Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, March 19, 2024

Catholic Bishops Mobilize Special Prayer Efforts for Supreme Court's Decision on Abortion Pill Availability

On March 26, the U.S. Supreme Court will hear oral arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine and a companion case Danco Laboratories, LLC v. Alliance for Hippocratic Medicine. (SCOTUSblog case page.) At issue are challenges to the Food and Drug Administration's relaxation of restrictions on the administration and use of the abortion drug mifepristone. (See prior posting.) On March 14, the U.S. Conference of Catholic Bishops issued a letter (full text) calling for the recitation of a special prayer beginning the day before oral arguments and daily until the date in June when the case is decided.  The letter reads in part:

The USCCB Committee on Pro-Life Activities is inviting Catholics to join a focused effort of prayer for the end of abortion and the protection of women and preborn children, beginning on March 25, the eve of the oral arguments, and the anniversary of St. John Paul II’s landmark, pro-life encyclical, The Gospel of Life (Evangelium vitae). In particular, we will invoke the intercession of St. Joseph, Defender of Life....

The Tablet and Catholic World Report both report on the Bishops' Nationwide Invitation to Prayer.

Wednesday, December 13, 2023

Supreme Court Grants Review of FDA's Rules on Prescribing and Distributing Abortion Pill

The U.S. Supreme Court today granted certiorari in two related cases, FDA v. Alliance for Hippocratic Medicine, (Docket No. 23-235, cert. granted 12/13/2023) and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, (Docket No. 23-236, cert. granted, 12/13/2023). (Order List.) (SCOTUSblog case pages 23-235, 23-236) In the single opinion applying to both cases, the U.S. 5th Circuit Court of Appeals upheld portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used and lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds. (See prior posting.) 

The Supreme Court denied review in Alliance for Hippocratic Medicine v. FDA, (Docket No. 23-395, cert. denied, 12/13/2023) which sought review of the FDA's original approval of mifepristone in 2000. (SCOTUSblog case page.)

The district court's orders are not currently in effect because in April, the U.S. Supreme Court stayed the orders while appeals work their way through the courts. (See prior posting.) 

SCOTUSblog reports on the Supreme Court's grants of review.

Friday, August 25, 2023

West Virginia's Ban on Prescribing Mifepristone By Telemedicine Is Pre-Empted By FDA Rules

In GenBioPro, Inc. v. Sorsaia,, (D WV, Aug. 24, 2023), a West Virginia federal district court dismissed a challenge to West Virginia abortion restrictions that are no longer in effect. The restrictions will go back into effect only if provisions of the more recent Unborn Child Protection Act (UCPA) are held unconstitutional. The court held that neither federal statutes nor FDA rules pre-empt state restrictions on when abortions may be performed. However, the court refused to rule further on the UCPA provisions, saying in part:

[T]he Court has not found that the UCPA is unconstitutional. As none of these prior restrictions are currently in effect, this Court may not issue an advisory opinion as to the constitutionality of a law not presently operative.

The court also rejected arguments that state restrictions on the sale of mifepristone violate the Commerce Clause, saying in part:

[T]he Supreme Court and Courts of Appeals have repeatedly affirmed that morality-based product bans do not intrinsically offend the dormant Commerce Clause. 

However the court did find that West Virginia's ban on prescribing mifepristone by telemedicine, which is still in effect, is pre-empted by FDA rules allowing telemedicine prescriptions for the drug. The Hill reports on the decision.

Thursday, August 17, 2023

5th Circuit Says FDA Improperly Reduced Abortion Pill Restrictions, But Prior Supreme Court Order Keeps FDA Rules In Effect During Appeals

In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (5th Cir., Aug. 16, 2023), the U.S. 5th circuit Court of Appeals upheld the portions of a Texas federal district court's orders that stayed actions taken by the FDA in 2016 and 2021 regarding the administration and distribution of the abortion pill mifepristone. The 2016 action increased the gestational age when the drug can be used from 49 to 70 days. It also lightened certain other dosage and prescribing restrictions. In 2021, in connection with the Covid epidemic, the FDA removed the in-person prescribing requirement for mifepristone, allowing it to be sent by mail. The court found that doctors have standing to challenge these actions, among other things citing conscience injuries to objecting doctors.  Challenges to two other FDA actions on mifepristone were rejected on standing and statute of limitations grounds.

The court concluded that plaintiffs are likely to succeed on their Administrative Procedure Act challenges that the FDA's actions were arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law. This was the case as to the 2016 action because the FDA did not consider the cumulative effect of the changes it was proposing. They were likely to succeed on their challenge to the 2021 action because the FDA did not adequately study adverse event data.

However, as the court recognized, the U.S. Supreme Court has already ordered a stay of all the district court's orders until federal appeals are completed. Thus the 5th Circuit's action does not reinstate the district court's bans. 

Judge Ho concurred in part and dissented in part, saying tht he would also hold that the initial approval of mifepristone in 2000 should be set aside.

NPR reports on the decision.

