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Democrats and Republicans Square Off in Lawsuits Against FDA

Democrats and Republicans Square Off in Lawsuits Against FDA

Democrats and Republicans are squaring off in dueling legal efforts in opposition and defense of the widely used abortion pill.

Dozens of attorneys general from both red and blue states are taking sides in a battle that will ultimately determine the fate and availability of the widely used abortion pill.

Blue states are suing the United States Food and Drug Administration (FDA) from the position that it is too strict in limiting access to mifepristone, one of the two drugs used for medication abortion.

In the meantime, red states are suing the FDA from the position that it never had the authority to allow the drug to be made available online and shipped through the mail, and are seeking to have it removed from the U.S. market entirely.

On its own behalf, the FDA has asked the court to dismiss the lawsuits.

The Republican Argument

The Republican complaint (pdf) was filed on Nov. 18, 2022, in the U.S. District Court for the Northern District of Texas Amarillo Division by Julie Marie Blake on behalf of Alliance Defending Freedom (ADF).

The complaint takes the abortion pill story back to its beginnings when, on the second day of his presidency in January 1993, Bill Clinton “directed his cabinet to legalize chemical abortion drugs in the United States.”

The complaint alleges that Clinton and the FDA “then pressured” the manufacturer of mifepristone “to donate for free the U.S. patent rights of the drug to the Population Council,” described as “an entity focused on population control.”

After receiving the patent rights, the Population Council submitted a new drug application, coordinated closely with Clinton’s FDA, and obtained approval on Sept. 28, 2000.

“The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments,” the complaint argues.

“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”

Julie Marie Blake, senior counsel for ADF, says the FDA has failed in its primary responsibility of protecting American lives.

“The FDA failed in its responsibility to protect Americans when it approved chemical abortion drugs and when it removed even basic safeguards on their use,” Blake told The Epoch Times.

“Our lawsuit is brought on behalf of emergency room doctors, local OBs, and medical professionals who have had to care for women harmed by these dangerous chemical abortion drugs. They’re standing up on behalf of their patients and we’re asking the court to order the FDA to put the politics aside, to follow the science, and to protect women and girls from chemical abortion drugs.”

On Feb. 10, Mississippi Attorney General Lynn Fitch filed an amicus brief (pdf) in the same court on behalf of her state as well as the AGs of 21 additional red states.

“Rather than respect the Constitution, the Supreme Court, and the democratic process, the Biden Administration has attacked and worked to undermine the considered judgments of the elected representatives of States like amici,” Fitch wrote in the complaint.

“The Administration’s actions on abortion drugs typify that effort. The day Dobbs was decided, President Biden directed his Administration to ensure that abortion drugs are ‘as widely accessible as possible,’ including ‘through telehealth and sent by mail.’”

Fitch further argued that “the FDA’s actions will undermine States’ ability to protect their citizens,” which “will lead to the widespread shipment and use of abortion-inducing drugs,” and “force States to devote scarce resources to investigating and prosecuting violations of their laws. As the FDA continues a campaign that will harm amici’s citizens, amici will not sit by.”

Mississippi Attorney General Lynn Fitch.(Courtesy of Lynn Fitch)

“The FDA’s brazen attempt to not only sidestep but outright defy federal and state laws threatens both the health of women and democracy,” Fitch wrote further.

“In the Dobbs case, the Supreme Court affirmed that states may enact laws that protect unborn life, women’s health, and the integrity of the medical profession, and we will not allow the Biden administration to trample on this fundamental Constitutional building block.”

On Jan. 13, Danco Laboratories, LLC, filed a motion to intervene (pdf). According to reports, Judge Matthew Kacsmaryk ordered Danco Laboratories to explain its opposition to the plaintiff’s case.

“Forcing FDA to withdraw a longstanding approval would seismically disrupt the agency’s governing authority as to whether drugs are safe and effective, and would cause Danco direct and immediate harm by shuttering its business,” attorneys for Danco Laboratories told the court.

The Democrat Argument

On Feb. 23, AGs from 12 Democrat-led states filed a lawsuit (pdf) against the FDA arguing that its current regulations are too restrictive. Doctors who prescribe the abortion pill, and the pharmacies that dispense the drug, must obtain a special certification to do so.

The Democrat states want to expand access to the abortion drug by having the FDA allow any doctor to prescribe it and any pharmacy to dispense it, like most drugs. They complain further about the time-consuming requirements placed on the University of Washington—Patient Agreement Form must be signed by both the patient and a certified provider, which “poses significant challenges in the telehealth setting,” before a prescription can be filled by a certified pharmacy.

“This work has been further complicated by the fact that some patients may not have access to or comfort with certain technologies (such as smartphones with scanning apps),” they argue further, adding that some physicians “have expressed concern that by completing the Prescriber Agreement Form and having their name on a list of certified medication abortion prescribers, they could become a target of anti-abortion violence or harassment in the event the list were leaked or compromised.”

New York Attorney General Letitia James speaks during a press conference in New York, on Sept. 21, 2022. (Yuki Iwamura/AFP via Getty Images)

On Feb. 10, a coalition of 22 attorneys general, led by New York Democrat AG Letitia James, asked the court to dismiss the case, arguing that the withdrawal of federal approval for the abortion drug would have a negative impact on millions of people.

“The consequences of annulling the FDA’s approval of medication abortion—currently the most common method of obtaining early abortion—would be nothing short of catastrophic,” James stated in the brief (pdf), adding that removing the pills from the market will have “devastating consequences for the residents of amici States.”

