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Quality of Imported Drugs

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Title: Quality of Imported Drugs


1
Quality of Imported Drugs
  • Paul J. Seligman, M.D., M.P.H.
  • Associate Director, Safety Policy Communication
  • U.S. Food and Drug Administration
  • Royal Danish Embassy Conference
  • Copenhagen November 5, 2008

2
Objectives
  • Discuss challenges that globalization presents
    for assuring drug safety
  • Discuss activities to address these challenges
  • Discuss how FDA integrates with a other
    governmental activities to assure the safety and
    security of imported products

3
FDA and Globalization
  • One factor demanding our transformation into a
    more expansive agency is the surging
    globalization process that, among many other
    changes, has all but eliminated trade barriers
    along the U.S. borders. Globalization is flooding
    our markets with a myriad of imported goods that
    our consumers want and need, and we are
    responsible for regulating a vast amount of them.
    This means that we have to recreate the FDA.
    After 100 years of operating as a
    quintessentially domestic agency, we must expand
    FDAs reach abroad, and make it a global agency.
    Our modernization is designed to keep substandard
    products off the U.S. market through prevention,
    intervention as well as response. And recognizing
    that inspections at the borders are not an
    impermeable barrier to defective products, we
    must change to oversight of the entire life cycle
    of products -- even as those products grow
    increasingly complex.
  • Andrew von Eschenbach, MD
  • Commissioner, U.S. Food and Drug
    Administration
  • April 25, 2008

4
Traditional Import Approach
Ports of Entry
Regulatory Import Decision
Customs Broker
Various Distribution Centers
Foreign Shippers
Importer
Limited Snapshot of Information available to
Regulators Decision Making
5
Full Import Life Cycle
U.S Ports of Entry
Foreign Activities
Domestic Activities
Raw Materials
Foreign Mfrs
Foreign Distribution
Foreign Carriers
Domestic Mfrs
Domestic Distributors
Retailers
Consumers End Users
Regulatory Import Decision
Information Flow
Additional Monitoring Points
Additional Monitoring Points
Prevention and Verification Risk-Based
Decision-Making Process
6
Traditional Challenges for Assuring Drug Product
Integrity
  • Counterfeiting
  • Tampering
  • Adulteration
  • Diversion
  • Falsification of original manufacturers

7
Globalization
  • Imported Drug Shipments
  • 2000
  • Approx. 1,300 line entries
  • 2006
  • Over 145,000 line entries
  • lt 100x increase over 6 years

8
GlobalizationChina and India alone
Listed Number of Drug Manufacturers
Different Types of Imported Drug Items
China 7x increase India 25x increase
China 4x increase India 7x increase
9
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10
Globalization
  • More sources
  • More participants
  • More challenges in tracking the whole
    manufacturing and distribution process
  • More direct consumer access to prescription
    drugs through the internet and mail

11
  • Why the concern?

12
Elixir of Sulfanilamide
  • Sulfa drugs introduced in 1935
  • One company uses diethylene glycol to flavor and
    serve as a solvent
  • 107 deaths, many of them children
  • Led to 1938 FDC Act

13
Diethylene Glycol
  • Additional outbreaks from medications
    contaminated with DEG
  • Bangladesh 1990 over 300 children with kidney
    failure
  • Haiti 1996 85 deaths in children
  • India 1998 33 deaths in children
  • Panama 2006 100s ill and over 40 deaths

14
DEG
15
Heparin
16
Heparin
  • Contaminated with overly-sulfated chondroitin
    sulfate
  • Not a naturally occurring molecule in levels
    detected
  • Similar effect to heparin for blood thinning
  • Previously studied as a potential alternative to
    heparin
  • Over 60 deaths associated with use of
    contaminated heparin in U.S.
  • Additional reports of adverse events related to
    contaminated heparin in Germany and Japan
  • Subsequently identified in 11 countries

