>>195822, >>195823, >>195824, >>195825, >>195826, >>195827, >>195828, >>195829, >>195830, >>195831, >>195832, >>195833, >>195834, >>195835, >>195836, >>195837, >>195838, >>195839, >>195840, >>195841, >>195842, >>195843, >>195844, >>195845, >>195846, >>195847, >>195848, >>195849, >>195850, >>195851, >>195852, >>195853, >>195854, >>195855, >>195856, >>195857, >>195858, >>195859, >>195860, >>195861, >>195862, >>195863, >>195864, >>195865, >>195866, >>195867, >>195868, >>195869, >>195870, >>195871, >>195872, >>195873, >>195874, >>195875, >>195876, >>195877, >>195878, >>195879, >>195880, >>195881, >>195882, >>195883, >>195884, >>195885, >>195886,>>195887, >>195888, >>195889, >>195890, >>195891, >>195892, >>195893, >>195894, >>195895, >>195896, >>195897, >>195898, >>195899, >>195900, >>195901, >>195902, >>195903
FDA's confirmed reliance on Sentinel data, along with ambiguity as to whether FDA acquired other commercially available data, raises questions about whether FDA's study can adequately assess the impact of the Biden Administration's 2023 REMS. According to the Sentinel Initiative, the date range of available data varies by source. For example, the end date of Sentinel's Medicaid data appears to be 2021-leading to a nearly 50 percent drop in database enrollment after that year-while data from 2024 "and possibly 2023" appear incomplete from publicly available sources.³
Compounding the uncertainty, FDA's filing states that its study confirmed adequate exposures and outcomes "across relevant time periods," but it never identifies those periods.⁴ This suggests that if the agency primarily relies on data from Sentinel, its analysis may rest largely on procedures that occurred before the 2023 REMS took effect and possibly exclude analysis of a large Medicaid population after that date. If the FDA's review does not capture this population, the study may not properly inform the agency's analysis about whether to modify the REMS by excluding women who have received the drug by mail. Other commercially available data from all-payer claims could help fill the gap left by Sentinel's time-limited Medicaid data. Yet according to the DOJ status report, while the FDA "continues to gather and analyze additional data" outside Sentinel, it does not say what those datasets are or even what years they cover.⁵
To resolve these issues and provide assurance to patients that FDA is reviewing all relevant data, please answer the following questions in writing by October 22, 2026:
1. Does the FDA's Sentinel database include all data after 2021 or 2023, such as that of the Medicaid population?
2. Has the FDA sought to acquire this data? If not, why not?
3. Identify the "additional data" outside Sentinel that FDA is gathering and analyzing, and the precise period each source covers.
4. Did the FDA originally plan to acquire a broader set of insurance data? If so, when and why did the agency change to reviewing primarily Sentinel data?
Thank you for your prompt attention to this request.
Sincerely,
Josh Hawley
United States Senator
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¹ Fed. Defs. Status Report ¶ 2, Louisiana v. FDA, No. 6:25-cv-01491 (W.D. La. Oct. 7, 2026), ECF No. 278.
² https://media.cppc.org/2025/04/25-04-The-Abortion-Pill-Harms-Women.pdf
³ Sentinel Initiative, Key Database Statistics,
https://www.sentinelinitiative.org/about/key-database-statistics