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U.S. FDA Global Engagement, Murray Lumpkin M.D. M.Sc., Deputy Commissioner

Presentation in Pdf Format (912 KB)

Embassy Briefing:
Office of International Programs
U.S. Food and Drug Administration

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner, International Programs
U.S. Food and Drug Administration

01 December 2009

Slides 2 and 3: FDA’s Statutory Mission

  • (a)SEC. 903. [ 21 U.S.C. 393] FOOD AND DRUG ADMINISTRATION. 
  • (b) MISSION.—The Administration shall— 
  1. promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; 
  2. with respect to such products, protect the public health by ensuring that— 
    1. foods are safe, wholesome, sanitary, and properly labeled; 
    2. human and veterinary drugs are safe and effective; 
    3. there is reasonable assurance of the safety and effectiveness of devices intended for human use; 
    4. cosmetics are safe and properly labeled; and 
    5. public health and safety are protected from electronic product radiation; 
  3. participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements;

Slide 4: INTERNATIONAL WORK

  • DISCRETIONARY? 
  • INTEGRAL?

Slide 5: Basic Principal: International Cooperative Activities

  • Bilateral and multilateral efforts: 
    • to leverage the human, scientific, and financial resources and the knowledge and experience of other key regulatory authorities: 
      • to get information so Centers and border agents can make better decisions 
      • to avoid duplication of effort, 
      • to make our activities more efficient 
      • to allow us to focus our limited resources on higher-risk areas of concern 
      • to positively impact the public health of the US and the world.

Slide 6: International Work - Past Decade

Covers the full scope of all FDA-related products:

  • Regulatory and Enforcement Cooperation 
  • Harmonization of Regulatory Policy and Science-based Standards 
    • ICH/VICH/GHTF/Codex/ICCR/WHO/OECD 
  • Scientific Collaboration and Exchange 
  • Technical Assistance and Training Emergency Response and Preparedness 
  • Public Health Consultants to Trade Negotiations and Trade Agreements

Slide 7: Venues and Tools

Venue:

  • Bilaterally 
  • Regionally or multilaterally 
  • Multilaterally with major International Organizations 
    • WHO, PAHO, FAO, OIE, OECD, APEC 

Tools:

  • FDA’s Agreements Umbrella 
    • Confidentiality Commitments 
    • Memoranda of Understanding/Agreement or Exchange of Letters 
    • Implementation or Action Plans 
    • Formal Harmonization activities

Slide 8: FDA’s Collaborations (Agreements)

  • Over 100 bilateral agreements 
  • Confidentiality Commitments 
    • 17 Countries 
    • European Commission (2 different DGs) 
    • World Health Organization 
    • EDQM 
  • Most tools for information exchange; others developed affirmative collaborations.

Slide 9: Confidentiality Arrangements

  • Don’t require us to do anything 
  • They are a TOOL if we chose to use it 
  • Allows exchange of otherwise non-public information EXCEPT trade secret and personal 
    • Commercial confidential, investigative, pre-decisional

Slide 10: Wake Up Calls of 2007-08

  • Melamine in pet food 
  • Melamine in infant formula and dairy products 
  • Over-sulfated chondroitin sulfate in heparin 
  • DEG in Cough syrup 
  • DEG in toothpaste 
  • Cantaloupes with Salmonella 
  • Peppers with Salmonella 
  • Aquacultured fish with residues (chem / abx) 
  • Innumerable adulterated “dietary supplements”

Slide 11: Main Lessons Learned

  • FDA – To do our job more effectively at home, we’ve got to do our job more efficiently abroad. Build on the foundation we had established. 
  • Industry – Its “brand” reputation is dependent on the quality of suppliers with whom they choose to engage. 
    • Both individual corporate and industry-wide “brands” 
  • Consumer – When it comes to food and drugs, maybe cheapest isn’t the most desirable attribute.

Slide 12: Main Lessons Learned

  • All – In the world of sourcing our food and drugs, it’s a GLOBAL SUPERMARKET – and Americans are shopping everywhere. 
  • In 2007, the United States imported more than $2 billion worth of FDA-regulated products, from roughly 200 countries or territories, using 825,000 importers, through over 300 U.S. ports–of-entry.