“Procedural abortion is not only more invasive than medication abortion, but it is also generally more costly and difficult to obtain,” the brief argues.

“Indeed, the availability of mifepristone has been particularly critical in providing access to abortion in low-income, underserved, and rural communities where procedural abortion may be unavailable. And because medication abortion is the most common method used to terminate pregnancy during the first trimester, eliminating access to this method will result in more abortions taking place later in pregnancy, further increasing costs and medical risks.”

The FDA’s Argument

In a response (pdf) filed on Jan. 13, attorneys for the FDA argued that the case should be dismissed, since there is no precedent where a court has “second-guessed FDA’s safety and efficacy determination” and “ordered a widely available FDA-approved drug to be removed from the market.”

“Removing access to mifepristone would cause worse health outcomes for patients who rely on the availability of mifepristone to safely and effectively terminate their pregnancies,” the FDA’s attorneys argued.

FDA A sign for the Food And Drug Administration is seen outside of the headquarters in White Oak, Md. (Sarah Silbiger/Getty Images)

ADF senior counsel Blake sees it differently.

“By illegally approving chemical abortion drugs, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women,” she told the Epoch Times.

“The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.”

Blake also insists the FDA never had the authority to allow chemical abortion drugs to be sent by mail in the first place.

“Long-standing federal laws, passed by Congress, say that you can’t send chemical abortion drugs through the mail or by FedEx or UPS,” Blake noted.

Federal criminal law 18 U.S.C. §§ 1461, 1462 does prohibit the distribution of abortion-inducing drugs through the mail. By obstructing the law, Fitch insists that Biden’s FDA has “undermined the public interest.”

Blake also said there are important reasons why chemical abortion drugs should be dispensed in person by a doctor rather than being prescribed remotely.

“An in-person medical exam or an ultrasound can rule out important reasons why a woman shouldn’t take chemical abortion drugs, such as when she may be farther along in her pregnancy than she realizes,” she said. “It can also help rule out an entopic pregnancy. Chemical abortion drugs can kill a woman if she takes them, and while she thinks her pain is just being caused by going through a chemical abortion, she’s really going through a life-threatening entopic pregnancy.”

‘Abortion Pill’ Explained

In 2000, the FDA approved mifepristone as a method of abortion in 2000. When taken along with misoprostol, the two-drug combination is known as medication abortion or the “abortion pill.”

A study published by the Guttmacher Institute—first published in February of 2022 and updated in December of 2022—showed that over half of the abortions in the United States (54 percent) were induced chemically by abortion pills in the year 2020.

“That year is the first time medication abortion crossed the threshold to become the majority of all abortions and it is a significant jump from 39 percent in 2017 when Guttmacher last reported these data,” the report revealed.

Epoch Times Photo File photo: A poster advertising illegal abortion pills is seen on a bin in Sophiatown, Johannesburg, on September 29, 2020. (Luca Sola/AFP via Getty Images)

According to Willow Women’s Center (WWC), the term “abortion pill” leads some to believe that only one pill is required to end a pregnancy.

“But in reality, a medical abortion requires taking multiple pills of two different abortion medications; mifepristone and misoprostol,” WWC explains on its website, adding that “the first abortion medication, mifepristone, is taken to block progesterone. When progesterone is blocked, the uterine lining breaks down, and the embryo’s heart stops beating. The second medication, misoprostol, is taken approximately 24 hours later. Misoprostol causes the embryo to detach from the uterus and be expelled by producing heavy uterine cramping.”

Abortion pills are usually taken when the abortion is to take place at home. There are side effects, which include painful uterine cramps, nausea, vomiting, heavy bleeding, and passing blood clots. Serious risks, which would require medical attention, include heavy bleeding that does not stop, future infertility, and undetected ectopic pregnancy. Death is also possible.

Of the estimated 5.6 million women who have used the “abortion pill” for the termination of pregnancy through June 30 this year, the FDA acknowledges 28 deaths since the product was approved in September 2000, including two cases of ectopic pregnancy and several fatal cases involving severe systemic infection, also known as sepsis.

The FDA also acknowledges there were 98 injuries from using the abortion pill with undetected entopic pregnancies. In all, there were 1,473 reported cases of adverse events, 280 hospitalizations, 188 cases of blood loss that required transfusions, and 106 cases of severe infections.

On January 3, 2023, the FDA approved Risk Evaluation and Mitigation Strategy (REMS) modifications to the Mifepristone REMS Program.

Key changes include:

Pharmacies that become certified in the Mifepristone REMS Program may dispense the drug directly to patients upon receipt of a prescription from a certified prescriber, provided a Prescriber Agreement (pdf) has been provided or is on file with the certified pharmacy.
The “in person” requirement, which mandates that patients see healthcare providers at a physical locations and was temporarily removed during the COVID outbreak, has been permanently removed.

“Chemical abortion drugs are dangerous,” Blake asserted

“One in five women who take chemical abortion drugs will suffer complications and seek medical attention. Our doctors care for these women when they have life-threatening infections, severe, uncontrolled bleeding, or have the inability to have a future successful pregnancy.

“We see firsthand the harm caused by these chemical abortion drugs every day when they are dispensed online and delivered in the mail with no one there to help care for women when they go through this. Women and girls deserve better than the FDA’s complete failure to protect them.”

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