Supreme Court hearing case today on the chemical abortion drug and Biden's FDA support of the drug

 

Experts preview U.S. Supreme Court’s abortion pill case

By Kate Quiñones

CNA Newsroom, Mar 25, 2024 / 19:40 pm

The United States Supreme Court will hear arguments Tuesday regarding the Biden administration’s alleged deficient safeguards surrounding use of the chemical abortion drug mifepristone and the risk the drug poses to women.

Among the safeguards, the Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine case could see the restoration of the initial requirement of in-person doctor visits before prescription of the pill as well as the initial seven-week limit on use of the abortion pill. 

In the case, the FDA challenged an August 2023 federal court ruling that affirmed that the FDA did not follow proper testing and safety protocols when it approved the abortion drug in 2000. 

In 2021, the FDA eliminated the in-person doctor visit originally required to obtain the drug, allowing the abortion pill to be prescribed via telemedicine and distributed through the mail. Earlier this year, drug stores such as Walgreens began selling the abortion pill over the count

Elizabeth Gillette, who survived severe complications from a chemical abortion, is set to testify about the lack of sufficient safeguards surrounding the drug and spoke with “EWTN News Nightly” anchor Tracy Sabol about the case.

In the interview, Gillette shared her experience with a chemical abortion — severe bleeding, labor pains, and seeing her dead child — that inspired her to testify against the lack of safeguards. 

“I was not properly prepared for the powerful drug that is the abortion pill. I suffered devastating side effects,” Gillette explained.

Chemical abortions involve a two-pill regimen consisting of the drugs mifepristone and misoprostol. This type of abortion cuts off the nutrients necessary for an unborn child to develop and then expels him or her from the womb. 

“I found myself on the bathroom floor in a pool of blood until I ended up expelling the entire amniotic sac with my baby — a recognizable baby inside,” she continued. “The trauma from this horrific experience still follows me today in the form of post-traumatic stress disorder.”

“This is nothing like what they told me would happen,” Gillette said. “It was minimized and the care was subpar.”

Chemical abortions account for over half of all U.S. abortions, according to a recent study.

Senior Counsel at Alliance Defending Freedom (ADF) Kellie Fiedorek also spoke about the case in an interview with Sabol.

“The FDA recklessly removed its original safeguards that provide women with in-person, ongoing care when taking abortion drugs,” she said. “Because they removed those, they put women’s lives in danger.”

“We sued the FDA on behalf of doctors to hold them accountable, and we’re asking the Supreme Court to reinstate those vital safeguards to protect the health and safety of women across this country,” Fiodorek indicated.

“The FDA’s own label says that roughly one in 25 women who take these drugs will end up in the emergency room,” Fiedorek continued. “So regardless of what people’s beliefs might be about abortion, we should all agree that women deserve the ongoing in-person care of a doctor when they’re taking high-risk drugs.”

The FDA first approved mifepristone for abortion in 2000 but included some restrictions on dispensation to prevent severe side effects. One restriction was that the drug had to be prescribed and dispensed in person.

That changed in 2021 when the FDA decided that the in-person requirement put a “burden on the health care delivery system.”

Over the years, other restrictions on the drug have also been removed. In 2016, the FDA determined that the drug can be used when a woman is pregnant with a child at 70 days’ gestation. Before 2016, the gestational limit was seven weeks. The FDA also decided in 2016 that non-physicians could prescribe the pill. 

In August 2023, the Fifth Circuit Court affirmed a lower court ruling that the FDA must reinstate the restrictions on the mifepristone pill that were in place before 2016. Those restrictions are currently on hold pending the U.S. Supreme Court’s decision. 

America’s Catholic bishops expressed concern about chemical abortions. In a February statement, the bishops noted that if the FDA policies are allowed to remain in place, “potentially harmful drugs [will] be mailed directly to girls and women who did not see a medical professional in person and may be injured or killed without public knowledge of the cause.”

“I would like everybody to remember that this is an extremely powerful drug, and women deserve ... to be treated with respect and with the safeguards in place,” Gillette said. “We’re worth it.”

