Tag: pill

Lawmakers stay in their lanes on Supreme Court abortion pill ruling

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On Sunday, Sen. Lindsey Graham (R-S.C.) said he will “live with whatever decision” eventually emerges from the court, while also attacking abortion as a practice and citing his previous support for national legislation limiting it.
“It’s a human rights issue,” Graham said on CNN’s “State of the Union.” “At 15 weeks you have a developed heart and lungs, and to dismember a child at 15 weeks is a painful experience. It’s barbaric [it’s] out of line with the rest of the civilized world.”
That’s the stance that any Republican who hopes to have a shot at the GOP presidential nomination in 2024 will have as well, Graham said.
“Anybody running for president who has a snowball’s chance in hell in the 2024 primary is going to be with me, the American people, and all of Europe, saying late-term abortions should be off the table,” Graham said.
But Republican Rep. Nancy Mace (R-S.C.) cautioned against going too far on anti-abortion legislation ahead of 2024.
“I want us to find some middle ground,” Mace said on ABC’s “This Week,” after voicing support for the court’s decision to protect mifepristone. “There are — in my home state of South Carolina, there was a … very small group of state legislatures that filed a bill that would execute women who have abortions and gave more rights to rapists than women who have been raped. That is the wrong message heading into ’24. We’re going to — we’re going to lose huge if we continue down this path of extremities.”
New Hampshire Gov. Chris Sununu voiced the same concerns Sunday. “If we stay in our traditional lanes, we’re going to lose. There’s no doubt about it,” Sununu said on NBC’s “Meet the Press.”
The Republican governor, a possible 2024 presidential candidate, referenced polls that he said show dwindling support for legislation banning abortion from younger generations of Republicans.

“Look, the next generation of Republicans, right, if you look at the polls from about [ages] 45 and under, when you look at their priorities, you know, banning abortion is not one of their priorities. It’s not,” he said.
Former Gov. Asa Hutchinson — a 2024 presidential contender — said that while he supports limits on abortions, Republicans have fought for decades to have states determine the rules, instead of the federal government. “I would prefer that this is an issue that is resolved by the states,” he said on “Fox News Sunday.”
Meanwhile, Democratic lawmakers applauded Friday’s ruling as being a legally and medically sound decision that lets women maintain control of their own health.
Rep. Debbie Dingell (D-Mich.) voiced support for the Supreme Court’s decision, and noted that the drug is used for medical conditions other than abortion.
“I’m certainly not in a position to know, I’m not a medical expert, nor are the Supreme Court justices,” Dingell said on “Fox News Sunday.” “We have agencies designed and set up to do the scientific process and that is where I think the responsibility belongs.”
Sen. Mark Warner (D-Va.) also challenged the logic behind the initial decision that was built around a challenge to the FDA’s processes.
“I think it was crazy. The notion that you would take a drug that has been used safely for more than two decades and somehow then take that away from availability,” Warner said of the lower court decision.
“You know, I frankly think this is an issue that women’s healthcare choices ought to be made by women, and the idea of this judge so radically intervening with a safe procedure … undermines the very integrity of our FDA process,” he said on “This Week.”
Sen. Amy Klobuchar (D-Minn.) also said the Supreme Court’s decision Friday was the correct one.
“The people of this country believe that the women of this country should be able to make their own decisions about their health care … and they don’t want Ted Cruz in the waiting room,” Klobuchar said on State of the Union, citing a Texas Republican senator who is an abortion foe.
During his interview, Graham pointed to the Comstock Act, a sweeping anti-obscenity measure passed by Congress in 1873 that District Court Judge Matthew Kacsmaryk cited in his initial decision to block abortion medication from being sent by mail.
“I think it’s a law on the books and it was placed there for a reason,” Graham said when asked about applying the 19th century law to the case.
“But sending the abortion drug through the mail is a big change in how it is provided. In 2000 when it was first approved, you had to have four visits to the doctor. In 2021, the Biden administration said you don’t have to even consult a physician anymore and send it through the mail. Is that safe? … That’s what the court will decide,” Graham said.
But Klobuchar said that legislation is outdated.
“The Comstock Act that [was] literally passed, Dana, in 1873,” Klobuchar told CNN’s Dana Bash. “That is 10 years before the ‘Yellowstone’ prequel. … that is at a time when healthcare — when you were treated for pneumonia through bloodletting,” she said.
“The American people do not want to go backward. And what I heard today is that Republican leaders in Washington aren’t backing down on their opposition to reproductive freedom. They are doubling down,” she said.
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( With inputs from : www.politico.com )

