Speakers
Melvin S. Drozen, Partner, and Frederick A. Stearns, Partner, Keller and Heckman LLP
Benjamin L. England, Attorney & Co-Founder, FDA Imports
Jeannie M. Perron, Of Counsel, Covington & Burling LLP
Evan P. Phelps, Attorney, Olsson Frank & Weeda, PC
Peter O. Safir, Partner, and Carrie A. Harney, Associate, Covington & Burling LLP
Robert M. Spiller, Jr., former FDA Attorney (1971-2003)
Stephen D. Terman, Principal, and Evan Phelps, Attorney, Olsson Frank & Weeda, P.C.

Program Description
At this updated two-day program, you will learn the fundamentals of the laws and regulations that affect all Food and Drug Administration (FDA)-regulated products: food, drugs, biologics, medical device and radiological health, veterinary products, dietary supplements and cosmetics. This course is designed to provide you with an overall landscape of food and drug law.  It will also include information on how the newly passed legislation, the Food and Drug Administration Amendments Act of 2007 (FDAAA), impacts the industries.

From the difference in regulations for over-the-counter (OTC) and prescription (Rx) drugs to requirements of food manufacturing and nutrition labeling, this meeting walks you through the major regulations to help you develop a clearer understanding and working knowledge of all FDA products. You will gain a broad overview of FDA, and the history and details of specific areas of regulations, including international issues.  Additionally, you will learn about United States Department of Agriculture (USDA), Federal Trade Commission (FTC), Centers for Medicare and Medicaid Services (CMS), U.S. Department of Justice, and other government agencies, and how they implement and enforce the regulation of foods and pharmaceuticals, medical devices and radiological health, veterinary medicine, dietary supplements, cosmetics, and biological and biotechnology products. The basic regulatory requirements that may arise when developing, processing, labeling, distributing, and competitively marketing various kinds of food and therapeutic products, will also be discussed. You will learn how FDA implements and enforces the laws enacted by Congress and how all of this affects what you do every day.

Who Should Attend?
You should attend this program if you are new to the food and drug regulatory community, are in regulatory affairs, the legal community, or are with a federal or state regulatory agency and need a foundation of food or drug law and regulation. It also is a good refresher meeting for regulatory affairs professionals wanting an overview of all the laws and regulations in the food and drug law and regulation fields.  This meeting is designed to precede other FDLI programs because it provides a broad overview of all FDA-regulated products.

The intense nature of this program requires that attendance be limited.  Early registration is recommended.  This program will be held in an informal, classroom atmosphere where dialogue and questions will be encouraged.  FDLI suggests that attendees dress comfortably, i.e., “casual business attire.”

Attendee Handouts
Binder of speaker handouts and materials

FDLI's FDCA Statutory Supplement, including the FDA Amendments Act and Related Sections of Additional Statutes

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

CLEs to be awarded from the following state(s):
Ohio 13.50

Registration Fees
Early Bird Rate (Received before Monday, November 3, 2008)
$920 FDLI Members
$1,345 Non-members
$745 Academics, 501(c)(3) Nonprofit, Government

Standard Rate (Received after Monday, November 3, 2008)
$1,020 FDLI Members
$1,420 Non-members
$820 Academics, 501(c)(3) Nonprofit, Government

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 addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

Conference Registration Policy  

December 2

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

Welcome and Announcements

I. Background of Food and Drug Law and Regulation, and, FDA’s Mission, Jurisdiction, Functions and Organization
        A. FDA Mission – Protecting the Public
        B. Focus on the Law
                1. Things, not people
                2. Interstate commerce
                3. Regulated entities
                4. Statutory definitions
                5. FDA and medicine
        C. Milestones and Turning Points in Food and Drug Law
        D. FDA’s Place in Government
                1. Part of the U.S. Department of Health and Human Services (HHS) and its
                    relationship with the Centers for Medicare and Medicaid Services (CMS)
                2. Subject to Office of Management and Budget (OMB)
                3. U.S. Department of Justice – FDA’s attorneys
                4. U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC),
                    Environmental Protection Agency (EPA)
        E. FDA and Congress
        F. FDA’s statutory authority
        G. FDA’s internal organization – headquarters, ombudsmen, centers, regions
        H. A summary (chapters and themes) of the Federal Food, Drug, and Cosmetic Act
            (FDCA), and the Food and Drug Administration Amendments Act of 2007
            (FDAA Act)

Refreshment Break  | Back To Top >

        I. Approvals, Enforcement, Inspections, Recalls
                1. No private right of action.
        J. Administrative Practices and Procedures; Policy documents
                1. Administrative adjudication
                2. Federal Register and CFR
                3. Rulemaking
                4. Guidance documents
                5. Approval and withdrawal of approval
                6. Citizen’s petitions
                7. Freedom of Information Act (FOIA)
                8. Debarment and disqualification
                9. Public participation
                10. Transparency
                11. Advisory committees; Conflicts of Interest – Title VII
               12. § 10.85 - Advisory opinions
        K. FDA and States
                1. Preemption
                2. Cooperative activities
                3. Division of labor
        L. FDA and the First Amendment
        M. Recent Issues

