FDA Boot Camp

Thursday, September 20 to Friday, September 21, 2012

Omni Parker House, Boston, Boston, MA

A: Fundamentals of FDA Regulatory Law

Gary Yingling
Partner
K&L Gates, L.L.P. (Washington, DC)

Aimed at providing a primer to professionals who have limited or no experience working with FDA on regulatory matters, this workshop will provide you with a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and walk you through the pre-approval, approval, and post-approval process.

Get the background you need to fl ow seamlessly into the conversations at FDA Boot Camp.

Topics to include:

• FDA Mission
• FDA Organization
• History of FDA Laws
• Acronyms and Terminology
• Clinical Trials Process
• Types of New Drug Applications
• Th e Review Process
• Th e Hatch Waxman Act
• Legal Barriers to Approval
• Biological Products
• Th e Basics of Device classifi cation and approval
• Post-marketing issues and enforcement, including recalls

4:00 Resolving Ethical Challenges Encountered During the Drug Approval Process

This one hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority.

For example:

(1) In the context of citizen petitions FDA requires certification that the petition includes all information and views on which
the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30.
The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules
of Professional Responsibility.

(2) In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. The discussion will cover the implications of the lawyer's participation in light of the requirements of Rules 1.3, 3.4, and 4.1.

(3) Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11.

5:00 Workshop A Concludes

---

B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

1:15 Biosimilars

Stephan Mahinka
Partner
Morgan, Lewis, & Bockius, L.L.P. (Washington, DC)

• Overview of Title VII of the Patient Protection and Affordable Care Act
(PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Biosimilar pathway vs. 505(b)(2) and BLAs
• Defining “biological” and “biosimilars” under BPCIA
− addition of the word “protein” to the PHSA definition of biologics
− identifying the “reference” product and proving biosimilarity
• analytical data requirements
• when will clinical data submission be necessary?
• Exploring interchangeability requirements
• Understanding the significance of the methods of making claims in this legislation
− query: if a protein is made by a completely different process than the reference product, is the patent infringed?
• Examining the effect of this abbreviated approval pathway on innovation
− how will this impact brand name and generic companies
• A look at FDA Rule making and guidance relative to biosimilars
• How will biosimilars fit in with life cycle strategies?
− targeting R&D efforts
− re-examining prosecution efforts
− anticipating vulnerable patents and litigation

2:30 Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

Chad Landmon
Partner
Axinn, Veltrop, & Harkrider L.L.P. (Hartford, CT)

• Defining bioequivalence in drugs and biologics
− drugs v. biologics
• What an ANDA-fi ler must demonstrate for bioequivalence?
− bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays
• Exploring bioequivalency under a biosimilar pathway pursuant to BPCIA
• How does bioequivalence relate to patents?
− patenting of bioequivalence characteristics
• extended-release drug products
− bioequivalence v. Doctrine of Equivalents – what is the difference?
− arguments about bioequivalence raised in Paragraph IV patent litigation
• infringement, copying (non-obviousness)

3:30 Afternoon Refreshment Break

3:45 Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies

Sarah Cooleybeck
Partner
Foley Hoag, L.L.P. (Boston, MA)

There are a number of different modes and methods of exclusivity (non-patent). This session will outline what they are and what challenges, opportunities, and current controversies arise in relation to them, including the role that the FDA plays in regulating these modes of exclusivity. Modes and methods of exclusivity to be discussed include:

• Orphan Drug Exclusivity (7 years)
• New Chemical Entity Exclusivity (5 years)
• New Clinical Study Exclusivity (3 years)
• Pediatric Exclusivity (6 months)
• First Generic Applicant Exclusivity (180 days)

4:45 Master Class B Concludes

---

C: Post-Approval Marketing Guidance and Preemption Protocols

1:15 Advertising and Promotion

Scott Lassman
Partner
Kleinfeld, Kaplan & Becker L.L.P. (Washington, DC)

Advertising and Promotion Overview

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
− 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
− guidance documents
− what duties and responsibilities are DDMAC charged with?
− what are its enforcement capabilities and jurisdiction?
− DDMAC 2011: a year in review
− Consumer fraud class action litigation
− Off label cases
− Identifying the role of the FTC in the advertising and promotion of drugs
− Advertising requirements for prescription v. nonprescription products
− Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
• What constitutes a launch?
• What defines an advertisement?
• Exploring the role of the label in advertising

Special Concerns for DTC Advertising

• How is direct-to-consumer advertising regulated and monitored?
• What information must every DTC ad contain?
• How do the PhRMA DTC guidelines interplay with current FDA regulation?
• FDA’s DTC Television User Fee Program
• Advertising and new media

2:30 Regulation and Dissemination of Off -Label Information

Joseph Poluka
Partner
Blank Rome, L.L.P. (Philadelphia, PA)

Michael Walsh
Partner
Strasburger & Price, L.L.P. (Dallas, TX)

• Overview of the FDA’s regulation of off -label promotion
• How can information on off -label or unapproved uses of drugs and biologics be disseminated?
− peer review articles v. ghost-writing
− MSLs v. sales reps
• What are the consequences of inappropriate off -label promotion?
− implementation of the Park Doctrine: criminal liability for failure to prevent or correct violations
− how the PPACA now defi nes a violation of FDCA as healthcare offense
− the role of the OIG, U.S. Attorney's Office, and states in monitoring off -label promotion

3:30 Afternoon Refreshment Break

3:45 Preemption Fundamentals

James Beck
Partner
Reed Smith, L.L.P. (Philadelphia, PA)

• Defining express and implied preemption
• Recognizing the basis for drug and device preemption
• Uncovering how the presumption against preemption has been applied in drug and device litigation
• Recognizing the interplay between preemption and the FDA regulatory process
• Emerging precedents: Riegel v. Medtronic and Wyeth v. Levine
• Understanding the “parallel requirements” exception to preemption

4:45 Master Class C Concludes

Brochure

- click image for pdf -

- Actions -

- Share -

Location:
Omni Parker House, Boston
Boston, MA