April 23, 2023
Alito extends reprieve for abortion pill access, maintaining status quo for 2 more days

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The justices are mulling whether a ruling from the 5th Circuit Court of Appeals should go into effect or whether it should be blocked while further appeals proceed.
If allowed to take effect, the 5th Circuit’s April 12 ruling would suspend various policies the FDA has enacted since 2016 to make mifepristone more accessible — including telemedicine prescription, mail delivery, retail pharmacy dispensing and the approval of a generic version of the drug. The ruling also would scale back the approved “on label” use of the drug from 10 weeks of pregnancy to seven weeks — before many patients know they are pregnant.
The appeals court suggested its ruling was a middle-ground approach because it did not go along with a Texas federal judge’s order to suspend mifepristone’s registration altogether.
However, the FDA and the two drug companies that make mifepristone told the Supreme Court that the 5th Circuit’s ruling could amount to a nationwide ban of the drug because of lengthy delays in returning to labeling and protocols that have not been required for years.
Anti-abortion medical groups that are challenging the drug disputed that characterization, saying the ruling would reimpose important safety restrictions on the drug.
Alito acted single-handedly because he oversees emergency appeals from the 5th Circuit. It is not a clear signal about how Alito or the other justices will ultimately vote on whether to allow the 5th Circuit’s ruling to go into effect.
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( With inputs from : www.politico.com )

April 20, 2023
Abortion pill maker sues FDA to preserve access

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A ruling by the 5th Circuit Court of Appeals now pending before the Supreme Court would unwind policies the FDA has approved since 2016 to make the abortion pill more accessible — including telemedicine prescription, mail delivery and retail pharmacy dispensing — and shrink the window of time patients are approved by FDA to take the drug from 10 to seven weeks of gestation — before many know they are pregnant.
The 5th Circuit’s decision, which endorses much of a challenge brought by the anti-abortion medical group Alliance for Hippocratic Medicine, would also suspend the FDA’s 2019 approval of the generic version of mifepristone made by GenBioPro.
“If the AHM Fifth Circuit Order goes into effect, the result will be chaos,” GenBioPro warned in its suit. “No court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval, and FDA has no template for responding to — or implementing — those decisions.”
The FDA declined to comment on the litigation.
Making similar arguments to the company’s, some Democratic lawmakers and activists have recently demanded that the Biden administration ignore a potential court order suspending approval of the pill or direct the FDA to use enforcement discretion to keep the pill on the market.
GenBioPro claims that, before suing, it repeatedly approached the FDA to ask what the process would be for suspending approval and what rights the company has under that scenario and received no response.
“Notwithstanding the exigent circumstances and the numerous tools available to FDA, FDA has repeatedly refused to assure GenBioPro or the public that it will afford GenBioPro adequate procedures before suspending GenBioPro’s … approval,” the company wrote.
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( With inputs from : www.politico.com )

April 19, 2023
Abortion pill manufacturer to pay $765K to U.S. to settle suit over incorrect labeling

