# Presentation: 202495

## Pregnancy Labeling Subcommittee Meeting
March 28-29, 2000

Sandra L. Kweder, MD
Pregnancy Labeling Team 
Office of Drug Evaluation IV
Center for Drug Evaluation & Research

**March 28-29, 2000**
**Sandra L. Kweder, MD**
**Pregnancy Labeling Team **
**Office of Drug Evaluation IV**
**Center for Drug Evaluation & Research**

**Medicines and Pregnancy**** ****Labeling and Beyond**

## Goals for Meeting

**Update on FDA activities related to pregnancy labeling**
**Your feedback on guidance document on pregnancy registries**
**Broader discussion of strategies**
**Getting the most out of each effort**
**Thinking beyond current models**

## Progress on label model
Discuss ongoing activities related to “data”
Partnerships and leveraging
Considerations beyond fetal outcomes

**Progress on label model**
**Discuss ongoing activities related to “data”**
**Partnerships and leveraging**
**Considerations beyond fetal outcomes**

## Staffing 

_**Full Time for Pregnancy Labeling Activities**_
**	****Holli A. Hamilton, MD, MPH**
**	****Dianne L. Kennedy, RPh**

## Proposed Label Concept, 1999

**Goal:  Structure and organization adaptable to widely varying bodies of data and vastly different disease states**
**Distinguish clinical considerations from risk information**
**Different levels of information for different needs**
**Narrative text, not letter categories**

## Model Format

**Clinical Considerations**
**Links risk assessment to practical application**
**Summary Risk Assessment**
**Incorporate human and animal data and clearly states relevant factors considered**
**Discussion of Data**
**Brief summary to convey body of science**

## Committee’s Advice

**Committee’s Advice**

**Model label is a good start**
**Give clinical directives and advice sparingly **
**Recognized the importance and challenge of consistency across labels**
**There may be role for standard terminology, perhaps in risk assessment statements**

## Progress Key Decision Points

**What requires regulation**
**Elements more appropriate for guidance**
**Implementation schedule**
**	****How to make room for human data and experience**
**	****How specific in clinical considerations**

## Why Is This So Difficult?

**Complexity dictates need for clarity**
**Uncertainty predominates in data**
**Animal data are basis for risk assessments**
**Human data are rare and often scattered**
**Experts often disagree on interpretation**
**Breadth of user needs is great**
**Leave room for clinical judgement**

## Why Does This Take So Long?

**Complex**
**Paradigm shift from toxicity search**
**Regulations are rarely simple or fast**
**One of several labeling initiatives**
**Essential that other systems be in place**
**Data collection**
**Data submission to FDA**

## Pregnancy Labeling:Scope of FDA Activities 

**Label model development**
**Improving data**
**Expanding**
**Other aspects of risk management**

## Improving Data

**Main focus remains fetal/infant outcomes**
**Registries are principal tool**
**Remain rare**
**Reliance on product sponsors**
**Where others conduct studies no link to label**
**Confront controversy about value of normal outcomes when numbers are small**

## FDA: Improving Registry Data

**“****Guidance Document:  Establishing Pregnancy Registries”**
**New FDA regulation will require sponsors to address available data**
**Facilitate inclusion in labels**
**Expand discussion of registries**
**CDC & OTIS, March of Dimes - registry models**
**International Society of Pharmacoepidemiology **

## Thinking More Broadly

**Registries are important for collection of some types of data**
**General pregnancy/fetal outcomes**
**General margins of safety**
**Other elements of “safety” and rational prescribing must be considered**
**Pharmacokinetics and Pharmacodynamics**
**Lactation**

## Pharmacokinetics & Pharmacodynamics

**Once treatment is decided, right dose is essential**
**Few drug labels include PK or dose data**
**Clinicians seek “lowest effective dose”**
**Literature is limited**
**Where it exists, it is not in labels (e.g. amoxicillin)**
**Hormones of pregnancy warrant attention **
**Physiologic changes**
**Metabolism of drugs**

## Pharmacokinetics & Pharmacodynamics  (Continued)

**FDA Activities**
**New safety regulation labels**
**NICHD Collaboration (Fall 2000 workshop)**
**FDA sponsored conference, November 2000**
**American Society of Clinical Pharmacology & Therapeutics , 2001**

## Lactation

**Product labels rarely informative **
**Health benefits of breastfeeding**
**Natural link from the pregnant or nursing mother to child**
**Safety**
**Pharmacokinetics**
**Pharmacodynamics **

## Lactation (continued)

**FDA Activities **
**FDA Pediatrics Team - integrating concerns  **
**Assess state of art/science **
**Combined meeting: Pregnancy Labeling and Pediatrics Advisory Committees**

## Dietary Supplements

**Hearing on 3/30/00**
**Structure-function claims related to dietary supplements**
**Distinct from disease or treatment claims**
**How that relates to pregnancy and ensuring the safe use of such products**

## Summary

**Steady progress in label model development**
**Increasing emphasis on addressing data needs to enhance risk management**
**Developing sound registries**
**Thinking outside of usual models**
**Finding ways to increase pk/pd data**
**Lactation as link of mother to baby**
**Collaboration is essential to progress**

## Goals for Meeting

**Update FDA activities related to pregnancy labeling**
**Joseph DeGeorge, PhD : Preclinical**
**Catherine Spong, MD: NICHD**
**Guidance document on pregnancy registries**
**Evelyn Rodriguez, MD, MPH**
**Broader discussion of strategies**
**Getting the most out of each effort**
**Thinking beyond current models**

## The End

**The End**