Speakers
Frederick H. Branding, RPh, JD, Reed Smith LLP
Cathy L. Burgess, Counsel, Crowell & Moring
Linda S. Carter, Senior Director, Global Regulatory Policy and Intelligence, Johnson & Johnson Pharmaceutical
Robert P. Charrow, Shareholder, Greenberg Traurig
Scott D. Danzis, Attorney, Covington & Burling, LLP
Nicholas M. Fleischer, RPh, PhD, Vice President, Clinical Pharmacology &
Biopharmaceutics, The Weinberg Group, Inc.
Naomi J.L. Halpern, Partner, Frommer, Lawrence & Haug LLP
Marc J. Scheineson, Partner, Alson & Bird, LLP
Deborah M. Shelton, Special Counsel, Sheppard, Mullin, Richter, and Hampton, LLP
Frederick A. Stearns, Partner, Keller & Heckman LLP

Program Description
This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. Learn how the drug industry is being impacted by the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAA Act).  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.

Who Should Attend?
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
FDLI’s Statutory Supplement: Federal Food, Drug, and Cosmetic Act
Copy of the Food and Drug Administration Amendments Act of 2007
Binder of speaker handouts and materials

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

CLEs to be awarded from the following states:
Pennsylvania 13.00
New York 13.00
Ohio 13.25

CLEs will be published as we gain state approval

Registration Fees
Early Bird Rate (Received before Monday, October 20, 2008)
$920 Member
$1,345 Non-member
$745 Gov't/Academic/Non-Profit

Regular Rate (Received after Monday, October 20, 2008)
$1,020 Member
$1,420 Non-member
$820 Gov't/Academic/Non-Profit

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 

NOVEMBER 20
View the agenda for Day Two

8 AM
Registration and Continental Breakfast

8:30-8:45 AM
FDLI Welcome and Announcements

8:45-9:15 AM
Origins and Overview of the Organizational Structure of FDA and the
Regulation of Drugs

1. 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. Food and Drug Administration Modernization Act of 1997 (FDAMA)
   6. Prescription Drug User Fee Act (PDUFA)
   7. Food and Drug Administration Amendments Act of 2007 (FDAA Act)
      a. PDUFA IV
      b. Best Pharmaceuticals for Children Act   (BPCA)
      c. Pediatric Research Equity Act (PREA)
      d. Reagan-Udall Foundation
      e. Clinical Trials Registry
2. 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
3. Relevant Functions of Other Governmental Entities
   1. U.S. Department of Health and Human Services (HHS)
      a. Office of the Inspector General (OIG)
      b. Centers for Medicare & Medicaid Services (CMS)
      c. National Institutes of Health (NIH); Office of Human Risk Protection (OHRP)
      d. Centers for Disease Control and Prevention (CDC)
   2. U.S. Department of Justice (DOJ)
      a. FDA’s lawyers - Office of Consumer Litigation
      b. U.S. Attorneys                                                                        
      c. Drug Enforcement Administration (DEA)
   3. The Securities and Exchange Commission (SEC)
   4. Federal Trade Commission (FTC)
   5. Congressional Budget Office (CBO)
   6. The States; State Attorneys General
4. How FDA Regulates Compounding of Drugs by Pharmacies
   
   

9:15-10:00 AM
FDA's Regulatory Processes

1. Sources of Legal and Regulatory Requirements and FDA Policies
   1. Statutes; FDCA
      a. Structure/Sections
   2. Regulations
      a. Substantive Rules
      b. Interpretive Rules and Statements of Policy
   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 Web site
2. Non-FDA/External Requirements and Pronouncements/ Standards
   1. International Conference on Harmonization (ICH)
   2. United States Pharmacopeia (USP)
3. Participating in FDA Policymaking
   1. Citizen Petitions
   2. Rulemaking Comments and Hearings
   3. Judicial Review
4. Product Specific Regulatory Proceedings
   1. Informal Adjudications
      a. Dispute Resolution; Appeals
      b. Office of Chief Mediator and Ombudsman
   2. Regulatory Hearings
   3. Formal Adjudications
   4. Judicial Review
5. Obtaining and Protecting Information under the Freedom
   of Information Act (FOIA)
   1. Mandatory Disclosures on Request
      a. Categories of Disclosable Information
      b. Exemptions from Mandatory Disclosure
   2. Discretionary Disclosure on Request
   3. Preventing Disclosure of Information Submitted to FDA
      a. Pre-Submission Review by FDA
      b. Right to Notice of Proposed Disclosure
      c. Reverse FOIA Litigation

10:00-10:15 AM
Refreshment Break

10:15-11:30 AM
The New Drug Approval Process:
Basic Concepts and Regulatory Approval Pathways

