Pharmaceutical Labeling Summit 2011 Agenda

Untitled Document

Revised as of Sept. 8, 2011


8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:05 a.m.

Chair Welcome and Introduction

Dave Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company

9:05 a.m. – 10:15 a.m.

Keynote Address: Understanding the Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Guidance
Section 505(o)(4) authorizes FDA to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after approval of the drug or biological product.

Attendees will learn:

  • What was the impetus for the guidance and what factors did FDA take into consideration while drafting it?
  • Examples of where changes were necessary under the guidance and how they improved patient safety

Dr. Susan Honig, Medical Reviewer, Office of New Drugs, CDER, FDA

10:15 a.m. – 11:00 a.m.

The Tipping Point of FDA's Public Health Voice: Has the Proliferation of Warnings Diminished the Agency's Impact on Clinical Practice
A proliferation of warnings from FDA, including increasing numbers of black box warnings, has raised concerns that a tipping point may have been reached limiting their effectiveness. This presentation aims to explore where the middle ground is between effective safety communications and the risk of overwarning.

Attendees will learn:

  • What’s the signal-to-noise ratio of the FDA’s current safety communications programs?
  • Do recent changes in labeling and patient inserts support a more robust clinical environment?

Dr. Scott Gottlieb, Resident Fellow, American Enterprise Institute, former Deputy Commissioner for Medical and Scientific Affairs, FDA

11:00 a.m. – 11:15 a.m.

Morning Break

11:15 a.m. – 12:00 p.m.

How SPL Is Shaping the Future of Labeling
Many are interested to learn how the current SPL implementation approach is actually defining what the content of labels will say and look like — especially in a world of electronic prescribing and pharmacy communications. A quick peek at the intricacies of SPL and what the future holds.

Attendees will learn:

  • Update on SPL implementation and its implications for electronic labeling
  • Review of FDA guidance on SPL to reflect advances in electronic labeling
  • Comprehend the utility of electronic content of labeling and other regulatory product information available in SPL format.
  • Identify the purpose of indexing SPL data as it is to be utilized in clinical decision support systems.

Lonnie Smith, Project Manager, FDA Data Standards Council, CDER, FDA

12:00 p.m. – 1:30 p.m.

Lunch Break

1:30 p.m. – 1:45 p.m.

Recap of Morning Sessions

1:45 p.m. – 2:30 p.m.

Spotlight on Recent and Pending Labeling-Related Cases — Including Matrixx v. Siracusano and PLIVA Inc. v. Mensing
Issues involving drug labeling have been increasingly popping up in the courts. Whether it's malpractice related, reporting requirements regarding adverse events or failure to warn, each new development impacts your medical, regulatory and legal affairs. In this fast-paced session, you’ll learn what cases should be on your radar.

Attendees will learn:

  • Which cases will have the most short-term and long-term impact on your operations?
  • 5 tips to assure that your labeling operations are always in compliance with newly developed regulations, guidances and court rulings

Coleen Klasmeier, Partner, Sidley Austin, former Special Assistant to the Chief Counsel, FDA

2:30 p.m. – 3:15 p.m.

Two Very Important Square Inches — How USP’s New Labeling Standards Can Improve Patient Comprehension
Recent research suggested that nearly 50% of patients do not properly dose their medications and an equal number do not understand the warning information related to their medications. In January, the U.S. Phamacopeial Convention called for new standards to improve patient comprehension.

Attendees will learn:

  • How could these new standards affect drug and biologics sponsors?
  • Can safety-related information be effectively communicated with such limited space while still providing proper disclosure?

Dr. William Shrank, Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Member of Committees on Prescription Drug Labeling for the American College of Physicians Foundation and for the USP

3:15 p.m. – 3:30 p.m.

Afternoon Break

3:30 p.m. – 4:15 p.m.

FDA Update on Patient Medication Information (PMI)
FDA is working on a new framework for the development and distribution of patient medication information (PMI) to be provided to patients who are prescribed drug products. In order to use prescription medications safely, consumers need to receive clear, actionable information. This medication information must be accurate, balanced, and delivered in a consistent and easily understood format. Under the current system, patients may receive several types of information, developed by different sources that may be duplicative, incomplete, or difficult to read and understand. FDA has determined that the system is not adequate to ensure patients receive the essential medication information needed to use a drug safely. FDA sees merit in adopting the use of a single document standardized with respect to content and format. PMI is intended to replace patient package inserts, consumer medication information, and medication guides.

