Explore the essentials of drug law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and the new regulatory pathway for biosimilars
  • Post-approval drug safety issues
  • Advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FDAMA)
  • Food and Drug Administration Amendments Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic Drug User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of drug law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

Register

Industry & Firms

$1199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Curriculum Advisor:
Jur Strobos, Partner, Baker & McKenzie LLP

Wednesday, April 26

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–10:00 AM
Overview of Drug Law and Regulation

Jur Strobos, Partner, Baker & McKenzie LLP

10:00–10:15 AM
Refreshment and Networking Break

10:15–11:15 AM
The New Drug Approval Process: Basic Concepts

Jennifer Davidson, Partner, Kleinfeld, Kaplan & Becker, LLP

11:15 AM–12:15 PM
Networking Lunch

12:15-1:45 PM
The New Drug Approval Process: New Drug Research and Development

Kaiser Aziz, Senior Consultant, EAS Consulting Group, LLC

1:45–3:20 PM
The New Drug Approval Process: NDA Submission and Review

K.S. Reagan, Partner, Kleinfeld, Kaplan & Becker, LLP

3:20–3:35 PM
Refreshment and Networking Break

3:35–5:00 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

Nathan Beaver, Partner, Foley & Lardner LLP
David Rosen, Partner, Foley & Lardner LLP

Thursday, April 27

8:00–8:30 AM
Registration and Continental Breakfast

8:30–9:45 AM
Biologics and Biosimilars

Deborah Shelton, Partner, McCarter & English LLP

9:45–10:30 AM
Post-Approval Issues

Jennifer Zachary, Partner, Covington & Burling LLP
Mingham Ji, Associate, Covington & Burling LLP

10:30–10:45 AM
Refreshment and Networking Break

10:45–11:30 AM
Over-the-Counter (OTC) Drugs

Rikin Mehta, Head of US Regulatory Policy, Pfizer, Inc.

11:30 AM–12:45 PM
Regulation of Drug Manufacturing

James Johnson, Partner, Hogan Lovells US LLP

12:45–2:00 PM
Networking Lunch

2:00–3:30 PM
Regulation of Drug Marketing

Katlin Backfield, Attorney, Backfield LLC

3:30–3:45 PM
Refreshment and Networking Break

3:45–5:00 PM
Violations and Enforcement

William Gould, Partner, Holland and Knight LLP

5:00 PM
Adjournment

Speaker Biographies

KAISER AZIZ (former FDA Director of Mechanics and Materials Science, Associate Director of Clinical Lab Devices) is currently Managing Director of KJ Biomedical Consulting LLC, a clinical research, medical product development, and training organization.  He has successful regulatory and scientific experience in medical device premarket evaluations, approvals, standards, good manufacturing and quality system compliance auditing.  He has served as an adjunct faculty in the Department of Medicine and Physiology, NIH Graduate School, where he developed and taught courses/workshops in medical devices clinical study design and evaluation, and as an adjunct faculty at the Center for Applied Health Sciences, Virginia Polytechnic Institute and State University, where he teaches medical device and pharmaceutical risk management courses and workshops.  He has published numerous scientific and regulatory articles in professional and trade journals, and he has published individual text book chapters.  He serves as a member of editorial advisory boards of professional journals.  He was an invited guest editor on Nanotechnology and Clinical Trials in the Journal of Clinical Ligand Assay.  His expertise includes FDA’s Quality System Inspection Techniques (QSIT), medical products risk management using hazard analysis and critical control points (HACCP) techniques, Clinical Evaluation and Monitoring of Medical Devices.

KATLIN BACKFIELD is an attorney and consultant at Backfield LLC who advises on issues related to the regulation of pharmaceuticals.  Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years.  She was a regulatory counsel in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research at FDA from 2006 to 2008.  Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts.  She graduated cum laude from Georgetown University Law Center in 2001 and received her undergraduate degree from Davidson College.  Katlin is a member of the Food and Drug Law Institute’s Academic Programs Committee.  She is based in Washington, DC.

