The Scottsdale-based Alliance Defending Freedom (ADF) secured a federal court ruling that effectively halts mail-order abortions.
On Wednesday, the Fifth Circuit Court of Appeals ruled that the Food and Drug Administration (FDA) must reinstate its safety restrictions for mifepristone use. In effect, the ruling limits mifepristone’s use to the first seven weeks of pregnancy, as well as requires an in-person visit with a provider prior to prescription.
This is the Texas court’s second ruling against mifepristone access. In April, the court issued an injunction against the abortion drug. The same hour of that injunction, a Washington federal court ruled that the FDA must continue providing mifepristone. Several weeks after those conflicting orders, the Supreme Court halted the Texas court’s injunction until all litigation had concluded.
BREAKING🚨 The 5th Circuit Court of Appeals has ruled the FDA must do its job and restore crucial safeguards around chemical abortion drugs, including ending illegal mail-order abortions. It's a significant victory for the doctors we represent, and for women's health and safety.
ADF sued the FDA last November on behalf of four pro-life medical groups, who argued that mifepristone shouldn’t have been approved by the FDA over 20 years ago and should be removed from the market.
The FDA approved mifepristone in 2000, during the Clinton administration, using a fast-tracked approval process. The FDA justified approval by reclassifying abortion as a “serious or life-threatening illness” and mifepristone as a “meaningful therapeutic benefit.” In a 2008 report, the Governmental Accountability Office (GAO) noted the medical community’s widespread criticism of the basis for mifepristone’s approval.
“Critics have argued that unwanted pregnancy should not be considered a serious or life-threatening illness,” stated the GAO report.
Mifepristone’s efficacy and safety are dubious. The drug’s usage has been linked to hundreds of cases of infections and death, if not more. Government studies have estimated adverse effects of the drug occurring in as many as one in five women. The FDA also failed to convince the New Orleans court of the drug’s safety.
“[I]n loosening mifepristone’s safety restrictions, [the] FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” read the majority opinion.
Yet, state leaders have advocated for access to the abortion drug. Attorney General Kris Mayes’ office claims the drug is “incredibly safe” and that restrictions on it are “unnecessary.”
In June, Hobbs issued an executive order usurping county attorneys’ authority over prosecuting abortion law violations.
In March, Mayes encouraged pharmacies to give out abortion pills. In May, Mayes joined an amicus brief to advocate for the upholding of mifepristone’s FDA approval.
Hours after the circuit court ruling, Mayes’ new Reproductive Rights Unit issued guidance on how individuals can hide their data, such as internet history and communications, when seeking abortions. The new unit is headed by deputy solicitor general Hayleigh Crawford.
The attorney general didn’t issue a direct response to this week’s ruling, but the data privacy guidance and corresponding meeting appeared to be an indirect response of sorts.
Arizona stands by its reproductive health providers and those seeking care. Thank you to these stellar advocates for joining us yesterday to discuss our new data privacy guidance. Ft. @BreThomas68, @LegallyLove, Sheena Chiang, @JodiLiggett, Dr. @CadeyHarrel and Tonya Irick. pic.twitter.com/Ek8TsVDjTq
— AZ Attorney General Kris Mayes (@AZAGMayes) August 17, 2023
Featured guests at the meeting included:
Chris Love, board member and senior advisor for Planned Parenthood Advocates of Arizona, and attorney at Kewenvoyouma Law;
Sheena Chiang, co-chair of the Planned Parenthood Arizona Board of Directors, and attorney for the Maricopa County Legal Defender’s office;
Jodi Liggett, founder of the progressive think tank and advocacy group Arizona Center for Women’s Advancement, former deputy chief of staff for Phoenix Mayor Kate Gallego, former vice president of external affairs and executive director for Planned Parenthood of Arizona, former senior policy advisor for Phoenix Mayor Greg Stanton, former CEO of Arizona Foundation for Women, and former policy advisor for former Gov. Jane Hull;
Bré Thomas, CEO of Affirm Sexual and Reproductive Health For All, former Arizona Department of Health Services manager and senior policy advisor, former Arizona Department of Economic Security executive assistant to the deputy director, and former women’s health policy advisor for former Gov. Janet Napolitano;
Cadey Harrel, doctor and founder of Agave Community Health and Wellness;
Tonya Irick, director of abortion clinic Family Planning Associates Medical Group
We brought together health care providers, advocates & community leaders to discuss @arizonaago's new data privacy guidance for those seeking reproductive health care. In a world in which we do everything online, we leave a trail in web and app data. Privacy should be the default pic.twitter.com/pFcbpcxzJ2
— AZ Attorney General Kris Mayes (@AZAGMayes) August 17, 2023
Corinne Murdock is a reporter for AZ Free News. Follow her latest on Twitter, or email tips to corinne@azfreenews.com.
