{"database": "press", "table": "releases", "rows": [["https://www.hawley.senate.gov/hawley-demands-answers-from-fda-following-reports-agency-delayed-review-of-mifepristone/", "Hawley Demands Answers from FDA Following Reports Agency Delayed Review of Mifepristone", "2025-12-10", "2025", "2025-12", "Republican", "Senate", "MO", "Josh Hawley", "H001089", "www.hawley.senate.gov", "hawley", "https://www.hawley.senate.gov/press-releases/page/", "scraper", "WASHINGTON \u2014 Today, U.S. Senator Josh Hawley (R-Mo.) sent a letter to Food and Drug Administration (FDA) Commissioner Marty Makary following reports that he ordered the agency to delay a review of the chemical abortion drug mifepristone.\n\nSenator Hawley wrote, \u201cSix months ago, you told me you were \u201ccommitted to conducting a review of mifepristone,\u201d the chemical abortion drug. You repeated this commitment to state attorneys general and other members of Congress. Yet according to news reports yesterday, you have ordered this promised safety review delayed until after the midterms. Indeed, it is unclear whether you are conducting an independent safety review at all.\u201d\n\n\u201cThis is totally unacceptable. I cannot emphasize enough the danger of playing politics with women\u2019s health. In President Trump\u2019s first term, HHS required an in-person visit with a licensed physician before dispensing the chemical abortion drug. The safety rules also required in-person dispensing of the drug in a clinical setting. But Joe Biden removed those guardrails,\u201d Senator Hawley continued. \u201cThe safety regulations from President Trump\u2019s first term should be reinstated. But you have not done so. And news reports indicate you are attempting to sideline any review of mifepristone safety.\u201d\n\nSenator Hawley first sent a letter to Commissioner Makary after he stated the FDA had \u201cno plans to take action\u201d on mifepristone. In his response, Makary assured Senator Hawley that he was \u201ccommitted to conducting a review of mifepristone.\u201d Months later, the FDA inexplicably approved a new generic abortion drug. Senator Hawley sent Commissioner Makary another letter in October, questioning the timing of that decision after Makary committed to conducting a full review of the chemical abortion drug.\n\nRead the full letter here or below.\n\nDr. Marty Makary\n\nCommissioner\n\nU.S. Food and Drug Administration\n\n10903 New Hampshire Avenue\n\nSilver Spring, MD 20993\n\nCommissioner Makary:\n\nSix months ago, you told me you were \u201ccommitted to conducting a review of mifepristone,\u201d the chemical abortion drug. You repeated this commitment to state attorneys general and other members of Congress. Yet according to news reports yesterday, you have ordered this promised safety review delayed until after the midterms. Indeed, it is unclear whether you are conducting an independent safety review at all.\n\nThis is totally unacceptable. I cannot emphasize enough the danger of playing politics with women\u2019s health. In President Trump\u2019s first term, HHS required an in-person visit with a licensed physician before dispensing the chemical abortion drug. The safety rules also required in-person dispensing of the drug in a clinical setting. But Joe Biden removed those guardrails. Now, new studies from more than 865,000 insurance claims report that nearly 11% of women using mifepristone suffer a serious adverse health event\u2014like sepsis or hemorrhaging\u2014within 45 days. That is 22 times the likelihood of risk currently listed on mifepristone\u2019s \u201cblack box\u201d warning. The safety regulations from President Trump\u2019s first term should be reinstated.\n\nBut you have not done so. And news reports indicate you are attempting to sideline any review of mifepristone safety. In fact, you have repeatedly wavered in public on whether you are conducting a safety review at all. On April 24, you told an interviewer you had \u201cno plans to take action\u201d on mifepristone. You wrote to me on June 2, however, that you were \u201ccommitted to conducting a review of mifepristone.\u201d Then, a few months later, you reversed course again and inexplicably approved a new generic abortion drug, with no meaningful safety guardrails or conditions. Despite your claims to the contrary, that approval was in no way compelled by law.\n\nYesterday, in response to the latest reports, you said, \u201cThere has been an ongoing review of mifepristone. It\u2019s actually required as part of a policy called REMS.\u201d But that is not what you promised. You promised a new and comprehensive study taking account of all available safety data, not the standard monitoring FDA already performs for countless drugs.\n\nThere are more abortions in America now than when Roe was still law. And this is largely because of the chemical abortion drug and its generics, like the one you approved. Chemical abortions account for almost 70 percent of all abortions nationwide. The science is clear. The chemical abortion drug is not safe.\n\nIt is time for direct answers about what, precisely, FDA is doing. Please answer the following questions by no later than Monday, December 15, 2025:\n\nIs the FDA conducting a comprehensive safety review of mifepristone separate from the REMS process?\n\na. When did it begin?\n\nb. Please provide a specific timeline for its completion.\n\nIf you are conducting a comprehensive safety review, did you order it to be delayed?\n\na. Why?\n\nb. Until when?\n\nDoes the FDA have any plans to update the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) to restore basic safety guardrails from President Trump\u2019s first term, such as in-person dispensing?\n\nI await your responses.", 1, "2026-03-30T01:40:41Z", "2026-04-06T20:09:11Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.hawley.senate.gov/hawley-demands-answers-from-fda-following-reports-agency-delayed-review-of-mifepristone/"], "units": {}, "query_ms": 2.1119387820363045, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}