Summer Program

Courses

day 1 - Introduction to the national and international regulation of the food and drug supply

Session 1 – Welcome and Introductions

  • Welcome to the O’Neill Institute
  • Introduction of participants
  • Opening lecture

Speakers: Oscar Cabrera (Executive Director, O’Neill Institute), “The O’Neill Institute’s Role in Closing Educational and Regulatory Gaps in a Globalizing Environment of Food Production and Drug Manufacturing”; Sam Halabi, (O’Neill Institute) “Welcome”

Session 2 – Challenges and Opportunities in Changing Food and Drug Supply Chains, Research, Public Health and Regulation

The lecture will address:

  • Food and Drug Law Governance: Industry, the Academy, Government and Global Health Advocacy Organizations
  • Medical Product Safety and Security Across the Global Manufacturing Supply Chain
  • Big Data and the Reorientation of Drug Regulation
  • The Human Microbiome and the Future of Drugs for Non-communicable Diseases
  • Regulation in the Face of Antimicrobial Resistance

Speakers: Dr. Jesse L. Goodman (Georgetown University Center on Medical Product Access, Safety and Stewardship); Sandra Eskin (The Pew Charitable Trusts) Moderator: Sam Halabi (O’Neill Institute)

Session 3 – Current Trends in the Architecture and Enforcement of US Federal Food and Drug Law

This panel will provide an overview of the core federal statutes regulating food and drug safety as well as trends in civil and criminal enforcement actions, including the:

  • The Federal Food, Drug and Cosmetics Act and Recent Additions and Revisions
  • The Federal False Claims Act and Trends in Off-Label Marketing Enforcement
  • The Park Doctrine and Criminal Enforcement of FDCA Regulations

Speakers: Professor Joseph A. Page (Georgetown University); Ariel Glasner (Blank Rome LLP); Jodi Avergun (Cadwalader Wickersham and Taft)
Moderator: Aliza Glasner (O’Neill Institute)


Session 4 – Roundtable on Non-US Approaches to Food and Drug Regulation

This session features participants from African Union Member Countries, Brazil, Canada, China, EU Member Countries, India, Korea and Mexico and what the regulatory infrastructure looks like in these jurisdictions as well as the role of advocates, regulators, and industry participants in the regulatory regime. This interactive discussion forum will examine comparative theories of regulation, including those relating to correction of market failures, paternalism, and the practicalities of interacting with regulators in comparative context.

Moderator: Sam Halabi (O'Neill Institute)


day 2 - Best practices

Day 2 will focus on current trends in the best practices of manufacturing processes, doing business in foreign jurisdictions, and attending to regulatory regimes based not just from FDA, but from the FTC and the EPA as well.

Session 1 – Before the FDA Comes Knocking: Current Good Manufacturing Practices and Dealing with FDA Enforcement Actions

This session will examine:

  • Best practices in manufacturing quality control
  • FDA Enforcement Actions: Investigation, Communication and Execution
  • Best practices in light of recent legislative and regulatory changes

Speakers: Jennifer Zachary (Covington and Burling, LLP); Marc Scheineson (Alston and Bird, LLP)
Moderator: Sam Halabi (O’Neill Institute)

Session 2 – Food and Drug Regulation in Shared Regulatory Space: Perspectives from the Federal Trade Commission and Environmental Protection Agency

This session will examine:

  • FTC authority over food and nutrition advertising including deceptive acts or practices and “materiality” standards for food and nutrient claims
  • Coordination between FTC and USDA or FDA over food and drug claims
  • Relationship between regulatory enforcement actions and private litigation to enforce accurate labeling standards
  • EPA policies toward food safety especially agricultural policy
  • EPA’s International Partnerships with Codex Alimentarius, OECD and NAFTA

Speakers: David Vladeck (Georgetown University and Former Director of FTC’s Bureau of Consumer Protection); Lisa Heinzerling (Georgetown University and Former Associate Administrator, EPA Office of Policy
Moderator: Sam Halabi (O’Neill Institute)