Arizona has been one of the nation’s most-ardent pro-life states, but its new Democrat Attorney General is seeking to quickly reverse that standing as she reacts to recent cases in the federal court system.
Last Friday, United States District Judge Matthew J. Kacsmaryk, who was appointed by former President Donald Trump, issued an order in Alliance for Hippocratic Medicine, et al. v U.S. Food and Drug Administration, granting a motion to stay “the effective date of the Food and Drug Administration’s (FDA) September 28, 2000 Approval of mifepristone and all subsequent challenged actions related to that approval – i.e., the 2016 Changes, the 2019 Generic Approval, and the 2021 Actions.”
Yet the same day, United States District Judge Thomas O. Rice, who was appointed by former President Barack Obama, issued an order in State of Washington, et al. v. U.S. Food and Drug Administration, et al., preliminarily enjoining the FDA and other defendants from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. 355-1 in Plaintiff States.”
The plaintiffs in Judge Rice’s order were Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and the District of Columbia.
Judge Kacsmaryk stayed his own order for seven days “to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.” Judge Rice’s order went into effect immediately for the plaintiff states.
Arizona Attorney General Kris Mayes previously joined the Washington case in February, stating that the lawsuit “asserts that the FDA exceeded its authority by continuing its unnecessary and extremely burdensome restrictions on mifepristone,” and it “asks the court to find the FDA’s REMS (Risk Evaluation & Mitigation Strategies) restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone.”
After Friday’s two judicial orders, Mayes assured her fellow Arizonans “that legal access to the drug (mifepristone) remains available for providers and patients in this state.” She promised that her office would join other states in filing an amicus brief to oppose Judge Kacsmaryk’s ruling, which came Monday. The court filing from several attorneys general across the country urged the U.S. Court of Appeals for the Fifth Circuit “to stay pending appeal the district court’s ruling.” Mayes said that “Judge Kacsmaryk’s outrageous and appalling ruling, if allowed to stand, would upend decades of scientific research and established legal principles.”
A three-judge panel quickly considered the appeal and decided that “the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” However, the judges noted that the plaintiffs’ arguments brought before the district court in “2016 and subsequent years” were timely. The FDA’s changes from 2016-on were as follows: “increased gestational age to 70 days (from 50 days); reduced required in-person office visits to one (from three), allowed non-doctors to prescribe and administer mifepristone; and eliminated reporting of non-fatal adverse events.” In 2021, the FDA also announced “’enforcement discretion’ to allow mifepristone to be dispensed through the mail during COVID-19.”
After the decision from the Appeals Court panel, Kristen Waggoner, the CEO and President for Alliance Defending Freedom, tweeted, “Last night’s Fifth Circuit decision is a step forward for the rule of law. Critical safeguards removed by the @US_FDA will be restored and abortion by mail will end. The FDA put politics over science when it unlawfully approved dangerous chemical abortion drugs. It has evaded legal responsibility for years and has jeopardized the health of women and girls. While there is still work to do to hold the FDA accountable for its lawlessness, girls and women are safer today.”