Saturday, April 22, 2023

Supreme Court Stays District Court's Order That Invalidated FDA's Approval of Abortion Pill

The U.S. Supreme Court yesterday evening in Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, (Sup. Ct., April 21, 2023), and in a companion case in which the FDA was a party, granted stays of a Texas federal district court's order that had found the FDA's approval of the abortion drug mifepristone to be invalid. The stays will remain in effect while appeals work their way through the courts. Justice Thomas indicated that he would have denied the applications for stays.  Justice Alito filed an opinion dissenting from the grant of the stays, saying that the applicants have not shown that they would suffer irreparable harm if the stays were not granted. SCOTUSblog has additional reporting on the Supreme Court's action.

Friday, April 14, 2023

Supreme Court Grants 5-Day Administrative Stay of Texas District Court's Abortion Pill Order

U.S. Supreme Court Justice Samuel Alito this afternoon in Food & Drug Administration v. Alliance for Hippocratic Medicine, (Docket No. 22A902, April 14, 2023), granted a 5-day administrative stay of a Texas federal district court's order invalidating the FDA's approval of the abortion drug mifepristone. Any response to the application for a lengthier stay must be filed by 11:59 pm April 18. Any response to that filing must be submitted by noon the next day. CNN reports on developments.

UPDATE: Here is the White House's reaction to the Court's stay.

Supreme Court Asked to Stay Abortion Pill Rulings

Today both the FDA and the manufacturer of the abortion drug mifepristone filed with the U.S. Supreme Court applications for a stay of the Texas federal district court's Order invalidating the FDA's approval of the drug. The 5th Circuit Court of Appeals allowed part of the district court's order to remain in effect. Today's Applications for a Stay were filed with Justice Alito, the Justice assigned by the Court to receive emergency applications from the 5th Circuit.  Here is the filing by Danco Laboratories, and here is the Solicitor General's filing on behalf of the FDA.  Axios reports on the filings.

Thursday, April 13, 2023

5th Circuit Allows Part of Stay on Abortion Pills To Remain; U.S. Will Appeal to Supreme Court

 In Alliance for Hippocratic Medicine v. Food & Drug Administration,(5th Cir., April 12, 2023), the U.S. 5th Circuit Court of Appeals granted a partial stay of a Texas federal district court's decision invalidating the FDA's approval of the abortion drug mifepristone. The appeals court held that the statute of limitations barred a challenge to the FDA's initial approval of the drug in 2000. However, the court refused to stay the district court's disapproval of changes the FDA made in 2016.  Those changes significantly reduced prior restrictions on the administration and use of the drug. The court said in part:

Here, applicants have failed to carry their burden at this preliminary stage to show that FDA’s actions were not arbitrary and capricious. We have two principal concerns in that regard. First, FDA failed to “examine the relevant data” when it made the 2016 ... changes.... That’s because FDA eliminated ... safeguards based on studies that included those very safeguards....

Second, the 2016 ... Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.”... This ostrich’s-head-in-the-sand approach is deeply troubling.... It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.

Reuters reports on the decision. 

Earlier today, the Justice Department announced that it would seek emergency relief from the U.S. Supreme Court.

Tuesday, April 11, 2023

FDA Seeks Stay Pending Appeal of Order Ending Approval of Mifepristone

The Justice Department on behalf of the U.S. Food and Drug Administration yesterday filed an Emergency Motion for a Stay Pending Appeal (full text of motion) in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, (5th Cir., filed 4/10/2023). The motion seeks a stay while an appeal is heard by the 5th Circuit of a Texas federal district court decision setting aside the 2000 FDA order approving doctors prescribing mifepristone for medical abortions. The FDA argues in part:

The [district] court repeatedly characterizes mifepristone as unsafe. But over the last two decades, the available evidence conclusively demonstrates that mifepristone is safe under the approved conditions of use. More than five million women have used mifepristone to terminate their pregnancies in the United States.... Mifepristone is also approved in dozens of other countries..... The literature reflects “exceedingly rare” rates of serious adverse events.

AP reports on the appeal.

Saturday, April 08, 2023

Contradictory Orders From 2 District Court on FDA's Approval of Abortion Pill

In Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration, (ND TX, April 7, 2023), a Texas federal district court held that plaintiffs have a substantial likelihood of success on their claim that the FDA's 2021 action allowing the abortion drug mifepristone to be distributed by mail violates the Comstock Act and thus was also in violation of the Administrative Procedure Act. The court also concluded that the FDA's approval in 2000 of doctors prescribing mifepristone violated the agency's rules for approval of new drugs. The FDA rules (Subpart H) relied upon to approve the drug apply to "new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments...."  The court said in part:

[T]o satisfy Subpart H, FDA deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.” See 21 C.F.R. §§ 314.500; 314.560. FDA was wrong on both counts....

Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an “illness.”...

FDA also exceeded its authority under the second requirement of Subpart H. In addition to treating a serious or life-threatening illness, chemical abortion drugs must also provide a “meaningful therapeutic benefit” to patients over surgical abortion... [T]his cannot be the case because chemical abortion drugs do not treat “serious or life-threatening illnesses” — a prerequisite to reaching the second requirement.... Similarly, chemical abortion drugs cannot be “therapeutic” because the word relates to the treatment or curing of disease.

