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A three-judge panel heard arguments in a lawsuit brought by anti-abortion groups asking the court to pull the widely used drug from the market.
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(Video) Legal expert examines federal appeals court ruling on abortion pill mifepristone424
go throughAbby Van HoltzIPam Barack
Abbie VanSickle reported from New Orleans, and Pam Belluck from New York.
On Wednesday, a federal appeals court appeared poised to rule that the widely used abortion pill should be restricted, signaling skepticism about the Food and Drug Administration's decision on the drug.
The question is whether to uphold the Texas federal judge's initial decision thatannounced in aprilThe pill mifepristone, approved by the FDA 23 years ago, is not effective.
Criticism of the FDA was reflected in questions and comments from three judges on the U.S. Court of Appeals for the Fifth Circuit since the two-hour hearing in New Orleans began. and a lack of knowledge about abortion drugs, especially how to prescribe them.
While the case is still in its early stages and any decision is subject to appeal, it could end up with dire consequences.
If upheld, the first judge's ruling would ban drug abortions in states where abortion is legal, not just in states with bans and restrictions. The FDA's regulatory power over other drugs could be challenged in other lawsuits,Pharmaceutical companies express uncertaintyAbout the FDA's role in possibly inhibiting drug development in the US.
At issue is whether the parties who filed the lawsuit — organizations that oppose abortion and don’t prescribe the pill and a coalition of doctors — can show that they will suffer real harm if the drug remains available and waits too long to challenge approval. Mifepristone, the first tablet in a two-drug regimen.
The plaintiffs argued that mifepristone was dangerous, the FDA argued. It failed to follow proper regulatory protocols when it was approved in 2000, and the agency has since overly loosened restrictions on the pill. The government strongly disputes the claims, citing years of research showing mifepristone is safe and arguing that the agency acted responsibly.
A panel consisting of two of President Donald J. Trump's nominees, Justices James C. Ho and Cory T. Wilson, and George W. Bush's nominee, Judge Jennifer Walker Elrod, did not reach a decision at Wednesday's hearing. That will happen at a later date, although the court has not had time to make a decision. Any decision is subject to appeal, first to the full bench and then to the Supreme Court.
Less than a minute after Justice Department attorney Sarah Harrington, who is representing the FDA, made her statement, Judge Ho paused to criticize her for describing the case as an "unprecedented and unprovoked attack on the FDA." scientific experience".
"I don't want to break it so quickly, but he said it's unprecedented," he said, adding that the appeals court has heard other cases against the FDA.
Ms. Harrington responded that these cases are different, and it is the FDA's job to determine whether the drugs are safe enough to be approved. "It's not the court's job to go in and speculate about that experience, and no court has ever done that," he said.
Judge Ho advised them to "focus only on the facts of the case, not on a reason that the FDA can't do wrong."
The central argument on Wednesday was whether the plaintiffs, four pro-abortion doctors and an umbrella group called the Hippocratic League of Medicine could show that they would suffer real harm if access to and acceptance of the pill remained the same. Lawyers say this is a longstanding requirement.
At the hearing, both Ms. Harrington and Jessica Ellsworth, an attorney for mifepristone maker Danco Laboratories, said the plaintiff doctors did not cite any instances where they were forced to treat patients with drug-related complications. Spontaneous abortion.
"They never asserted that any identified claimant was required to have an abortion, which was against their religious beliefs or conscience," Ms Harrington said. Even if anti-abortion doctors find one of the few patients in whom mifepristone is causing serious complications, they can ask their colleagues to treat that patient, he said, because state and federal laws provide health professionals with "respect for conscience and religion." Strong protections", allowing them to refuse treatment.
The plaintiffs' attorney, Erin Hawley, said the pro-choice doctors had been wronged and thus had standing to sue.
"They don't claim damage because they were forced to have an abortion," he said, adding: "The damage to their conscience is much wider. They say they feel complicit in having a selective abortion because they were forced to Carry out the procedure."