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Under the settlement dated March 31 and released last week, Danco agreed to pay $765,000 to the U.S. to resolve allegations that, from 2011 to 2019, the company failed to both properly label imports of the drug as originating in China and pay customs duties on imports lacking those labels.
Under the deal, Danco denied the allegations leveled by the Life Legal Defense Foundation in a lawsuit filed in a Sherman, Texas, federal court back in January 2021. However, the drugmaker said it was settling to “avoid the delay, uncertainty, inconvenience, and expense of protracted litigation,” according to the agreement.
The DOJ’s April 12 press release about the settlement names Danco, but does not mention the now high-profile abortion drug at the center of the dispute, mifepristone.
“Danco is committed to operating ethically and legally and reaffirms that this case did not concern the safety or efficacy of Danco’s product,” the company said in a statement. “The settlement allows Danco to continue to focus on providing high quality, safe, and effective medication to women in the United States.”
Life Legal, a Napa, Calif.-based nonprofit group that opposes abortion, brought its suit under whistleblower provisions of the False Claims Act. That allows third parties to file challenges on behalf of the U.S. government and claim between 15 percent and 30 percent if the action is successful.
Life Legal will receive approximately $116,000 from Danco’s payments to the Justice Department over the next roughly nine months, according to the settlement.
In a particularly awkward provision for Danco, which was specifically founded to ease access to medication abortion by distributing mifepristone in the U.S., the drug firm agreed to pay over $46,000 directly to the anti-abortion organization to cover its legal fees and costs related to the suit.
The suit was filed nine days after Joe Biden was sworn into office in January 2021, seemingly setting up a showdown between a president who supports abortion rights and the drugmaker. In accordance with federal law, the complaint was kept under seal while the government investigated. A judge unsealed portions of the records earlier this month.

Last week, the Justice Department and Danco asked the Supreme Court to preserve access to mifepristone after a lower court suspended FDA approval of the drug. Justice Samuel Alito issued a short-term stay while the court considers the request.
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( With inputs from : www.politico.com )

April 18, 2023
Alito keeps access to abortion pill unchanged for next five days while Supreme Court reviews emergency appeals

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The appeals court ruling — if it takes effect — would suspend several policies the FDA has approved since 2016 to make mifepristone more accessible, including telemedicine prescription, mail delivery and retail pharmacy dispensing. The ruling also would suspend approval of the generic version of the drug and would narrow the window of time the drug can be prescribed from 10 to seven weeks of pregnancy — though off-label prescription after seven weeks would still be possible. The Biden administration warned the court in its Friday petition that letting these changes move forward would wreak “regulatory chaos” nationwide and harm patients.
The ruling had been scheduled to take effect on Saturday. But it is now temporarily frozen by Alito’s interim orders — known as administrative stays — keeping everything on hold until next Wednesday night while the justices receive further briefing and decide whether to issue a longer stay.
The anti-abortion medical groups challenging the pill’s approval have until noon on Tuesday to file responses. In a statement Friday, their attorney, Alliance Defending Freedom Senior Counsel Erin Hawley, called Alito’s stay orders “standard operating procedure” that would give justices “sufficient time to consider the parties’ arguments before ruling.”
Alito’s move maintains for now the current national patchwork of abortion access, with near-total bans on all forms of abortion in many red states and broad access to both medication abortion and surgical abortion in blue states.
Alito, a George W. Bush appointee who wrote the court’s decision last year overturning Roe v. Wade and allowing a wave of GOP-led states to impose abortion bans, single-handedly issued the administrative stays on Friday because all emergency appeals from the 5th Circuit are initially directed to him. As is customary with interim orders, he did not elaborate on why he granted the temporary relief. But administrative stays are typically intended only to buy the court time in fast-moving litigation and do not foreshadow the justices’ substantive views.
The FDA did not immediately comment on the stay orders or how the agency plans to enforce the restrictions if the high court allows them to go into effect.
Abortion rights groups cheered the stay orders and vowed to keep pressing the court to permanently halt the looming restrictions on the drug. Anti-abortion groups called them disappointing, with one group, Students for Life, accusing the Supreme Court of “playing politics.”
The legal battle over mifepristone escalated last week when a federal district judge in Texas, Matthew Kacsmaryk, issued an order suspending the approval of mifepristone nationwide and halting the various moves FDA has made since 2016 to broaden access to the drug.