USCCB opposes making contraceptive over-the-counter; fertility is a gift, not a disease says Bishop Barron

 

Catholic bishops to FDA: Don’t make ‘minipill’ contraceptive over-the-counter

By Kevin J. Jones

Denver, Colo., May 16, 2023 / 14:10 pm

Federal regulators with the Food and Drug Administration should reject proposed over-the-counter use of the progestin-only “minipill” contraceptive, the U.S. bishops have said. They echo other critics who say the drug’s side effects mean patients should have physician supervision while taking the drug.

“It is concerning that the FDA has a recommendation before it to approve over-the-counter hormonal contraception when there is strong evidence of the many harmful risks to women’s health,” Bishop Robert E. Barron of Winona-Rochester, chairman of the U.S. Conference of Catholic Bishops’ (USCCB) Committee on Laity, Marriage, Family Life, and Youth, said May 15.

An advisory panel to the FDA on May 10 unanimously voted to recommend approval of the Opill birth control pill for over-the-counter availability. A final decision is expected this summer.

The progestin-only contraceptive, sometimes called the “minipill,” was proposed for over-the-counter use by its France-based manufacturer Laboratoire HRA Pharma.

“I urge the FDA to reject this recommendation,” Barron said.

“Fertility is a gift, not a disease,” Barron’s statement on behalf of the USCCB continued. 

“Contraceptives exist to suppress the healthy functions of human reproduction. The mounting evidence of the many harmful side effects of hormonal contraceptives demonstrates that they are not good medicine,” the statement said.

To allow hormonal contraception access without medical supervision, he said, is “antithetical to the Hippocratic Oath that guides physicians to first ‘do no harm.’” 

In Nov. 14, 2022, comments submitted to the FDA advisory panel, the USCCB joined the National Catholic Bioethics Center, the Catholic Medical Association, and the National Association of Catholic Nurses, who represent thousands of health care providers and medical ethicists, to oppose allowing over-the-counter use of Opill.

“The failure rate of the minipill is higher than that of other hormonal contraceptive methods and will result in many unintended pregnancies, leading to potentially more abortions,” the letter said. It warned of serious harm to teens who will have access to the drug without parental notification.

The letter cited the potential for negative side effects such as organ failure, cardiovascular disease, or neurological issues. The hormonal contraceptive may cause abnormal bleeding, ovarian cysts, and depression. Prescription use, the letter said, would allow the oversight from health care professionals that is necessary to monitor side effects.

Physicians and other health care professionals, the letter said, should monitor a patient’s use of the drug for side effects. Prospective patients should also be screened for known or suspected pregnancy, known or suspected breast cancer or other progestin-sensitive cancer, undiagnosed abnormal uterine bleeding, hypersensitivity to Opill components, acute liver disease, and benign or malignant liver tumors.

The USCCB cited the FDA’s May 2022 change to safety prescribing protocols because of evidence that hormonal contraception increases breast cancer risk. The change came in response to a Citizen’s Petition from the Contraceptive Study Group. The group of concerned health care professionals and educators submitted their analysis of hormonal contraceptives’ harmful side effects and asked the FDA to add a “black box” warning to the drug labeling requirements to inform the public of these risks.

According to the USCCB, the FDA offered “modest acknowledgment” of the risks of breast cancer and “quietly changed” safety protocols for prescribing hormonal contraception and the required information to be dispensed to patients with a prescription.

Progestogens, also known as progestins, are synthetic hormone drugs that mimic progesterone, a natural hormone vital for menstruation and pregnancy. Progestogen-only contraceptives are provided in various ways: as an implant, a hormonal intrauterine device, a contraceptive injection, or the “minipill.”

In March Oxford researchers published a study showing a 20% to 30% relative risk for breast cancer associated with progestogen-only contraceptives, compared with women who did not take oral contraceptives. The study drew on data from almost 10,000 U.K. women who were diagnosed with invasive breast cancer over a 21-year period and data from more than 18,000 women who were not diagnosed with breast cancer.

These contraceptives differ from the most popular contraceptive drug, a combined oral contraceptive pill that includes estrogen.

The World Health Organization’s International Association for Research of Cancer on its website lists estrogen-progestogen oral contraceptives as among 122 carcinogenic agents. It also notes “convincing evidence” that the drug has a “protective effect against cancer in the endometrium and ovary.”

Since overturn of Roe v. Wade, using pills to kill babies

 Since Roe v. Wade ended, the battle over legal abortion has largely shifted to access to pills.

