|
Patte Bittner and Wiley Interscience
A Teratology Society Public Affairs Committee
position paper that reviews the history and rationale behind
the effort to change pregnancy labeling for prescription drugs
and calls for the immediate approval of new rules that have
been proposed by the FDA will be published in a future volume
of Birth Defects Research Part A. (Teratology Public
Affairs Committee Position Paper: Pregnancy Labeling for Prescription
Drugs: Ten Years Later,” The Public Affairs Committee
of the Teratology Society, Birth Defects Research Part A.
http://www.interscience.wiley.com/journal/bdr.)
This paper, written by Tony Scialli and the Committee during
2006-2007, expresses frustration that the process of revising
the pregnancy labeling for prescription drugs, begun by the
FDA ten years ago, has not yet been completed.
The FDA convened a public hearing in 1997 to
discuss the content and format of pregnancy labeling after
the Teratology Society had held a public symposium (1992)
on the issue that was followed by a position paper (1994).
Presentations at the 1997 FDA hearing almost unilaterally
identified the pregnancy labeling categories as a source of
inaccurate counseling. An FDA summary of the meeting acknowledged
that the categories are confusing, inadequate to communicate
risk, create the incorrect impression that drugs within the
same category have a similar toxic potential, and do not contain
information on possible adverse effects based on severity,
incidence, type of effect, dosage, frequency, or gestational
timing of exposure.
The 1997 hearing prompted the FDA to revise
its pregnancy labeling regulations by replacing the categories
with clearer and more complete summaries of information on
risk. The FDA has drafted proposed rules that would include
information on pregnancy registries, a narrative description
of the risks of using the medication, and a discussion of
considerations to address inadvertent exposures. While categories
would be eliminated, it is believed that standardized language
would still lead to categorization, since the likelihood of
risk would be categorized as none, low, moderate, high, or
unknown.
Still, the FDA proposed rules still not been
modified ten years later. The Public Affairs Committee believes
|
that this delay has resulted
in anxiety on the part of physicians and patients and the
unnecessary termination of wanted pregnancies.
The committee recommends immediate approval
of the new rules proposed by the FDA, with release for public
comment without further delay. Even with these actions, the
FDA estimates that the new system will not become effective
before 2010, 13 years after the FDA public hearing calling
for change. In its statement, the Committee also recommends
applying the categorical language flexibly; including the
reasoning behind the language; and testing the new system
among physicians and consumers to determine whether it is
effective at communicating risk and appropriate for clinical
decision-making. •
|
Principles for Evaluating Health Risks
in Children Associated with Exposure to Chemicals
Elaine Faustman
A new WHO Environmental Criteria monograph
has been published that is entitled “Principles
for Evaluating Health Risks in Children Associated with
Exposure to Chemicals”. As is evident from the
title the focus of this volume is children and it is
of direct relevance to the Teratology Society. In fact,
you will recognize some of the contributors as Teratology
members.
Previous Environmental Health Criteria
publications have evaluated the potential chemical exposures
to affect sensitive populations and Environmental Health
Criteria 30, Principles for Evaluating Health Risks
to Progeny Associated with Exposure to Chemicals during
Pregnancy (IPCS, 1984) and Environmental Health
Criteria 59, Principles for Evaluating Health Risks
from Chemicals during Infancy and Early Childhood: The
Need for a Special Approach (IPCS, 1986b) are very
relevant resources. The new document was prepared and
celebrates a critical time (10 year anniversary) of
EPA/NIEHS funding of the Children’s Environmental
Health Center (CHC) and many of the new areas of research
described in this criteria report highlight research
findings and lessons learned from the CHC. |
WHO Report - continued
on page 4 |
Publications