Put Another Way

Karen C. Corallo, Esq.
Director
Division of Drug Imports, Exports, and Recalls
Center for Drug Evaluation and Research
Food and Drug Administration
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Put Another Way . . .
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What We’ll Cover
 Strategic priorities for drug imports/exports
 How we got here
 Imports 101, or How To Avoid Entry Delays
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We’ll Try to Keep It Interesting…
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The Challenge Is Great
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So, Let’s Pause Here
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And, Get A Baseline
Frustrating import experiences?
Wish List for change?
Emblematic good experiences?
Needs?
Complaints?
Compliments???
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The Story Begins
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Statistics
• FDA-regulated products = approx 20% of consumer
spending
• FDA-regulated shipments = approx 32 million lines per year
• 3-fold increase over last 10 years
“If the statistics are boring, then you have the wrong statistics.”
Edward Tufte
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6 Sep 2013
Dr. Hamburg charged PAG*:
 Streamline agency functions to achieve mission
critical objectives
 IMPORTS IS MISSION CRITICAL
 Align import operations with CDER’s risk-based
strategies and policy
* Program Alignment Group
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3 Feb 2014
Comm’s Memorandum Decision re: Imports
 More specialization around imports
 Ensure FDA speaks with one voice on import
field operations
 Align CDER risk-based compliance strategies
and policies with operations
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19 Feb 2014
Executive Order: “Streamlining the Export/Import
Process for American Businesses”
- improve infrastructure
- policies
- operations
- collaboration with stakeholders
- technology
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Administration’s Objectives
 Encourage compliance
 Reduce unnecessary trade delays
 Reduce costs to agencies and industry
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Aug 2015
FDA Pharmaceuticals Action Plan FY2015
 Establish a strategic plan for imports
 Establish strategic priorities for imports
 Streamline imports decisions
 Establish and implement a risk-based entry
review strategy
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A Big Undertaking
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How Working Group Responded
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31 Mar 2015
Drug Imports Action Plan (DRAFT)
 Why Develop a Drug Imports Action Plan?
 What Goals Will We Set?
 How Will We Accomplish Each Goal?
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Question For You:
Which way did FDA go??
Risk-based targeting?
Swift and efficient processing?
Facilitating compliant trade?
All of the above?
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Statement of Purpose
FDA will:
- promote and protect the public health by
- adopting a risk-based approach to drug imports
- to help ensure safe, effective, and high quality drugs
- are swiftly and efficiently imported into the U.S., and
- dangerous drugs are kept out,
- while also facilitating compliant trade.
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Simply Put…
 Get good medicines in swiftly
 Keep bad medicines out effectively
 While facilitating compliant trade
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How?
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1st Goal:
Efficient Processing Of Compliant Entries
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Improve data quality
Modernize IT systems and infrastructure
ACE/ITDS
Centralized Entry Review
Initial Admissibility Project
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2nd Goal:
Improved Targeting of High-Risk Drugs
From manual review
Low risk review activities
Less border intervention
to high-risk targeting methods
high-risk surveillance
more pre-entry prevention
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2nd Goal
Improved Targeting, cont’d
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PREDICT risk scoring
Inherent product risk
Risk assessments (e.g. Medwatch reports)
Rapid screening
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3rd Goal:
Education and Outreach
To Consumers
 Safe purchasing practices
 Public health hazards from importation of
dangerous drugs
 Risks of certain violative products
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3rd Goal:
To Importers, Manufacturers, Brokers
 Train, educate, learn from industry
 How-to videos, webinars, seminars, fact sheets
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U.S. import requirements and terminology
FAQs
Instructive import actions
Drug import statistics
Good practices and compliance tips (e.g., how to get
registration and listing right in import submissions)
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3rd Goal:
Importers, Manufacturers, Brokers
 Improve transparency on admissibility process
 Participate in industry conferences, training,
speaking opportunities
 Educate trade on DATA ACCURACY & risk
mitigation strategies
 Town Halls and public meetings on import safety
 Leverage drug approval process to improve drug
import practices pre-entry
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3rd Goal:
Inside FDA
 Improve training
 Promote consistent and informed decisionmaking across all ports
 Consider specialized import or drug
compliance officer cadre for entry review
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3rd Goal:
Inside FDA cont’d
 Engage with overseas offices and foreign
regulatory authorities
 Partner with other FDA components
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3rd Goal:
Foreign and State Regulators
 Asia-Pacific Economics Council (APEC)
 Partner with foreign authorities to identify
opportunities for outreach
 Leverage other FDA ongoing activities for
actionable imports info - Operation Pangea
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3rd Goal:
To Medical Professionals
 To educate patients re risks of unapproved
foreign drugs
 Consider collecting data re prevalence of
internet pharmacy purchases
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3rd Goal:
To Legislators
 Identify opportunities to engage with State
and Federal lawmakers
 Share facts and data on issues of compelling
interest to FDA and stakeholders
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Goal # 4:
Consistent Policies to Drive Strategy
 Collaborate across FDA, CDER, and ORA
 Coordinate and ALIGN compliance and
enforcement strategies
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Exports
CDER eCATS
 Allows electronic submissions of export
applications
 Quicker turnaround
 More frequent and effective interaction with
industry
 Go live – projected end of 2015
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Will All This Work?
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It’s About Overcoming Obstacles
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Doing More With Less
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Being Creative
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In Closing…
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Conclusion
“ Success doesn’t necessarily come
from breakthrough innovation
but from flawless execution.”
- Naveen Jain
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Remain Watchful
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Hold Us Accountable
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Questions?
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