NATHAN BEAVER is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufactures who products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and the Federal Trade Commission (FTC).  He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval process and patent and exclusivity issues related to the Hatch-Waxman Act.  Mr. Beaver is a member of the firm’s Government & Public Policy and FDA Practices, and the Food & Beverage Industry and Life Sciences Industry Teams.  Mr. Beaver also has significant experience in FDA and Hatch-Waxman involving drug approvals, withdrawals and other types of litigation involving FDA regulated products.

JENNIFER DAVIDSON is a partner at Kleinfeld, Kaplan and Becker LLP, where she represents large, small, and start-up companies on a wide range of FDA-related matters.  Ms. Davidson counsels pharmaceutical companies on promotional and marketing practices, other post-approval requirements, development and approval processes, market entry strategies, combination product questions, user fees, and matters arising under the Hatch-Waxman, and subsequent, amendments to the Federal Food, Drug and Cosmetic Act.  A significant component of her practice involves advice and advocacy concerning lifecycle management considerations, including strategic planning for the development of new drugs, exclusivity questions, bioequivalence and substitution considerations, patent listing and certification obligations, and patent term extension.  In addition, Ms. Davidson has significant experience presenting complex issues to FDA via the agency’s Citizen Petition procedures.  Her practice also includes representation of industry in registration and scheduling proceedings before the Drug Enforcement Administration, and counseling companies on all aspects of promoting and marketing OTC drugs, medical devices, dietary supplements, foods and cosmetics.  Ms. Davidson earned her BA from the University of Michigan, and received her law degree from the University of Virginia School of Law.

WILLIAM GOULD is a partner in the Washington, DC office of Holland & Knight LLP.  As a co-chair of Holland & Knight’s Health Care and Life Sciences team, Mr. Gould’s practice involves domestic and international enforcement defense with a focus on litigation and corporate compliance work on behalf of pharmaceutical and medical device companies.  Mr. Gould’s recent engagements include litigation and internal investigations involving the False Claims Act, the Foreign Corrupt Practices Act, and the federal Anti-Kickback Statute.  He also provides advice regarding risk management to companies in the health care sector.  Mr. Gould currently holds a Top Secret/SCI level security clearance.  Prior to returning to private practice, Mr. Gould was a federal prosecutor with the U.S. Department of Justice for over 10 years.  From 2002-08, Mr. Gould was an Assistant U.S. Attorney and then a Managing Assistant U.S. Attorney in the U.S. Attorney’s Office for the Western District of Virginia.  In addition, during that time Mr. Gould was appointed as a Special Assistant U.S. Attorney for two specially assigned investigations in the U.S. Attorney’s Offices in the District of Columbia and the Eastern District of Virginia.  From 1997-2002, Mr. Gould was an Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of Columbia.  From 1999-2011, Mr. Gould was an adjunct professor of law at the University of Virginia School of Law.  Prior to his government service, Mr. Gould was an associate with a multi-national law firm based in New York City.  He also served as a law clerk for the Honorable Morton A. Brody, U.S. District Court Judge in the District of Maine.

MINGHAM JI is an associate in Covington & Burling’s Washington, DC office, where she advises on a range of preapproval and postapproval issues relating to FDA’s regulation of drug products. She has particular experience with enforcement matters, prescription drug promotion, pediatric drug development, clinical trial data confidentiality and transparency, and compliance with the DSCSA. Mingham also advises pharmaceutical clients on legislative and transactional matters.

JAMES JOHNSON is a partner in Hogan Lovells FDA/Pharmaceutical and Biotechnology practice group.  Jim works with life science clients on FDA compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (CGMP) requirements, data integrity responsibilities, and pharmacovigilance obligations.  Jim knows the FDA well.  Prior to joining Hogan Lovells, he served as Associate Chief Counsel for Enforcement in the FDA’s Office of the Chief Counsel.  There he handled CGMP enforcement and provided legal counsel on a range of inspectional and compliance issues.  Whether preparing an international manufacturing site for an FDA inspection, or working with a U.S.-based facility in response to a Form FDA 483, Jim uses his extensive agency and private practice experience to assist pharmaceutical companies worldwide. He regularly conducts CGMP assessments and investigations, resolves warning letters and import alerts, and appears in front of the FDA on behalf of companies to resolve enforcement actions.

