I worked at F.D.A and the abortion pill decision is dangerous


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It set up a legal collision which is going to end up at the Supreme Court. It is questionable if the judge overstepped his power when he halted the FDA’s approval for the pill used for most abortions in the US. The Washington judge’s ruling sets up dueling interpretations of law only the Supreme Court can resolve.

In heated rhetoric, Republicans and Democrats talked about how bad the storm was on Sunday. The administration launched a legal appeal to stop the suspension from going into effect on Friday and the Secretary of Health and Human Services promised safe and effective medication for women.

Kacsmaryk argued that the FDA failed to take into account psychological effects of the drug and long term medical consequences. The American Medical Association president said that the judge had ignored well-established scientific facts and speculative allegations in favor of ideological assertions that will cause harm to our patients. He stated that the court has intruded into the exam room and had influence over decisions that belonged to patients and physicians.

Such a move could severely impede a critical arm of the American health care system and deepen acrimony surrounding the regulatory approval process, which was attacked by conservatives amid skepticism of the Covid-19 vaccine.

“It’s important that we have real discussions on women’s health care and … get off the abortion conversation,” Gonzales told Bash. There are a lot of other issues women have to contend with. Let’s have those real conversations, and let’s talk about the other things that are happening in this world.”

There is at least one federal court ruling that is at odds with Kacsmaryk’s order in the case brought by anti-abortion rights activists in Texas.

Now, the drug’s future is in jeopardy. There was a preliminary injunction issued by a Texas federal judge that halted the FDA’s approval of the drug. Meanwhile, a competing ruling out of Washington state could limit the Texas injunction’s reach.

The decision is so stunning that it is reasonable to ask whether courts should have any role in reviewing the F.D.A.’s scientific decision-making at all. The ability to use science and expert judgement to support the health of America’s people is something that judges are tasked with protecting. The Texas decision is a perversion of this role and, by undermining the F.D.A., represents a threat to the safety of millions of Americans.

There is a day of the week when the F.D.A. finds itself in court. Also, Tuesday, Wednesday, Thursday and Friday. Sometimes the weekends, too. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. These include routine administrative matters such as whether the agency moved too fast or too slow on a generic drug approval or whether the agency has missed regulatory deadlines.

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But some of those states have disputed the idea that Kacsmaryk’s ruling outlaws medication abortion — a procedure that’s widely considered safe and accounts for more than half of US abortions. California will not stand by as fundamental freedoms are taken away because abortion is still legal in the state, according to the Governor’s office. The Attorney General of New York issued a statement stating that abortion is legal in New York and anyone who wants it can go there.

The case is also notable for relying on the Comstock Act, a 150-year-old obscenity law that, among other things, bans the shipping of materials related to abortion. The opinion approvingly interprets its ban on any article, instrument, substance, drugs, medicine, or thing which is advertised or describes in a way calculated to lead another to use it or apply it for producing abortion, as a ban on mailing Mifepristone even for legal abortions. “The statute plainly does not require intent on the part of the seller that the drugs be used ‘unlawfully,’” Kacsmaryk writes. It’s the latest sign that long-dormant obscenity rules are being resurrected following an unsuccessful attempt to ban books in Virginia using a mostly forgotten state statute.

Important but dry issues of legal standing, the deadline for filing a lawsuit against the FDA, and whether or not the merits of the case are reached are some of the issues that are at the center of the new abortion medication dispute.

“While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Newsom’s office said in a statement provided to NPR.

A Republican congresswoman who represents a swing district in South Carolina urged the Food and Drug Administration on Monday to ignore a recent ruling by a federal judge suspending the approval of a medication drug used for abortion.

“This is an FDA-approved drug. I support the usage of FDA-approved drugs, even if we might disagree,” Rep. Nancy Mace told CNN’s Kaitlan Collins on “This Morning.” “It’s not up to us to decide as legislators or even, you know, as the court system that whether or not this is the right drug to use or not.”

The Republicans have been largely on the wrong side of this issue. “We have, over the last nine months, not shown compassion towards women, and this is one of those issues that I’ve tried to lead on as someone who’s ‘pro-life’ and just have some common sense.”

Tina Smith said that ignoring the ban would make her want to know where that ends up.

The case against misoprostol and Inslee against the availability of the abortion drug nationwide after Kacsmaryk’s ruling

The Justice Department said on Monday that it wanted to put on hold a judge’s ruling that the abortion drug can be unavailable nationwide starting Friday midnight.

The FDA could not change their rules because of the order issued by US District Judge Thomas Rice after Kacsmaryk in the FDA challenge.

The appeals court’s decision is likely to come before Friday, April 14. No matter which way it rules, the decision will almost surely be appealed to the Supreme Court.

The Justice Department has not said yet whether it will appeal Rice’s order. If Kacsmaryk’s ruling is allowed to go into effect, the Justice Department asked Rice to clarify how FDA should comply with his order, with a filing that pointed to a ” significant tension” between the two rulings.

