Pharmaceutical Labeling Summit 2012 Agenda

Untitled Document


8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:05 a.m.

Chair Welcome and Introduction

9:05 a.m. – 9:50 a.m.

The FDA’s Expectations for Compliant Labeling in 2013 and Beyond
This keynote presentation will describe current approaches to the labeling approval and review process. Attendees will learn how the FDA is working to manage the label approval process while balancing safety and efficacy.

Attendees also will learn:

  • What is the FDA’s focus for the remainder of 2012 and looking ahead to 2013
  • Labeling-related accomplishments in 2012 and programs still in development
  • Examples of warning letters and other enforcement actions related to label management
  • Best practices for developing and maintaining a compliant labeling program

9:50 a.m. – 11:00 a.m.

Examination of How the FDA Applies Boxed Warnings
What is the role of company signal detection and evaluation programs with respect to serious safety concerns that necessitate labeling changes ranging from a new Warning/Precaution up to instituting a new Boxed Warning? What’s the process the FDA goes through with sponsors when they feel a Boxed Warning is warranted? What avenues do sponsors have when working with the FDA regarding a Boxed Warning being applied to their product?

11:00 a.m. – 11:15 a.m.

Morning Break

11:15 a.m. – 12:00 p.m.

Accessing Package Insert (Content of Labeling) Information Via Mobile Devices
Whether it’s smart phones, tablets are other wireless devices, mobile is the future. The FDA, in conjunction with other associated groups, has been expanding the use of SPL into mobile applications. This presentation will detail FDA’s moves into accessing package insert (PI) information via mobile devices. The FDA strongly believes these moves will increase efficiency and enhance patient safety.

Attendees will learn:

  • Current state of FDA’s work on PI access via mobile devices
  • How FDA and industry can work together to develop additional uses and applications involving mobile devices
  • What are the advantages to sponsors who promote access of PI content via mobile devices

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.

Downstream Use of SPL
SPL labeling is readily available today on the DailyMed. However, the information an individual can gather is not limited to just the labeling text. In today's presentation, we will learn the downstream uses of this information.

Attendees will learn:

  • What is Downstream Use of SPL?
  • What are the current and future possibilities of downstream use of SPL?
  • Other uses for SPL Metadata — other than content of labeling

2:30 p.m. – 3:15 p.m.

ANDA Labeling — Current Status of the FDA’s Labeling Review and Approval Process
The history of ANDA labeling is 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

3:15 p.m. – 3:30 p.m.

Afternoon Break

3:30 p.m. – 4:15 p.m.

Do Drug Product Labels Confirm and Correct Consumers' Medication Preconceptions?
Label comprehension studies rarely consider preconceptions that consumers have about the safe and effective use of prescription and nonprescription drugs. Text comprehension research has amply demonstrated the important contribution that one’s prior knowledge and beliefs make to the process. If drug product labels are to be effective in guiding the safe and effective use of medications, they must confirm and correct preconceptions that patients and consumers have.
Attendees will learn:

  • What preconceptions consumers hae
  • How these preconceptions influence label comprehension
  • How an OTC label should confirm and correct preconceptions
  • How OTC labels may not correct mistaken preconceptions

4:15 p.m. – 5:00 p.m.

The Impact of Labeling on Advertising and Promotion
Each word chosen to be a part of a drug's label can both positively and negatively impact its marketing potential. Open communication between labeling professionals and marketing departments has proven to be an important part of the labeling process. This session will discuss the ways to create open communication between labeling professionals and their marketing colleagues and how important labeling decisions impact successful promotion.
Attendees will learn:

  • The roles of labeling and marketing during initial labeling submission and subsequent labeling negotiations
  • The impact of how a single word could affect commercial potential

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. – 9:15 a.m.

Chair Welcome and Introduction

9:15 a.m. – 10:15 a.m.

The Role of Labeling in REMS: Examples from the Opioid and Other REMS
To date, the FDA has approved more than 100 Risk Evaluation and Mitigation Strategies (REMS) plans ranging from simple medication guides to complex, multi-part programs.  In March, the FDA began a REMS for transmucosal immediate-release fentanyl medicines.  In July, manufacturers of extended-release and long-acting (ER/LA) opioid pain relievers learned the details of their long-awaited REMS.  This presentation will delve into the role that labeling plays in REMS.

Attendees will learn:

  • What the FDA was looking for regarding labeling as it developed recent REMS
  • How to analyze recent REMS and apply various attributes to your labeling program
  • Examples of REMS and their parallels to labeling

10:15 a.m. – 12:45 p.m.

Panel Discussion:  Pilva v. Mensing Redux?  What Does the First Circuit Court of Appeals Decision in Barlett v. Mutual Mean for Generic Preemption?
Generic preemption issues may again wind up before the Supreme Court as generic maker Mutual Pharmaceutical is calling on it to reverse an appeals court decision that upheld a $21 million jury award.  In the landmark case Pliva v. Mensing, the Supreme Court said a generic company can’t be held responsible for failing to list an adverse event not listed in the brand’s drug label.  But the First Circuit said Mensing didn’t apply in the Mutual case as that ruling dealt with failure-to-warn-claims in a generic drug’s warning label, not product design issues, as was the case in Bartlett v. Mutual.  This panel of legal experts from industry and outside counsel will discuss and debate the intricacies of the case and read the tea leaves regarding what SCOTUS might do.

12:45 p.m. – 1:45 p.m.

Lunch Break

1:45 a.m. – 4:15 p.m.

Panel Discussion: Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions
A major issue in safety-related labeling changes is the concept of threshold and causality, i.e., how powerful an association is needed between the drug and event before a labeling change is warranted? Then, what type of labeling change is justified based on the adverse reaction of concern, and how is it to be communicated to healthcare professionals and consumers? We will discuss how these public health issues can be a source of contention between the FDA and sponsor as to the most appropriate regulatory action, and associated legal implications.

4:15 p.m. – 4:30 p.m.

Day Two Adjourn, Closing Remarks