KINSEY REAGAN (KS Reagan) is a partner in the Washington, DC law firm of Kleinfeld, Kaplan & Becker, LLP.  After serving in the Office of the General Counsel in the U.S. Department of Health and Human Services, Mr. Reagan joined the firm in 1981.  He specializes in pharmaceutical regulation (e.g., drug marketing approval and enforcement policies, drug advertising and promotion, controlled substances, drug manufacturing regulations); medical device regulation (e.g., Quality System requirements, combination products, in vitro diagnostics, medical device recalls); and food and beverage production, labeling, and promotion (e.g., food safety, organic labeling, agricultural products).  He has a specialty in veterinary drug regulation, assisting companies seeking FDA or USDA approval of animal drugs and biologics, and advising veterinary drug manufacturers on product labeling and promotion.  He also represents pharmaceutical and medical device clients on health care financing, price reporting, and fraud and abuse issues.  Mr. Reagan received his BS, cum laude, from Rensselaer Polytechnic Institute and his JD, cum laude, from Harvard Law School.

DAVID ROSEN is a partner and public policy lawyer with Foley & Lardner LLP.  Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics.  He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.  Mr. Rosen was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities. 

DEBORAH SHELTON is Leader of the Food & Drug Law Practice at McCarter & English LLP.  Deborah provides clients with deep industry-relevant expertise in biopharmaceuticals, informed by a strategic, rigorous, and pragmatic approach to client counseling gained from 20 years of serving in diverse settings, including in senior corporate counsel roles.  She counsels clients navigating complex regulations that affect business planning, product development and approval, post-market compliance, life-cycle management, due diligence and contracting, litigation strategy, and legislative and regulatory advocacy.  Deborah has nearly two decades of experience with Hatch-Waxman matters and regulatory exclusivities, a subject on which she has taught numerous courses for various organizations, including the Food & Drug Law Institute (FDLI).  Deborah has also been an industry leader in the development of the legislative biosimilar pathway and FDA’s ongoing implementation.  She came McCarter & English from her role as Deputy General Counsel for Healthcare at BIO, the world’s largest biotech trade association. She joined BIO from a global biotechnology company, where she was lead U.S. counsel to the company’s Global Biosimilars Legislative and Regulatory Policy teams.  Prior to her work as senior corporate counsel, Deborah was a partner in the FDA practice of a Global 100 firm. During her years in private practice, Deborah provided regulatory counseling across FDA-regulated industries, including biopharmaceuticals.

JUR STROBOS is a partner at Baker McKenzie in the Firm’s Healthcare and intellectual Property practices in Washington, DC.  He has extensive experience in providing legal and regulatory support, problem-solving, and strategic advice for US and international life science companies.  Dr. Strobos has previously worked with an American law and lobbying firm where he supported clients for the last 20 years, except for a two-year period in which he did charitable work under a grant from the Bill and Melinda Gates Foundation.  He also teaches a graduate course on drug development at the University of California, Berkeley.

JENNIFER ZACHARY is a partner in Covington & Burling’s Washington, DC office, where she advises on compliance with FDA requirements for the development, manufacture, and sale of drugs and biologics and assists clients with issues relating to GMP and GCP requirements, inspections, warning letters, recalls, import detentions, and compliance with the DSCSA. Before joining Covington, Jennifer served for six years as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel.

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Ohio: 13.25 CLE credit hours
Pennsylvania:  13.5 CLE credit hours
Virginia: 13.0 CLE credit hours

Location and Overnight Accommodations

Course Location

Foley and Lardner
3000 K St NW # 600
Washington, DC 20007

Overnight Accommodations

The following hotels are within walking distance of the meeting location:

The Westin Georgetown, 2350 M Street NW
Four Seasons Hotel, 2800 Pennsylvania Avenue NW
Avenue Suites Georgetown, 2500 Pennsylvania Avenue NW
Residence Inn, 801 New Hampshire Avenue

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.