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In It to Win It

In It to Win It's Journal
In It to Win It's Journal
March 22, 2024

The Supreme Court, Medication Abortion, and the FDA: What's at Stake?

The Supreme Court, Medication Abortion, and the FDA: What’s at Stake?


On March 26, 2024, the Supreme Court is scheduled to hear oral arguments in Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM), and Danco Laboratories LLC v. AHM. While the Supreme Court stated in the Dobbs decision that it “returns the issue of abortion to the people’s elected representatives,” the outcome of this case could limit access to medication abortion throughout the country, including in states where abortion is legal and protected. The interest in this case expands far beyond the issue of access to mifepristone and abortion; many people are watching whether the Court will block the FDA’s independence in determining the conditions required to assure a drug’s safe use— something the Court has never done before.

What Is the Case?

In the case, AHM v. FDA, the plaintiffs contend the FDA did not act within its authority when it approved mifepristone (one of the two drugs used in the medication abortion regimen) and also when it revised the protocol for prescribing and dispensing the medication in 2016 and 2021 (See Table 1). The plaintiffs also claim that the approval violated an 1873 anti-obscenity law, the Comstock Act, which prohibits the mailing of any medication used for abortion. The plaintiffs claim they have legal standing, arguing they are injured because they must treat patients who present to the emergency room after taking mifepristone, forcing them to divert time from their other patients and violating their conscience rights.

Danco, the manufacturer of Mifeprex, the brand name of mifepristone, has intervened in this case and is a defendant along with the FDA. The FDA and Danco claim the FDA approved changes in the Risk Evaluation and Mitigation Strategies (REMS) (special conditions FDA applies to some drugs) and other conditions for mifepristone use in 2016 after extensively reviewing the scientific evidence and 15 years of data reflecting the drug’s safety profile. Based on numerous studies, the FDA concluded mifepristone was safe to use up to 70 days gestation, misoprostol was effective and safe to use at home, and the efficacy and safety was the same with physicians and non-physician providers. The FDA also determined that the continued reporting of non-fatal adverse events by prescribers under the REMS was not warranted because of mifepristone’s safety record. During the COVID-19 public health emergency, the in-person dispensing requirement for mifepristone was enjoined by a court order for 6 months from July 2020 to January 2021. Based on the research and data collected during this period, the FDA found no indication that modification of the in-person dispensing requirement had increased adverse events. In April 2021, the FDA notified the American College of Obstetricians and Gynecologists (ACOG) that the agency would exercise enforcement discretion of the in-person dispensing requirement. In January 2023, the FDA formally amended the REMS, to permanently remove the in-person dispensing requirement, and adding a requirement that certified pharmacies can dispense mifepristone.
March 22, 2024

Johnson's margin drops to one vote as Gallagher heads for early exit

POLITICO


Speaker Mike Johnson is about to drop to a one-vote majority, as retiring Rep. Mike Gallagher has decided he will exit the House as soon as next month, according to two people with knowledge of the matter.

The Wisconsin Republican announced earlier this year that he would not seek reelection, which came on the heels of receiving blowback for voting against impeaching Homeland Secretary Alejandro Mayorkas. His allies, however, say he was long jaded by the antics of the House following the ouster of Speaker Kevin McCarthy.


Gallagher’s office did not immediately return a request for comment.

The timing couldn’t be worse for Johnson, who is now potentially facing a vote on his ouster in the coming weeks. Rep. Marjorie Taylor Greene (R-Ga.) filed the so-called motion to vacate on Friday, over Johnson working with Democrats to pass a massive spending bill, but it’s unclear when she’ll try to force the vote on the floor.
March 22, 2024

Sixteen Republican-led US states sue federal government over ban on LNG permits

Sixteen Republican-led US states sue federal government over ban on LNG permits


NEW YORK (Reuters) -Sixteen Republican-led states on Thursday filed a lawsuit to challenge the federal government's ban on approving applications to export liquefied natural gas (LNG), saying the federal government lacks the authority to broadly deny those permits.

The lawsuit was filed in federal court in Lake Charles, Louisiana, by the Republican attorneys general of a coalition of states including Texas, Louisiana and Florida that claim the U.S. Department of Energy's (DOE) pause on exports will harm the U.S. economy and undermine efforts to supply foreign allies in Europe with steady supplies of LNG as the region seeks to wean itself off piped gas from Russia.

The Biden administration said in January the pause will allow officials to review its process for analyzing economic and environmental impacts of projects seeking approval to export LNG to Europe and Asia where the fuel is in high demand.

The states said the pause on new approvals for LNG exports oversteps DOE’s authority under the Natural Gas Act, which they said requires the agency to affirmatively show projects are inconsistent with the public interest before denying applications.