The court stayed the FDA's approval of mifepristone, but stayed the effectiveness of its order for 7 days so the government can appeal to the U.S. 5th Circuit Court of Appeals for emergency relief.  President Joe Biden issued a statement (full text) criticizing the court's decision and reporting that the Justice Department has already filed an appeal.  Vice President Kamala Harris also issued a statement (full text) criticizing the decision.

Meanwhile, in State of Washington v. U.S. Food & Drug Administration(ED WA, April 7, 2023), a Washington federal district court issued a preliminary injunction barring the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone" in the 17 states and District of Columbia that are plaintiffs in the case. Plaintiffs are challenging certain requirements for prescribing mifepristone added in 2023.

Seattle Times reports on the decisions.

Sunday, March 19, 2023

Transcript of Hearing Released in Challenge to FDA Approval of Mifepristone

On March 15, Judge Matthew Kacsmaryk in the federal district court in the Northern District of Texas held a hearing on the preliminary injunction motion in the widely-watched case of Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The full transcript of the hearing has now been released. As previously reported, the case challenges the FDA's long-standing approval for use in the United States of the chemical abortion drug mifepristone. Axios reports on the hearing.

Sunday, December 25, 2022

FDA Approves Label Change for Plan B Emergency Contraceptive: Not an Abortifacient

The U.S. Food and Drug Administration announced on Friday that it has approved a labeling change for the emergency contraceptive Plan B One-Step, sometimes known as the morning-after pill.  The labeling change states clearly that the medication is not an abortifacient.  The FDA says in part:

Plan B One-Step will not work if a person is already pregnant, meaning it will not affect an existing pregnancy. Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation. Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.

The original label had been required to say in part: "this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation)."

The FDA supports its conclusion that it does not affect implantation with a detailed Decisional Memorandum discussing more recent studies of the drug.

In the extensive litigation challenging rules under the Affordable Care Act that mandated health insurance policies cover contraceptive methods for women, religious objectors had pointed to Plan B as one of the medications that they considered an abortifacient because it could prevent implantation of a fertilized egg.  Also, since the Supreme Court's Dobbs case, abortion bans in some states might possibly be broad enough to cover medication that prevents implantation.

In a 2015 Memorandum, relying on research available at that time, the Catholic Medical Association rejected the use of Plan B even after a rape. AP reports on the FDA's approval of the labeling change.

Monday, November 21, 2022

Medical Organizations Challenge FDA's Past Approval of Chemical Abortion Drugs

In a new test of abortion rights, four medical organizations and four doctors filed suit last week in a Texas federal district court challenging the FDA's long-standing approval for use in the United States of the chemical abortion drugs mifepristone and misoprostol. The 113-page complaint (full text) in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, (ND TX, filed 11/18/2022), alleges in part:

3. To date, the FDA’s review, approval, and deregulation of chemical abortion drugs has spanned three decades, correlated with four U.S. presidential elections, and encompassed six discrete agency actions...

7. 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.

8. But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion....

9. What’s more, the FDA needed to disavow science and the law because the FDA never studied the safety of the drugs under the labeled conditions of use....

10, Since then, the FDA has not followed the science, reversed course, or fixed its mistakes,,,

22...  [A]ll of the FDA’s actions on chemical abortion drugs—the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement—failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier.,,,

ADF issued a press release announcing the filing of the lawsuit.                                                         

Monday, September 06, 2021

Satanic Temple Seeks RFRA Exemption From Texas Abortion Restrictions

In a press release last week, The Satanic Temple announced that it has sent a letter to the FDA arguing that its members should have unrestricted access to the medical abortion-inducing drug Mifepristone.  The move is an attempt to counter the new "heartbeat" abortion restrictions in Texas. As reported by KVUE News:

The Satanic Temple argues its members should have access to the pills under the Religious Freedom Restoration Act, the same law that allows Native Americans to access peyote for use in rituals. SB 8 “imposes an undue burden on the ability of TST members to undergo the Satanic Abortion Ritual” within the first 24 weeks of pregnancy, the group said.

“I am sure Texas Attorney General Ken Paxton – who famously spends a good deal of his time composing press releases about religious liberty issues in other states – will be proud to see that Texas’s robust religious liberty laws, which he so vociferously champions, will prevent future Abortion Rituals from being interrupted by superfluous government restrictions meant only to shame and harass those seeking an abortion,” Satanic Temple spokesperson Lucien Greaves said in a statement.

Thursday, April 15, 2021

FDA Lifts In-Person Dispensing Requirement For Abortion Drug During COVID Emergency

On Monday, the U.S. Food and Drug Administration in a letter (full text) to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine announced that during the COVID-19 emergency, it is lifting the in-person dispensing requirement for the abortion drug  Mifepristone. The agency said that it was exercising enforcement discretion because of the additional COVID-related risks to patients and healthcare personnel involved in clinic visits solely to obtain the drug.  It likewise will allow prescriptions for Mifepristone to be filled by mail. Washington Free Beacon reports on criticism of the FDA's move by Republican lawmakers and anti-abortion groups.