Planning Committee and Faculty
Thomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER, FDA
Deborah M. Autor, JD, Director, Office of Compliance, CDER, FDA
Raymond A. Bonner, Partner, Sidley Austin  LLP
Sarah Botha, Staff Attorney, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom
Jeffrey S. Bucholtz, Partner, King & Spalding, LLP
David K. Elder, Director, Office of Regional Operations, Office of Regulatory Affairs, FDA
Douglas B. Farquhar, Shareholder, Hyman, Phelps & McNamara, P.C.
Steven N. Gersten, Divisional Vice President and Associate General Counsel, Legal Regulatory & Compliance, Abbott Laboratories
Brent J. Gurney, Partner, WilmerHale, LLP
Steven M. Kowal, Partner, K&L Gates LLP
Leslie Kux, Deputy Director, Office of Compliance, CBER, FDA
Daniel G. McChesney, PhD, Director, Office of Surveillance and Compliance, CVM, FDA
Kathleen McDermott, Partner, Morgan, Lewis & Bockius, LLP
Elaine C. Messa, RAC, Director, Medical Device Quality Systems and Compliance Practice, Becker & Associates Consulting, Inc.
Daniel R. Miller, Deputy Attorney General and Director, Medicaid Fraud Control Unit, Delaware Department of Justice
James B. Mintz, President, James Mintz Group, Inc., and, Adjunct Faculty, Toni Stabile Center for Investigative Journalism, School of Journalism, Columbia University
Steven Niedelman, Senior Consultant, Crowell & Moring LLP
Lynn A. Neils, Partner, Mayer Brown LLP
Patrick C. O'Brien, Attorney, Burke O'Neil LLC
Jeremy Perisho, Partner, Deloitte Financial Advisory Services LLP, National Practice Leader, Life Sciences, Deloitte & Touche LLP
Georgia C. Ravitz, Partner, Arent Fox LLP
Douglas W. Stearn, Supervisory Regulatory Counsel, Office of Regulatory Affairs, FDA
Eugene M. Thirolf, Jr., Director, Office of Consumer Litigation,
U.S. Department of Justice
Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
Timothy A. Ulatowski, Director, Office of Compliance, CDRH, FDA
Roberta F. Wagner, Director, Office of Compliance, CFSAN, FDA
Nora L. Zorich, MD, PhD, Vice President, Regulatory, Procter & Gamble

Based on the Commissioner's speech at FDLI on August 6, there will be change in how FDA deals with enforcement matters. What will change for FDA-regulated industries? How about 483 response deadlines, expedited warning letter issuance, swift and aggressive enforcement action, and a warning letter closeout process? One thing is certain, FDA's enforcement efforts will not be business as usual. Find out about FDA's new enforcement environment.

Program Description
FDA Commissioner Dr. Margaret Hamburg delivered a key policy speech at FDLI on August 6, 2009. She promised a more aggressive posture with respect to enforcement and provided insight into those areas where FDA would focus. The FDLI Enforcement Conference is the single best source for understanding where FDA and other enforcement officials are planning to focus.  No other conference brings together more government officials to speak about enforcement, and this year, more than ever, you can’t afford to miss what they have to say.

Not only is there likely to be more FDA heat for industry with Commissioner Hamburg at the helm, there is sure to be a surge in whistleblower cases, major criminal investigations, and increasing state prosecutor attention to pharmaceutical and medical device manufacturers and distributors.  So, if you think you know FDA enforcement, think again.  The laws and the enforcers have changed.

More specifically:

Now that the Supreme Court has limited the preemption previously provided to the federal Food, Drug and Cosmetic Act, how will state legislators, health departments, and prosecutors change their enforcement efforts?

A rash of recent indictments, convictions, settlements and sentencings demonstrates that officials in FDA-regulated industry – even (or especially) at mainstream companies – cannot feel comfortable about their compliance efforts.

Use of Import Detentions by FDA has notably increased.