1. What is a Drug?
   1. Statutory and Regulatory Definitions
   2. The Key Principle - Intended Use
   3. Drugs vs. Other Regulated Products
      a. Drug vs. Food
      b. Drug vs. Dietary Supplement
      c. Drug vs. Medical Device
            i.  Regulatory status of clinical laboratory tests and
                analyte specific reagents
      d. Drug vs. Cosmetic
      e. Drug vs. Biologic
      f. Drug vs. Animal Drug
   4. Combination Products
2. 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
3. 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
      a. Differing Perspectives on Safety (pre-approval and post-approval analyses)
      b. Determination of Safety and Risk
   4. Drugs for Serious or Life-Threatening Illnesses
4. New Drug Approval Pathways
   1. Full New Drug Applications (NDAs)
   2. Abbreviated NDAs (ANDAs)
   3. Paper NDAs/505(b)(2) Applications

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11:30 AM -12:30 PM
Lunch

12:30-2:00 PM
The New Drug Approval Process: New Drug Research and Development

1. Preclinical Testing/Investigation
   1. "Good Laboratory Practice" (GLP) Regulations
2. Clinical Testing/Investigation and Good Clinical Practice (GCP) Requirements
   1. Investigational New Drug (IND) Applications
   2. Phase I, Phase II, Phase III
   3. Role of the Protocol
   4. Informed Consent
   5. Institutional Review Boards (IRBs)
   6. Obligations of Sponsors and Investigators; Role of Contract Research Organizations (CROs)
      a. Monitoring
      b. Reporting Requirements
      c. Disqualification of Investigators
      d. Financial Disclosures
   7. Clinical Holds
   8. Use of foreign studies
   9. Exemptions from the IND requirement
3. Pediatric Testing Requirements
   1. Pediatric Research Equity Act of 2003 (PREA) – FDAA Act Reauthorized
4. Treatment INDs and Emergency Use
5. Fast Track Review/Accelerated (Conditional) Approval
   1. Use of Surrogate Endpoints, Post-Approval Restrictions, and Other Clinical Trial Design Issues
   2. Paragraph viii Notices
6. Orphan Drugs
   1. Designation
   2. FDA Assistance in Study Design
7. Clinical Trial Registry
   1. Suppressing Data
   2. FDAMA Section 113
   3. FDAA Act Title VIII
      

2:00-3:00 PM
The New Drug Approval Process: NDA Submission and Review

1. 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
2. The Review Process
   1. User Fees and Goals - Prescription Drug User Fee Act (PDUFA)
   2. The Review Clock and the Impact of PDUFA
   3. Interacting with FDA
      a. Premarket Review/Good Review Management Principles (GRMP)
      b. Postmarket Safety
      c. Approval Meetings; Product Application Meetings
      d. Special Protocol Assessment (SPA)
      e. Dispute Resolution
      f. Advisory Committees
      g. Pre-Approval Inspections (PAIs)
      h. Approvable/Complete Response and Approval Letters
   4. Special Issues
      a. Risk Management Plans (Risk MAPs)
      b. DEA Scheduling; Controlled Substances
3. 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
4. Post-Approval (Phase IV) Study Commitments

3:00-3-15 PM
Refreshment Break

3:15-5:00 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent
Exclusivity Issues

1. Eligibility for ANDA Consideration
   1. Approved Drug Products with Therapeutic Equivalence Evaluations
      (Orange Book)
   2. Suitability Petitions
2. Content and Organization of an ANDA
3. “Sameness”, Bioequivalence, and Therapeutic Equivalence
4. 505(b)(2) Applications
5. Patent Provisions
   1. Patent Listing
   2. Patent Certifications
      a. Paragraph I, II, III, IV Certifications
      b. Notice of Paragraph IV Certification
      c. Challenges to Patent Listings
      
   3. 30-Month Stays on ANDAs and 505(b)(2) Approvals
6. Marketing Exclusivity
   1. For Innovator Products
      a. Exclusivity for New Chemical Entities (NCEs)
      b. 3-Year Exclusivity for New Uses/Formulations
      c. Pediatric Exclusivity
      d. Orphan Drug Exclusivity
   2. For Generic Products
      a. 180-Day Generic Drug Exclusivity
7. Patent Term Restoration (PTR)
8. 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
9. Generic Biologics
   

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5:00 PM
Adjournment for the Day

NOVEMBER 21
View the agenda for Day One

8 AM
Continental Breakfast

8:30-9:00 AM
Post-Approval Issues

1. Annual Reports
2. Adverse Drug Experience (ADE) Reports
3. FDA Drug Safety Initiative
4. Post-Approval Changes and Supplemental NDAs (sNDAs) and ANDA’s
5. Grounds for Withdrawal of Approval
6. Sale/Transfer of NDAs/ANDA’s
7. Post-Approval Safety Issues
   1. Postmarket Studies
   2. Change in Label Safety Information
   3. Risk Evaluation and Mitigation Strategies (REMS)
   4. Penalties for Noncompliance
8. Medicare, Medicaid and Reimbursement Issues
   
   

