{"id":257230,"date":"2021-11-15T18:43:46","date_gmt":"2021-11-16T00:43:46","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=257230"},"modified":"2021-11-15T18:52:33","modified_gmt":"2021-11-16T00:52:33","slug":"biden-fda-commissioner-expanded-abortion-pill-obama","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/biden-fda-commissioner-expanded-abortion-pill-obama\/","title":{"rendered":"Biden’s nominee for FDA Commissioner expanded access to abortion pill under Obama administration"},"content":{"rendered":"
<\/div>

President Joe Biden’s latest nominee to head the\u00a0Food and Drug Administration (FDA) previously headed the agency in 2016, when the agency\u00a0extended<\/a>\u00a0the use of the deadly abortion pill regimen to preborn babies 10 weeks old.\u00a0Robert Califf\u00a0served<\/a> as the Obama Administration’s FDA Commissioner from 2016-2017 following his 2015 nomination<\/a>.\u00a0If approved by the current Senate, Califf\u00a0will replace acting FDA Commissioner Janet Woodcock, who\u00a0previously<\/a>\u00a0served as Director of the FDA\u2019s Center for Drug Evaluation and Research in the years when the agency first approved the abortion pill in the U.S.<\/p>\n

In 2016<\/a>, under Califf’s leadership<\/a>, the FDA enabled several modifications to a safety requirement for the abortion pill (Mifeprex) known as the\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0(REMS),\u00a0which the FDA<\/a>\u00a0requires “for certain medications with serious safety concerns.\u201d Only a few medications require REMS.<\/p>\n

According to the FDA<\/a>, that year “the agency approved a supplemental application submitted by the drug company that markets Mifeprex.”\u00a0That company was Danco Laboratories<\/a>, a highly\u00a0secretive<\/a>\u00a0abortion pill manufacturer set up by the\u00a0eugenics-founded<\/a>\u00a0Population Council<\/a>, which\u00a0brought<\/a>\u00a0the abortion pill into the U.S.\u00a0Danco was heavily funded by\u00a0several abortion philanthropy groups, even receiving a\u00a0$14 million loan<\/a>\u00a0from the David and Lucile Packard Foundation.<\/p>\n

According to the FDA, the 2016 modifications<\/a>\u00a0to the FDA’s safety requirements included “changes in the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol (including the dose of misoprostol and a change in the route of misoprostol administration from oral to buccal [in the cheek pouch], the interval between taking Mifeprex and misoprostol, and the location at which the woman may take misoprostol).”<\/p>\n

At this time, women and teen girls were required to take the abortion drugs at the abortion facility where they were dispensed. But under Califf’s leadership, the FDA modified this requirement, enabling women and teens to take the drug regimen at home or a place of their own choosing.<\/p>\n

In addition, FDA reports, “The approval also modified the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug.”<\/p>\n

READ:\u00a0If the FDA removes abortion pill safety protocols, it won\u2019t be because the drug is safe<\/a><\/em><\/strong><\/p>\n

In other words,\u00a0Califf’s FDA modified the REMS safety protocols to allow the deadly drug to be used on babies who were 10 weeks (70 days)<\/a>, past the 49 days (7 weeks) the drug was approved<\/a> for in 2000. These changes prompted several lawmakers to express deep “disappointment” in a letter<\/a> to Commissioner Califf, calling the drug’s approval process “extremely controversial.”<\/p>\n

At that time, according to a Danco release<\/a>, the deadly regimen had been used by\u00a0more than 2.75 million women in the United States to end a pregnancy. By 2018, this number had grown<\/a> to 3.7 million.<\/p>\n

\"Image:

2011 to 2016 FDA changes to Mifeprex the abortion pill (Chart credit: The Guttmacher Institute)<\/p><\/div>\n

While Califf’s FDA kept Mifeprex under the REMS, the agency’s\u00a02016 changes<\/a>\u00a0no longer mandated\u00a0that Danco report\u00a0complications<\/a>\u00a0(adverse events), only deaths. For this reason, we may ever know just how many teen girls or women have suffered complications from the abortion pill as there are no federal mandates to report or track abortion complications.<\/p>\n

