PREGNANCY LABELING SUBCOMMITTEE MEETING

March 28 & 29, 2000

A Sub-Committee of the Advisory Committee for Reproductive Health Drugs

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# QUESTIONS TO THE COMMITTEE

## March 28, 2000: Pregnancy Registry Issues

1.  Under what circumstances are registries most useful and when are
    they NOT? Please be specific regarding:

-   Type of drugs

-   Expected clinical use patterns of products

-   Types of maternal or fetal outcomes (e.g., maternal toxicities,
    congenital anomalies, cognitive

development, infertility, etc.).

2.  What are the most important data elements that should routinely be
    collected in a registry? (You may wish to refer to Attachment 1 in
    the "Draft Guidance for Industry: Establishing Pregnancy
    Registries")

-   Under what circumstances should a qualitative assessment (e.g.,
    pathological) be incorporated

to evaluate products of conception in cases of fetal loss in 2^nd^/3^rd^
trimester?

3.  The questions below consider several aspects of patient follow-up in
    registries.

-   In general, what is the minimum length of follow-up required to
    assess pregnancy outcomes? (e.g., 1 week post delivery?)

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-   Under what circumstances is it most useful or appropriate to end
    data collection and follow-up immediately after delivery?

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-   In considering alternatives, such as 30 days post-delivery or one
    year post-delivery, what additional types of information can be
    expected to be gained?

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-   What factors should guide decisions regarding length of follow-up
    (e.g., drug pharmacology, animal findings, specific outcomes, class
    concerns)?

-   What strategies should registries consider to enhance patient
    recruitment and retention as well as facilitate follow-up?

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-   Should an additional mechanism be put in place to re-contact
    subjects after extended time periods in case the need arises? If so,
    considering the practical aspects of conducting registries, under
    what circumstances should it be done?

4.  What criteria should be used to determine when a registry should be
    closed down?

5.  The questions below consider the use of information from a pregnancy
    registry.

-   Under what circumstances should information from a registry be
    incorporated into a product's labeling? For instance, what types of
    information from registries would be useful to include and at what
    point in a registry's conduct (e.g., after "x" number of patients
    enrolled)?

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-   Many observers have expressed concern that if drug exposure
    experience from registries is included in labels there is a risk
    that patients and clinicians will perceive a false assurance of
    complete safety when the data lack the power to detect certain
    levels of risk. What qualifying information should be included in
    the labeling so that the registry data are understandable?

PREGNANCY LABELING SUBCOMMITTEE MEETING

March 28 & 29, 2000

A Sub-Committee of the Advisory Committee for Reproductive Health Drugs

# 

# QUESTIONS TO THE COMMITTEE

# March 29, 2000: Strategies for Monitoring Drug Risks in Pregnant Women

1.  What are your thoughts on the role of some type of centralized
    pregnancy registry?

-   How could a centralized model help to overcome existing obstacles?
    Would additional obstacles be introduced?

-   What areas would need to be specifically addressed to ensure that
    useful information would come from such a centralized system?

-   How could a central registry be operated in order to maximize gains
    and minimize real or perceived obstacles to conducting a registry
    (e.g., public/private models, foundations, contracts, central
    control, funding, etc.).

2.  How can systems and databases already in existence be better
    utilized in this effort? What has been learned from existing
    methods? How can they be improved upon?

3.  In general, what other strategies might be helpful for collecting
    information relevant to the safe use of drugs during pregnancy (case
    control, pk/pd studies, randomized controlled trials)? Under what
    circumstances should such strategies be employed?