The states also argued the ban jeopardizes billions of dollars in investments planned to build export facilities.
March 21, 2024

Florida AG Ashley Moody urges Florida Supreme Court to consider whether 'unborn children' are protected by the state

Ashley Moody urges Florida Supreme Court to consider whether 'unborn children' are protected by the state


With the Florida Supreme Court deciding whether an abortion-rights constitutional amendment should go on the November ballot, Attorney General Ashley Moody's office and abortion opponents are urging justices to consider another part of the state Constitution that they say could apply to "unborn children."

Moody’s office Monday raised the possibility of filing an additional brief about what is described as the “natural persons” provision of the state Constitution. A day later, the group Susan B. Anthony Pro-Life America urged justices to order briefs on an “expedited basis.”

The proposed constitutional amendment seeks to ensure abortion rights, but the Supreme Court would need to sign off on its wording before the issue could go on the ballot. Justices look at issues such as whether the proposed wording would be clear to voters and would not address more than one subject.

The ballot summary of the proposal says, in part: “No law shall prohibit, penalize, delay, or restrict abortion before viability or when necessary to protect the patient's health, as determined by the patient's healthcare provider.”

The filings this week stem from questions that Chief Justice Carlos Muniz raised during Feb. 7 oral arguments on the proposal. Those questions involved whether the “unborn” are covered by part of the Constitution that says, in part, “All natural persons, female and male alike, are equal before the law and have inalienable rights, among which are the right to enjoy and defend life and liberty, to pursue happiness.”
March 21, 2024

Florida AG Ashley Moody urges Florida Supreme Court to consider whether 'unborn children' are protected by the state

Ashley Moody urges Florida Supreme Court to consider whether 'unborn children' are protected by the state


With the Florida Supreme Court deciding whether an abortion-rights constitutional amendment should go on the November ballot, Attorney General Ashley Moody's office and abortion opponents are urging justices to consider another part of the state Constitution that they say could apply to "unborn children."

Moody’s office Monday raised the possibility of filing an additional brief about what is described as the “natural persons” provision of the state Constitution. A day later, the group Susan B. Anthony Pro-Life America urged justices to order briefs on an “expedited basis.”

The proposed constitutional amendment seeks to ensure abortion rights, but the Supreme Court would need to sign off on its wording before the issue could go on the ballot. Justices look at issues such as whether the proposed wording would be clear to voters and would not address more than one subject.

The ballot summary of the proposal says, in part: “No law shall prohibit, penalize, delay, or restrict abortion before viability or when necessary to protect the patient's health, as determined by the patient's healthcare provider.”

The filings this week stem from questions that Chief Justice Carlos Muniz raised during Feb. 7 oral arguments on the proposal. Those questions involved whether the “unborn” are covered by part of the Constitution that says, in part, “All natural persons, female and male alike, are equal before the law and have inalienable rights, among which are the right to enjoy and defend life and liberty, to pursue happiness.”
March 21, 2024

Born to die: Florida's infant mortality crisis - A special report

Sun Sentinel - Gift Link



Tiffanie Williams holds framed photos of her stillborn son Liam, who died in 2016. (Will Dickey/Contributor)


For 24 hours in a Jacksonville hospital, Tiffanie Williams clutched her son to her chest, stroking his face gently and singing him hymns.

Liam, only 10 ounces and 10 inches long, smaller than a water bottle, never met his mother’s gaze. He never squirmed or grasped his mother’s finger.

Williams could hear babies crying as she recovered from her delivery in the maternity ward.

Liam never cried.

Liam had visitors. His father. His aunts. His grandmother.

One of his visitors was a pastor who performed the rites of passage over Liam as Williams wiped away a continuous flow of tears. Liam, too premature to live outside the womb, never took a breath.

“I got to keep him and hold him all night,” said Williams, who cradled Liam’s limp body close in her hospital bed.

She was handed a pen. Then a death certificate. Her hand trembled as she signed it. Next came a list of funeral homes. She stared at it.

She handed Liam to a nurse and left the hospital with grief she never thought possible. Three days after his birth, Williams buried her son.

Each year in Florida, this “gut-wrenching heartbreak,” as WIlliams describes it, occurs hundreds of times: More than 1,300 babies a year, about four a day, die in Florida. In the early 2000s, the infant mortality rate was higher, but dropped slightly and then plateaued about a decade ago. Despite a declining birth rate, and millions of dollars spent by the state in the past 10 years on maternity programs, research, outreach and reports, the rate of infant mortality remains unchanged.
March 21, 2024

Born to die: Florida's infant mortality crisis - A special report

Sun Sentinel - Gift Link



Tiffanie Williams holds framed photos of her stillborn son Liam, who died in 2016. (Will Dickey/Contributor)


For 24 hours in a Jacksonville hospital, Tiffanie Williams clutched her son to her chest, stroking his face gently and singing him hymns.