What we do know is that by\u00a0December of 2018<\/a>,\u00a0the FDA had\u00a0reported<\/a>\u00a024 deaths<\/b>*\u00a0associated with the abortion pill since its approval, with nearly 4,200\u00a0adverse<\/a>\u00a0events \u2014\u00a0including 1,042 hospitalizations, nearly 600 instances of blood loss requiring transfusions, and other serious complications. However, nearly three years later, despite repeated requests from Live Action News,\u00a0the FDA has failed to publish an update to the data<\/a> on abortion pill related deaths or overall distribution.<\/p>\n

The abortion industry has pulled out every stop to pressure<\/a> the FDA to lift the REMS so they can expand access to the abortion pill via online, mail order, in pharmacies and even over-the-counter.\u00a0This can\u2019t happen if REMS continues to apply to mifepristone.<\/p>\n

In\u00a0April of 2021<\/a>, the Biden FDA temporarily enabled abortion pill distribution by mail during the\u00a0COVID-19 pandemic<\/a>.\u00a0Then, days before Califf’s nomination was made public, the agency coincidentally\u00a0announced<\/a>\u00a0their intention to finalize a review of the REMS on the abortion pill by December 16, 2021.<\/p>\n

As the abortion pill politicization continues, the media refuses to investigate the\u00a0potentially dangerous<\/a>\u00a0impact of expanding abortion pill access. They also refuse to report on the many\u00a0conflicts of interest<\/a>\u00a0and\u00a0ties<\/a>\u00a0of\u00a0study authors<\/a>\u00a0and\u00a0commentators<\/a> \u2014 who claim the abortion pill is safe \u2014 to the abortion pill’s manufacturer.<\/p>\n

*EDITOR\u2019S NOTE: THE FDA HAS RECEIVED REPORTS OF SERIOUS ADVERSE EVENTS IN WOMEN WHO TOOK MIFEPREX. AS OF DECEMBER 31, 2018, THERE WERE REPORTS OF 24 DEATHS OF WOMEN ASSOCIATED WITH MIFEPREX SINCE THE PRODUCT WAS APPROVED IN SEPTEMBER 2000, INCLUDING TWO CASES OF ECTOPIC PREGNANCY RESULTING IN DEATH; AND SEVERAL CASES OF SEVERE SYSTEMIC INFECTION (ALSO CALLED SEPSIS), INCLUDING SOME THAT WERE FATAL.\u00a0<\/em><\/h6>\n
THE ADVERSE EVENTS CANNOT WITH CERTAINTY BE CAUSALLY ATTRIBUTED TO MIFEPRISTONE BECAUSE OF CONCURRENT USE OF OTHER DRUGS, OTHER MEDICAL OR SURGICAL TREATMENTS, CO-EXISTING MEDICAL CONDITIONS, AND INFORMATION GAPS ABOUT PATIENT HEALTH STATUS AND CLINICAL MANAGEMENT OF THE PATIENT. A SUMMARY REPORT OF ADVERSE EVENTS THAT REFLECTS DATA THROUGH DECEMBER 31, 2018 IS\u00a0HERE<\/a>.<\/em><\/h6>\n

\u201cLike\u201d Live Action News on Facebook<\/a>\u00a0for more pro-life news and commentary!<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

President Joe Biden’s latest nominee to head the\u00a0Food and Drug Administration (FDA) previously headed the agency in 2016, when the agency\u00a0extended\u00a0the use of the deadly abortion pill regimen to preborn babies 10 weeks old.\u00a0Robert Califf\u00a0served as the Obama Administration’s FDA Commissioner from 2016-2017 following his 2015 nomination.\u00a0If approved by the current Senate, Califf\u00a0will replace acting […]<\/p>\n","protected":false},"author":303,"featured_media":257326,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[15],"tags":[11650,14161,10350,10195,617,14159,14160,6888,2819,10194,14158],"yoast_head":"\nBiden's nominee for FDA Commissioner expanded access to abortion pill under Obama administration<\/title>\n<meta name=\"description\" content=\"President Joe Biden's latest nominee to head the\u00a0FDA previously headed the agency in 2016, extending the 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