On Thursday, Attorney General Mayes “provided a summary of the legal status of mifepristone in Arizona” – as it stood at the moment. Mayes admitted that “this is a fast-moving situation, and we are likely to see further court orders in the coming days and weeks.” She vowed to “use every tool at our disposal to fight back against rulings from extremist judges seeking to interfere with the rights of individuals to make their own personal medical decisions.” Her release broadcasted that “under Arizona law, patients in other states who need reproductive care can still travel to Arizona to receive care here.”
The case is expected to be expedited to the U.S. Supreme Court based on the conflicting rulings from the District Courts in Texas and Washington, and the updated decision from the U.S. Court of Appeals for the Fifth Circuit.
Daniel Stefanski is a reporter for AZ Free News. You can send him news tips using this link.
Following a controversial vote against a bill addressing the baby formula shortage, Congressman Andy Biggs (R-AZ-05) claimed that Congress’ plan would exacerbate the crisis. Not only that: Biggs ventured that the legislation, HR7791 or the “Access to Baby Formula Act of 2022,” would put the nation in worse shape amid the burgeoning inflation crisis.
Biggs explained that the bill would only bloat the Federal Drug Administration (FDA) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) at the expense of families. Only families between 100 and 185 percent of the federal poverty income guidelines qualify for WIC.
“Throwing tens of millions of dollars at the FDA — an agency arguably responsible for facilitating this crisis — is not a viable solution. Empowering the Secretary of the USDA so that they can waive administrative requirements for the WIC program is ineffective and artificial,” wrote Biggs. “This legislation would make baby formula shortages worse for most Americans. It will allow WIC to utilize a far greater portion of the baby formula market, crowding out many hard-working American families. The better solutions are to distribute formula currently in the hands of federal agencies and reduce regulatory barriers that would allow for the expansion of domestic formula production.”
THREAD re: Baby Formula Vote.
It is imperative to find solutions to address Biden’s baby formula crisis.
But what my congressional colleagues have proposed tonight does not address the core issues of this crisis.
HR7791 was one of two bills considered by Congress to address the baby formula crisis; it was passed Thursday in the Senate following passage in the House on Wednesday. It does not produce more formula, and it doesn’t help all families. Rather, it enables the FDA to scale back on its traditional regulatory powers to fast-track approvals and open up more options within WIC — not families outside the program. It was introduced by Congresswoman Jahana Hayes (D-CT-05) on Tuesday.
The other bill, HR7790 or the “Infant Formula Supplemental Appropriations Act,” passed the House on Wednesday largely along party lines, 231-192, with 12 Republicans joining Democrats to pass the bill. HR7790 would allocate $28 million to the FDA to increase staffing, therefore increasing the speed by which it inspects baby formula prior to being sold, and to commence research on best practices to prevent future shortages.
Congressman Paul Gosar (R-AZ-04) also voted against the HR7790, joined by Lauren Boebert (R-CO-03), Matt Gaetz (R-FL-01), Louie Gohmert (R-TX-01), Chip Roy (R-TX-21), Marjorie Taylor Greene (R-GA-14), Clay Higgins (R-LA-), and Thomas Massie (R-KY-).
The other legislators offered similar rationale for voting against the bill.
Boebert blamed the shortage on the FDA for closing the Abbott plant.
The FDA caused the baby formula shortage by unfairly closing the Abbott plant based on charges proven untrue.
Now, Pelosi wants to give the FDA a $28 million raise!
Democrats should be ashamed for pushing messaging bills & not real solutions. End the games and feed the babies!
Gaetz noted that the legislation was just another emergency authority to grow government.
“All considered, government-empowered swings to markets typically create more problems than they solve,” wrote Gaetz.
H.R. 7791 would make baby formula shortages worse for most Americans. It will allow WIC to utilize a far greater portion of the baby formula market, crowding out many hard-working American families. (1/2)
Gohmert proposed a different plan altogether: remove the FDA from the equation entirely. He rebutted claims that the Abbott plant was shut down over contamination concerns, noting that the FDA found no proof to justify their contamination claims and didn’t employ a plan to cover potential shortages once they forced the plant’s shutdown.
