An Overview of the
Biotechnology Innovation
Organization
CURE Government Affairs Meeting
& Annual Meeting
June 13, 2017
Patrick Plues
Vice President,
State Government Affairs
BIO
BIO Fact Sheet
Founded
1993
Tax Status
Non-profit trade association
CEO
James C. Greenwood
Board Chair
Ron Cohen
President & CEO, Acorda Therapeutics, Inc.
Headquarters
Washington, DC
Staff
~170
Members
~1,000
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BIO Membership Breakdown
March 2017
Approximately 1,000 members
R&D Company Focus
R&D Company Revenues
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2017 Federal Priorities
• Repeal and Replace of Affordable Care Act
• Prescription Drug User Fee Act (PDUFA)
• Medicare Reform
• 340B
• Funding models for NIH, CDC, etc.
• Tax Reform
• Patent Reform
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Avoiding Harmful Provisions/Amendments
in “Must-Pass” Legislation or Trump
Administration Action
Importation
Government Negotiation in Part D
Part B Negotiation/Moving Part B to Part D
New/Additional Rebates in Part B or Part D
Harmful “Transparency” Measures
Pay-for-Delay/CREATES Act (REMS restrictions)
ICER-Type Value Assessments
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Federal Activities
Prescription drug pricing is top priority in 2017 that will
overarch everything
Repeal and Replace of Affordable Care Act
– Pursue priorities that ensure patients have robust access to therapies
– Prevent detrimental “pay-for” policies
Prescription Drug User Fee Act (PDUFA)
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Reauthorize current PDUFA VI Agreement
Generic Entry (REMS, PRVs, etc)
Importation
BPCA/PREA Reforms
Expanded Access
Transparency
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2017 BIO SGRC Priorities
LEAD ISSUES
These are issues where BIO will
proactively engage by:
• Convening interested stakeholders
• Participate in work groups and/or
stakeholder meetings to provide
technical expertise
• Actively Lobby to Support or
Oppose
• Provide Testimony
• Publically Support or Oppose
(Letters, Position Papers, TPs)
Biotechnology Innovation Organization
December 2016
1. Drug Pricing: Oppose
pharmaceutical price
transparency legislation; oppose
price control legislation and/or
ballot initiatives
2. Biologic Substitution: Support
Biologic Substitution Legislation
That Contains BIO’s 5 principles
3. 340B: Work to encourage states
to adhere to the federal 340B
statute; oppose attempts by
states to expand 340B outside
the confines of the federal statute
2017 BIO SGRC Priorities
CONTRIBUTE ISSUES
These are issues where BIO will
contribute where appropriate:
• Provide testimony
• Participate in workgroups and/or
stakeholder meetings to provide
technical expertise
• Publically support or oppose
(Letters, Position Papers, TPs)
Biotechnology Innovation Organization
1. Take Back: Oppose prescription drug
takeback legislation that imposes a
mandate and does not meet BIO
principles on take back.
2. Fetal Tissue: Oppose legislation to
ban or criminalize research using fetal
tissue
3. Patent Troll: Amend patent troll
legislation to carve-out biopharma
industry and university research
4. Universal Vaccine Purchase: Oppose
attempts by states to expand universal
vaccine purchase programs (into new
states & adult populations)
December 2016
2017 BIO SGRC Priorities
MONITOR ISSUES
These are issues where BIO will
monitor
1. Right To Try
2. Specialty Tier Price Caps
3. Step Therapy
4. Medication Adherence
5. Medicaid Expansion
Biotechnology Innovation Organization
December 2016
BIO State Affiliate Network
BIO Affiliates in 48 States
Chair:
Russell Allen, Georgia A Bio
Incoming Chair:
Nate Tinker, New York Bio
Two Meetings A Year
BIO Contacts:
• Brian Johnston: [email protected]
• Brian Smith: [email protected]
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International Priorities
Programs to advance IP, regulatory approvals and market access in
key global markets
China, India, Brazil, Mexico, Japan, Middle-East – top priorities
BIO has unique voice in global markets –builds on desire to build
biotech sector; good access with foreign government officials
BIO Convention use to meet key foreign delegations to do advocacy
Trade policy & USG advocacy
Use US trade agreements to advance IP rights and market access
Engage US trade and international agencies to address industry issues
and problems globally Bilateral trade negotiations/re-negotiations –
enhance IP protections; pay for value
Global Regulatory platform
Advance harmonization of key regulatory systems, through APEC &ICH
Provide input directly to countries on regulatory issues
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Reimbursement Priorities: 2017 Work
Plan
Lead
