{"id":312137,"date":"2024-05-13T10:37:08","date_gmt":"2024-05-13T15:37:08","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=312137"},"modified":"2024-07-05T19:05:44","modified_gmt":"2024-07-06T00:05:44","slug":"senator-fda-women-lives-risk-abortion","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/senator-fda-women-lives-risk-abortion\/","title":{"rendered":"Senator grills FDA head: ‘You… allow women to put their lives at risk’ for ‘the pro-abortion agenda’"},"content":{"rendered":"
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FDA Commissioner Dr. Robert Califf<\/a> appeared before a Senate Agriculture Appropriations Subcommittee\u00a0hearing<\/a> on May 8, 2024, where he was grilled about the dangers of the abortion pill. He was specifically asked why the FDA is allowing the drug to be prescribed without “ever seeing a doctor” and why there is a lack of oversight by the Food and Drug Administration (FDA) regarding “advanced provision” and ”stockpiling” of the drug.<\/p>\n

The hearing was centered around a review of the FY2025 budget request, where the FDA Commissioner presented a budget of “$7.22 billion, which represents an overall increase of approximately $341 million in annual funding above the FY 2024 Enacted level,” Califf said<\/a> in his testimony.<\/p>\n

But during the hearing, U.S. Senator Cindy Hyde-Smith (R-Miss.)<\/a>, chair of the Senate Pro-Life Caucus, asked Califf questions about the abortion pill, mifepristone.<\/p>\n

Califf served<\/a>\u00a0as the Obama Administration\u2019s FDA Commissioner from 2016-2017 following his\u00a02015 nomination<\/a>.\u00a0Under\u00a0Califf\u2019s leadership<\/a>, in\u00a02016<\/a>, the FDA loosened<\/a> several modifications to a safety requirement for the abortion pill (Mifeprex\/mifepristone) known as the Risk Evaluation and Mitigation System<\/a>\u00a0(REMS),\u00a0which the\u00a0FDA<\/a>\u00a0requires \u201cfor certain medications with serious safety concerns.\u201d Only a few medications require REMS.<\/p>\n

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U.S. Senator Cindy Hyde-Smith grills FDA Commissioner Califf on abortion pill May 2024<\/p><\/div>\n

“You can get this without doctor oversight”<\/strong><\/p>\n

Senator Hyde-Smith pointed out to Califf that her own husband was required to see his physician in person<\/em> “for a sinus medication” yet she was perplexed why the abortion pill was available under FDA safety regulations without an in-person visit with a physician.<\/p>\n

\u201cCommissioner Califf, I have repeatedly brought your attention to the dangers that women face when allowed dangerous life-ending chemical abortion drugs, which can be ordered by consumers through the mail or purchased in retail pharmacies without ever seeing a doctor in person,\u201d Senator Hyde-Smith said. “So, it blows me away that you can get this with no doctor oversight.”<\/p>\n

\u201cThe FDA is supposed to protect Americans from taking medications that could be harmful,” she added. “However, you continue to look the other way and claim mifepristone is \u2018safe,\u2019 in part, based on the lack of reports of non-fatal adverse events, due to the FDA\u2019s own relaxed reporting requirements<\/strong>, and continue to allow women to put their lives at risk in the name of the pro-abortion agenda” (emphasis added).<\/p>\n

Under\u00a0Califf\u2019s leadership<\/a>, in\u00a02016,<\/a> the FDA removed<\/a> the in-person requirement for prescribing the drug, allowed non-physicians to prescribe the pill<\/a>, and removed the requirement that all adverse events (complications) be reported to the FDA by the pill’s manufacturer, requiring only deaths<\/em> to be reported.<\/p>\n

A lawsuit recently argued<\/a> before the U.S. Supreme Court has addressed several of these dangers and is challenging<\/a> the legitimacy of the FDA\u2019s recent expansions of the abortion pill \u2014\u00a0likely the most important case since the Dobbs v. Jackson<\/em>\u00a0case which overturned\u00a0Roe v. Wade<\/em>.<\/p>\n

Because Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA)<\/em> was in the litigation phase, Califf claimed he had to be cautious about his response. “I know you are aware that I’m limited in what I can say because the issues around this are currently under consideration by the Supreme Court,” Califf replied.<\/p>\n

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FDA Commissioner Robert Califf grilled about advanced provision of abortion pill May 2024<\/p><\/div>\n

