Online registration for this event has closed.
Walk-ins are welcome and on-site registration will be available.
- General Information
- Agenda
- Hotel Information
Speakers
David G. Adams, Chairman, FDA Group, Venable, LLP
Frederick R. Ball, Partner, Duane Morris LLP
Frederick H. Branding, RPh, Partner, Reed Smith LLP
Cathy L. Burgess, Counsel, Crowell & Moring LLP
Robert P. Charrow, Shareholder, Greenberg Traurig
Lisa M. Dwyer, Counsel, Sonnenschein Nath & Rosenthal LLP
Nicholas M. Fleischer, RPh, PhD, Vice President, Clinical Pharmacology & Biopharmaceutics, The Weinberg Group Inc.
Michael S. Labson, Partner, Covington & Burling LLP
Teresa Stanek Rea, Partner, Crowell & Moring LLP
Frederick A. Stearns, Partner, Keller and Heckman LLP
Clark G. Sullivan, Partner, Arnall Golden Gregory, LLP
Program Description
This is the premier course to help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you develop a clearer understanding of how they work. You will receive a broad overview of FDA, the history of drug regulation, and details on specific areas of drug regulation. Additionally, you will examine FDA’s role in managing the drug approval process and how that process governs competition between branded and generic drugs. This program will help you think like an experienced drug professional. You will become more familiar with many of the acronyms used in the drug arena, such as, ANDA, IND, NDA, PDUFA and others. Further, you will gain a clearer understanding of how FDA enforces and implements the laws handed down by Congress. You will learn how all of these provisions and regulations affect what you do every day. This program will also cover the latest topics and important new developments affecting the drug industry, including prescription drug imports, risk management, OTC switches, Hatch-Waxman reform, and more.
You should attend this program if you’re in regulatory affairs, from the legal community or from a federal or state agency, and need an overview on drug law and regulation. It also is a good refresher program for seasoned regulatory affairs and legal professionals.
This meeting will promote an informal, classroom atmosphere where dialogue and questions will be encouraged. FDLI suggests that attendees dress comfortably, i.e., “casual business attire.”
Attendee Handouts
FDCA Statutory Supplement, including the FDA Amendments Act and Related Sections of Additional Statutes
Binder of speaker handouts and materials
Continuing Legal Education (CLE) Credits
CLEs have been approved from the following state(s):
Pennsylvania = 13 credits
Virginia = 13 credits
Registration Fees
Early Bird Rate (Received before Monday, October 5, 2009)
$945 Member
$1,370 Non-member
$770 Academics & Government
Regular Rate (Received after Monday, October 5, 2009)
$1,045 Member
$1,445 Non-member
$845 Academics & 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 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 CSDept@fdli.org, if you have any questions about your conference registration or CD order.
November 5
Go to Agenda for Day Two >
8:00 a.m.
Registration and Continental Breakfast
8:30 a.m.
FDLI Welcome and Announcements
I. Origins and Overview of the Organizational Structure of FDA
and the Regulation of Drugs
A. Landmark Legislative Enactments for Drug Regulation and Development of Today’s Statutory Framework
1.
History
2.
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
3. The 1962 Drug Amendments/Kefauver-Harris
4.
Drug Price Competition and Patent Restoration Act of 1984
5.
Prescription Drug User Fee Act (PDUFA)
6. Food and Drug Administration Modernization Act of 1997(FDAMA)
7. Food and Drug Administration Amendments Act of 2007 (FDAAA)
B. Food and Drug Administration
1. History
2. FDA’s Dual Mission -- The Dilemma
3. The Food and Drug Administration Act of 1988
4. FDA’s Place in Government
5. Responsibilities and Structure of Headquarters and the Field
C. Relevant Functions of Other Governmental Entities
1. Congressional Oversight
2. U.S. Department of Health and Human Services (HHS)
3. U.S. Department of Justice (DOJ)
4. The Securities and Exchange Commission (SEC)
5.
Federal Trade Commission (FTC)
6.
Government Accountability Office (GAO)
7.
The States; State Attorneys General
8.
U.S. Department of Homeland Security (DHS)
D. How FDA Regulates Compounding of Drugs by Pharmacies
II. FDA’s Regulatory Processes
A. Sources of Legal and Regulatory Requirements and FDA Policies
1. Statutes; FDCA
2. Regulations
3. Federal Register (FR) Notices
4. Advisory Opinions and Preambles; Advisory Committees
5. Guidance Documents; Good Guidance Policy (GGP)
6. Compliance Policy Guides (CPGs)
7. Staff Manuals, Guides and Programs
8. Miscellaneous Publications
9. Enforcement Actions and Letters
10. Citizen Petition Responses
11.
Informal Statements and Advice
12.
FDA’s Website
B.
Non-FDA/External Requirements and Pronouncements/ Standards
1. International Conference on Harmonization (ICH)
2.
United States Pharmacopeia (USP)
C. Participating in FDA Policymaking
1. Citizen Petitions
2. Rulemaking Comments and Hearings
3.