On Wednesday, a panel of the New Orleans-based 5th Circuit issued a 2-1 ruling putting a hold on the portion of the lower judge’s order that suspended the drug’s approval but allowing the rest of his decision to kick in on Saturday.
That prompted the Justice Department and Danco, which makes the brand-name version of mifepristone, to turn to the high court for relief. They said that even the 5th Circuit panel’s approach – leaving the drug approved but rolling back expanded access in recent years – would be highly disruptive and could force the company to stop selling and distributing the drug for months.
Adding to the turmoil is a separate ruling from a federal judge in Washington state, who last week ordered the FDA not to permit any new restrictions on access to mifepristone in 17 states and the District of Columbia.
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( With inputs from : www.politico.com )

April 15, 2023
What last night’s abortion pill twist means for access — even in blue states

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Unless the Supreme Court intervenes, the 5th Circuit’s decision means that starting Saturday, mifepristone will remain legal at the federal level but access will be much more restricted.
Mifepristone, one of two drugs commonly used together to cause an abortion, was approved 23 years ago by the FDA for use in the first 10 weeks of pregnancy and recently became the most common method of abortion in the United States.
The 5th Circuit did not go as far as U.S. District Court Judge Matthew Kacsmaryk, whose ruling last Friday would have effectively removed the pill from shelves nationwide, but it did significantly roll back much of the FDA’s recent efforts to expand access.
The court decision cuts off — at least temporarily — many of the pathways patients have used to obtain the pill in the last few years, including telemedicine prescriptions and mail delivery, and moves the cutoff for prescriptions from the current 10 weeks of pregnancy to seven.
Should the ruling stand, retail pharmacies will no longer be authorized to dispense the drug. Physicians will not be able to prescribe the drug via telemedicine; instead, patients will have to make multiple in-person office visits to get a prescription. Additionally, non-physicians will not be able to prescribe or administer the drug, and prescribers will have to resume reporting “non-fatal adverse events” related to mifepristone to the federal government. The decision also suspends FDA approval of the company GenBioPro’s generic version of mifepristone, another blow to access.
Isn’t there another abortion pill?
Yes, misoprostol. The two pills are usually taken together to end a pregnancy during the first 10 weeks. Numerous studies have found both pills to be safe and effective.
The new restrictions set to take effect don’t apply to misoprostol, because it is subject to fewer FDA regulations as the medication is primarily prescribed for non-abortion purposes, including treatment for stomach ulcers. Misoprostol can still be used on its own to end a pregnancy and abortion providers around the country say they’ve been preparing for months to pivot to offering misoprostol-only abortions if needed. However, there is a slightly higher risk of side effects and complications when the pills are used without mifepristone. States including California and New York announced this week that they’d be stockpiling misoprostol as a way to ensure access to an alternative method of abortion.
What does the Biden administration do now?
Attorney General Merrick Garland said Thursday that the Justice Department will seek emergency relief from the Supreme Court in order “to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” It would take five justices to put the 5th Circuit’s decision on hold and maintain the status quo while further appeals continue, although it’s possible Justice Samuel Alito — who oversees the 5th Circuit — could issue a temporary stay while the other justices weigh in.

Can doctors use “off label” prescribing beyond seven weeks of pregnancy?
Yes, but they may be reluctant to do so. The 5th Circuit’s decision rolled back an FDA policy that had expanded the use of mifepristone for use in the first 10 weeks of pregnancy rather than just the first seven weeks. Many doctors currently prescribe the drug beyond 10 weeks as an off-label use. Under the court decision, prescribing the drug after seven weeks would now be considered off-label. Some doctors may exercise that option, but there is likely to be a chilling effect from the court’s decision, with many doctors wary of running afoul of the court order during a time of legal uncertainty.
What does this mean for people who live in states where abortion is illegal after six weeks?
Most people do not know they are pregnant before six weeks. Abortion pills, which could be ordered online and delivered through the mail, had been seen as a way for people who live in states with six-week bans to terminate their pregnancies even after six weeks. Reining in the drug’s availability is likely to dramatically diminish its usefulness in these states.
What about in blue states, where most abortions remain legal?
The decision could also hamper access in blue states that have sought to maintain access to the pills, making them harder to access both for their own residents and the wave of people traveling from red states to terminate a pregnancy.
Jennifer Dalven, the director of the ACLU’s Reproductive Freedom Project, argued to reporters Thursday that a competing district court ruling out of Washington state ordering the FDA to maintain the status quo should mean that nothing changes in the 17 states and Washington, D.C., where attorneys general sued the FDA — but without clear direction from judges and administration officials the legal status in those states remains uncertain.
“In some places, FDA is under an obligation, a court order, not to further restrict access to abortion,” she said. “But it is completely unclear right now exactly how this will play out. We really need guidance both from the Supreme Court and potentially, ultimately the FDA.”
Even if those 17 states and D.C. are shielded from the impact of the ruling for now, several of the country’s biggest states, including New York and California, are not part of the case and thus could be hit with the new restrictions ordered by the 5th Circuit.
What will the anti-abortion challengers do?
Alliance Defending Freedom, which represents the anti-abortion medical groups seeking to block access to mifepristone, told reporters on a call Thursday that it has “no immediate plans” to appeal the 5th Circuit’s decision even though the panel did not give anti-abortion groups the total suspension of the pills’ approval the groups requested and won from Kacsmaryk last week.
“For now, we’ve got a great victory in the fact that there are now three required doctor visits to make sure women are safe, and the FDA complies with the rule of law,” said Erin Hawley, ADF’s senior counsel in the case. Hawley added, however, that the plaintiffs will continue pushing to have the FDA’s original approval of mifepristone overturned.
“We anticipate that we might be able to persuade the 5th Circuit on a fuller briefing that the 2000 ruling is in play,” she said, noting that the appeals court did not take issue with the core of their arguments that the FDA approved the pills without adequately studying their safety risks and only took issue with the timeliness of the challenge to a decision the agency made 23 years ago.
Josh Gerstein contributed to this report.
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( With inputs from : www.politico.com )