Since FDLI’s last Enforcement and Litigation Conference, courts also reversed the conviction of a food company executive (U.S. v. Farinella), upheld state statutes forbidding “data mining” by drug companies (IMS Health v. Sorrell, IMS Health v. Ayotte), and held that FDA approval of medical devices can protect against certain product liability suits (Riegel v. Medtronic).

More developments are on the horizon in a variety of enforcement areas.  For example, the potential criminal liability of clinical investigators for clinical trials was reinforced in U.S. v. Palazzo. The indictment of Synthes and four of its executives further underscored the exposure for companies–and the executives of companies – that market medical devices.  Additionally, the still unresolved requirements for clinicaltrials.gov, suggest potential risks relating to compliance with those requirements.  Moreover, the Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative, which was launched in 2006 and has already, brought increased oversight to clinical trials can only be expected to ramp up in today’s more aggressive enforcement atmosphere.

The major change in preemption and the huge increase in staff at FDA offices overseas mean that regulated companies need to think more globally (both figuratively and literally) about what FDA enforcement means to them before it is too late.  Come hear FDA enforcement decision makers discuss how FDA will be enforcing the laws that affect your company /client before you face an enforcement action, and hear from leading members of the private food and drug bar about how they are adapting to the new global enforcement environment.

Who Should Attend?
In-house and outside counsel, compliance officers, regulatory affairs specialists for pharmaceutical, biological, medical device, dietary supplement and food companies.

Non-attorneys who manage government and civil litigation, regulatory compliance matters and other healthcare compliance activities.

Handout Materials
Speaker PowerPoint presentations will be posted as they are received. View the posted presentations here.

Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.

Registration Fees
Early Bird Rate (Received before Monday, September 14, 2009)
$845 Member
$1,220 Non-member
$670 Academics & Government
$375 Student

Regular Rate (Received after Monday, September 14, 2009)
$945 Member
$1,295 Non-member
$745 Academics & Government
$375 Student

Special CD Price!
Purchase the CD set for just $99 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC and Maryland addresses will be charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420,
or by e-mail at service@fdli.org, if you have any questions about your conference registration or CD order

October 13

7:30-8:30 a.m.             
Registration and Continental Breakfast

8:30a.m.                      
FDLI Welcome and Announcements

Conference Chairman’s Overview and Opening Remarks

I. Compliance Central: FDA Compliance Directors Describe What Has Already Changed under the New Administration and What Changes to Expect in the Coming Months
         A. Statistics, Trends, Focus Areas
                  1. Enforcement Actions Figures and Statistics
                  2. Where will the FDA Searchlight Land?
         B. FDA Commissioner’s Initiative - The Future of  Enforcement
                  1. Commissioner Hamburg’s Six Initiatives
                  2. Other Directions that Enforcement Components will Head
         C. Corporate Accountability
                  1.  Advise as to What You, or Your Clients, Should be Doing
                       to Ensure Compliance

Refreshment Break

II. That’s “Billion” with a “B:” FDA’s Most Prolific Enforcer: Whistleblowers, Qui tam Suits, Criminal Prosecutions and Their Continued Influence on FDA Enforcement
         A. Qui tams – The Impetus for Many of the Largest Settlements in History are Qui               tams; Most of them Involve FDA-regulated Companies
                  1. Status/Trends – Number of Open Qui tams Involving FDA-regulated                                Companies (under seal, public; Lilly $1.4 billion settlement; Quest                                Diagnostics $302 million; Cephalon $425 million) 
                  2. The Government’s Qui tam Review Process, or the Qui tam as Only the                       Beginning of Your Troubles; Parallel Criminal Investigations
         B. Qui tams - Strategies & Tactics
                  1. What to do when Filed
                  2. Preventing a Qui tam
         C. Corporate Integrity Agreements (CIAs)
                  1. New Provisions
                  2. Setting Standards in Areas Where There is No Other Guidance