Gov. Gavin Newsom’s office says it’s made plans to secure an emergency stockpile of up to 2 million pills of misoprostol, a drug used in combination with another pill that is now the subject of legal battles in federal courts. Officials say the state currently has more than 250,000 of the pills already on hand, which were purchased for about $100,000.

Meanwhile, Massachusetts Gov. Maura Healy said Monday afternoon that her state has stockpiled some 15,000 mifepristone pills or more than a year’s worth of doses. Last week, Washington Gov. Jay Inslee announced his state had prepared a stockpile of about three years’ worth of mifepristone.

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According to Dr. Werner the Department of OB/Gyn at the university medical center, we are more likely to see failures and the need for surgery after using the drug alone.

California has provided information about the purchase agreement it has with other states that may be interested in taking similar action, according to the office of the governor.

Pharmacies facing shortages will be directed to a state website where they can find information about how to request pills from the misoprostol supply.

Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. FDA data shows that less than 1% of women who take it have significant adverse events. Mifepristone was found to be less risky than Viagra and penicillin by a CNN analysis.

The Texas ruling has been appealed by the U.S. Department of Justice. The Fifth Circuit Court of Appeals is generally a more conservative appeals court.

The state policy director at Susan B. Anthony Pro-Life America stated that everyone’s eyes are now pointing towards D.C. We think there will be some way in which the Supreme Court will weigh in on this case and these injunctions.

The Texas lawsuit, filed by a coalition of abortion rights opponents, raised questions about the process by which the FDA originally approved the drug in 2000.

In Washington state there’s a case where attorneys general from 17 states are trying to force the FDA to expand access to the drug.

The states are Alaska, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota,Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.

For residents of those states, Rice’s decision “preserves the status quo on ensuring that access to mifepristone remains available,” said Washington Attorney General Bob Ferguson to NPR on Friday.

“Can the prescriptions for the medication be filled if they are already in the pharmacy?” asked David Donatti of the American Civil Liberties Union of Texas. “These are questions that the lowest court order just does not answer.”

The Supreme Court should resolve this issue once and for all. It’s been decades in the making,” said Chelsey Youman, an attorney with Human Coalition, an anti-abortion-rights group that filed an amicus brief in the Texas case.

Less than a year after the US Supreme Court ended legal protection for abortions nationwide, clinics that provide reproductive health care across the United States are bracing for more restrictions on the care they provide to women.

“It’s going to be working closely with legal advisers in a really rapidly changing environment. “That’s what I anticipate in seven days, and likely beyond that,” said Ms. Grant, the chief operating officer at Carafem, an abortion provider.

At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.

Doctors also use mifepristone before procedures in which they need to go into the uterus, such as to remove bleeding polyps. Studies have shown that the drug helps reduce the amount of force needed to open the cervix and reduces the amount of blood loss associated with the procedure.

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In certain situations, when a pregnancy has become too risky, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.

Studies also show that mifepristone has moderate to strong benefits for inducing labor and treating uterine fibroids and endometriosis, sometimes helping avoid surgery, according to the American Society of Health Systems Pharmacists.

Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.

The gold standard of the regimen we provide is the safest and most effective, so if it is not available, we use the next best one. And that is what we will be left with.

Carafem, which provides telehealth abortion care, has been using a misoprostol-only regimen since the Covid-19 pandemic began, Chief Operating Officer Melissa Grant says.

“The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. I don’t want to be in that position as a clinician.

If the decision stands, it will make it harder to get abortion even in states that currently allow it. The Supreme Court majority made it clear in the case that they were taking judges out of the abortion debate and putting the decision back to the states.

Justice Brett Kavanaugh, the apparent key fifth vote in favor of that decision, wrote a separate statement, declaring that judges would no longer decide “difficult moral and policy questions” related to abortion.

The Supreme Court used the termfetus in its decision but he was favoring unborn human or child.

There are questions about a woman’s right to make deeply personal decisions about her unborn child, along with religious and cultural passions related to abortion-rights.

The DOJ argues that the FDA is safer than penicillin than Mifepristone and that it’s safer than some prescription drugs

DOJ lawyers have argued that the medical groups challenging the FDA lack standing to sue because they have no actual injury and offer baseless speculation regarding harms to women and the medical profession from mifepristone.

CNN analyzed data and found that it’s safer than some prescription drugs, including penicillin and Viagra. A study shows the risk of death is four times higher for penicillin than it is for Mifepristone.

The FDA missed the trauma women experience from chemical abortion, argued Kacsmaryk. He said the FDA had overstated the deaths and adverse reactions caused by the drug.

The DOJ lawyers said Kacsmaryk cherry- picked dubious materials to support his position, and some doctors tried to refute the judge’s medical conclusions.