Ms Hawley also tried to portray the government as downplaying concerns about medical abortion.
"Abortion is different: we're talking about ending the life of an unborn child," he said, adding: "This case is very different from a doctor who claims to have harmed a child with asthma or the treatment of a shooting victim because the behavior here is not the same as breaking the law." Behavior is directly related.” FDA’s Actions for Mifepristone Approval and Deregulation. "
Judge Wilson offered several criticisms of the FDA's decisions in recent years to make drugs more accessible, including allowing them to be mailed.
"This makes it more likely that patients will go to an emergency room or a medical clinic where a doctor is a member," he said. "I don't understand how you square the circle."
"I don't think any of that is true or supported by the evidence," Ms Harrington replied.
Judge Elrod noted that the appeals court had received numerous testimonies from friends of the court, which had been vigorously debated on both sides, including women in sexually abusive relationships who said "if you don't mail them pills, they'll never escape "Because they will be caught by the perpetrators. "
The judge asked Ms Hawley how the courts should look at the cases.
"In the dire circumstances you describe, there are other methods available to people to obtain abortions," Ms. Hawley said, adding: "This case is not about ending abortion. It's about ending a particularly dangerous type of abortion."
Ms Harrington cites research showing the method is very safe, adding that "the rate of serious complications is well below 1 percent".
The plaintiffs argued that the F.D.A. illegally approved mifepristone in a flawed process that "prioritized politics over women's health" and then made "politically motivated decisions that unlawfully promoted a dangerous regime."
The government strongly retracted its document, saying "FDA's action is fully supported by the decades-long track record of safe and effective use of mifepristone in the United States and around the world."
The agency also argued that the plaintiffs waited too long to file a lawsuit.
"After mifepristone was approved, they have not filed a lawsuit for more than two decades," the government wrote.
More than a dozen medical societies filed friend-of-the-court letters in support of the agency.
Wa short, the Medical Association questioned the reasoning of Texas federal judge Matthew J. Kasmarik's ruling, saying it was based on "pseudoscience and speculation."
Judge Kacsmaryk ignored "decades of clear analysis supporting the use of mifepristone to treat miscarriage and abortion," they wrote.
Judge Elrod in particular seemed to take issue with Danko's prosecution, which harshly criticized Judge Kaczmarik's ruling, going so far as to call it an "unrelentingly one-sided narrative."
In an unusual exchange, Judge Elrod sharply criticized Danko's language in his statement, telling the firm's lawyer, Ms Ellsworth, that his statement "personally weakened the District Court" and "Tricks we don't usually learn again" are used.
Ms Ellsworth said the remarks were intended to express views "that we believe the District Court is very unrestricted" and not intended to "make any personal attacks". But when the judge reiterated her criticism, saying she wanted to give Danko an "opportunity" to respond differently, Ellsworth said, "Maybe we could reduce it a bit, given more time."
The plaintiffs stand on the steps of the federal courthouse after the trial.
Dr. Christina Francis, an Indiana physician and executive director of the American Society of Obstetricians and Gynecologists for Supporting Life, issued the statement cited by the judges, saying: "We see women go to the emergency room after taking this drug in large quantities. The chamber is bleeding, and we as doctors take an oath to care for our patients."
Bleeding and cramping are normal side effects of the medical abortion process and are signs of loss of pregnancy tissue, medical experts say.
Asked if she had treated women for mifepristone side effects, Dr. Francis said she had noticed an increase in such cases since the FDA. It eased some restrictions on the drug in 2016. She did not give figures or provide details.
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FAQs
Can a court overturn FDA approval? ›
Legal analyses have determined that judges do not have the authority to overrule FDA decisions on drug approvals and market availability; however, further litigation will likely be required before the decision is reversed.
What is the FDA decision on mifepristone? ›The high court's ruling allows the current FDA rules to remain in effect, keeping mifepristone available for medication abortion where and when abortion is legal as the case proceeds through the courts. Telehealth abortions can also continue, where state law permits.
