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Introduction to Drug
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November 8-9, 2010 |
Conference Registration Policy
- General Information
- Agenda
- Hotel Information
Speakers
Frederick R. Ball, Partner, Duane Morris LLP
Jennifer S. Blakely, Attorney, and William H. Kitchens, Partner,
Arnall Golden Gregory LLP
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
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
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.
Early Bird Rate (Register by Friday, October 8, 2010)
$ 995 Member
$1,450 Non-Member
$ 795 Government Member
$ 920 Government Non-Member
$ 795 Academic Member
$ 920 Academic Non-Member
$ 995 Sole Practitioner Member
$1,450 Sole Practitioner Non-Member
Regular Rate (Registered after Friday, October 8, 2010)
$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
Event Location
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.
FREDERICK R. BALL is a Partner with the law firm of Duane Morris LLP in Chicago, IL. He concentrates his practice in areas in which companies or individuals are adverse to state or federal governments, including administrative, civil and criminal matters, with the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), Centers for Medicare and Medicaid Services (CMS) and other regulatory agencies. Mr. Ball conducts internal investigations for healthcare companies in the area of compliance and advises them on implementing corporate compliance programs and corporate integrity agreements. He also regularly deals with enforcement of noncompetition agreements, protection of trade secrets, regulatory compliances and Hatch-Waxman litigation. He regularly publishes and presents on issues related to pharmaceutical law including compliance, promotion, reimbursement and enforcement. Mr. Ball graduated from the University of Colorado at Boulder and received his JD, cum laude, from Cornell Law School.
JENNIFER S. BLAKELY is an Associate in the Life Sciences Practice Group and Healthcare Practice Group at the law firm of Arnall Golden Gregory LLP in Atlanta. She also practices in the area of Government Affairs and Public Policy. She has written numerous articles for publications such as Regulatory Focus, Pharmaceutical Formulation and Quality and the Medical Association of Georgia Journal. Ms. Blakely received her BA from Emory University, her MPH from Rollins School of Public Health of Emory University and her JD from the University of Georgia School of Law.
WILLIAM H. KITCHENS is a Partner and practice leader of the Healthcare and Life Sciences Practice Groups in the Atlanta law firm of Arnall Golden Gregory LLP. He served as the firm's Managing Partner for twelve years and formerly chaired the firm's Food and Drug Law Practice. His practice focuses on food and drug law, environmental law, and trade association law, and he advises clients on matters relating to litigation, compliance and enforcement, product approvals, advertising and labeling, and regulatory, licensing and permitting strategies. He has many years of experience representing clients in state and federal courts and before FDA, the U.S. Department of Agriculture, the Federal Trade Commission and the Environmental Protection Agency. Mr. Kitchens also serves as an Adjunct Professor at Emory University School of Law, where he has taught food and drug law since 1979. He has written and lectured extensively on topics relating to food and drug law and trade regulation and is a past member of the Editorial Advisory Board of the Food and Drug Law Journal. Mr. Kitchens received his BA from Emory University with high honors and his JD from the University of Georgia School of Law where he was an editor of the Law Review and a member of the Moot Court Board.
LINDA PISSOTT REIG is a Principal and Vice President of Compliance Services with the law firm of Porzio, Bromberg & Newman, P.C. in Morristown, NJ and New York City. She has wide-ranging experience with the laws and industry standards relating to the marketing and sale of prescription drugs, medical devices and biologics. Ms. Reig writes agreements with vendors, consultants and other third parties, assesses promotional materials, conducts training, provides business advice on consulting agreements and advisory boards, and evaluates continuing medical education and other sponsorship opportunities. She evaluates compliance programs and company practices in relation with annual declarations required by state law, and also develops work plans for development of comprehensive compliance programs for companies preparing to launch an FDA-approved product for the first time. Ms. Reig is a summa cum laude graduate of Rutgers Newark College of Arts & Sciences, and cum laude graduate of Georgetown University Law Center. Following law school, she was a judicial law clerk with then New Jersey Supreme Court Justice Marie L. Garibaldi. She is a past Chairman of the Board of the New Jersey Defense Association, and past chairperson of the NJDA's Products Liability Committee. Ms. Reig is also a member of the Defense Research Institute's Drug & Medical Device Committee and the NJ State Bar Association Appellate Practice Committee.
JENNIFER A. SANFILIPPO is an Associate and a member of the Pharmaceutical Marketing and Sales Compliance and Litigation Department at the law firm of Porzio, Bromberg & Newman P.C. in Morristown, NJ and New York City. She also serves as a Manager of Regulatory and Compliance Services for Porzio Pharmaceutical Services. Ms. Sanfilippo advises pharmaceutical, medical device, and biotechnology companies on a wide range of compliance-related issues, including federal and state fraud and abuse laws, FDA promotional regulations, industry standards regarding healthcare professional interactions, wholesale distribution and licensing, and sample compliance. She also develops compliance programs for companies governing the sale and marketing of drugs and devices and the distribution of samples under federal and state law and as such has experience related to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics for Interactions with Healthcare Professionals, and the Prescription Drug Marketing Act. In addition, Ms. Sanfilippo drafts agreements with vendors, consultants and other third parties, and reviews and evaluates promotional materials and marketing activities directed towards consumers and healthcare professionals. She also performs audits, gap analyses, and risk assessments in an assortment of areas, including sampling compliance, medical science liaison interactions, professional association activities, and compliance with state disclosure and limitation requirements. Ms. Sanfilippo received her BA in History from New York University and her JD from Rutgers University School of Law.
ARTHUR Y. TSIEN is a Principal of Olsson Frank Weeda Terman Bode Matz PC in Washington, DC, where he heads the firm's drug and litigation practices. He focuses on matters and litigation affecting the generic drug industry. Mr. Tsien and the firm have represented clients in a number of federal court cases involving FDA generic drug approval and exclusivity issues, including recent litigation involving generic versions of Allegra-D (fexofenadine/pseudoephedrine), Glucophage XR (metformin), Macrobid (nitrofurantoin, amicus brief), Mevacor (lovastatin), and many others. He is a regular speaker on FDA regulatory and litigation issues. Before joining the firm, he worked in FDA's Office of Chief Counsel. Mr. Tsien received his BS in chemistry and physics from Tufts University and his JD from the University of Washington School of Law.