Who can prescribe, and who holds prescribers accountable?<\/strong><\/p>\n

The FDA Commissioner claimed in his response to the Senator that “Companies can’t write prescriptions. It’s doctors. Remember, we don’t regulate the practice of medicine. It has to be a doctor that writes the prescription.”<\/p>\n

But Califf is not entirely correct.<\/p>\n

Under the FDA’s REMS, the abortion pill can only be prescribed by approved clinicians. This would entail any<\/em> medical professional (physician, nurse, or midwife etc.) legally permitted by the state in which they are licensed to prescribe a drug. To become a prescriber, all the “clinician” must do is sign the prescriber agreement.<\/p>\n

This can be problematic, as a lawsuit<\/a> filed against Planned Parenthood of Southern New England revealed. It alleged<\/a> that the assessment of Planned Parenthood\u2019s certified nurse midwife Gannon Ward was so egregiously incorrect that she misdated the late pregnancy of Plaintiff Christin Lafo at just six weeks and three days before selling her an abortion pill. Lafo gave birth two days later in a toilet to a 22-week stillborn baby boy\u00a0<\/strong>whom she named Kyle Shawn Brady.<\/p>\n

The current\u00a0prescriber agreement<\/a> (March 2023) states that prescribers must have the \u201c[a]bility to provide surgical intervention in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.\u201d<\/p>\n

Those tasked with holding prescribers to these requirements, however, are the ones with the most to gain: the drug\u2019s manufacturers, Danco Laboratories and the generic GenBioPro<\/a>.<\/p>\n

So, while some “clinicians” can legally prescribe medications, they may not be permitted to provide surgeries which might be needed to treat a possible complication. As a result, prescribers may be sending women to emergency rooms<\/a> if the women feel they are experiencing a complication.<\/p>\n

\"March

March 2023 FDA prescriber agreement for Mifepristone<\/p><\/div>\n

The rapid expansion of the abortion pill<\/strong><\/p>\n

In April of\u00a02021<\/a>, under the guise of the\u00a0COVID-19 pandemic<\/a>, the Biden administration\u2019s FDA began to allow limited mail-order pharmacy<\/a>\u00a0distribution<\/a> by\u00a0expanding<\/a> the REMS safety regulations. By\u00a0December of 2021, the Biden FDA had further\u00a0weakened<\/a>\u00a0the\u00a0REMS<\/a>\u00a0by eliminating the\u00a0in-person dispensing requirement<\/a>\u00a0and enabling the abortion pill to be\u00a0permanently<\/em>\u00a0shipped by mail<\/a>.<\/p>\n

Then, in January 2023, the Biden FDA further gutted the REMS by announcing it would\u00a0allow retail pharmacies to dispense the drug<\/a> after they have been<\/a> prescribed. Pharmacy chains CVS and Walgreens<\/a> among other retail outlets<\/a> have already begun to dispense the drug.<\/p>\n

Despite clear limitations on who can prescribe the drug, Big Abortion is already allowing pharmacists<\/a> in some states to both prescribe and dispense<\/em> the abortion pill.<\/p>\n

The problem of stockpiling and “advance provision”<\/strong><\/p>\n

Live Action News has documented<\/a>\u00a0multiple times how Big Abortion is more than willing to\u00a0market<\/a>\u00a0abortion drugs as \u201cmissed period<\/a>\u201d pills or to ship \u201cadvance provision<\/a>\u201d of the abortion pill in\u00a0violation of the Food and Drug Administration\u2019s (FDA) REMS safety standards<\/a>. These standards require<\/a> prescribers of the drug to be able to properly date an actual pregnancy \u2014\u00a0a concern pointed out in the hearing.<\/p>\n

In addition, Live Action News has\u00a0previously documented<\/a>\u00a0abortion pill stockpiles in multiple states<\/a>. While mifepristone is the only drug approved by the FDA for the termination of pregnancy, some states are also stockpiling misoprostol, the companion drug used in the abortion pill regimen.<\/p>\n

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Riddle me this @US_FDA<\/a> requires prescribers + dispensers MUST be certified by abortion pill mfg Danco\/GBP + have ability to provide specific care. <\/p>\n

How are states #1) prescribers (clinicians) or dispensers (pharmacies) + able to stockpile abortion pills? https:\/\/t.co\/shq9nEuS7E<\/a><\/p>\n

— Carole Novielli (@CaroleNovielli) June 8, 2023<\/a><\/p><\/blockquote>\n