“There was no easing of restrictions by the FDA, no reopening plan from the FDA and not even an apparent awareness of the consequences of their actions until there was a critical shortage and American mothers were unable to feed their babies,” wrote Gohmert. “The FDA got us into this mess and they cannot get us out of it.”
1/6 Giving #FDA millions won't produce one ounce of #babyformula. Getting the FDA out of the way would accomplish that new production. The shutdown and subsequent investigation of the Abbott facility by the Biden FDA found no deadly bacteria in products. #BidenBabyFormulaCrisis
President Joe Biden announced earlier this week that he was invoking the Defense Production Act (DPA) and launching a program, Operation Fly Formula, to curb the baby formula shortage. The DPA will require suppliers to prioritize baby formula producers in their distribution above other customers. The program directs the Defense Department to secure baby formula overseas.
Corinne Murdock is a reporter for AZ Free News. Follow her latest on Twitter, or email tips to corinne@azfreenews.com.
Remdesivir: the only FDA-approved treatment for COVID-19. It’s an antiviral drug that the federal government touts as an effective and safe treatment for COVID-19 hospitalizations. However, the opposite may be proving true.
Despite governmental reassurances of remdesivir’s safety and efficacy, there continue to be reports and studies that indicate otherwise.
Remdesivir’s origins:
The FDA granted full approval to remdesivir – or, Veklury – on October 22, 2020. It wasn’t a new drug developed for this virus. Remdesivir was developed years earlier in 2009 by Gilead Sciences to fight hepatitis C and respiratory syncytial virus. At that point, remdesivir was known as Adenine C-Nucleoside, or GS-5734.
In 2014, remdesivir was given another opportunity to be deployed with the 2013 to 2016 West African Ebola virus. They received backing from the U.S. government for this effort. Before remdesivir could be implemented widely, the Ebola outbreak had subsided. Then the drug received another opportunity to treat Ebola in a 2018 outbreak. However, remdesivir failed to improve survival rates. Instead, a different treatment with a familiar name increased survival rates – monoclonal antibody therapies.
Over the past four years, the National Institutes of Health (NIH) has awarded Gilead Sciences just under $6 million in research grants for remdesivir. These grants were for researching its efficacy against MERS-CoV and any emerging coronaviruses.
It was after remdesivir’s failure to make a significant impact in the last Ebola outbreak in 2018 that Gilead Sciences looked to repurpose the drug. When the COVID-19 outbreak occurred, that became another opportunity for the experimental antiviral drug.
Since remdesivir had around a decade of research and trials behind it, Gilead Sciences was able to quickly submit its preclinical data and initiate further clinical trials to obtain an emergency use authorization (EUA) in May of 2020.
With nearly a year of full FDA approval, there exists more data and research on remdesivir.
More FAERS deaths than hydroxychloroquine and ivermectin:
The FDA Adverse Events Reporting System (FAERS) reports that remdesivir has caused nearly 1,500 deaths from 2020 to present. A total of nearly 6,000 cases, over 4,500 of them considered “serious.”
By comparison, hydroxychloroquine has just over 1,100 deaths, with over 14,150 cases from 2020 to present; just over 13,500 cases were considered serious.
Ivermectin had the lowest FAERS reports: under 30 deaths last year and this year, with nearly 430 cases and under 200 of those considered serious.
FAERS only has data for remdesivir from 2020 to 2021, when it was first used as a therapeutic treatment for COVID-19. In contrast, FAERS has tracked hydroxychloroquine for 35 years, and ivermectin 25 years – neither are FDA-approved as a treatment for COVID-19.
The current narrative around ivermectin paints the antiviral as ineffective at best and deadly at worst (in the case of overdosing or taking the version designed as a horse dewormer). Thursday, Banner Hospital told news outlets that they were experiencing heightened cases of ivermectin poisoning. They reiterated that ivermectin wasn’t FDA-approved and shouldn’t be used to treat COVID-19.