Is Mifeprex approved by the FDA? ›The FDA first approved Mifeprex in 2000 and approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg in 2019.
What are the side effects of the drug mifepristone? ›The most common side effects of Mifeprex treatment include: nausea, weakness, fever/chills, vomiting, headache, diarrhea and dizziness. Your provider will tell you how to manage any pain or other side effects.
Who can override the FDA? ›“Congress has delegated scientific decision-making to FDA and it is not up to courts to override it.”
Can you appeal an FDA decision? ›A person requesting an appeal of a decision may request an in-person meeting or teleconference with the review authority. If this request is included in the request for appeal of a 517A decision, then the Center must schedule the meeting or teleconference to occur within 30 days of the request.
Is misoprostol approved by the US FDA? ›A regimen of mifepristone, followed by misoprostol, a drug that is also used to treat ulcers, manage miscarriages, induce labor, and assist with IUD insertions, is an FDA approved protocol for abortion during the first 70 days, or up to 10 weeks, after the first day of the pregnant person's last menstrual period.
What is the FDA warning for Cytotec? ›Cytotec may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception.
When was Mifeprex FDA approval? ›Approval Date: 9/28/2000.
Why is Cytotec not FDA approved? ›However, it should be noted that the FDA has NOT approved Cytotec for the use of labor induction or cervical ripening. The FDA has made it known publicly that because of the possible side effects associated with the drug, they do not allow it to be marketed as a solution to post-date pregnancy or labor complications.
Who is the owner of Mifeprex? ›
A federal appeals court recently imposed severe restrictions on how the brand name version of the drug Mifeprex, which is sold by Danco Laboratories, is used and distributed.
Is Cytotec FDA approved for pregnancy? ›Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy.
What effect does mifepristone have on the uterus? ›Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.
What does misoprostol do to the uterus? ›Misoprostol softens the cervix and contracts the uterus to expel the pregnancy.
What are the worst side effects of misoprostol? ›- Blistering, crusting, irritation, itching, or reddening of the skin.
- breast pain.
- burning, dry, or itching eyes.
- change in taste.
- continuing ringing or buzzing or other unexplained noise in the ears.
- cracked, dry, scaly skin.
- depression.
- discharge, excessive tearing.
Vaccines for Animal Diseases– FDA does not regulate vaccines for animal diseases. Veterinary biologics, including vaccines for animal diseases, are regulated by the U.S. Department of Agriculture.
What does the US FDA not regulate? ›The FDA does not regulate the practice of medicine, medical services, the price or availability of medical products and whether they are reimbursed by health insurance or Medicare.
Does the FDA have to approve everything? ›How to get FDA approval depends on the type of product you are marketing in the United States. FDA does not require FDA approval for all types of products.
What are the 4 possible decisions that can be issued after an appeal? ›A court order may be upheld, overturned, modified, or remanded by appellate courts. When the higher court rules that, the lower court's decision is invalid and reverses it, this is known as a reversal.
Whose decision cannot be appealed? ›The jury verdict is not appealable. However, the judgment entered by the judge, which is based on the jury's verdict, can be appealed. Judgment entered after a court trial, or a trial by a judge without a jury.
Can you sue if a drug is FDA approved? ›
No FDA Defective Drugs Lawsuits
Under a legal concept known as "sovereign immunity" you cannot sue the FDA for approving a drug that is later proven to be defective and dangerous. Sovereign immunity says: Federal, state and tribal governments, as well as foreign governments, are immune from lawsuits.
Do not take misoprostol to prevent ulcers if you are pregnant or plan to become pregnant. Misoprostol may cause miscarriages, premature labor, or birth defects.
Is misoprostol discontinued? ›Lupin discontinued misoprostol tablets. Pfizer has Cytotec tablets available.