By Emily Bazelon Staff Writer, NYT Magazine

Gabriela Bhaskar for The New York Times

Becoming mainstream

Since the end of Roe v. Wade last June, access to abortion pills has muted some of the effect of the severe restrictions on abortion that 14 states have imposed. Abortion opponents have responded by trying to reduce access to those pills. The resulting struggle has become the main battle to watch in the post-Roe landscape.

Today’s newsletter examines the latest developments — including a court ruling expected soon — and explains what’s likely to happen next.

How pill access grew

The most effective and safest method of medication abortion requires two drugs. The first, mifepristone, ends the pregnancy. The second, misoprostol, causes cramping and bleeding to empty the uterus, like a miscarriage. In approving this regimen in 2000, the F.D.A. imposed restrictions on mifepristone because of questions then about its safety. Among other rules, patients had to visit a clinic, doctor’s office or hospital to receive the medication.

In 2021, during the pandemic and after President Biden took office, the F.D.A. lifted the in-person requirement. The shift opened a new avenue for telemedicine abortions. In about 30 states, women could legally end their pregnancies at home, with pills prescribed through an online consultation and mailed to them. If they had questions, they could call a private national hotline to talk to medical professionals.

After the Supreme Court overturned Roe last year, demand surged for abortion pills by mail. An international organization, Aid Access, provided prescriptions for the pills from European doctors, often filled in India, to patients in states with bans. Overseas pharmacies, advertising online, also ship abortion pills without a prescription to every state.

These offshore routes to access, which operate in a legal gray area in states with abortion bans, will probably remain open. But they carry potential legal risks for women and it can take a few weeks for the drugs to arrive from overseas, a delay that can create problems since medication abortion is more effective and less likely to cause complications early in pregnancy.

How opponents are fighting back

Opponents of abortion have a bold counterstrategy. They want to block the use of mifepristone not only in states with abortion bans but also nationwide.

In November, anti-abortion organizations and doctors sued in Texas to challenge the F.D.A.’s approval of medication abortion 23 years ago. They argue that mifepristone is unsafe. In fact, research has clearly established the safety and efficacy of the F.D.A.’s approved regimen. Serious complications are possible but rare. So, on the merits, the suit may seem far-fetched.

But the plaintiffs made sure to file suit (a practice some experts call “judge shopping”) in a division of a Federal District Court with one judge, a Trump appointee named Matthew Kacsmaryk who has longstanding views against abortion. If he blocks the F.D.A.’s approval, it would be unprecedented, experts said in an amicus brief.

The drugstore battle

Separate from the Texas case, the national divide over abortion is playing out in pharmacies.

In January, Walgreens, CVS and other companies said they would apply for a newly available certification from the F.D.A. to dispense both drugs in states where abortion remains legal. But 21 Republican attorneys general — including four in states where abortion is still legal — threatened legal action against the pharmacy chains. Walgreens promised not to provide the pills within those states.

The chains see an opportunity for another new market. Their interest signals that medication abortion is becoming mainstream. In large parts of the country, that’s unwelcome.

What’s next

Other lawsuits are trying to protect access to abortion pills. One, filed by states where Democrats are in power, asks a judge to affirm the F.D.A.’s approval of mifepristone and remove the remaining restrictions on the medication. Another, by a U.S. manufacturer of the medication, is challenging state bans on the pill.

For now, mifepristone and misoprostol remain widely and quickly available in states where abortion is legal. And the medications can be obtained through avenues like Aid Access, with a delay, in states where abortion is not legal.

Taken together, the drugs are more than 95 percent effective, research shows. Alternatively, people can take only misoprostol in higher doses, but this method is 88 percent effective, according to a study in the U.S. published last month, and is also more likely to cause side effects like nausea and diarrhea.

A ruling from Judge Kacsmaryk could come any day. If he issues a nationwide injunction to block the provision of mifepristone, his ruling could increase health risks and physical discomfort for women.

“The Texas lawsuit is based on the false claim that mifepristone is unsafe and leads to a high need for physician intervention,” Abigail Aiken, one author of the new study, said. “And yet, if we move to a miso-alone protocol, the need for physician intervention will, if anything, be increased.”

A nationwide injunction would be immediately appealed. It’s also possible that Judge Kacsmaryk can’t actually stop the legal provision of mifepristone, at least in the short term, three law professors argue. Congress set procedures for the F.D.A. to withdraw approval from a drug, and the process takes time to follow. A judge can order a review but shouldn’t have the power to circumvent the rules, the law professors say.