“Ivermectin is not an FDA-approved treatment for COVID. Clinical trials are ongoing to assess ivermectin for COVID, but no clear findings have been released that confirm this drug as a safe or effective form of treatment for COVID. For this reason, it is not currently a drug that Banner hospitals or providers will prescribe,” stated Banner Hospital.
Yet, doctors are still prescribing ivermectin – along with other non-FDA-approved treatments like hydroxychloroquine, azithromycin, and monoclonal antibodies.
A higher cost and financial incentive:
Whereas both hydroxychloroquine and ivermectin are available in generic brands over the counter for low prices (as low as under $20 for the former and under $30 for the latter, according to the latest deals we could find around press time), remdesivir doesn’t have a generic alternative and is only available to hospitalized patients.
Remdesivir costs $520 a vial, or $3,120 for a patient with private health insurance undergoing the typical six-vial treatment course. For 2020, Gilead Science reported around $24.35 billion in sales.
By comparison, the EUA-only monoclonal antibodies from Regeneron (REGEN-COV, a combination of casirivimab and imdevimab) cost less: around $2,100 per dose. The federal government covers that cost. Any costs to the patient would have to do with administration of the treatment; those costs can vary per health insurance.
Hospitals have a financial incentive if they administer remdesivir. The Centers for Medicare and Medicaid Services (CMS) gives hospitals a New COVID-19 Treatments Add-On Payment (NCTAP), a 20 percent bonus for any remdesivir treatments.
Mixed results on efficacy and safety:
Research on remdesivir’s efficacy and safety have arrived at mixed conclusions.
Some studies cast doubt on its safety, citing findings of adverse effects including respiratory and organ failure, low potassium, low red blood and platelet cell counts, gastrointestinal distress, low blood pressure, nausea, and vomiting. A pervasive concern has focused on remdesivir’s connection to kidney failure in COVID-19 patients.
Johns Hopkins Medicine speculated last May that COVID-19 itself might be the culprit for kidney damage or failure. That was published several weeks after remdesivir received its emergency use authorization (EUA) from the FDA.
In July, a study found that veterans who received remdesivir experienced longer hospital stays than those who didn’t. They also found no difference in mortality rates between those who received remdesivir and those who didn’t.
Some research abroad has concurred with these findings. A German study released last month stated that they weren’t confident in remdesivir’s ability to reduce or prevent intubation or mortalities.
In February and April studies, French researchers reported a correlation between remdesivir and kidney failure. A January review of remdesivir published by the American Society of Nephrology suggested that remdesivir not be administered to COVID-19 patients due to the kidney failure that occurred in animal testing.
And then there are the anecdotal reports of remdesivir’s impact. State Senator Kelly Townsend (R-Mesa), reported that two law enforcement officers were denied their choice of treatment – either ivermectin or hydroxychloroquine – and were instead given remdesivir. Shortly after, Townsend said that the two officers died due to kidney failure.
“I have asked @dougducey’s office for consideration re people’s right to try Ivermectin or HCQ [hydroxychloroquine] but are being denied while in hospital. A healthy border patrol agent just died who was denied access to potentially life-saving treatment & now a retired female Tucson police officer. She is on a ventilator,” wrote Townsend. “Both given Remdisivir, both have/had kidney failure. This denial of meds is criminal.”
Other studies say that the remdesivir may be more helpful than harmful, or that its benefits outweigh the risks.
Last October, the European Medicines Agency (EMA) launched an investigation into the potential link between remdesivir and acute kidney failure. After several months of research, they concluded that remdesivir wasn’t connected to kidney failure in COVID-19 patients.
The Journal of American Medical Association (JAMA) Network sought to reconcile the conflicting reports of remdesivir being both useful and ineffective, in a report issued in July. They determined that those receiving remdesivir in real-world hospital settings were more likely to be more severely ill than those who received it in a randomized, controlled hospital study.
Remdesivir’s drug information sheet doesn’t mention kidney damage or failure as one of the adverse reactions discovered in their trials.
Corinne Murdock is a reporter for AZ Free News. Follow her latest on Twitter, or email tips to corinne@azfreenews.com.