April 14, 2023
Dueling abortion pill rulings put Biden administration in legal pickle

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Also on Monday, DOJ and a drug company that makes mifepristone asked a federal appeals court to freeze the ruling of the Texas-based judge, Matthew Kacsmaryk. He has put his ruling on hold until this Friday, but the government and the drug company want the appeals court to keep it on hold while they pursue their appeals.
The legal turmoil caused by the rival decisions may ultimately need to be resolved by the Supreme Court, which eliminated the constitutional right to abortion 10 months ago.
Kacsmaryk, an appointee of President Donald Trump, acted in a lawsuit filed by anti-abortion medical groups that claimed the FDA broke the law when it approved mifepristone for abortion in 2000 and recently expanded access to the drug.
Kacsmaryk’s ruling appears to be the first time that a court has invalidated an FDA drug approval. If the ruling takes effect, selling the drug would become a criminal offense nationwide.
The Justice Department immediately appealed Kacsmaryk’s ruling on Friday night, even as some prominent Democrats — and at least one Republican — called on the administration to ignore the ruling. The administration suggested that step is premature and signaled that it would work through the appeals process for now.
It did just that on Monday, following up its notice of appeal with a 49-page emergency motion asking the conservative-leaning 5th U.S. Circuit Court of Appeals to keep the ruling on hold.
“If allowed to take effect,” DOJ said in its motion, Kacsmaryk’s ruling “will irreparably harm patients, healthcare systems, and businesses.”
In a similar filing, drug maker Danco, which produces the brand-name version of mifepristone, called Kacsmaryk’s ruling “an extreme outlier” and contended he bent “every rule” to reach it. The company also said that Rice’s ruling indicates that Kacsmaryk’s decision went too far and should be blocked.

“The public is understandably confused by these two orders, issued the same day,” the company’s lawyers wrote. “Staying the nationwide injunction that alters the status quo would avoid creating an unnecessary judicial conflict.”
The 5th Circuit gave the anti-abortion groups who brought the lawsuit against the FDA until midnight Central Time on Tuesday to respond to the requests from the Justice Department and Danco to block Kacsmaryk’s order while the appeals are heard.
Rice, who was appointed by former President Barack Obama, issued his ruling in a case brought against the FDA by blue-state attorneys general who want to further loosen the agency’s restrictions on how mifepristone can be dispensed. Rice ordered the FDA to maintain current access to the drug in 17 states and the District of Columbia, the plaintiffs in the case.
Technically, the two rulings may not be incompatible. Kacsmaryk’s ruling is framed as a “stay” of the FDA’s approval of mifepristone — an order that would subject Danco and others to a risk of criminal liability but does not actually direct the FDA to do anything. So, it’s possible that the agency could comply with both by doing nothing at all.
But the rulings have created sufficient uncertainty that the Justice Department asked Rice on Monday to fast-track the government’s request for clarification about how the two rulings interact.
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( With inputs from : www.politico.com )

