Program Description

Stay in compliance with FDA's drug regulations and help minimize regulatory problems by attending this course. Examine the essential elements of the laws and regulations that affect the drug industry. 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. 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.”

Speakers

Paul Aebersold, PhD, Principal, Global Regulatory Strategy Consulting, Quintiles
Frederick R. Ball, Partner, Duane Morris LLP
Jennifer S. Blakely, Attorney, and William H. Kitchens, Partner, Arnall Golden Gregory LLP
Cathy L. Burgess, Counsel, Crowell & Moring, LLP
Robert P. Charrow, Shareholder, Greenberg Traurig LLP
Dean R. Cirotta, Vice President, EAS Consulting Group, LLC
Areta L. Kupchyk, Partner, Reed Smith LLP
Madeleine M. McDonough, Partner, Shook, Hardy & Bacon L.L.P.
Linda Pissott Reig, Principal, and Jennifer A. Sanfilippo, Associate,
Porzio, Bromberg, & Newman, P.C.
Arthur Y. Tsien, Principal, Olsson Frank Weeda Terman Bode Matz PC

 

Attendee Handouts

FDLI's Statutory Supplement: Federal Food, Drug, and Cosmetic Act, 2010 Edition
Binder of speaker handouts and materials

Continuing Legal Education (CLE) Credits

Continuing Legal Education credits are available after attending this program. FDLI applies directly to Ohio, Pennsylvania and Virginia. These states are generally recognized as approved jurisdictions by other states. Please contact your Bar Association for guidance.

CLE credits for Introduction to Drug Law and Regulation have been approved for the following:

Virginia = 13.5 credits

Registration Fees

$1,095 Member
$1,525 Non-Member

$ 895 Government Member
$ 995 Government Non-Member

$ 895 Academic Member
$ 995 Academic Non-Member

$1,095 Sole Practitioner Member
$1,525 Sole Practitioner Non-Member

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.

Monday, November 8

8:00 a.m.
Registration and Continental Breakfast

8:30-8:45 a.m.
FDLI Welcome and Announcements

8:45-9:15 a.m.
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. Historical Context
                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)
                        a. PDUFA IV
                        b. Best Pharmaceuticals for Children Act (BPCA)
                        c. Pediatric Research Equity Act (PREA)
                        d. Reagan-Udall Foundation
                        e. Clinical Trials Registry
                        f. Postmarket Studies and Surveillance (REMS)
                8. Health Care Reform Bill 2010
        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)
                        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)
                3. U.S. Department of Justice (DOJ)
                        a. FDA's Lawyers - Office of Consumer Litigation
                        b. U.S. Attorneys
                        c. Drug Enforcement Administration (DEA)
                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

9:15-10:00 a.m.
II. FDA's Regulatory Processes

        A. 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 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
                        a. Dispute Resolution; Appeals
                        b. Office of Chief Mediator and Ombudsman
                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
                        a. Categories of Disclosable Information
                        b. Exemptions from Mandatory Disclosure
                2. Discretionary Disclosure on Request
                3. Preventing Disclosure of Information Submitted to FDA
                        a. Presubmission Review by FDA
                        b. Right to Notice of Proposed Disclosure
                        c. Reverse FOIA Litigation

10:00-10:15 a.m.
Refreshment Break

10:15 -11:30 a.m.
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 FDA 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. Biologics
                        f. Animal Drugs
                        g. Tobacco
        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
                        a. Determination of Safety and Risk
                        b. Differing Perspectives on Safety (pre- approval
                        and post-approval analyses)
                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

12:30-2:00 p.m.
IV. The New Drug Approval Process: New Drug Research and Development

        A. Preclinical Testing/Investigation
                1. "Good Laboratory Practice" (GLP) Regulations
                2. Preclincal Data Requirements
        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)
                        a. Monitoring
                        b. Adverse Event Reporting (AER)
                        c. Financial Disclosures
                8. Clinical Holds
                9. Use of Foreign Studies
                10. Exemptions from the IND Requirement
                11. Disqualification of Investigators/Debarment
        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
        H. Requirements Associated with Federally Funded Studies

