The FDA is monitoring the progress of abortion medicine in the U.S. after the COVID-19 birthlaw apexpansion
In response to a February 1 letter from GOP attorneys general in some states, the company said it wouldn’t sell the first of two drugs in the abortion process in 20 states.
The Supreme Court decision last year to overturn the ban on abortion in the US caused a furor when it came to medication abortion.
The medication can be taken up to 11 weeks after the last menstrual period in some states. Telehealth prescriptions are an option in some states, or a person could travel to a state where abortion is legal to get the pills.
About half of all abortions in the US are done with medication, which is more popular than surgery.
The Office of Legal Counsel’s opinion dated December 23, 2022, stated that the 1873 Comstock Act does not forbid mailing drugs that can be used to perform abortions, even if the sender doesn’t mean to.
In the wake of the Supreme Court ruling, Attorney General Merrick Garland issued a statement promising to work with the FDA and other federal agencies to protect access to such drugs, which some states have sought to ban.
In the past, the FDA had limited the amount of product they could sell to a subset of specialty offices due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said a new scientific review by agency staff supported easing access, concurring with numerous medical societies that had long said the restriction wasn’t necessary.
The biggest abortion-related case since last year’s Supreme Court decision could be decided by a federal judge later this month.
The FDA has asked the two drugmakers that make abortion pills for a label update. Agency rules require companies to file an application if they want to change their policy on drugs.
In 2000 the FDA approved the drug Mifepristone to be used when you want to end a pregnancy up to 10 weeks. One way to dilate the cervix and block the hormone progesterone is to take Mife pristone first. The uterus contracts and expels pregnancy tissue after being exposed to omeprostol for 24 to 48 hours.
Bleeding is a common side effect, though serious complications are very rare. The FDA says over 3.8 million U.S. women have used the drug.
Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the case of excessive bleeding. Pharmacies that dispense the pills also need a certification.
There is no clear picture about what impact it will have on abortion access in places where it is banned or restricted.
Walgreens responded to NPR’s latest request for comment by pointing to a statement it published on Monday, reiterating that it was waiting on FDA certification to dispense mifepristone “consistent with federal and state laws.”
Honeybee Health, an online pharmacy company that had been supplying and shipping abortion medications, posted on its verified Facebook page Tuesday that it “officially became the first pharmacy certified to dispense medication abortion.”
But for many pharmacies, it will take some time to review and decide whether to undergo the certification process – and the certification process may be complicated.
The Implications of a High-Dimensional U.S. Supreme Court Case for Abortion Information in the Postwar Era
“The unfortunate reality is that there are more than a dozen states right now where abortion is illegal or close to fully illegal, it is banned. Miller said that it is likely that a person in a state where abortion is banned will travel to another state to seek medication abortion.
“We don’t believe that anyone should be forced to travel in that way, and certainly, as this moves forward, there are a lot of very smart lawyers who are looking at the question of how they’ll be incorporated into drugstores and pharmacy chains, and where that can happen – and how these different federal and state provisions interplay,” she said.
He asked, “Would a state that was prosecuting somebody for diversion have access to those records? If they do it, that will make it harder to give it to people in states that are banning it.
The stakes of the lawsuit are so high that we should expect the worst from this Trump-appointed federal judge. Americans want access to abortion, but anti-choice bad actors are scheming to restrict it by all means possible, said the group’s vice president of communications and research.
Most Americans support at least some access to legal abortion, so the supporters of abortion rights are able to use the best strategies available to them.
The law he inspired barred not just the mailing of “obscene books” but also birth control and abortion drugs and devices. The 19th and early 20th century saw the use of the Comstock Act, a law that prevented the mailing of some of the great literature of the 19th century.
But by the time Comstock died in 1915, Americans were having second thoughts about his crusade and courts started to limit the application of the law. Judges suggested that there were lawful uses of some drugs, like contraceptives, and that the Comstock Act applied only to those who intended to violate the law. That meant that patients acting under the advice of their physician would not need to follow the Comstock Act when it came to prescriptions.
The anti abortion movement wants to bring the Comstock Act back, because they say local government has an obligation to follow federal law.
The department of justice will likely not make the enforcement of the act a priority if the Supreme Court interprets the Comstock Act in a way that makes mailing abortion pills illegal. That would sharpen the already-high stakes of the 2024 election, especially for blue states. A Republican president could take a very different position on enforcing of the Comstock Act, with dire consequences.
