Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation.
Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation.
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美国食品和药物管理局对怀孕和哺乳期的上市后承诺和要求的描述。
DOI：
10.1002/cpt.3059
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发表时间：
2023
影响因子：
6.7
通讯作者：
Birnbaum,AngelaK
中科院分区：
文献类型：
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作者：
Avachat,Charul;Younis,IslamR;Birnbaum,AngelaK
2007年颁布的《美国食品药品监督管理局修正案》（FDAAA）和2015年颁布的《妊娠和哺乳期标签规则》（PLLR）是重要的里程碑，赋予了FDA要求在妊娠和哺乳期女性中进行研究的权力。我们的目标是描述2000年至2022年期间FDA批准的新分子实体的妊娠和哺乳相关上市后承诺（PMC）和上市后要求（PMR）的趋势。从FDA网站获得新分子实体的原始新药申请（NDA，N= 488）批准函。确定了基于妊娠和哺乳的PMC/PMR的NDA，并提取了数据。数据包括：PMC/PMR时间表和要求研究的属性（类型、设计元素和结局）（如可用）。59项NDA包括92项与妊娠和哺乳相关的PMC/PMR。41例NDA存在妊娠相关PMR/PMC，4例存在哺乳相关PMR，14例两者均存在。大多数PMR/PMC用于神经系统药物（N= 33）。47项NDA规定了至少在出生后第一年内收集婴儿的安全性数据。所有妊娠相关PMR均在2008年之后发布，大多数PMC（N= 8）在2008年之前发布。只有一个PMC要求在妊娠女性中进行药代动力学研究。所有与哺乳相关的PMR（N= 18）都要求测量母乳中的药物浓度，其中一项还要求测量母体血液浓度。89%的哺乳相关PMR是在2015年之后申请的。FDAAA和PLLR颁布后，妊娠和哺乳相关PMR稳步增加。增加内容涉及收集妊娠期和哺乳期妇女以及妊娠期和哺乳期暴露于药物的儿童的药物安全性相关信息。
Enactment of the US Food and Drug Administration Amendments Act (FDAAA) in 2007 and the Pregnancy and Lactation Labeling Rule (PLLR) in 2015 are important milestones giving the FDA the authority to request studies in pregnant and lactating women. Our objective was to characterize trends of pregnancy and lactation‐related postmarketing commitments (PMCs) and postmarketing requirements (PMRs) for new molecular entities approved by the FDA between 2000 and 2022. Approval letters of original New Drug Applications (NDAs,N= 488) for new molecular entities were obtained from the FDA website. NDAs with pregnancy and lactation‐based PMCs/PMRs were identified, and data extracted. Data included: PMC/PMR timelines and attributes of requested study(ies) (type, design elements, and outcomes) when available. Fifty‐nine NDAs included 92 PMCs/PMRs related to pregnancy and lactation. Forty‐one NDAs had pregnancy‐related PMRs/PMCs, 4 had lactation‐related PMRs, and 14 had both. Most PMRs/PMCs were for nervous system medications (N= 33). Forty‐seven NDAs specified safety data collection in infants in at least the first year of life. All pregnancy‐related PMRs were issued after 2008, most PMCs (N= 8) were issued before 2008. Only one PMC requested a pharmacokinetic study in pregnant women. All lactation‐related PMRs (N= 18) requested measurement of drug concentrations in breast milk with one also requiring measurement of maternal blood concentrations. Eighty‐nine percent of lactation‐related PMRs were requested after 2015. There was a steady increase in pregnancy and lactation‐related PMRs following enactment of FDAAA and PLLR. Additions involved information collection pertaining to safety of the medication in pregnant and lactating women and children exposed to medications during pregnancy and breastfeeding.