Regulation of Controlled Substances –
Balancing Medical Need and Diversion Control
 |
December 4-5, 2008 Already Registered? |
Online registration for this event has closed.
Walk-ins are welcome and on-site registration will be available.
- General Information
- Agenda
- Hotel Information
Moderators
Jodi L. Avergun, Special Counsel, Cadwalader, Wickersham & Taft
Douglas J. Behr, Partner, Keller and Heckman LLP
David M. Fox, Partner, Hogan & Hartson, LLP
John A. Gilbert, Jr., Principal, Hyman, Phelps & McNamara, P.C.
Deborah B. Leiderman, MD, MA, Principal Consultant, CNS Drug Consulting LLC
Speakers
Ronald W. Buzzeo, RPh, Chief Regulatory Officer, Cegedim Dendrite Compliance Solutions Powered by BuzzeoPDMA
Anita T. Ducca, Director, Regulatory Affairs, Healthcare Distribution Management Association
David L. Durkin, Principal, Olsson Frank Weeda Terman Bode Matz PC
Dean Hart, Executive Vice President, Commercial Operations, NanoGuardian
Jason A. Hill, Partner, Connelly, Jackson & Collier LLP
Michael Klein, PhD, Director, Controlled Substance Staff, Office of the Center Director, CDER, FDA
Peter R. Mathers, Partner, Kleinfeld, Kaplan & Becker
Frank L. Sapienza, MS, Partner, The Drug & Chemical Advisory Group, LLC
Sherry Siegel, MD, Senior Director, Medical Development - Neuroscience Medical Affairs, King Pharmaceuticals, Inc.
Paul L. Uhrig, General Counsel, Exec. Vice Pres., Corp. Development, SureScripts-RxHub
David S. Weinstock, Esq., Director, Senior Regulatory Counsel, Boehringer Ingelheim Pharmaceuticals
Program Description
Prescription drug abuse is a growing problem in the United States as diversion and abuse of drug products continue to escalate. With these troubling trends in mind, how can patients, who have legitimate medical conditions, obtain drug therapies that contain controlled substances, without being hindered by controls intended to minimize diversion? Once the drug leaves the manufacturer, what assurances are in place to ensure that consumers purchase safe and effective products after the drug travels along the distributor, medical doctor and pharmacy routes? Further, how is REMS, Risk Evaluation and Mitigation Strategy, impacting controlled substances? This conference will explore these and other current and emerging issues in the regulation of controlled substances. Participate in the discussions on how the laws and regulations enforced by the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) seek to balance the need to ensure the availability of these medicines while reducing the risk of diversion and abuse.
Who Should Attend?
This conference is designed for intermediate to upper level experienced professionals in the regulatory affairs, distribution, consulting, pharmacy, management and legal arenas who work in the pharmaceutical industry.
Handout Materials
A binder containing speaker presentations and handouts.
Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.
CLEs to be awarded from the following states:
PA/NY = 9.0
OH = 9.0
VA = 9.0
CLEs will be published as we gain state approval
Registration Fees
Early Bird Rate (Received before Monday, November3, 2008)
$720 FDLI Members
$1,145 Non-members
$545 Academics, 501(c)(3) Nonprofit, Government
Standard Rate (Received after Monday, November 3, 2008)
$820 FDLI Members
$1,220 Non-members
$620 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.
December 4, 2008
7:30 a.m.
Registration and Continental Breakfast
8:30 a.m.
FDLI Welcome and Announcements
I. Overview of Program
Program Committee Member
II. The Federal Scheduling Process
Moderator
Deborah B. Leiderman, MD, MA, Principal Consultant, CNS Drug Consulting LLC
Speakers
Michael Klein, PhD, Director, Controlled Substance Staff,Office of the Center Director, CDER, FDA
Frank L. Sapienza, MS, Partner, The Drug & Chemical Advisory Group, LLC
A. Why schedule?
B. How to schedule
C. Interaction between FDA’s Controlled Substances Staff and DEA Staff
1. What data is being examined?
2. When is the product subject to FDA and DEA jurisdictions?
3. Review and approval
4. Studies
5. Status of approval decision
Refreshment Break
III. State and International Scheduling Processes
Moderator
John A. Gilbert, Jr., Principal, Hyman, Phelps & McNamara, P.C.
Speakers
TBA
A. International Conventions
B. World Health Organization’s (WHO) Expert Committee on Drug Dependence
C. DEA and FDA’s Role
D. Impact of U.S. Scheduling
12 Noon-1:00 p.m.
Lunch
1:00 p.m.
IV. Registration Issues and their Impact on Scheduling
Moderator
David S. Weinstock, Esq., Director, Senior Regulatory Counsel, Boehringer Ingelheim Pharmaceuticals
Speakers
Anita T. Ducca, Director, Regulatory Affairs, Healthcare Distribution Management Association (HDMA)
Paul Uhrig, General Counsel, EV, Surscripts-RXHub
Jason Hill, Connelly, Jackson & Collier LLP
A. Suspicious orders
B. Online pharmacies
C. Pain drugs
D. Human growth hormone
E. Quotas
F. Generic and branded drugs; launching
G. Recent case law
H. E-Prescribing
Refreshment Break
V. Listed Chemicals
Moderator
David L. Durkin, Principal, Olsson Frank Weeda Terman Bode Matz PC
Speakers
David Durkin
Jason Hill, Connelly, Jackson & Collier LLP
A. New issues on regulation of precursor chemicals
B. Restrictions affecting industrial use
VI. Investigations and Inspections
Moderator
Jodi L. Avergun, Special Counsel, Cadwalader,Wickersham & Taft
Speakers
Jodi Avergun
John Gilbert
A. DEA
B. State
5:00 p.m.
Adjournment for the Day
5:30-7:00 p.m.
FDLI's Annual Holiday and Awards Reception
December 5, 2008
8:00 a.m.
Continental Breakfast
8:30 a.m.
Recap of Day 1, Overview of Day 2
VII. Risk Evaluation and Mitigation Strategy (REMS) for Controlled Substances
Moderator
David M. Fox, Partner, Hogan & Hartson, LLP
Speakers
Ronald W. Buzzeo, RPh, Chief Regulatory Officer, Cegedim Dendrite Compliance Solutions Powered by BuzzeoPDMA
Deborah Leiderman
Sherry Siegel, MD, Senior Director, Medical Development- Neuroscience Medical Affairs, King Pharmaceuticals, Inc.
A. DEA’s role
B. REMS for different drug substances
1. Prevention of abuse and diversion
2. Safety and effectiveness
Refreshment Break
VIII. Enforcement Actions
Moderator
Douglas J. Behr, Partner, Keller and Heckman LLP
Speakers
Ron Buzzeo
John Gilbert
A. Administrative actions
B. Civil issues
1. Fines
2. Recordkeeping and reporting
Adjournment
Meeting Date(s) December 4-5, 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/DEA 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