Animal Drug Import Tolerances Under ADAA of 1996

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Animal Drug Import Tolerances Under ADAA of 1996

• FDAs Public Health Protection,
• International Harmonization, and
• Trade-Related Goals
• Merton V. Smith, Ph.D., J.D.
• Special Assistant for International Activities
• Office of the Center Director, CVM
• Veterinary Medicine Advisory Committee Meeting
• January 22, 2002

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Increasing Emphasis on International Harmonization

• Growing volume of FDA-regulated imports
• Demand for quick consumer access to new products
• European movement toward a unified market
• Bilateral and multilateral trade negotiations
• New legislative mandates
• Recommendations for increased international
  harmonization

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Increasing Emphasis on International Harmonization

• Growing volume of FDA-regulated imports
• Demand for quick consumer access to new products
• European movement toward a unified market
• Bilateral and multilateral trade negotiations
• New legislative mandates
• Recommendations for increased international
  harmonization

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Policy Statements and Recommendations

• Food and Drug Law Institute Study of Future
  Trends in Regulation (1988)
• Advisory Committee on the FDA (1991)
• Administrative Conference of the United States
  (1991)
• White House Council on Competitiveness (1991)
• World Health Organization Resolution (1992)
• FDA Task Force on International Harmonization
  (1992) FDA Policy on International Memoranda of
  Understanding (1995)
• FDA Policy on Standards (1995)
• National Performance Review Reinventing Food
  Regulations (1996)

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International Agreements

• North American Free Trade Agreement
  (NAFTA)--signed December 17, 1992
• World Trade Organization Agreements (WTO)--signed
  April 15, 1994
• Others trade, environment, scientific and
  regulatory cooperation

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NAFTA Provisions Covering Sanitary
Phytosanitary (SPS) Measures

• Each party may establish and enforce levels of
  protection that it considers appropriate
• Measures must be nondiscriminatory
• No unnecessary obstacles to trade
• Parties shall work toward compatibility of
  measures and treat as equivalent measures meeting
  the importing partys legitimate objectives

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NAFTA Provisions Covering SPS Measures (continued)

• International standards are to be used as the
  basis for national standards
• Parties can apply any measure that results in a
  level of protection higher than an international
  standard but it must be science-based and only
  applied to the extent necessary to achieve the
  established level of protection
• Technical Working Groups

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WTO Provisions CoveringSPS Measures

• Countries have the right to adopt and enforce
  measures necessary to protect health
• Countries shall ensure that measures are applied
  only to the extent necessary to protect health
• Measures must be nondiscriminatory
• Measures shall be based on scientific principles
  and not be maintained without sufficient
  scientific evidence

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WTO Provisions Covering SPS Measures (continued)

• Importing country must accept measures as
  equivalent if the exporting country objectively
  demonstrates to the importing country that
  measures achieve the importing countrys
  appropriate level of protection
• Measures shall be based on international
  standards, except where they provide a higher
  level of protection and then they must be
  scientifically justified

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FDA Legislation

• Before 1997 Federal Food, Drug, and Cosmetic
  Act did not specifically mention international
  harmonization but the following sections provide
  FDAs authority
• Section 701(a) of FFDCA broad rulemaking
  authority
• Section 801 of FFDCA decisions on imports
• Section 301 of PHSA broad authority for public
  health cooperation
• Section 351 of PHSA authority to control drugs
  and medical devices
• Section 361 of PHSA authority to control
  communicable disease

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FDA Legislation (continued)

• Provisions of the FDA Modernization Act of
  1997
• FDA must participate with other countries to
  reduce the burden of regulation, harmonize
  regulatory requirements, and achieve reciprocal
  arrangements as determined to be appropriate by
  FDA in consultation with experts in science,
  medicine, and public health, and in cooperation
  with consumers, users, manufacturers, importers,
  packers, distributors, and retailers of regulated
  products

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FDA Legislation (continued)

• Provisions of the FDA Modernization Act of 1997
• FDA must support USTR in meetings with other
  governments to discuss ways to reduce the burden
  of regulation and harmonize regulatory
  requirements for medical devices if FDA
  determines that such harmonization is consistent
  with the purposes of the Federal Food, Drug, and
  Cosmetic Act

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FDA Legislation (continued)

• Provisions of the FDA Modernization Act of 1997
• Support USTR in efforts to move toward acceptance
  of mutual recognition agreements relating to the
  regulation of drugs, biological products,
  devices, foods, food additives, and color
  additives, and the regulation of good
  manufacturing practices between the European
  Union and the United States

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FDA Regulations and Guidance Related to
International Harmonization and Equivalence
Determinations

• 21 CFR 130.6 Review of Codex Alimentarius food
  standards
• 21 CFR Part 26 Mutual Recognition of
  Pharmaceutical Good Manufacturing Practice
  Reports, Medical Device Quality System Audit
  Reports, and Certain Medical Device Product
  Evaluation Reports United States and the
  European Community
• Draft Guidance on Equivalence Criteria for Food
  (62 FR 30593 June 4, 1997)

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Approaches to International Harmonization by
other U.S. Regulatory Agencies

• Animal and Plant Health Inspection Service
• Food Safety and Inspection Service
• Environmental Protection Agency

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Summary

• FDAs primary goal with regard to its
  international harmonization activities is to
  preserve and enhance its ability to accomplish
  its public health mission including
• maintaining high standards of protection
• enhancing regulatory effectiveness, and
• increasing worldwide consumer access to safe,
  effective, and high quality products

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Summary (continued)

• Trade agreements permit the establishment and
  enforcement of measures that provide a level of
  protection considered appropriate by the
  importing country.
• Measures may be more protective than
  international standards but they must be
  science-based and serve to effect the importing
  countrys chosen level of health protection.
• Where consistent with the consumer protection
  purposes of FFDCA, FDA must harmonize
  requirements and seek appropriate reciprocal
  arrangements based on determinations of
  equivalence

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Summary (continued)

• FDAs regulations satisfy the obligations in
  NAFTA and WTO because they are nondiscriminatory,
  solidly grounded in science, and based on what
  the United States has chosen as the appropriate
  level of protection