9:00-9:50 AM
Over-the-Counter (OTC) Drugs

1. Rx vs. OTC Status
   1. Statutory Definition; Examples
   2. Durham-Humphrey Amendment of 1951
2. The OTC Review and the Monograph Process
   1. Legal Nature and Basis
   2. Scope of the Review
   3. Completing and Amending the Monograph
      a. Requirements Pending Monograph Completion
      b. Updating the Monographs
   4. Monograph Requirements
      a. Ingredients
      b. Labeling Claims
   5. Marketing New Dosage Forms under the OTC Review
   6. New OTC Drug Labeling Requirements
   7. Time and Extent Application (TEA)
3. 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”
4. “Behind-the-Counter” OTC Drugs

9:50-10:05 AM
Refreshment Break

10:05-11:10 AM
Regulation of Drug Manufacturing

1. Establishment Registration and Drug Listing
2. Adulteration
   1. Current Good Manufacturing Practices (cGMPs)
   2. Departure from Compendial or Represented Standards
   3. Insanitary Conditions
3. Inspections
   1. Inspection Process and Procedure
   2. Search Warrants
      a. Administrative
      b. Criminal
   3. Photographs and Recordings
   4. Affidavits and Declaration
   5. Pre-Approval Inspections (PAIs)
      a. Clinical data
      b. Manufacturing
      c. Packaging
      d. GMP Compliance
      e. Validation
4. Responding to 483 Observations - Closing an Inspection
   1. Establishment Inspection Report (EIR)
5. Field Alert Reports
6. Radiofrequency Identification (RFID) and Drug Pedigree Requirements
   
   

11:10 AM -12:30 PM
Regulation of Drug Marketing

1. 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
      a. The Adequate Directions for Use “Squeeze Play”
      b. False or Misleading Labeling
      c. Material Omissions
      d. Lack of Adequate Directions or Warnings
      e. Absence of Label Statements of Identity, Source, Ingredients, or Quantity
      f. Danger to Health when Used According to Labeling
   4. Division of Drug Marketing, Advertising, and Communications ( DDMAC)
2. 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. Quality of Life (QOL)
   8. Direct-to-Consumer (DTC) Advertisements
      a. FDAA Act Established a New DTC User Fee Program – Status Report
      b. Side Effects and Adverse Effects Statements
      c. Civil Penalties
   9. Interactions with SEC – Reporting and Disclosures
   10. Use of Internet
3. 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
      a. Continuing Medical Education (CME)
      b. Scientific Exchange
   5. Medical Science Liaisons (MSLs), Professional Information Requests, and Unsolicited Requests for Information
4. OTC Drugs
   1. Labeling - Regulated by FDA
   2.  Advertising - Regulated by FTC
   3. National Advertising Division (NAD), Council of Better Business Bureaus, Inc.
5. Interactions with DDMAC
   1. Preclearance
   2. Post Marketing Letters
   3. Corrective Actions
6. Prescription Drug Marketing Act (PDMA) of 1987; Drug Sampling
7. Anti-Kickback Statute
8. False Claims Act
9. Other Considerations – the States, Product Liability, the Lanham Act; PhRMA Code
10. Corporate Compliance Programs
    

    1. Code of Conduct
    2. Corporate Integrity Agreements (CIAs)

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12:30-1:40 PM
Lunch

1:45-2:45 PM
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)
   
3. Brand vs. Generic: The Strategic Battle for the Marketplace (ANDA)
4. Drug Promotion: Are You Ready for Prime Time? (Advertising, Promotion, Marketing)

2:45-3:00 PM
Refreshment Break

3:00-3:35 PM
Import and Export Requirements and International Issues

1. Imports
   1. Importation from Foreign Sources; Canada
   2. Import for Export (IFE)
   3. Bovine Spongiform Encephalopathy (BSE) Issues; Product Sourcing
   4. Import Detentions and Refusals
   5. Alerts
2. Exports
   1. Exporting Unapproved Drugs and Vaccines
   2. NDA-Approved Product
   3. Exports for Investigational Use; FDA’s Office of International Programs
3. International Harmonization
4. Counterfeit Drugs
5. Role of U.S. Department of Homeland Security (DHS)/Customs and Border Protection (CBP)
   1. Compliance with FDA and CBP Regulations
6. Drugs and Vaccines for Emergency Use; Personal Use
   
   

3:35-4:25 PM
Violations and Enforcement

1. The Interstate Commerce Element
2. Prohibited Acts
3. 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
      a. Preliminary Injunctions before Trial
      b. Permanent Injunctions and Consent Decrees
      c. Continuous FDA Oversight of Operations
   7. Criminal Prosecutions
      a. Strict Liability Without Criminal Intent
      b. Individual Liability and the Park Doctrine
      c. Misdemeanors versus Felonies
      d. Penalties
      e. Office of Criminal Investigations (OCI), Criminal Process Referrals,
      U.S. Department of Justice
   8. How FDA Decides an Enforcement Action
      a. FDA's Articulated Enforcement Policies for Unapproved Drugs and OTC Drugs
      b. What Motivates FDA to Take Action, i.e., Not Sending Two Warning Letters on the Same Type of Violation
      c. Enforcement Action Against a Competitor
   9. Debarment
   10. Application Integrity Policy (AIP)
       
       

4:25-4:50 PM
New, Emerging, and Continually Interesting Issues

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5 PM
Adjournment