17
Internet Pharmacies and Sales
18
Internet Pharmacies and Sales
  • Estimates of over 2 million websites selling
    pharmaceuticals
  • Unknown sites
  • Unknown location
  • Unknown credentials
  • Unknown products
  • Exaggerated claims
  • Often cheaper, similar looking
  • Internet creates access to U.S. market for
    international companies

19
Counterfeits
  • Estimated at about 1 in developed countries ..
    but more than 10 in developing countries.

20
Counterfeits
21
Traditional FDA approach to assure Drug Product
Integrity of Imports - Inspections
  • Inspections of imports
  • Inspections of manufacturers/suppliers/
    labelers/repackagers/wholesalers

22
Why the Traditional Approach is Overrun by
Globalization
  • Lack of good information on overseas drug
    manufacturers/suppliers/distributors
  • Limited number of FDA inspections overseas
  • Lack of authority (international and internet)

23
Databases/Information on Imports and Foreign
Manufacturers
  • Limited information on drug manufacturers,
    suppliers, etc.
  • Siloed information systems - OASIS, FACTS, DRLS
    and CBP
  • Unreliable information from foreign sources

24
GAO Report
  • Drug Safety Preliminary Findings Suggesting
    Weakness in FDAs Program for Inspecting Foreign
    Drug Manufacturers
  • Testimony before the Subcommittee on Oversight
    and Investigations, Committee on Energy and
    Commerce, House of Representatives
  • November 2007

25
GAO Reports
  • Weak Databases (inaccurate data)
  • Few Inspections (about 200/yr since 2000)
  • Unique challenges with overseas inspections
  • no dedicated cadre of inspectors
  • not unannounced
  • limited time and flexibility
  • lost in translation
  • no regular requirement for foreign inspections
    compared to domestic manufacturers (every 2 yrs)

26
Domestic vs. Foreign Inspections
27
Flat Funding
28
FDA Foreign Inspections
29
Inspections
  • Unrealistic to inspect every foreign facility
    even if identified
  • Unlikely to have authority to perform unannounced
    and complete inspections
  • Implications on foreign trade and agreements when
    adverse findings are identified

30
  • Comprehensive Federal Approach
  • To
  • Import Safety

31
National Strategy on Import Safety
  • Interagency Working Group on Import Safety
  • Executive Order 13439, July 18, 2007
  • Protecting Consumers Every Step of the Way A
    Strategic Framework for Continual Improvement in
    Import Safety, Sept 10, 2007
  • Action Plan for Import Safety A roadmap for
    continual improvement, Nov 1, 2007
  • 50 action steps in 14 broad recommendations

32
Challenges with Current Import System
  • Need for comprehensive consideration of risk
  • Recognize overlap of the security and safety
    relationship
  • Need for additional authorities
  • Insufficient data
  • Siloed systems
  • Circumvention
  • Protecting American Consumers Every Step of the
    Way a Strategic Framework for Continual
    Improvement in Import Safety. A Report to the
    President, Interagency Working Group on Import
    Safety, September 2007.

33
Import SafetyStrategic Framework
  • Prevention
  • Intervention
  • Response

34
Import SafetyAction Plan Building Blocks
  • Advance a Common Vision
  • Increase Accountability, Enforcement and
    Deterrence
  • Focus on Risks Over the Life Cycle of an Imported
    Product
  • Build Interoperable Systems
  • Foster a Culture of Collaboration
  • Promote Technological Innovation and New Science

35
Recommendations of the Action Plan for Import
Safety
  • 1. Safety Standards Create new and strengthen
    existing safety standards.
  • 2. Certification Verify compliance of foreign
    producers with U.S. safety and security standards
    through certification.
  • 3. Good Importer Practices Promote Good Importer
    Practices.
  • 4. Penalties Strengthen penalties and take
    strong enforcement actions to ensure
    accountability.