Attendees will learn:

  • Overview of current patient information systems
  • FDA's intended framework for the development and distribution of PMI
  • Current and future activities related to PMI

Bryon Pearsall, JD, RPh, Health Scientist Policy Analyst, Office of Medical Policy, CDER, FDA
Murewa Oguntimein, MHS, CHES, Social Science Analyst, Office of Medical Policy, CDER, FDA

4:15 p.m. – 5:00 p.m.

The role of Labeling in Class Action and Failure-to-Warn Liability Litigation
The defense of potential class action and failure-to-warn liability cases can impact the approach to drug labeling. This presentation will focus on what types of decisions sponsors can make to label drugs in a way that informs prescribers while at the same time not creating product liability risks.

Attendees will learn:

  • Examination of "labeling lessons learned" from product liability cases
  • What types of label statements cause problems in depositions and litigation

Andrew Kantra, Partner, Pepper Hamilton

5:00 p.m. – 7:00 p.m.

Cocktail Reception and Networking


8:00 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 9:05 a.m.

Chair Welcome and Introduction

Dr. Leander Fontaine, Principal Consultant, Pharmiceutics, former Head of Labeling, Wyeth

9:05 a.m. – 10:15 a.m.

Keynote Address: ANDA Labeling — Current Status of the FDA’s Labeling Review and Approval Process
The history of ANDA labeling was pretty clear; the generic’s label would follow the Reference Listed Drug’s (RLD) label and any changes to the RLD label would flow to the generic label. But recent court cases and various “carve outs” have created a new environment.

Attendees will learn:

  • How is the FDA viewing recently submitted ANDA labels and are potential changes on the horizon?
  • Best practices for ANDA holders as RLD labels undergo changes
  • How to discuss with the FDA newly discovered safety signals and potential label revisions

Koung Lee, RPh, MSHS, Commander, U.S. Public Health Service, Team Leader, Labeling Review Branch, Division of Labeling and Program Support, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, FDA

10:15 a.m. – 12:45 p.m.

Panel Discussion: For New Products, Can We Submit the Same List of ADRs in Canada, EU, Japan and the USA?
Regulatory agency approaches to identifying risks for inclusion in the adverse reaction section of labeling have become increasingly similar while there are still fundamental differences in how the probability of adverse reactions is illustrated and how the section is structured. This session explores if it has become possible to evaluate the safety database of a new product so that, complying with regulatory requirements and expectations in Canada, EU, Japan and US, the same list of "adverse reactions for the purposes of labeling" can be submitted.

Attendees will learn:

  • Where regulatory expectations for the content of the adverse reactions section still differ
  • How and to which extent sound safety evaluation and decision making can generate one list of adverse reactions for submission in all regions
  • How to populate the adverse reactions section in Company Core Safety Information so that it can serve as a foundation of, and link between, local submission labeling

Moderator and Introductory Presentation: Dr. Leander Fontaine, President, Pharmiceutics LLC


  • Dr. Barton Cobert, President, BLCMD Associates
  • Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, formerly Medical Director, MedWatch, FDA
  • Dr. Michael Klepper, Independent Safety Consultant
  • Dr. Sidney Kahn, President, Pharmacovigilance & Risk Management, Inc.

12:45 p.m. – 1:45 p.m.

Lunch Break

1:45 a.m. – 4:15 p.m.

Panel Discussion: What Could an Actual Biosimilars Label Look Like? Watch One Built Before Your Eyes
This unique panel of experts from different organizations and disciplines will collaborate to develop fictitious biosimilars labels for various product and regulatory scenarios, using the USPI structure as a template. Labels will be assembled using typical biologics labeling modules and elements as they may be needed for biosimilars labeling. This exercise will illustrate important aspects of biologics and biosimilars labeling and help focus the discussion on differences in viewpoints. A truly innovative exercise — and a great way to end the Summit —this session is shaping up to be the most anticipated of the event.

Moderator and Introductory Presentation: Dr. Leander Fontaine, President, Pharmiceutics LLC


  • Erika Lietzan, Partner, Covington and Burling
  • Becky Cleavenger, Senior Director, Global Advertising and Promotion Center of Excellence, Baxter Healthcare
  • Dr. Peter Mueller, President, Epicenter Consulting

4:15 p.m. – 4:30 p.m.

Day Two Adjourn, Closing Remarks