Is misoprostol a pro drug? ›Misoprostol is a prostaglandin E1 analog which was manufactured for treatment of gastric ulcers. It is a pro drug metabolized through rapid de-esterificiation into the active metabolite misoprostol acid, MPA.
What medication has a black box warning for pregnancy? ›WARNINGS. CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION.
Is Cytotec the same as Pitocin? ›Pitocin and Cytotec are drugs used to induce or hasten labor in women struggling with delivery. Both Pitocin and Cytotec are synthetic forms of oxytocin, which is a naturally occurring female hormone that is produced during labor in order to cause contractions.
Who should not use Cytotec? ›Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Cytotec should not be taken by anyone with a history of allergy to prostaglandins.
What is the generic name for Mifeprex? ›Health care providers should review the approved labeling for Mifeprex and the approved generic, Mifepristone Tablets, 200 mg.
What is the half life of Mifeprex? ›Following a distribution phase, elimination of mifepristone is slow at first (50% eliminated between 12 and 72 hours) and then becomes more rapid with a terminal elimination half-life of 18 hours.
Was the mifepristone rems program modified on january 3 2023? ›The Mifepristone REMS Program was modified on January 3, 2023. Under the Mifepristone REMS Program, the FDA requires that: Mifepristone must be prescribed by a healthcare provider that meets certain qualifications and is certified under the Mifepristone REMS Program.
How can I open my cervix naturally? ›
- Acupuncture.
- Breast stimulation.
- Castor oil.
- Enemas (injection of water or liquid into the rectum to clear the colon).
- Herbal supplements.
- Hot baths.
- Sexual intercourse.
- Transcutaneous electrical nerve stimulation (TENS).
- Generic Name: Misoprostol.
- Brand Name: Cytotec.
- Drug Class: Gastrointestinal Agents, Other.
US FDA pregnancy category: Not assigned. Risk summary: This drug may endanger pregnancy by producing uterine contractions, bleeding, and expulsion of the products of conception. Comments: -Patients of childbearing potential should be apprised of the potential harm to the fetus.
Who owns Cytotec? ›CYTOTEC® Quick Finder
Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Misoprostol Tablets. Misoprostol is a medication that can prevent stomach ulcers if you also take NSAID medications. It reduces the amount of acid in your stomach, which protects your stomach lining. The brand name of this medication is Cytotec®.
Can pharmacies dispense mifepristone? ›Fact: No major retail pharmacy has received certification from the FDA to dispense mifepristone. Walgreens is currently seeking certification, so that it can dispense mifepristone. It never “stopped dispensing” as it does not have the required authority to dispense in the first place.
What are the black box warnings for Cytotec? ›Nonteratogenic effects: See boxed WARNINGS.
Cytotec may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception.
Abortion pills, such as mifepristone (Mifeprex) and misoprostol (Cytotec), work very differently from Plan B. Mifepristone blocks your body's natural progesterone, which is needed to start and maintain a pregnancy. Misoprostol causes your cervix to open and your uterus to contract, helping you to push tissue out.
Is misoprostol FDA approved for inducing labor? ›Misoprostol has four primary effects. Although clinicians use misoprostol around the world in gynecology and obstetrics, however, none of these indications are FDA approved. It is used for termination of pregnancy in the first and second trimesters as either monotherapy or combination with intramuscular methotrexate.
Does mifepristone cross the placenta? ›Mifepristone crosses the placenta.
Can mifepristone cause uterine rupture? ›
It also revealed normal endometrial decidualization and myometrial hypertrophy and no underlying weakness. This case is the first recorded of uterine rupture after administration of oral mifepristone and vaginal misoprostol. Uterine rupture occurs rarely in second trimester medical terminations of pregnancy.
Does mifepristone cause endometrial hyperplasia? ›In conclusion, High doses of the antiprogestagen mifepristone over a prolonged period of time may promote an unopposed oestrogen milieu leading to endometrial hyperplasia.