Slide 13: Challenges of Globalization

Globalization has fundamentally changed the environment for regulating food and medical products

Created unique regulatory challenges for FDA:

  • More foreign facilities supplying the U.S.; 
  • Increasing volume of imported products; 
  • More outsourcing of manufacturing and clinical trials; 
  • Greater complexity in supply chains; 
  • Growing complexity of products and manufacturing methods; 
  • Imports coming from countries with less well developed regulatory systems; and 
  • Greater opportunities for economic fraud.

Slide 14: GLOBAL SUPERMARKET

Global Supermarket

This slide depicts the rise in food imports in the global supermarket.

 

 

 

 

 

 

 

 

 

 

Slide 15:

Number of Drugs* Manufactured at Foreign Sites Has More Than Doubled Since 2001

This chart is a vertical bar chart with blue bars rising up from the bottom of the page.  On the 'Y' axis are the number of the active products which range from zero to 50,000.  On the 'X' axis are the calendar years from 2001 to 2007.  The chart is titled "Number of Drugs Manufactured at Foreign Sites Has more than doubled since 2001".

 

 

 

 

Slide 16:

Number of Foreign Sites Making FDA-Regulated Drugs Has More Than Doubled Since 2001.

This chart is a vertical bar chart with blue bars rising up from the bottom of the page. On the 'Y' axis are the Number of Active Sites which range from zero to 3,000. On the 'X' axis are the calendar years from 2001 to 2007. The chart is titled "Number of Foreign Sites making FDA-Regulated Drugs Has more than doubled since 2001".

 

 

 

 

 

Slide 17: Top 10 countries exporting foods - FY 2008

Top 10 countries exporting foods - FY 2008

This chart is a vertical bar chart indicating the top 10 countries that exported food products in fiscal year 2008. On the 'Y' axis is the percentage of foods that have been exported from the top 10 countries. On the 'X' axis are the countries in the following decreasing order: Canada, Mexico, Japan, France, Italy, China, Thailand, India, United Kingdom, Germany. The chart is titled "Top 10 countries exporting foods - FY 2008".

 

 

Slide 18: Top 10 countries exporting drugs & biologics - FY 2008

Top 10 countries exporting drugs & biologics - FY 2008

This chart is a vertical bar chart indicating the top 10 countries that exported drugs and biologics in fiscal year 2008. On the 'Y' axis is the percentage of drugs and biologics that have been exported from the top 10 countries. On the 'X' axis are the countries in the following decreasing order: Canada, Mexico, Germany, India, United Kingdom, Israel, France, Italy, Japan, Australia. The chart is titled "Top 10 countries exporting drugs and biologics - FY 2008".

 

Slide 19: Top 10 countries exporting devices - FY 2008

Top 10 countries exporting devices - FY 2008

This chart is a vertical bar chart indicating the top 10 countries that exported drugs and devices in fiscal year 2008. On the 'Y' axis is the percentage of devices that have been exported from the top 10 countries. On the 'X' axis are the countries in the following decreasing order: Mexico, China, Germany, Canada, Ireland, Japan, United Kingdom, France, Switzerland, Dominican Republic. The chart is titled "Top 10 countries exporting devices - FY 2008".

 

Slide 20: Top 10 Countries exporting electronic products - FY 2008

Top 10 Countries exporting electronic products – FY 2008

This chart is a vertical bar chart indicating the top 10 countries that exported electronic products in fiscal year 2008. On the 'Y' axis is the percentage of electronic products that have been exported from the top 10 countries. On the 'X' axis are the countries in the following decreasing order: China, Mexico, Japan, Malaysia, philippines, Korea, Republic of (South), Germany, Taiwan, Thailand, Indonesia. The chart is titled "Top 10 countries exporting electronic products - FY 2008".

 

Slides 21, 22, and 23: 21st Century Reality

  • Our borders are still boundaries
  • No longer barriers 
    • Not barriers to disease 
    • Not barriers to information flow 
    • Not barriers to product acquisition 
    • Not barriers to the challenges of globalization 
  • Are boundaries to our jurisdiction but not barriers to our realm of activities 
  • Borders can no longer be the first line of defense 
  • We can no longer “inspect” out bad products at the border 
  • Borders must be places where we “audit” that indeed quality has been built in at the point of manufacture 
  • We must: Engage more effectively abroad in order to be more effective at home

Slide 24: The Response

  • FDA Global Presence 
    • Continued bilateral and multilateral engagement with trusted counterparts 
      • Regulatory Capacity Building 
      • International Standards Development and Harmonization 
      • Foreign Inspections – cadre and individual volunteers 
      • Receive and Use Inspection Reports from trusted foreign counterpart authorities 
      • Third Party Certification 
    • 24/7 Presence in Strategic Areas

Slide 25: Reportable Food Registry

  • Intended to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. 
  • Required by 2007 Act 
  • Electronic portal opened on September 8, 2009 and reports can be submitted through FDA the website at http://rfr.fda.gov 
  • Food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States (Responsible Parties) should be registered and such facilities are required to report via the reportable food registry within 24 hours if they find a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. 
  • FDA has issued guidance for industry regarding the Reportable Food Registry. It can be found on the FDA website.