The F.D.A. also has a workaround: When the risk is low, the agency can give manufacturers permission to keep distributing products, like some baby formula, which violate the law in some way.

It’s a strange idea: a federal agency using its discretion to avoid enforcing a court ruling. But it could also be the only way for women in the U.S. to continue accessing the safest and most effective method of medication abortion — as long as a president who supports abortion access is in office.

Faithful Catholics fight back against FDA and abortion inducing drugs

 

Catholic groups join fight against FDA approval of abortion pill

By Tyler Arnold

Washington, D.C. Newsroom, Feb 15, 2023 / 16:25 pm

Several Catholic organizations are making their voices heard in the legal battle against the Food and Drug Administration’s approval of an abortion-inducing drug by signing onto an amicus brief in a lawsuit against the agency.

Mifepristone, which the FDA approved in 2000, can be used to abort a preborn child up to 10 weeks of gestation. Although a prescription is needed, a person can receive a prescription for the drug without having any in-person care and obtain the drug in person or through the mail.

A pro-life health organization, the Alliance for Hippocratic Medicine, filed a lawsuit against the FDA in Texas, which claims the FDA failed to abide by its legal obligations when approving the drug. The group is represented by Alliance Defending Freedom. The lawsuit alleges that the FDA never studied the drug under its current labeled conditions of use and “ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls.” It also states that the agency disregarded evidence that chemical abortions cause more complications than surgical abortions.

The lawsuit further alleges that the FDA recently eliminated certain safeguards. In January, the FDA changed its rules to permanently allow mifepristone to be provided through the mail, which the lawsuit claims is a violation of federal law. In January, the FDA also approved the sale of mifepristone through pharmacies if they receive FDA certification. The FDA has not granted any certifications so far, but the pharmacy chains CVS and Walgreens are currently working with the federal government to get approval.

According to the lawsuit, ending these safeguards increases the risk of forced abortions and “helps sex traffickers and sexual abusers to force their victims into getting abortions while preventing the authorities from identifying these victims.”

According to the Guttmacher Institute, chemical abortions make up more than half of abortions in the United States. Those who perform chemical abortion commonly use a combination of mifepristone and misoprostol, with the latter being less regulated. This means the court ruling could drastically change the abortion landscape in the country.

An FDA spokesperson declined comment on the litigation.

Numerous pro-life organizations, 67 members of Congress, and nearly two dozen state attorneys general have signed amicus briefs, also known as “friend of the court” briefs, in support of the Alliance for Hippocratic Medicine lawsuit. Several Catholic organizations have recently joined the fight against the abortion pill.

“We think that there are very serious ethical issues of informed consent not being properly obtained in providing abortions through mifepristone,” Joseph Meaney, the president of the National Catholic Bioethics Center, told CNA. “Abortion is never ethical, but it is even worse to do it in ways that endanger those seeking it.”

The National Catholic Bioethics Center was one of several Catholic organizations that signed onto an amicus brief with Susan B. Anthony Pro-Life America. This includes the Catholic Bar Association, the Catholic Benefits Association, and the Catholic Health Center Leadership Alliance.

“A woman or girl cannot consent to a chemical abortion without knowing the specific risks that mifepristone poses to her life, health, and fertility,” the brief reads. “Voluntary consent is essential to genuine informed consent. Consent obtained through coercion is no consent at all. Abortion-inducing drugs are inherently different from other prescribed drugs because of the increased risk that women may be coerced to abort their children.”

The brief alleges that “informed consent cannot be properly obtained” because the FDA did not study the “safety of the drug when used by patients outside of a clinical trial. It adds that “post-marketing restrictions do not require reporting of non-fatal adverse events and both FDA and mifepristone’s sponsors have failed to demonstrate that mifepristone’s adverse events can be reliably reported by other means.” It also states that mifepristone is not an effective treatment for an ectopic pregnancy, but that removing the in-person requirement means doctors “are unable to adequately diagnose ectopic pregnancy.”

In addition to these safety risks, the brief alleges that the risk of forced abortions “is greatly increased by the removal of the in-person dispensing requirement” because “without in-person care, prescribing health care providers cannot adequately determine whether the patient is giving free consent without coercion or duress.”