It’s time for those in blue states to wake up. The time to start working on the repeal of the law is now.
Kacsmaryk’s Case against the Food and Drug Administration: Why a Small Company Cannot dispense Mifeprex
The FDA had to approve abortion drugs in order to protect women and girls, and now they need to be vacating their actions.
Reproductive rights advocates say that if Kacsmaryk sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.
If longstanding FDA drug approvals were so easy to modify, pharmaceutical companies would not be able to rely on FDA approval decisions to build a pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions.
“Danco is a small pharmaceutical company. It sells one drug: Mifeprex,” lawyers for the company wrote in court papers. “Entering the mandatory preliminary injunction plaintiffs seek would force FDA to withdraw approval for Danco’s only product, effectively shuttering Danco’s business.”
The company said in a statement to NPR that it has responded to all of the attorneys general to assure them it won’t distribute mifepristone in their states.
Since then, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, presiding over 95% of the civil cases brought in Amarillo, Texas.
The Biden administration tried to end the “Remain in Mexico” program in December, but Kacsmaryk put them on hold. He has overseen cases in Texas challenging vaccine mandates, gender identity guidance issued by the US Equal Employment Opportunity Commission, and the use of Covid-19 relief funds for tax cuts.
Before joining the court, Kacsmaryk served as deputy general counsel at the First Liberty Institute, a nonprofit religious liberty legal group, where he worked mainly on “religious liberty litigation in federal courts and amicus briefs in the US Supreme Court,” according to his White House biography.
The case is being closely watched by a number of interested parties, including Republican and Democratic state attorneys general. On Friday, two different multi-state coalitions filed brief with the court that urged them to either act or not act in the matter.
The attorneys general of a dozen Democratic-controlled states sued the Food and Drug Administration on Friday, asking a judge to remove special restrictions that the federal agency has long applied to the first of two drugs used in medication abortion.
Abortion rights advocates have sounded the alarm on the case, stressing that a ruling by Kacsmaryk in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.
The Women’s March plans to hold a demonstration at the federal courthouse in Amarillo, Texas, on Saturday.
State Attorney General Bob Ferguson says the FDA is not listening to a case of Mifepristone and why Walgreens is not allowed to do so
On Thursday, Kacsmaryk told the humans they had less than two weeks to respond to the Danco filing and that after that, briefing will be closed.
In an interview with NPR, Washington state Attorney General Bob Ferguson, who co-led the suit, noted that the REMS has been applied only to a few dozen high-risk prescription drugs — such as fentanyl and other opioids.
Two federal judges may look at the future of Mifepristone and whether to eliminate access or expand it.
“We find it incredibly ironic that the attorneys general who argued in favour of the FDA in our case two weeks ago are now arguing against them in a completely different court,” Baptist says.
The other pharmacy chains to which Republican attorneys general sent their letters — including CVS, Costco, Walmart, Rite Aid, Albertsons and Kroger — did not immediately respond to NPR’s request for comment about whether they are considering following suit.
walgreens will not be given business in California because they cower to extremists and put women’s lives at risk. “We’re done.”
Following the Supreme Court’s decision to overturn abortion rights, there has been an uproar over the clash between Newsom and Walgreens. The ruling, handed down in June of last year, shook up national politics ahead of the 2022 midterms – with many Democrats crediting the backlash for helping their candidates in tough, swing state and seat races – and complicated relationships between political and business leaders.
“Medication abortion is safe, effective, and serves as a lifeline for people in need of critical care, especially those from vulnerable and underserved communities,” Bonta said on Friday. I am not happy that Walgreens is cutting off access to necessary medication due to political pressure from anti-abortion states.
Abortion remains protected under Kansas state law. The state voted to block the efforts to ban the procedure after the Supreme Court reversed its position on abortion.
California’s healthcare buying power has a huge impact on its workforce and its retirement insurance system: The case of Walgreens and CAPERS
California, which is on track to become the fourth largest economy in the world, has great buying power in the healthcare market.
Even if the state only cut Walgreens out of state employee insurance plans, the company might see a big financial impact: The state insures more than 200,000 full-time employees. Another 1.5 million, including dependents up to the age of 26, are covered by CalPERS, its retirement insurance program.