Session 3 – Best Practices in Regulatory Compliance and the Interface of Manufacturing, Supply Chains and Standards in China

This panel will examine:

  • Best practices in establishing and maintaining pharmaceutical, medical device, health care, and other operations in China,
  • Clearing regulatory hurdles and navigating China’s legal and business environment
  • Standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements
  • Fraud, reimbursement, and off-label enforcement trends
  • Linkages between reimbursement, import-export, and quality control measures
  • Trade-related aspects of food and drug regulation in China including unique sanitary and phytosanitary measures and technical export and import requirements

Speakers: Philip Chen (Office of the US Trade Representative), Gordon Schatz (Reed Smith); Ed Zhao (US Pharmacopeial Convention)
Moderator: Susan Roosevelt Weld (Executive Director, Law Asia Leadership, Georgetown University)

Session 4 – Keynote: Dr. Margaret Hamburg, Commissioner, US FDA

This keynote will focus on:

  • The changing nature of FDA’s consumer protection role as its activities expand overseas fromraw materials and other ingredients to manufacture, storage, sale, and distribution
  • International cooperation between regulatory agencies
  • Challenges facing the FDA as emerging markets and developing countries contribute greater supplies of generic and new drugs
  • Balancing prevention and inspection as regulatory strategies
  • Data-driven risk analytics

Speaker: Dr. Margaret Hamburg (FDA)
Moderator: John Monahan (Georgetown University)

day 3 - public sector and private sector regulatory strategies

Day 3 will examine current trends in private, industry-driven regulatory initiatives as complements and alternatives to command and control, performance based or incentive based regulation accomplished through legislation and administrative action.

Session 1 – The Balance Between Regulation and Private Sector Initiative in Securing Healthy Sustainable Food

The lecture will provide an introduction to:

  • Market pressures to reduce salt, sugar and saturated fat content of processed foods
  • Supply chain management for fresh fruits, vegetables, and dairy
  • Governance structures between industry and government with respect to managing non-communicable diseases through food content regulation

Speaker: Derek Yach (The Vitality Group; Former Senior Vice President of Global Health and Agriculture Policy at PepsiCo; Former Representative of the Director-General of the World Health Organization)

Session 2 – The FDA’s Global Regulatory Activities

The panel will analyze:

  • The Process of FDA International Investigations
  • Oversight of overseas generics manufacturing facilities
  • Overview of FDA’s foreign facilities and cooperative networks

Speakers: Doug Stearn (FDA); Jennifer Devine (FDA)

Session 3 – Counterfeit Medicines, Safe Online Pharmacies and Detection Technologies

This session will engage participants in an interactive exercise that explores:

  • Trends in the sale of counterfeit and substandard medicines through third-party and internet based vendors
  • CD3 Detection Technology and its use at import sites, international postal facilities and remote areas of the developing world
  • International cooperative investigation and enforcement activities

Speakers: Jeff Gren (Alliance for Safe Online Pharmacies; Gren International Health & Trade Consulting); Ilisa Bernstein (FDA)
Moderator: Michele Forzley (O’Neill Institute)

Session 4 – Comparative EU and US Approaches to Food and Drug Regulation

This panel will examine:

  • Differences in regulatory communication and approval processes between US FDA and EU EMA
  • Norms in interacting with US and European regulatory authorities
  • Comparative approaches to risk assessment and analysis
  • Mutual cooperation and recognition after the TTIP

Speakers: Ben Haas (Latham and Watkins, LLP); Alberto Alemanno (HEC Paris and O’Neill Institute)(via video-link); Sabine Haubenreisser (European Medicines Agency)

 

day 4 - trade and investment limits on regulatory measures

Day 4 will examine the restraints that international trade and investment agreements impose on domestic regulation of food and drugs. These restraints have been highlighted by recent disputes at the WTO and international arbitration fora.