Does misoprostol cross the placenta? ›It is unknown whether this agent crosses the placenta or is distributed into breast milk, but because misoprostol can stimulate uterine contractions, it should not be used during pregnancy (see Contraindications).
Can misoprostol cause uterine rupture? ›Conclusion: Misoprostol use in the second trimester in a woman with a uterine scar can trigger severe contractions that can lead to uterine rupture.
What are the side effects of misoprostol on cervix? ›Some common side effects include: • abdominal cramping, • vaginal bleeding, • diarrhoea • nausea and vomiting. Rare side effects include shivering, hot flushes or chills. Please tell the nurse if you have any of these symptoms.
Is misoprostol high risk? ›It may cause a pregnancy to end, premature birth, or birth defects. In rare cases, serious complications (such as uterine rupture) have occurred when misoprostol was used to start labor or end a pregnancy. These complications have resulted in harm to the unborn baby and mother.
Can misoprostol harm baby? ›However, misoprostol use during early pregnancy can increase the chance for birth defects. Misoprostol can affect blood flow through the uterus, which could increase the chance for birth defects related to poor blood flow to the fetus (called vascular disruption).
What is the syndrome with misoprostol? ›The use of the drugs misoprostol or thalidomide by women during pregnancy has been linked to the development of Möbius syndrome in some cases. Misoprostol is used to induce abortions in Brazil and Argentina as well as in the United States.
Are FDA regulations legally binding? ›Congress enacts statutes, and FDA issues legally-binding regulations based on those statutes. FDA also issues non-binding guidance documents. Statutes tend to be the most general, and FDA may need to interpret and implement statutes by issuing more specific Agency regulations.
Can a federal judge revoke FDA approval? ›"But we should all be enraged that one judge can unilaterally reject medical evidence and overrule the FDA's approval of a medication that has been safely and effectively used for more than two decades."
Are FDA guidelines legally binding? ›
Introduction. The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non‐binding.
Can you sue if something is FDA approved? ›Know Your Rights and Hold Responsible Parties Liable
You can't sue the FDA, but we can help you get the settlement you deserve if you or a loved one have been injured or died through the actions of a drug company. Call us today if you believe you have been harmed by contaminated food or impure medications.
Laws Enforced by the FDA. Includes the Federal Food, Drug and Cosmetics Act, the 1997 Modernization Act, and over 30 other acts, amendments, provisions, and laws.
What is the difference between FDA regulation and approval? ›The FDA doesn't approve companies. The FDA does not approve health care facilities, laboratories, or manufacturers; however, the FDA does have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.
Who can overrule federal judges? ›Federal judges can only be removed through impeachment by the House of Representatives and conviction in the Senate. Judges and Justices serve no fixed term — they serve until their death, retirement, or conviction by the Senate.
Can a federal judge's decision be overturned? ›The losing party in a decision by a trial court in the federal courts normally is entitled to appeal the decision to a federal court of appeals.
Can a federal judge ruling be overturned? ›Yes, they can also send the case back to the lower court. By what process is the number of justices changed for the United States Supreme Court?
Can a drug be released without FDA approval? ›FDA Approval is Required by Law
Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.
If after reviewing all of the evidence, the FDA determines that your products are in violation of the FDA's laws and regulations, they will be refused admission. The FDA will issue a Notice of FDA Action indicating the products have been refused (known as a notice of refusal).
What are examples of FDA violations? ›adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards; misbranded, meaning the labels contain false or misleading information; an unapproved new drug; forbidden or restricted for sale.
How reliable is FDA approval? ›
The U.S. Food and Drug Administration is supposed to protect Americans from harmful drugs. But in reality, FDA-approval does not guarantee safety. Critics say Big Pharma funds FDA reviews of new drugs, creating a conflict of interest.
What is the FDA False Claims Act? ›Although physicians may prescribe a drug for an off-label use, pharmaceutical companies violate federal law, including the False Claims Act, when they market, promote or encourage physicians to use their drugs in an off-label or non-FDA approved manner.