Slide 26: Increased Food Inspections

  • As mandated by the U.S. Congress, FDA will increase its goal of inspections of foreign food processing/manufacturing facilities visited during Fiscal Year 2010 to 600 (from 200 in FY 2009). 
  • The countries and industries inspected under this FDA initiative have been selected based on a risk-based assessment of food imports into the United States and not targeted from any company-specific information. 
  • FDA plans to inspect many companies in several different countries each year. No one country or company is being targeted for specific inspection. 
  • FDA will not inspect companies without first notifying a country’s embassy and competent authority. FDA will then contact the firms, directly or through the competent authority, to coordinate the visit and to include trip planning logistics.

Slide 27: Present In-Country Focus - Better Information

  • Through several broad initiatives, many of which are specific to certain areas, obtain better and more robust information to help FDA officials in the centers and at the borders make better decisions about the products: 
    • that are being developed for the US market, 
    • that are being reviewed for marketing authorization in the USA, 
    • that are being presented for entry into the US, and 
    • that are presently already on the US market.

Slides 28, 29, 30, and 31: FDA Global Presence: Activities

  • (1) Working with counterpart agencies in-country, gather better knowledge about the production of these products and their transport to US ports 
  • (2) Engage with counterpart agencies overseas to leverage scientific, inspectional, and other resources FDA Global Presence: Activities 
  • (3) When requested, engage with counterpart agencies to help build their capacity 
  • (4) Engage private- and public-sector trusted third parties to provide helpful information about regulated industry compliance with FDA standards FDA Global Presence: Activities 
  • (5) Engage with regulated industry to provide greater information about expectations and standards for their products to be admitted to the USA 
  • (6) Engage with USG agencies already in-country with complementary missions FDA Global Presence: Activities 
  • (7) Have the capacity to perform more overseas inspections of high risk facilities 

RESULT: Must be assured that products meet our standards BEFORE they reach our ports Point of manufacture, point of export, in transit, and when presented for importation

Slide 32: FDA Global Presence

Initial In-Country Locations 

  • China 
  • India 
  • Latin America 
  • Europe 
  • The Middle East

Slides 33, 34, 35, 36, and 37: Current FDA Foreign Locations Status

  • China: Posts officially opened in Nov 2008. 
    • Beijing 
      • Director; Sr Tech Experts in foods, medicines, and medical devices 
    • Guangzhou 2 inspectors (foods expertise) 
    • Shanghai 2 inspectors (medicines expertise) 
    • Local hires in all three posts (n=5) 
  •  India: Post in New Delhi opened Jan ’09 Mumbai opened later in year. 
    • New Delhi 
      • Director, Sr Technical experts in medicines, medical devices, and foods 
    • Mumbai 
      • Inspectors (foods and medicines expertise)
    • Local hires in both posts 
  • Latin America: Post San José, Costa Rica opened in Jan ’09; Posts also in Mexico City, and Santiago. 
    • San Jose 
      • Director, Sr technical experts in laboratory medicine and foods 
    • Mexico city 
      • Sr technical experts in foods and medicines 
    • Santiago 
      • Sr Technical expert in foods 
    • Local hires at each post 
  • Europe: Main location in Brussels opened in Dec ’08; sr tech expert in medicines located at European Medicines Agency in London, and sr tech expert in foods located at European Food Safety Agency in Parma. 
  • Middle East: Locations under discussion with US State Department 
    • Director and Sr technical expert in medicines on board. Sr technical expert in foods to be selected. Inspector to be selected.

Total: 35 US nationals overseas 

         15 US nationals Rockville 

         19 Foreign nationals

Slide 38: The Office of International Programs

The Office of International Programs Organizational Chart

The Office of International Programs Organizational Chart.

 

 

 

 

 

 

 

 

 

 

 

 

 

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