Session 1 – Trade, Investment and Food and Drug Regulatory Measures: Basic Principles of Trade Policy and Law

This session will examine:

  • The impacts of trade and investment policies on planning and implementing regulatory measures including ractopamine content limitations and genetically modified organism labeling rules
  • The law and structure of the World Trade Organization (WTO) with special emphasis on the Agreement on the Application of Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade
  • Principles of non-discrimination and necessity and how they have been invoked in disputes concerning food and drug regulatory measures

Speaker: Benn McGrady (O’Neill Institute)

Session 2 – Regulatory Harmonization, Cooperation and Memoranda of Understanding

This session will examine:

  • FDA’s current mutual recognition policies and memoranda of understanding with foreign national regulatory authorities
  • Regulatory harmonization efforts under way in member countries of the African Union
  • Regulatory harmonization efforts under way in the region of the Americas

Speakers: Michele Forzley (O’Neill Institute); Katherine Cooper (FDA); James Fitzgerald (Pan American Health Organization)

Session 3 – The Codex Alimentarius and the Food Safety ModernizationAct

This session will examine:

  • Codex Alimentarius Commission Decision-Making with emphasis on Guidelines on Nutrition Labeling, Guidelines for Use of Nutrition and Health Claims and the General Standard for the Labeling of Prepackaged Foods
  • Consumer protection and enforcement aspects of the Food Safety Modernization Act
  • The general regime of food import regulation in the US and the operationalization of new regulations under the Food Safety Modernization Act

Speakers: Chris Waldrop (Consumer Federation of America); Sharon Mayl (US FDA); Aliza Glasner (O’Neill Institute)
Moderator: Sam Halabi (O’Neill Institute)

Session 4 – Food and Drug Regulation in India: Priorities for the New Government
This lecture will examine:

  • The Profile of Prime Minister Modi’s New Government
  • Clinical Trials Litigation
  • India’s Prescription Drug Market and Schedule H1
  • Doing Business in India after the Election: Continuity and Change

Speaker: Vince H. Suneja (Chief Executive Officer, TwoFour Insight Group, LLC; Former First Secretary, Market Access & Compliance Attaché at the U.S. Embassy in New Delhi, India)

 

Day 5 - National and international food and drug regulation: the open questions

The final day of the summer program will focus on two substantial sources of uncertainty in the future of food and drug regulation: regulatory capacity in low and middle income countries (LMICs) and the Affordable Care Act

Session 1 – Necessary Investments in Regulatory Infrastructure and Working with Governments Lacking Regulatory Capacity

This session will focus on the key regulatory failures in low and middle income countries and best practices for working with LMICs while avoiding the appearance of corruption, including:

  • Pfizer Pharmaceutical’s compliance plan for working in LMICs while complying with the US Foreign Corrupt Practices Act
  • Priority areas for investment in regulatory infrastructure 

Speakers: John Monahan (Georgetown University and U.S. State Department); Parth Chanda (Pfizer Pharmaceuticals); Bruce Gellin (HHS Deputy Assistant Secretary for Health; Director, National Vaccine Program Office)
Moderator: Sam Halabi (O’Neill Institute)

Session 2 – The Affordable Care Act and Congressional Priorities for Food and Drug Regulation


This panel will examine uncertainties arising under the major health reform legislation in the US as well as forecast Congressional priorities in the wake of the Food Safety Modernization Act and the Food and Drug Safety Administration Innovation Act, including:

  • How the essential benefit package will shape pharmaceutical demand in the near and long term
  • Nutritional labeling aspects of the Affordable Care Act and likely challenges and changes in food advertising and labeling
  • An interactive discussion of the issues

Speakers: Tim Westmoreland (Georgetown University); Prof. Samuel R. Wiseman (Florida State University)

Lunchtime Talk and Open Forum for Unanswered Questions

This interactive session will provide a forum for:

  • Participants to ask any unanswered questions
  • Discussion of the issues directed by participants