36
Recommendations of the Action Plan for Import
Safety (cont)
  • 5. Foreign Collaboration and Capacity Building
    Make product safety an important principle of our
    diplomatic relationships with foreign countries
    and increase the profile of relevant foreign
    assistance activities.
  • 6. Common Mission Harmonize federal government
    procedures and requirements for processing import
    shipments.
  • 7. Interoperability Complete a single-window
    interface for the intra-agency, interagency and
    private-sector exchange of import data.
  • 8. Information Gathering Create an interactive
    import-safety information network.

37
Recommendations of the Action Plan for Import
Safety (cont)
  • New Science Expand laboratory capacity and
    develop rapid test methods for swift
    identification of hazards.
  • 10. Intellectual Property Protection Strengthen
    protection of intellectual property rights
    (IPR) to enhance consumer safety.
  • 11. Recall Maximize the effectiveness of product
    recalls.
  • 12. Federal-State Rapid Response Maximize
    federal-state collaboration.
  • 13. Technology Expedite consumer notification of
    product recalls.
  • 14. Track-and-Trace Expand the use of electronic
    track-and-trace technologies.

38
Import Safety at Work
  • December 2007 Memoranda of Agreement with
    Chinese authorities to help ensure the safety of
    food, feed, drugs, biologics, and medical devices
    imported from China.
  • Sharing information, data and technical expertise
  • Establishing an FDA office in China (HHS also
    intends to open a FDA office in India)

39
CDER/FDA Import Safety Initiatives
  • Prevention
  • Promote adoption of Good Manufacturing Practices
    to build safety into the manufacturing and
    distribution processes
  • Sharing technical expertise with industry and
    foreign governments

40
CDER/FDA Import Safety Initiatives
  • Intervention
  • Information Technology
  • Improving Agency database interaction
  • RFID (Radiofrequency identification)
  • Holding U.S. Manufacturers accountable
  • Increase requirements for active pharmaceutical
    ingredient (API) testing
  • Increasing Surveillance Inspections
  • Greater emphasis on GMP inspections

41
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42
CDER/FDA Import Safety Initiatives
  • Response
  • Making the Border an Integrated Checkpoint
    (working with Customs Border Patrol)
  • Rapid Deployment of For Cause Inspections
  • Expanded Use of Track and Trace technologies
  • Expanding Laboratory Capacity and Development of
    Rapid Test Methods
  • Ramping up cadre of Field and International
    Inspections Staff
  • New Authorities Required

43
Proposed increase of 09
  • Presidential and Congressional Budget Proposals
  • Approximately 20 increase
  • 404.7 Million
  • 1,016 FTEs

44
Proposed Legislation
  • FOOD AND DRUG ADMINISTRATION GLOBALIZATION ACT
  • Authorizes Registration Fees to defray inspection
    costs
  • Requires both domestic and foreign firms be
    inspected every 2 yrs
  • Requires manufacturer testing of ingredients with
    inadequate documentation before importation
  • Requires country of origin labeling
  • Provides civil penalties
  • Creates dedicated foreign inspectorate

45
What Money and Legislation Cant Buy
  • Scientific Expertise
  • Time to Train Investigators and Reviewers
  • Authority over Foreign firms
  • Authority over the internet

46
Take Home Points
  • Funding in the right direction
  • Still need better data and analytical systems
  • International collaboration is crucial for better
    information and data to make better risk-based
    decisions!

47
References
  • J Woo, S Wolfgang, H Batista, The Effect of
    Globalization of Drug Manufacturing, Production,
    and Sourcing and Challenges for American Drug
    Safety, Clinical Pharmacology and Therapeutics,
    Vol 83, No 3, March 2008.
  • Action Plan for Import Safety a roadmap for
    continued improvement. Report to the President,
    Interagency Working Group on Import Safety, Nov
    2007.
  • Preliminary Findings Suggest Weakness in FDAs
    Program for Inspecting Foreign Drug
    Manufacturers, GAO Testimony before the
    Subcommittee on Oversight and Investigations,
    Committee on Energy and Commerce, House of
    Representatives, November 1, 2007.
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