• Value Frameworks
• Value Based
Arrangements
• Alternative Payment
Models/CMMI
• 340B Program
• Biosimilars
• Healthcare System
“Transparency”
• Affordable Care Act
(ACA) Repeal/Replace,
Medicare and Medicaid
Structural Reforms
Contribute
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Alternative Financing
Arrangements
Non-Discrimination
Policies
Patient Cost Sharing
Network Adequacy
Transitions Among
Plans
Communications
FFS Medicare Payment
Policy
IPAB
Medicaid
Monitor
• Manufacturer Fee
• Parallel Review
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FDA Priorities: 2017 Work Plan
Proactive
PDUFA VI
Legislation
• Passage of PDUFA VI
and BsUFA II (as
agreed)
• Engage with Congress
on the following
legislative proposals:
• Generic entry
• Importation
• BPCA/PREA
reforms
• Expanded access
• Other
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Hiring and financial
stability (Board
level)
Patient-focused
drug development
& enhanced sB/R
framework
Innovative Clinical
Trials
RWE Safety &
Efficacy
Enhanced
Communications
Proactive 21ST
Century Cures
• DDT qualification
pathway
• Extrapolate data for
rare/genetically
targeted therapies
• Expanded access
transparency
• FDA Inter-center
Institutes
• Improving
combination product
review
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Intellectual Property Priorities
Oppose or secure necessary changes to any legislative,
regulatory, or judicial attempts to:
Undermine strong and predictable patent protection for biotechnology
inventions
Restrict flexible licensing & tech transfer of federally-funded research
Impose barriers to patent enforcement or restrict patent
litigation/settlements
Promote reforms to enhance patentability of biotechnology
inventions, particularly those derived from products of nature
Promote reforms to protect against unfair use of PTO
administrative review proceedings to challenge validly issued
patents
Support and enhance pro-IP voices among a broader array of
stakeholders
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Coalition Solutions: “Prescriptions for
Competition, Value and Innovation”
– “Prescriptions for Competition, Value and Innovation,”
Increasing Competition: Bringing more generic and branded drugs to the market
will increase competition, driving down costs and improving patient and provider
choice.
Rewarding Value: Reward improved health outcomes and help to lower costs by
reforming legal and regulatory barriers that impede private sector value-based
contracting for prescription drugs based on outcomes in care.
Empowering Consumers: Providing consumers with relevant, easily understood
information about their drug choices, including information on their cost-sharing
obligations.
Preserving What Works: Reject proposals that would undermine functioning markets
and the thriving biopharmaceutical innovation ecosystem, or jeopardize patient access
or safety.
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Patient Advocacy
Identify areas of mutual interest and strategically engage key
partners on industry and stakeholder priorities with a focus on value
and innovation
Partner with stakeholders on special projects that share best
practices and resources to facilitate partnerships between the
biotechnology industry and stakeholder community
Integrate patient group feedback directly into BIO policy
development as it relates to access issues, PDUFA, and other
policy priorities
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BIO By The Numbers
Global Appeal
1 out of every 3 BIO attendees is from outside the US
BIO 2017 Educational Tracks
•
Biofuels & Renewable Chemicals
•
Infectious Diseases & Vaccines
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Brain Health
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Intellectual Property
•
Business Development & Finance
•
Next Generation Biotherapeutics
•
Critical Cross Disciplinary Issues
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Oncology
•
Digital Health
•
Orphan & Rare Disease
•
Emerging Opportunities in Global
•
Personalized Medicine & Diagnostics
Markets
•
Regulatory Science
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Food & Agriculture
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Translational Research
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Global Innovation Hubs
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Value, Patient Access, &
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Harnessing Big Data to Drive
Commercialization
Innovation in Drug Discovery & Dev
Visit convention.bio.org/program for details
Thank You
Patrick J. Plues
VP State Government Affairs
[email protected]
(202) 962-9514
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