April 11, 2023
White House says ignoring judge’s abortion pill ruling would set a ‘dangerous precedent’

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The White House said on Monday that it would be a “dangerous precedent” for the administration to ignore a federal judge’s decision last week blocking the sale of an abortion pill.
“But I’ll say this, you know, as a dangerous precedent is set for the court to set aside the FDA’s and expert judgment regarding a drug’s safety and efficiency, it will also set a dangerous precedent for this administration to disregard a binding decision,” White House press secretary Jean-Pierre said at her briefing on Monday. “We are ready to fight this. This is going to be a long fight. We understand this. We stand by FDA approval of mifepristone.”
Jean-Pierre’s comments came after a federal judge in Texas ruled on Friday to suspend the FDA’s approval of mifepristone, a drug that can be used in tandem with another to induce an abortion. Though it isn’t set to take effect for a week, the decision virtually bans the sale of the pills across the country.
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( With inputs from : www.politico.com )

April 11, 2023
The abortion pill rulings are scaring the FDA and drugmakers — here’s why.

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While Kacsmaryk stayed his decision until Friday and the Biden administration has already appealed to the 5th U.S. Circuit Court of Appeals, the ramifications from Friday’s decision for the FDA and the drug industry could be felt for decades regardless of how this case is ultimately decided.
Here’s what we know:
Will the decision turn the FDA approval process “upside down”?
Experts disagree. Kacsmaryk’s ruling focused on the procedures around mifepristone’s approval and the FDA’s delayed response to petitions from anti-abortion organizations asking the agency to reconsider. It did not directly address FDA’s approval authority, said Greer Donley, an associate professor at the University of Pittsburgh law school.
“The stay itself has no other impact on any drug other than mifepristone,” she said.
The concern, she said, is that the precedent, in this case, could be used to implicate other drugs should groups choose to challenge the procedures surrounding their approval.
Jane Henney, who was FDA commissioner when mifepristone was approved, said Monday that “this ruling sets a very dangerous precedent for the FDA’s authority in terms of other new medications.”
“Clearly, we would be entering totally uncharted territory in that regard,” she said during a call with reporters.
Beccera’s worry that other medical products are at risk was echoed by leaders in the pharmaceutical industry.