Judicial Review
D. Product Specific Regulatory Proceedings
1. Informal Adjudications
2. Regulatory Hearings
3. Formal Adjudications
4. Judicial Review
E. Obtaining and Protecting Information under the Freedom of
Information Act (FOIA)
1. Mandatory Disclosures on Request
2. Discretionary Disclosure on Request
3. Preventing Disclosure of Information Submitted to FDA
Refreshment Break
III. The New Drug Approval Process: Basic Concepts
and Regulatory Approval Pathways
A. What is a Drug?
1. Statutory and Regulatory Definitions
2. The Key Principle - Intended Use
3. Drugs vs. Other Regulated Products
4.
Combination Products
B. What is a New Drug?
1.
The Key Principle – “Old” vs. “New”
2. Old Drug/New Drug vs. Rx/OTC
3. Drug Substances vs. Drug Products
C. Legal Standard for Approval of New Drugs
1. Effectiveness - Substantial Evidence (SE)
2. Adequate and Well Controlled Studies
3.
Safety - Balancing Risk and Initial Benefit
4. Drugs for Serious or Life-Threatening Illnesses
D. New Drug Approval Pathways
1. Full New Drug Applications (NDAs)
2. Abbreviated NDAs (ANDAs)
3. Paper NDAs/505(b)(2) Applications
4. Bioterrorism Review Pathways
11:30 a.m.-12:30 p.m.
Lunch
•• Back to Top
12:30 p.m.
IV. The New Drug Approval Process: New Drug Research and Development
A. Preclinical Testing/Investigation
1. “Good Laboratory Practice” (GLP) Regulations
B. Clinical Testing/Investigation and Good Clinical Practice (GCP) Requirements
1. Investigational New Drug (IND) Applications
2. Phase I, Phase II, Phase III
3. Meetings with FDA
4. Role of the Protocol
5. Informed Consent
6. Institutional Review Boards (IRBs)
7. Obligations of Sponsors and Investigators; Role of Contract Research Organizations (CROs)
8. Clinical Holds
9. Use of Foreign Studies
10. Exemptions from the IND Requirement
C. Pediatric Testing Requirements
1. Pediatric Research Equity Act of 2003 (PREA) – FDAAA Reauthorized
2. Expanded Access Programs
D.
Treatment INDs and Emergency Use
E. Fast Track Review/Accelerated (Conditional) Approval
1.
Use of Surrogate Endpoints, Post-Approval Restrictions and Other Clinical Trial Design Issues
2.
Rolling Submissions
F. Orphan Drugs
1. Designation
2. FDA Assistance in Study Design
G. Clinical Trials Registry
1.
FDAMA Section 113
2.
FDAAA Title VIII
3.
Medical Publisher/State Policies
V. The New Drug Approval Process: NDA Submission and Review
A. Content and Organization of a Full NDA
1. Safety and Effectiveness Data
2. Chemistry, Manufacturing, and Controls (CMC) Information
3. Packaging
4. Proposed Labeling
5. Patent Information
6. Drug Master Files (DMFs)
7.
Certifications and Disclosures
8.
Use of the Common Technical Document
B. The Review Process
1. User Fees and Goals (PDUFA)
2. The Review Clock and the Impact of PDUFA
3. Interacting with FDA
4. Special Issues
C. Responses to FDA Adverse Decisions
1. Right to a Hearing on Refusal to Approve an Application
2. Judicial Review of Refusal to Approve an Application
3. Judicial Review of Approval of a Competitor’s Application
4. FDA and CDER Ombudsman
D. Post-Approval Study and Surveillance Requirements
E. Critical Path Innovations
Refreshment Break
VI. The Abbreviated NDA (ANDA), 505(b)(2) Applications, and, Patent
and Exclusivity Issues
A. Eligibility for ANDA Consideration
1. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
2. Suitability Petitions
B. Content and Organization of an ANDA
C.
“Sameness”, Bioequivalence and Therapeutic Equivalence
D.
505(b)(2) Applications
E.
Patent Provisions
1. Patent Listing
2. Patent Certifications
3. 30-Month Stays on ANDAs and 505(b)(2) Approvals
F.
Marketing Exclusivity
1.
For Innovator Products
2. For Generic Products
G. Patent Term Restoration (PTR)
H. Strategies Affecting Exclusivity
1. Challenges to Eligibility for Generic Marketing
2. Development of New Conditions of Use for Approved Products
3. Use of Generic Exclusivity Rules
4. Branded Generics
I. FDAAA Restriction on Use of Citizen Petitions
J. Biosimilars
5:00 p.m.
Adjournment for the Day
•• Back to Top
November 6
Go to Agenda for Day One >
8:00 a.m.
Continental Breakfast
8:30 a.m.
