:
President – Elect Transition Functions
Deliverable 6: Relationship with Congress ©2016 LEAVITT PARTNERS
PE Transition Function Project
PE Transition Organization
Legislative Affairs Project Presidential Outreach
President-Elect Outreach Initial Outreach
September 2016
October 2016
November 2016
December 2016
January 2017
February 2017
March 2017
April 2017
5
By the Numbers… 28 Nominees Advanced
Tom Price (Secretary, HHS) Seema Verma (Administrator, CMS) Mick Mulvaney (Director, OMB) David Shulkin (Secretary, VA Affairs)
8 Confirmed by the Senate
0 from the health-related positions above
8 Executive Actions 12 Presidential Memoranda Lots of tweets… ©2016 LEAVITT PARTNERS
6
Two Actions Most Important to FDA Action
Date
Notes/Context
Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs
January 30th
• For every one new regulation issued, at least two prior regulations be identified for elimination • Cost offsets required; must also be listed on Unified Regulatory Agenda • Impact: if applied at an Agency level, could create real challenges for FDA • Requires planning, careful financial analysis, “counting” • NDI Guidance a ‘saver’ or a ‘cost’?
Presidential Memorandum: Hiring Freeze
January 23rd
• Non-military Federal employee hiring frozen except for “public safety” positions • “Public safety” has traditionally included inspectors/consumer safety officers; Commissioned Corps also exempt • Can yield situation with less-than-optimal management • At least 1,000 open positions 7
©2016 LEAVITT PARTNERS
FDA and its New Supervisors…
FDA…HHS…White House Within FDA, limited number of political appointees Commissioner, some Deputies, formerly the Chief Counsel More appointees in HHS Secretary, Assistant Secretaries, Counselors…
Most in White House Political leadership sets agenda and tone
©2016 LEAVITT PARTNERS
Policy Posture Priorities Generally does NOT include product decisions nor enforcement actions 9
FDA Organization Chart Women’s Health
Chief Scientist
Food & Veterinary Medicine
Resource Planning & Strategic Mgmt
Minority Health
Commissioner of Food & Drugs Stephen Ostroff, M.D. (acting)
Chief Counsel
Chief of Staff Thomas Kraus
Counselor to Commissioner
Medical Products and Tobacco
Operations
Global Regulatory Operations and Policy International Programs
Special Medical Programs Oncology Center of Excellence
Coordinated Outbreak Response & Eval.
Executive Secretariat External Affairs
Policy, Planning, Legislation, & Analysis (Vacant) Policy Leslie Kux
Equal Employment Opportunity
Finance, Budget, & Acquisitions
Human Resources
Facilities Engineering & Mission Support
Information Management & Technology
Safety, Security, & Crisis Mgmt
Planning Malcolm Bertoni Legislation (Vacant) Public Health Strategy & Analysis Peter Lurie
National Center for Toxicology Research
Center for Food Safety & Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
Cntr for Biologics Evaluation & Research
Center for Tobacco Products
Center for Drug Evaluation & Research
Center for Devices & Radiological Health
William Slikker
Susan Mayne
Steven Solomon
Melina Plaiser
Peter Marks
Mitchell Zeller
Janet Woodcock
Jeffrey Shuren
©2016 LEAVITT PARTNERS
10
New FDA Leadership?
Nominee coming “soon”
Expected to focus on streamlining drug/device approval “We’re going to streamline FDA; we have a fantastic person.”
Senate confirmation process follows...
Frequently involves navigation of many issues on a variety of topics Can create a “low-profile” preference Safety issues don’t listen
©2016 LEAVITT PARTNERS
11
2017 Congressional Agenda (That Other FDA Supervisor…)
Congressional Agenda
Inauguration (Jan. 20)
Supreme Court Nomination (Jan. 31) Reconciliation for Possible ACA and Entitlement Reforms (Repeal and Replace?) (Feb-April)
Jan. 2017
Expiring Policies
UFAs (March-Sept.)
Cabinet Nominations (Jan/Feb.)
©2016 LEAVITT PARTNERS
Feb. 2017
FY18 Congressional Budget and Reconciliation Instructions (April)
March 2017
Tax Reconciliation Vehicle (April-Oct.)
FY18 Appropriations Bills (April-Sept.)
FY18 POTUS Budget (April)
April 2017
May 2017
June 2017
July 2017 Aug. 2017 September 2017 FY 17 Appropriations Expire Sept.
Debt Ceiling Reached (Can be extended with extraordinary measures) (March)
Continuing Resolution Expiration (April 28)
UFA Pink slips sent (July)
CHIP Expires Sept.
UFAs Expire Sept.
Oct. – Dec. 2017
Medicare, Medicaid, Public Health Extenders Expire Sept.12or Dec.
FDA and its Peers…
FDA…CMS…NIH Within ‘OpDivs’, limited number of political appointees Typically top leader and deputies
Most peer interaction is at political or top leadership level
Peer interaction will wait; top priority for new politicals is getting their own house in order
Dynamic may change if EO 13771 (2-for-1) applied at a Departmental level Who has ‘cost savers’?
©2016 LEAVITT PARTNERS
14
The FDA Agenda… Or at least what they think it will be.
Emerging User Fee Agreements: The UFAs. Reauthorization Due 9/30/17
PDUFA VI (Prescription Drugs)
MDUFA IV (Medical Devices) ©2016 LEAVITT PARTNERS
GDUFA II (Generic Drugs)
BsUFA II (Biosimilars) 16
Much on the horizon…
• Posture of FDA/Industry Interaction
• Supported? Discouraged? Just scrutinized?
• Commercial Speech and recent court cases • Foundation of food and drug law
• Interest in Food Safety? • Where Does Dietary Supplement Policy Fit? • Inspections Continue, Enforcement Action Continues • Safety • Contamination with drugs
©2016 LEAVITT PARTNERS
17
Smart on Value www.leavittpartners.com
