[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44997-44998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0001]


Evaluating Immunosuppressive Effects of In Utero Exposure to Drug 
and Biologic Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Evaluating Immunosuppressive 
Effects of In Utero Exposure to Drug and Biologic Products.'' The 
purpose of the public workshop is to discuss transplacental transfer of 
drug and biological products with immunosuppressive properties and the 
potential clinical impact on the developing fetus and newborn infant, 
understand the gaps in knowledge, and consider innovative approaches to 
improve collection of relevant data.

DATES: The public workshop will be held on July 11, 2024, from 9 a.m. 
to 5 p.m. Eastern Time and on July 12, 2024, from 9 a.m. to 1 p.m. 
Eastern Time. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus 
and online. Entrance for the registered public workshop participants 
(non-FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/about-fda/visitor-information.

FOR FURTHER INFORMATION CONTACT: Meshaun Payne and Michelle Pollack, 
Office of New Drugs Public Meeting Support Team, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver 
Spring, MD 20993-0002, 301-796-6668, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Drug and biological products are widely used in various therapeutic 
areas during pregnancy to treat various conditions. Some products can 
be actively or passively transported across the placenta from a 
pregnant individual to their fetus. When this occurs for products with 
immunosuppressive properties, it is biologically plausible that these 
products can exert immunosuppressive effects on the developing fetus 
and newborn infant. Historically, pregnant individuals have generally 
been excluded from clinical trials, resulting in a paucity of data 
available on transplacental transfer and its potential consequences to 
the developing fetus and newborn infant. This lack of data poses 
challenges in providing adequate information in product labeling to 
help prescribers and patients make informed decisions about use of 
these products during pregnancy.

II. Topics for Discussion at the Public Workshop

    Pregnant individuals may have chronic and/or acute conditions that 
need to be treated, and published data show that most pregnant 
individuals take at least one medication (excluding vitamins) during 
pregnancy. Therefore, understanding the safety of medications when used 
during pregnancy is important. The main objective of the ``Evaluating 
Immunosuppressive Effects of In Utero Exposure to Drug and Biologic 
Products'' workshop is to discuss the available data on the placental 
transfer of drug and biological products with immunosuppressive effects 
and the potential clinical impact on infants exposed in utero, identify 
gaps in knowledge, and explore innovative and practical approaches for 
collection of relevant data. In addition, the workshop will allow for 
an open dialogue among regulators, academia, industry, and patient 
organizations regarding the potential safety concerns of medicines that 
may need to be used during pregnancy and approaches to data collection.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://lu.ma/5vdmbibm. Please register by July 10, 
2024, at 11:59 p.m. Eastern time. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by July 10, 2024, at 11:59 p.m. Eastern time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted.
    If you need special accommodations due to a disability, please 
contact Brittany Witcher, OND Public Meeting Support Team at 
[email protected] no later than July 1, 2024.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be streamed virtually via Zoom. Virtual attendees may register at 
the following website to receive the Zoom link: https://lu.ma/5vdmbibm. 
Although FDA verified the website addresses in this document, please 
note that websites are subject to change over time.
    Transcripts and Recordings: Please be advised that as soon as 
transcripts and recordings of the public workshop are available, they 
will be accessible on the FDA event web page https://www.fda.gov/drugs/
news-events-

[[Page 44998]]

human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-
and-biologic-products-07112024. The transcripts and recordings will 
also be accessible at https://www.regulations.gov and may be viewed at 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11228 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P