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

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-0001]</DEPDOC> <SUBJECT>Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of public workshop. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for registration date and information. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> 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 <E T="03">https://www.fda.gov/about-fda/visitor-information.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">ONDPublicMTGSupport@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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. <HD SOURCE="HD1">II. Topics for Discussion at the Public Workshop</HD> 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. <HD SOURCE="HD1">III. Participating in the Public Workshop</HD> <E T="03">Registration:</E> To register for the public workshop, please visit the following website: <E T="03">https://lu.ma/5vdmbibm.</E> 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 <E T="03">ONDPublicMTGSupport@fda.hhs.gov</E> no later than July 1, 2024. <E T="03">Streaming Webcast of the Public Workshop:</E> This public workshop will also be streamed virtually via Zoom. Virtual attendees may register at the following website to receive the Zoom link: <E T="03">https://lu.ma/5vdmbibm.</E> Although FDA verified the website addresses in this document, please note that websites are subject to change over time. <E T="03">Transcripts and Recordings:</E> 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 <E T="03"> https://www.fda.gov/drugs/news-events- human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-and-biologic-products-07112024. </E> The transcripts and recordings will also be accessible at <E T="03">https://www.regulations.gov</E> and may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. <SIG> <DATED>Dated: May 17, 2024.</DATED> <NAME>Lauren K. Roth,</NAME> Associate Commissioner for Policy. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2024-11228 Filed 5-21-24; 8:45 am]</FRDOC> </NOTICE>