12 Noon-1:30 p.m.     
Lunch

1:30 p.m.                     
III.Roles & Responsibilities: The Government’s Prosecution of Lawyers, Compliance Officers and Others Within FDA Regulated Companies                                  
         A. The US v. Park Baseline:  Any Responsible Corporate Officer Can be Sent to Jail              for an FDCA Misdemeanor
                  1. Level of Exposure; Risks
                  2. Consequences for the Convicted Official
         B. Why Does the Government Prosecute an Individual? Individual Culpability
             and Accountability                                                                                   
                  1. Legal vs. Business Functions 
                  2. Implications; Prosecutions
                  3. False Statements
                  4. What Should the Company Official Do When He/She Thinks Something is                       Not Right or is in Violation of the FDCA?
                  5. When is it Time to Hire your Own Lawyer?

Refreshment Break

IV. Beyond FDA Enforcement Against FDA Regulated companies:
other Enforcement Concerns
         A. Other Enforcers Consumer Product Safety Commission (CSPC), Federal Trade               Commission (FTC), States Attorneys’ General, Securities and Exchange                        Commission (SEC)
         B. Private Lawsuits in a Post-Preemption World  
         C. Other Statutes Involved in Major Cases Against FDA-regulated Companies
                  1. False Claims Act (FCA); (reverse False Claims)
                  2. Anti-kickback
                  3. Securities Fraud
                  4. Foreign Corrupt Practices Act (FCPA)

5:00 p.m.                     
Adjournment for the Day

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October 14

8:00-8:30 a.m.             
Continental Breakfast

8:30 a.m.                     
Overview of the Day and Recap of Day 1

V. Global Enforcement Issues
         A. U.S. Enforcement Based on International Conduct
         B. International Enforcement: An Update on FDA’s International Posts
         C. Inspections of Facilities; Outsourcing: Show and Shadow Companies
         D. Enforcement at the Borders–Import Detentions; Import Alerts

Refreshment Break

VI. Transparency - Who is Imposing Disclosure Requirements
and What is being Required
         A. Required Disclosures
         B. Government Guidance
         C. Association Codes: AdvaMed and PhRMA Codes
         D. Voluntary Disclosures by Companies, Office of the Inspector General (OIG)                       Guidances
         E. Clinical Trials Disclosures
         F. Sunshine Act
         G. States
         H. Institute of Medicine
         I. Right to a Hearing
         J. Academic Institutions
         K. Relationships with Patient Advocacy Groups

11:45 a.m.-1:00 p.m.
Lunch

1:00 p.m.                     
VII.Economic Impact of Enforcement and the Impact of the Economy on Enforcement
         A. Cut-Backs, Belt-tightening and Their Effect on Enforcement Issues,
             Quality Systems, Compliance and SEC/Investor Communications
         B. Layoffs of Personnel
                  1. Qui tam Filings
                  2. Loss of Expertise

Refreshment Break

VIII. Hot Topics
         A. Commissioner’s Enforcement Agenda
                  1. Major Focus Areas Explained
                  2. Remaining Questions and Implementation
                  3. Likely Effects
         B. Off-label Guidance
                  1. First Amendment
                  2. Clinicaltrials.gov

5:00 p.m.                     
Adjournment

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Event Location
The Madison Hotel
1177 15th St. NW
Washington, DC 20005
Phone: (202) 862-1600
Visit the hotel's website

Room Rate
$259 single/double + applicable taxes
Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Enforcement conference attendee to receive the rate.

Reservation Cut-Off September 11, 2009

Check-in 3 pm
Check-out 12 noon

Directions via Metro

Orange/Blue Line: Take the Orange or the Blue Line to McPherson Square Metro station and exit through the White House exit to McPherson Square Park located at L Street and 15th Street. Cross I Street and walk up 15th Street, cross L Street but continue to walk up 15th Street. The Madison Hotel will be on your right.

Red Line: Take the Red Line to Farragut North and walk up K Street. Make a left onto 15th and proceed approximately 1.5 blocks to The Madison Hotel on the right hand side.

View more directions from the hotel's website.