{"id":279384,"date":"2022-11-10T10:42:39","date_gmt":"2022-11-10T16:42:39","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=279384"},"modified":"2022-11-09T14:29:27","modified_gmt":"2022-11-09T20:29:27","slug":"foia-lawsuit-hhs-safety-abortion-pill","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/foia-lawsuit-hhs-safety-abortion-pill\/","title":{"rendered":"Lawsuit against HHS seeks ‘basic safety information’ about abortion pill"},"content":{"rendered":"
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A Freedom of Information Act (FOIA) lawsuit<\/a>\u00a0recently filed by\u00a0Judicial Watch (JW) is seeking abortion pill stability and manufacturing information\u00a0from the U.S. Department of Health and Human Services (HHS), which oversees the U.S. Food and Drug Administration (FDA).<\/p>\n

Tom Fitton, president of the watchdog organization,\u00a0said<\/a> the group was forced to sue\u00a0after the FDA failed to respond to three FOIA requests. He called it “outrageous” that Judicial Watch had to sue in federal court “for basic safety information about the abortion pill, which is being pushed on women by a desperate pro-abortion movement.\u201d<\/p>\n

\u201cOur experience is that this chemical abortion pill did not and will not receive appropriate review from the politicized FDA,\u201d Fitton also stated.<\/p>\n

URGENT:\u00a0<\/b>For every dollar given, 34 more people can be reached with the truth about abortion. Will you join us in this life-saving work as a monthly donor today?<\/i><\/b><\/a><\/p>\n

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Judicial Watch sues HHS FDA over stability of abortion pill<\/p><\/div>\n

According to Judicial Watch’s press release<\/a>, they are seeking “records regarding drug stability test results, new drug applications and related materials of the abortion drug Mifeprex<\/span><\/a> (Mifepristone, formerly known as RU-486<\/span><\/a>), as well as requests for reviews and assessments of the manufacturing facilities DANCO and GenBio where the abortion pills are produced.” These should include records reflecting long-term stability, as well as accelerated and forced degradation results.<\/p>\n

The abortion pill (Mifeprex or mifepristone) was approved in 2000 during what many described as a\u00a0highly secretive<\/a> and politicized process<\/a> within the FDA. The pill\u2019s manufacturer,\u00a0Danco Laboratories, LLC,<\/a>\u00a0was set up as a\u00a0sub-licensee<\/a>\u00a0of the Population Council early on while the FDA only\u00a0approved<\/a>\u00a0GenBioPro\u2019s<\/a>\u00a0abbreviated new drug application<\/a>\u00a0for a generic Mifeprex on April 11, 2019.<\/p>\n

Stability testing<\/strong><\/p>\n

Stability testing verifies that the drug can maintain its effectiveness under a specified storage condition as well as during the proposed shelf-life of the drug.\u00a0This is important, given the fact that distribution of the abortion pill via mail-order delivery is expanding, while in-person distribution decreases.<\/p>\n

JW’s lawsuit requested:<\/p>\n