Liam, only 10 ounces and 10 inches long, smaller than a water bottle, never met his mother’s gaze. He never squirmed or grasped his mother’s finger.

Williams could hear babies crying as she recovered from her delivery in the maternity ward.

Liam never cried.

Liam had visitors. His father. His aunts. His grandmother.

One of his visitors was a pastor who performed the rites of passage over Liam as Williams wiped away a continuous flow of tears. Liam, too premature to live outside the womb, never took a breath.

“I got to keep him and hold him all night,” said Williams, who cradled Liam’s limp body close in her hospital bed.

She was handed a pen. Then a death certificate. Her hand trembled as she signed it. Next came a list of funeral homes. She stared at it.

She handed Liam to a nurse and left the hospital with grief she never thought possible. Three days after his birth, Williams buried her son.

Each year in Florida, this “gut-wrenching heartbreak,” as WIlliams describes it, occurs hundreds of times: More than 1,300 babies a year, about four a day, die in Florida. In the early 2000s, the infant mortality rate was higher, but dropped slightly and then plateaued about a decade ago. Despite a declining birth rate, and millions of dollars spent by the state in the past 10 years on maternity programs, research, outreach and reports, the rate of infant mortality remains unchanged.
March 21, 2024

Bus company sued by NYC agrees not to bring migrants to region anymore

Bus company sued by NYC agrees not to bring migrants to region anymore


NEW YORK — One of the 17 charter bus companies sued by Mayor Eric Adams’ administration over transfers of asylum seekers to the New York area has agreed to stop bringing travelers known to be migrants to the region, according to court papers filed Wednesday.

The agreement comes more than two months after New York City filed a lawsuit against the company, Roadrunner Charters, in response to a surge in migrant arrivals around New Year’s Day. The Republican-led state of Texas took credit for the operation.

“Defendant Roadrunner Charters Inc. will refrain forthwith from transporting individuals known as migrants from Texas to New York City, and/or from Texas to the vicinity of New York City, including but not limited to New Jersey,” said the two-page stipulation.

The agreement, filed in Manhattan Supreme Court, did not cover the other 16 bus companies sued by the city.

A lawyer for Roadrunner, Robert Hantman, said that the company is not currently bringing migrants to the city. But he added his client expects “to be successful in the major issue: which is that bus companies have nothing to do” with planning migrant transports to New York.
March 20, 2024

[5th Circuit] order puts Texas law allowing police to arrest migrants who cross illegally back on hold

Previous post: SCOTUS allows Texas's SB 4 to go into effect, allowing state criminal enforcement of a state immigration law

Court order puts Texas law allowing police to arrest migrants who cross illegally back on hold


A federal appeals court late Tuesday issued an order that again prevents Texas from arresting migrants suspected of entering the U.S. illegally, hours after the Supreme Court allowed the strict new immigration law to take effect.

The decision by the 5th U.S. Circuit Court of Appeals comes weeks after a panel on the same court cleared the way for Texas to enforce the law by putting a pause on a lower judge’s injunction.

But by a 2-1 order, a panel of the appeals court lifted that pause ahead of arguments before the court on Wednesday.

Texas authorities had not announced any arrests made under the law.

Earlier Tuesday a divided Supreme Court had allowed Texas to begin enforcing a law that gives police broad powers to arrest migrants suspected of crossing the border illegally as the legal battle over the measure played out.

The conservative majority order rejected an emergency application from the Biden administration, which says the law is a clear violation of federal authority that would cause chaos in immigration law.

Texas Gov. Greg Abbott had praised the order clearing the way for the law that allows any police officer in Texas to arrest migrants for illegal entry and authorizes judges to order them to leave the U.S.
March 20, 2024

Montana Supreme Court allows abortion ballot initiative to move forward

Montana Supreme Court allows abortion ballot initiative to move forward


Montana’s Supreme Court said a proposed ballot measure to protect abortion can continue through the initiative process, overruling the state’s attorney general and bringing the measure one step closer to the ballot.

In a 6-1 decision released Monday, the justices ruled that Attorney General Austin Knudsen (R) exceeded his authority when he concluded the ballot measure was invalid because it included multiple subjects that should have been separated.

Knudsen in January called the measure “legally insufficient” and blocked it from moving forward because he said it improperly “logrolls multiple distinct political choices into a single initiative.”

But Monday’s ruling authored by Chief Justice Ingrid Gustafson said the measure, which the court referred to as constitutional initiative CI-14, could proceed.

“CI-14 effects a single change to the Montana Constitution on a single subject: the right to make decisions about one’s own pregnancy, including the right to abortion. If CI-14 is placed on the ballot, voters may ultimately agree or disagree with the proposed change that CI-14 offers, but they will be able to understand what they are being asked to vote upon because CI-14 does not effect two or more changes that are not substantive and closely related,” Gustafson wrote.

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