2:00-3:00 p.m.
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
                        a. Premarket Review/Good Review Management Principles (GRMP)
                        b. Special Protocol Assessment (SPA)
                        c. Approval Meetings; Product Application Meetings
                        d. Advisory Committees
                        e. Pre-Approval Inspections (PAIs)
                        f. Complete Response and Approval Letters
                        g. Postmarket Safety/REMS
        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/Dispute Resolution
        D. Post-approval Study and Surveillance Requirements
                1. Risk Evaluation and Mitigation Strategies (REMS)
        E. Critical Path Innovations

3:00-3:15 p.m.
Refreshment Break

3:15-5:00 p.m.
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
                        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
        F. 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
        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; Legislation

5:00 p.m.
Adjournment for the Day

Tuesday, November 9

8:00 a.m.
Continental Breakfast

8:30-9:00 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
                5. Product Recalls/Market Withdrawals
        H. Medicare, Medicaid and Reimbursement Issues
        I. Prescription Drug Marketing Act (PDMA)/Pedigrees/Authentication
                1. Drug Distribution Issues
                2. Track and Trace Technolgies

9:00-9:50 a.m.
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
                        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)
        C. OTC by NDA
        D. 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"
        E. "Behind-the-Counter" OTC Drugs

9:50-10:05 a.m.
Refreshment Break

10:05-11:10 a.m.
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
                        a. Administrative
                        b. Criminal
                3. Photographs and Recordings
                4. Affidavits and Declaration
                5. Types of Inspections
                        a. Routine
                        b. For Cause
                        c. Follow Up
                        d. Pre-Approval Inspection (PAI)
        D. Responding to 483 Observations – Closing an Inspection
                1. Establishment Inspection Report (EIR)
        E. Field Alert Reports

11:10 a.m.-12:30 p.m.
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
                        a. Adequate Directions for Use
                        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)
                        a. Preclearance
                        b. Submission Requirements
                        c. Post Marketing Letters
                        d. Corrective Actions
        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
                        a. Broadcast Guidance
                        b. New DTC User Fee Program
                        c. Current Developments
                9. Interactions with SEC – Reporting and Disclosures
                10. Use of Internet, Electronic and Social Networking Media
        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
                6. Good Reprint Practices
        D. OTC Drugs
                1. Labeling - Regulated by FDA
                2. Advertising - Regulated by FTC
                3. National Advertising Division (NAD), Council of Better Business Bureaus, Inc.
        F. Drug Sampling
        G. Anti-Kickback Statute
        H. False Claims Act
        I. Other Considerations – the States, Product Liability, the Lanham Act; PhRMA Code
        J. Medicare/Medicaid Fraud
        K. Corporate Compliance Programs
                1. Codes of Conduct
                2. Corporate Integrity Agreements (CIAs)

12:30-1:40 p.m.
Lunch

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)

2:45-3:00 p.m.
Refreshment Break

3:00-3:35 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

3:35-4:25 p.m.
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
                        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)
        D. FDA Commissioner's Enforcement Initiatives
                1. Post-Inspection Deadlines
                2. Shift in OCC Review
                3. Development of Risk Control and Enforcement Strategies
                with Regulatory Partners
                4. Increased Commitment to Warning Letter and Recall Follow-Up
                5. Swift, Aggressive, Immediate Enforcement Action When Indicated
                6. Warning Letter Close-Out Process

4:25-4:50 p.m.
XIV. New, Emerging and Continually Interesting Issues

5:00 p.m.
Adjournment

Park Hyatt Washington Hotel
24 and M Streets, NW
Washington, DC 20037
Phone: (202) 789-1234
Visit the hotel's website

Room Rate $269 single/double plus prevailing taxes

Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/
Introduction to Drug Law conference attendee to receive the rate.

Reservation Cut-Off October 4, 2010

Check-in 3 pm
Check-out 12 noon

Directions

Via Metro
The nearest station to Park Hyatt Washington is Foggy Bottom/George Washington University Station (Blue/Orange Lines), located on the corner of 23rd and I Streets, NW.

Please visit the Maps & Directions page on the hotel's website for driving directions.