11:30 a.m.–12:30 p.m.
Lunch

II. Drugs and Biologics
        A. Introduction; definitions; intended use; safe and effective
        B. Investigational New Drug (IND) / New Drug Applications (NDA) / Abbreviated NDA
            (ANDA) / 505(b)(2)
               1. Prescription Drug User Fee Amendments (PDUFA) of 2007 - Title I;
                    user fees and performance goals
               2. Incentives and exclusivities; patents; Hatch-Waxman
               3. Pediatric and orphan drugs
                        a. Pediatric Research Equity Act (PREA) of 2007 – Title IV
                        b. Best Pharmaceuticals for Children Act (BPCA) of 2007 – Title V
        C. Clinical Trial Databases
        D. Postmarket Safety - Title IX
                1. Risk Evaluation and Mitgation Strategies (REMS)

Refreshment Break

        E. Over-the-Counter (OTC) drugs; switches
        F. Post-approval studies
        G. Biologics – How are biologicals different from drugs?
        H. Antibiotics, tropical diseases, genetic testing – Title XI
        I. Drug quality; sampling
        J. Labeling
        K. Advertising and promotion
                1. Off-Label promotion and use
                2. Direct-to-Consumer advertising
                3. False and misleading
        L. Combination products
        M. Current issues
                1. Generic biologics, follow-on biologics, biosimilars, biogenerics
                2. Reimbursement

5:00 p.m.                     
Adjournment for the Day  | Back To Top >

 

December 3

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

IV. Food, Dietary Supplements and Cosmetics
        A. Food - definitions and regulatory terminology                                               
        B. Adulteration; Good Manufacturing Practices (GMPs); Hazard Analysis Critical
            Control Point (HACCP)
        C. Food Safety – Title X
                a. Reportable Food Registry
                b. Improved communication requirements; recalls
                c. Seafood
                d. Annual Reports
        D. Imports; Interagency Import Safety Summit                                                               E. Food standards
        F. Nutrition
        G. Food labeling and claims
        H. Advertising

Refreshment Break

        H. Dietary supplements - definitions and regulatory terminology
                1. Dietary Supplement Health and Education Act of 1994 (DSHEA)
                2. GMPs
                3. Safety; adverse event reporting
                4. Claims
        I. Cosmetics - definitions and regulatory terminology
                1. Safety; Cosmetic Ingredient Review
                2. Labeling                                              
        J. Other federal agencies
                1. United States Department of Agriculture (USDA)
                2. Federal Trade Commission (FTC), National Advertising Division (NAD)
                3. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)
                4. Customs and Border Protection (CBP)
                5. Environmental Protection Agency (EPA)
        K. Emerging issues
                1. Nanotechnology and biotechnology

11:45 a.m.-12:45 p.m.
Lunch

IV. Medical Devices and Radiological Health
        A. Philosophy of regulation; What is a medical device?
        B. Classification of devices and combination products
        C. Investigational Device Exemption (IDE), Premarket Approval Application (PMA),
            and Premarket Notification (510(k)s)
        D. Medical Device User Fee Amendments of 2007 - Title II
                1. Fees
                2. Registration and listing
        E. Pediatric Medical Device Safety and Improvement Act of 2007 - Title III
        F. Clinical Trial Databases – Title VIII
        G. Institutional Review Boards; informed consent; financial disclosures
        H. Post-approval and post marketing surveillance
                1. General requirements
                2. Quality System Regulation (QSR)
                3. Marketing
                4. Medical Device Reporting (MDR); recalls
        I. Radiological health
                1. Standards, reporting and recording of radiation-emitting products
                2. Electronic Product Radiation Control Provisions (EPRC)
                3. Mammography Quality Standards Act
        J. Emerging issues 

Refreshment Break  | Back To Top >

V. Veterinary Products
        A. Animal products: similarities with and differences from other FDA and USDA-
            regulated products
                1. Applications, approvals, labeling, user fees; compounding, advertising and
                    promotion; licenses
        B. Food Safety - Title X
                1. Ensuring the safety of pet food
        C. Animal feed
        D. Drugs for food animals
        E. Drugs for companion animals
        F. Post-approval
                1. Field alert
                2. Adverse event; adverse experience
        G. State regulation; Association of American Feed Control Officials
        H. Genetically-engineered animals

VI. International Issues
        A. FDA’s Office of International Activities, Centers, inspections
        B. International Harmonization – Memoranda of Understanding (MOU),
            Mutual Recognition Agreement (MRA)
        C. Importation requirements and processes
                1. Samples
                2. Registration
                3. Prior notice
                4. Import for export
        D. Exportation requirements and processes
                1. Exporting non-FDCA compliant products
                2. Certificates
                3. Exporting drug products – labeling, “simple notification”
                4. FDA's Final Rule Implementing the Export Reform & Enhancement Act
        E. Other agencies
                1. CBP
                2. Drug Enforcement Administration (DEA)
                3. World Trade Organization (WTO)
        F. Emerging issues
                1. Chinese imports
                2. “Safe and secure” shipments
                3. Work Group on Import Safety
                4. Personal importation

Remaining Questions and Answers

5:00 p.m.                     
Adjournment  | Back To Top >

Meeting Date(s) December 2-3, 2008

Hotel Reservations
L'Enfant Plaza Hotel
480 L'Enfant Plaza, SW
Washington, DC 20024
Phone: 202-484-1000 | 800-635-5065
Web: www.lenfantplazahotel.com

Room Rate
$209 single/double + applicable taxes

Call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Fundamentals of Food conference attendee to receive the rate.

The L'Enfant Plaza Hotel will accept the FDLI group rate on a space available basis.

Reservation Cut-Off November 12, 2008

Check-in 3 pm
Check-out 12 Noon

Directions
The L'Enfant Plaza Metrorail Stop, which you can access from the blue, orange, yellow and green lines, is located directly under the lobby of L'Enfant Plaza Hotel. More Information.