VII. Post-Approval Issues
A. Annual Reports
B. Adverse Drug Experience (ADE) Reports
C. FDA Drug Safety Activities
D. Post-Approval Changes and Supplemental NDAs (sNDAs) and ANDA’s
E. Grounds for Withdrawal of Approval
F. Sale/Transfer of NDAs/ANDA’s
G. Post-Approval Safety Issues
1. Postmarket Studies
2. Change in Label Safety Information
3. Risk Evaluation and Mitigation Strategies (REMS)
4. Penalties for Noncompliance
H. Medicare, Medicaid and Reimbursement Issues
I. PDMA/Pedigrees/Authentication
1. Drug Distribution Issues
2. Track and Trace Technolgies
VIII. Over-the-Counter (OTC) Drugs
A. Rx vs. OTC Status
1. Statutory Definition; Examples
2. Durham-Humphrey Amendment of 1951
B. The OTC Review and the Monograph Process
1. Legal Nature and Basis
2. Scope of the Review
3. Completing and Amending the Monograph
4. Monograph Requirements
5. Marketing New Dosage Forms under the OTC Review
6. New OTC Drug Labeling Requirements
7. Time and Extent Application (TEA)
C. Rx-to-OTC Switches
1. By Monograph
2. By NDA
3. The Switch Regulation
4. Non-Patent Exclusivity
5. “Forced” OTC Switches
6. Partial OTC Switches, e.g. “Plan B”
D. “Behind-the-Counter” OTC Drugs
Refreshment Break
IX. Regulation of Drug Manufacturing
A. Establishment Registration and Drug Listing
B. Adulteration
1. Current Good Manufacturing Practices (cGMPs)
2. Departure from Compendial or Represented Standards
3. Insanitary Conditions
C. Inspections
1. Inspection Process and Procedure
2. Search Warrants
3. Photographs and Recordings
4.
Affidavits and Declaration
5. Pre-Approval Inspections (PAIs)
D. Responding to 483 Observations – Closing an Inspection
1. Establishment Inspection Report (EIR)
E. Field Alert Reports
F. Product Recalls/Market Withdrawals
X. Regulation of Drug Marketing
A. Key Principles of Advertising and Promotion
1. Basic Definition and Concepts of Labels, Labeling, Advertising
2. Intended Use and the New Drug Approval Requirement
3. Misbranding
4. Division of Drug Marketing, Advertising, and Communications (DDMAC)
B. Prescription Drug Promotion and Advertising
1. Promotional Labeling versus Advertisements
2. Conformance with Approved Labeling
3. Fair Balance
4.
Brief Summary for Advertisements
5. Comparative Claims
6. Pharmacoeconomic/healthcare economic/outcomes information
7. Patient Reported Outcomes
8. Direct-to-Consumer (DTC) Advertisements
9.
Interactions with SEC – Reporting and Disclosures
10.
Use of Internet
C. Off-Label Information and Other Current Issues
1. Washington Legal Foundation (WLF) vs. Henney and the Dissemination of Information on Off-Label Uses
2.
Disease and Help Seeking Ads
3. Pre-Approval Promotion and Advertising
4. Scientific and Educational Activities
5. Use of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medial Professionals
D. OTC Drugs
F. Drug Sampling
G.
Anti-Kickback Statute
H.
False Claims Act
I.
Other Considerations – the States, Product Liability, the Lanham Act;
PhRMA Code
J.
Corporate Compliance Programs
12:30-1:40 p.m.
Lunch
•• Back to Top
1:45-2:45 p.m.
XI. Concurrent Breakouts
(On the registration form, choose one breakout session you wish to attend.)
1.
To Market to Market: Getting Your Drug Approved (New Drug Development)
2. When FDA Knocks: How to Handle a cGMP Inspection (Manufacturing/Drug Safety)
3. Brand vs. Generic: The Strategic Battle for the Marketplace (ANDA)
4. Drug Promotion: Are You Ready for Prime Time? (Advertising, Promotion, Marketing)
Refreshment Break
3:00 p.m.
XII. Import and Export Requirements and International Issues
A. Imports
1. Importation from Foreign Sources; Canada
2. Import for Export (IFE)
3. Foreign Establishment Inspection/FDA Foreign Offices
4. Import Detentions and Refusals
5.
Alerts
B. Exports
1.
Exporting Unapproved Drugs and Vaccines
2.
NDA-Approved Product
3. Exports for Investigational Use; FDA’s Office of International Programs
C. International Harmonization
D. Counterfeit Drugs
E. Role of U.S. Department of Homeland Security (DHS)/Customs and Border Protection (CBP)
1. Compliance with FDA and CBP Regulations
F. Drugs and Vaccines for Emergency Use; Personal Use
G. Enforcement Discretion Related to Canadian Drugs
XIII. Violations and Enforcement
A. The Interstate Commerce Element
B. Prohibited Acts
C. Enforcement Tools and Procedures
1. Warning Letters (WLs) and Untitled Letters
2. Use of Media/Publicity
3. “Voluntary” Recalls
4. Civil Penalties/Disgorgement
5. Seizure Actions
6. Suits for Injunctions, Consent Decrees
7. Criminal Prosecutions
8. How FDA Decides an Enforcement Action
9. Debarment
10. Application Integrity Policy (AIP)
XIV. New, Emerging, and Continually Interesting Issues
5:00 p.m.
Adjournment
•• Back to Top
Meeting Date(s) November 5-6, 2009
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
$199 single/double + applicable taxes
Please call the hotel and identify yourself as an FDLI Introduction to Drug Law conference attendee to receive the rate.
Reservation Cut-Off October 6, 2009
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.