Pfizer CEO Albert Bourla was among the dozens of pharmaceutical executives to sign a letter calling for an immediate reversal of the ruling, citing the “uncertainty for the entire biopharma industry.”
“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the letter said.
And William Schultz, former deputy commissioner for the FDA and former general counsel for HHS, said the decision “could allow virtually anyone to challenge any FDA drug approval decision with a good chance of succeeding.”
“Any FDA drug approval involves hundreds of judgments by the agency. If a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those judgments is wrong,” Schultz said.
HHS did not immediately respond to a request for comment on Monday.
What happened in Washington state and how does it affect the Texas ruling?
Just after Kacsmaryk’s ruling, U.S. District Court Judge Thomas Rice in the Eastern District of Washington issued a conflicting order that blocks the FDA from rolling back access to the pills in the dozen blue states and Washington D.C. that brought the lawsuit. This seeming contradiction is one reason many believe the case is headed to the Supreme Court.
The Department of Justice on Monday asked the judge in Washington state to clarify the injunction while Danco, which manufactures and sells mifepristone under the name Mifeprex, and the Department of Justice have filed appeals to the conservative-leaning 5th U.S. Circuit Court of Appeals.
Donley noted that it is technically possible for the FDA to comply with both rulings by using its enforcement discretion to look the other way if companies distribute a drug that no longer has the agency’s approval.
“The only way for the FDA to comply with both orders is to allow the drug to become unapproved … but then issue a guidance document or something similar saying ‘We are not going to enforce the Food, Drug and Cosmetic Act against the manufacturers and distributors of mifepristone, so long as those manufacturers and distributors follow these carefully articulated rules,’” she said.
Would that work?
Andrew Pincus, a visiting lecturer at Yale Law School and an experienced Supreme Court and appellate attorney, said that may not be enough assurance for manufacturers and other potentially liable entities.
“It’s not clear that enforcement discretion is a route to give them the assurance they need,” Pincus said.
What would happen if mifepristone is removed from the market?
Misoprostol, the second drug in the two-pill regimen used for medication abortions, will still be available for patients across the country even if mifepristone is banned. The drug isn’t subject to the FDA’s drug safety program like mifepristone because it’s used for many non-abortion purposes, including treating stomach ulcers, making it harder to challenge and ban. Although the drug is commonly used alone for abortions in other countries, it has slightly higher rates of requiring surgery to complete an abortion than using misoprostol and mifepristone together.
“It would be devastating from a lot of different perspectives and there would be a lot of patients who would be left with a less-optimal regimen to manage pregnancy loss and abortion care,” Jennifer Villavicencio, an OB-GYN and member of leadership at the American College of Obstetricians and Gynecologists, told reporters on Monday.
In theory, Danco — or any other drug maker — could also resubmit an application for mifepristone’s approval. However, it could take two to three years for a drug maker and the FDA to go through another approval process, said Kirsten Moore, the director of the Expanding Medication Abortion Access Project, on a press call.
Why are drugmakers so concerned?
The pharmaceutical industry said the Texas lawsuit could curb drug development in the U.S. and throw the regulatory framework FDA uses to approve drugs into question if the case is upheld by higher courts.
“This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies,” Biotechnology Innovation Organization interim CEO Rachel King said on Saturday.
If the Supreme Court upholds Kacsmaryk’s decision, the industry would likely push Congress to pass legislation to cement the FDA’s authority, according to John Murphy, chief policy officer and deputy general counsel of healthcare at BIO.
“If that were to survive through sort of a theoretical SCOTUS challenge, you really have to look at Congress to ensure we get back to having FDA in the driver’s seat here,” Murphy said.
What are Democratic governors doing to support mifepristone access while the case winds its way through the courts?
Massachusetts Gov. Maura Healey announced Monday that she has requested UMass Amherst and state-contracted health care providers to stockpile mifepristone and issued an executive order “confirming protections for medication abortion under existing state law.”
The university purchased about 15,000 doses last week to ensure coverage for more than a year, with more doses expected to be purchased, and Healy is also allocating $1 million to help providers who are contracted with the state Department of Public Health purchase the drug.
The move comes on the heels of an announcement from Washington Gov. Jay Inslee who is having his Department of Corrections purchase a three-year supply of mifepristone. State lawmakers have introduced legislation to allow the department to sell mifepristone to licensed health providers across the state.
And in California, Gov. Gavin Newsom announced the state has secured an “emergency stockpile” of up to 2 million misoprostol pills, with 250,000 pills having already arrived in the state.

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( With inputs from : www.politico.com )

April 11, 2023
South Carolina Republican says to ignore FDA abortion pill ruling

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The ruling was appealed by the Biden administration as lawmakers, including Sen. Ron Wyden (D-Ore.) and Rep. Alexandria Ocasio-Cortez (D-N.Y.), called on President Joe Biden to use his executive powers to protect the drugs’ availability even sooner. Hundreds of thousands of patients in the United States use the medication both for abortions and treating miscarriages.
Mace sided with the outspoken Democrats, the first Republican to publicly do so.
“This is an issue that Republicans have been largely on the wrong side of,” she said. “We have, over the last nine months, not shown compassion toward 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.”
Mace said there’s “no basis” for the ruling, explaining that the Texas judge cited a Supreme Court decision, which was later overturned, for his decision.
Over the weekend, Rep. Tony Gonzalez (R-Texas) floated the idea of defunding FDA programs if the ruling is ignored. When asked about those comments, Mace emphasized that most Americans aren’t radically opposed to abortion access and would likely agree with the FDA’s authority to allow the drug’s sale.
“We are getting it wrong on this issue,” she said. “We’ve got to show some compassion to women, especially women who’ve been raped. We’ve got to show compassion on the abortion issue because by and large most Americans aren’t with us on this issue.”
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( With inputs from : www.politico.com )

April 10, 2023