{"id":283038,"date":"2023-01-10T12:39:37","date_gmt":"2023-01-10T18:39:37","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=283038"},"modified":"2023-01-09T21:34:42","modified_gmt":"2023-01-10T03:34:42","slug":"industry-end-fda-abortion-pill-safety-regulations","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/industry-end-fda-abortion-pill-safety-regulations\/","title":{"rendered":"Abortion industry seeks to end all FDA abortion pill safety regulations"},"content":{"rendered":"
<\/div>

Abortion pill safety regulations created by the U.S. Food and Drug Administration (FDA), known as REMS, are the next target of the profitable abortion industry, which has historically bemoaned all regulations to protect women. The ultimate goal of these abortion advocates \u2014 many\u00a0associated with\u00a0Advancing New Standards in Reproductive Health (ANSIRH<\/a>) \u2014\u00a0is to allow\u00a0over-the-counter<\/a> dispensing of the abortion pill.<\/p>\n

Calls to lift the REMS<\/strong><\/p>\n

The\u00a0FDA<\/a>\u00a0describes its\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0(REMS) as a\u00a0“drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.” Only a few medications require REMS, and although this safety requirement exists to\u00a0protect women<\/em>, abortion advocates have been pushing for years to have this safety protocol lifted.<\/p>\n

The latest push to end these safety measures follows a further weakening<\/a> of the REMS in recent months by the Biden FDA, enabling the abortion pill to be shipped by mail (December 2022) or dispensed by retail pharmacies (January 2023). But before the ink had time to dry, abortionist Daniel Grossman began demanding that the FDA remove the REMS,\u00a0tweeting<\/a>, “This is incredible news! Medication abortion pills are safe. I am glad the FDA has made this historic change, and it\u2019s time to end the non-evidence-based REMS, which makes it difficult for many providers to prescribe abortion pills.”<\/p>\n

\"Image:

Abortionist Daniel Grossman demands abortion pill safety regulations (REMS) be removed (Image: Twitter)<\/p><\/div>\n

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

Grossman has been a primary force behind<\/a> expanding the abortion pill regimen, which consists of the drugs mifepristone and misoprostol.\u00a0Grossman not only pushed for the FDA to completely remove the abortion pill safety protocols, but is also\u00a0advocating<\/a>\u00a0for the idea of shipping women (or teens) abortion pills\u00a0in advance<\/em>\u00a0of a verified pregnancy (often referred to as advanced provision of abortion pills). He also recently made the highly unethical\u00a0suggestion<\/a>\u00a0that emergency health care personnel should leave out important medical facts from the records of women presenting with abortion pill complications.\u00a0And while Grossman and his abortion cohorts claim there is no evidence for the REMS, the facts<\/a> show otherwise.<\/p>\n

Abortion trio demands FDA end REMS, pushes for over-the-counter abortion pill<\/strong><\/p>\n

Grossman was joined by abortion activist Renee Bracey Sherman and ANSIRH founder Tracy Weitz in an opinion piece published<\/a> by The Nation where they called the FDA”s recent changes “red tape” and “a barrier” to those seeking abortion. The three suggested again that the abortion pill should be available over-the-counter, like Tylenol or Advil.<\/p>\n

Grossman was referred to by The Nation as a professor<\/a> of obstetrics, gynecology, and reproductive sciences at the University of California\u2013San Francisco and director of ANSIRH. But what isn’t<\/em> stated is that Grossman is also an abortionist and recent<\/a> National Abortion Federation and NARAL Pro-Choice America board member who has\u00a0served as a consultant to Planned Parenthood Federation of America and the Center for Reproductive Rights (along with leadership in other pro-abortion groups). This frequently consulted “expert” on abortion has multiple\u00a0conflicts of interest<\/a>\u00a0and is deeply tied to abortion. For one, Grossman was a senior leader at IBIS Reproductive Health while conducting abortion pill studies at the same time<\/em> that the organization was getting direct funding from Danco<\/a>, the abortion pill manufacturer.<\/p>\n

Renee Bracey Sherman is founder and executive director of the abortion groups\u00a0We Testify<\/a>\u00a0and is a\u00a0former NARAL board member<\/a>. Tracy Weitz, as previously stated,\u00a0cofounded<\/a>\u00a0ANSIRH<\/a>\u00a0but\u00a0left to become<\/a> the Buffett Foundation\u2019s director of U.S. programs in 2014. The Buffett Foundation was an early investor in Danco. According to a\u00a0Fox Report,<\/a>\u00a0\u201cWeitz has worked at Planned Parenthood, The Bixby Center… and once defined abortion as \u2018a moral action undertaken by moral agents.’\u201d<\/p>\n

“When the FDA approved the drug in 2000, it did so under a little-known bureaucratic system known as the Risk Evaluation Mitigation Strategy (REMS). Drugs under REMS usually carry significant side effects or are highly addictive, neither of which is true for mifepristone,” the trio wrote. “Under these restrictions, clinicians who provide medication abortion must register with the FDA and then dispense mifepristone directly to the patient.”<\/p>\n

They added, “In an effort to reduce the risk of transmission at the onset of the Covid-19 pandemic, the FDA loosened these requirements to allow clinicians to mail the drugs to patients or to use one of two online specialty pharmacies. So the decision this week that health care providers will be allowed to write a normal prescription to be filled at a normal pharmacy is good news.”<\/p>\n

