>>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
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.
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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Document:
JOSH HAWLEY
MISSOURI
381 RUSSELL SENATE OFFICE BUILDING
TELEPHONE: (202) 224-6154