Herein lies the catch.<\/p>\n

In referring to recent changes, the abortion trio added, “this requirement has made it impossible for mifepristone to be available over the counter, or at the very least to be dispensed without\u00a0unnecessary certifications, despite the fact that it\u2019s\u00a0safer than Tylenol.” This claim about safety is in dispute, especially given the fact that if women are taking Grossman and the abortion industry’s advice<\/a> to claim they are having natural miscarriages instead of chemical abortions when visiting ERs with complications, these complications are not being reported against chemical abortions<\/em>. And one study<\/a> \u2014 which Weitz and Grossman co-authored!\u00a0\u2014 found that chemical abortion is four times as risky<\/a> for women as a first trimester surgical abortion.<\/p>\n

“But that\u2019s where our praise of the FDA ends,” the abortion trio noted, because “the FDA chose to alter rather than eliminate the REMS for medication abortion.”<\/p>\n

“Adding pharmacies to the already cumbersome REMS is unnecessary and further perpetuates the notion that medication abortion is dangerous. To become certified to dispense mifepristone, a pharmacy must commit to doing\u00a014 things<\/a>\u00a0that go far beyond what they do for other prescribed medications,” they claimed, suggesting it is “essentially a bureaucratic hoop that providers have to jump through that has little meaning.”<\/p>\n

The abortion trio referred to the recent move by the FDA as “crumbs and bureaucratic barriers” and demanded the removal of the REMS, writing, “This moment is an opportunity for the FDA to reduce or remove the limits associated with medication abortion, but instead it is changing and even increasing them under the guise of expanding abortion access.”<\/p>\n

More ANSIRH staff demand FDA remove REMS<\/strong><\/p>\n

University of California\u00a0professor<\/a>\u00a0and abortion advocate Ushma Upadhyay<\/a>, also an ANSIRH professor (and co-author with Weitz and Grossman of the study mentioned above)\u00a0joined<\/a> the clamor to demand the FDA remove the REMS, publishing<\/a> her views at the Los Angeles Times. There, she referred to recent FDA modifications of the REMS as “unnecessary” and “unjustified,” demanding the FDA “remove as many barriers as possible.” In\u00a02019<\/a>, well before the COVID-19 pandemic, Upadhyay advocated a \u201cno test\/no touch\u201d approach where she and her colleagues suggested that abortion providers should simply \u201cbelieve the woman\u201d about the exact dating of her pregnancy.<\/p>\n

But miscalculating gestational age (or not calculating it at all) can have disastrous and litigious consequences<\/a>.<\/p>\n

Referring to Grossman’s op-ed in the Washington Post<\/a>,\u00a0ANSIRH reiterated the call and tweeted<\/a>,\u00a0“Lifting the in-person dispensing requirement is an important first step to treat #mifepristone<\/a>\u00a0more like other drugs, but the eventual goal remains complete removal of the REMS.”<\/p>\n

Who is ANSIRH?<\/strong><\/p>\n

ANSIRH, as previously stated, was\u00a0co-founded<\/a>\u00a0by\u00a0Tracy Weitz\u00a0in 2002 with abortionist\u00a0Felicia H. Stewart<\/a>, and\u00a0publishes<\/a>\u00a0workbooks on abortion training. ANSIRH is part of a “program<\/a> within the UCSF Bixby Center for Global Reproductive Health,<\/a>” which trains abortion providers through its\u00a0Ryan Residency Training Program<\/a>. It is no secret that the Packard and Buffett Foundations,\u00a0original investors<\/a>\u00a0in abortion pill manufacturer Danco, have invested<\/a> in the UC system. In past years, Buffett gave<\/a> $78 million to UC \u2014 and according to the New York Times<\/a>, is the primary financier of the Bixby Center\u2019s<\/a> Ryan Residency Program at UCSF<\/a>.<\/p>\n

Bixby and ANSIRH<\/a> are both funded<\/a> by\u00a0the Packard Foundation, which seeded Danco with a $14 million investment<\/a> in its early days. ANSIRH’s TEACH\u00a0Early Abortion Training Curriculum<\/a>\u00a0was\u00a0established<\/a>\u00a0in\u00a02003<\/a>\u00a0with financial help from the Packard Foundation, which noted that, “In 2002, the Bixby Center launched the\u00a0Advancing New Standards in Reproductive Health (ANSIRH)<\/a>\u00a0Program\u2026 to enhance access to abortion. With seed funding from the Packard Foundation, ANSIRH established a Planned Parenthood training site for motivated residents and practicing physicians to learn early abortion procedures. In July 2003, support from an anonymous donor allowed the Center to expand its training initiatives by pioneering the TEACH Project\u2026.”<\/p>\n

The curriculum\u2019s website<\/a> also admits<\/a> that it \u201creceives unrestricted educational grant funding from Danco, LLC,\u201d and has for years<\/a>.<\/p>\n

\"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Abortion pill safety regulations created by the U.S. Food and Drug Administration (FDA), known as REMS, are the next target of the profitable abortion industry, which has historically bemoaned all regulations to protect women. The ultimate goal of these abortion advocates \u2014 many\u00a0associated with\u00a0Advancing New Standards in Reproductive Health (ANSIRH) \u2014\u00a0is to allow\u00a0over-the-counter dispensing of […]<\/p>\n","protected":false},"author":303,"featured_media":283145,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953],"tags":[],"yoast_head":"\nAbortion industry seeks to end all FDA abortion pill safety regulations<\/title>\n<meta name=\"description\" content=\""It\u2019s time to end the non-evidence-based REMS which makes it difficult for many providers to prescribe abortion pills," said media favorite Daniel Grossman.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/archive.liveaction.org\/news\/industry-end-fda-abortion-pill-safety-regulations\/\" \/>\n<meta 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