Tag: pills

  • 7 questions from the Texas ruling on abortion pills

    7 questions from the Texas ruling on abortion pills

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    What are abortion pills and why are they important?

    The FDA first approved Mifeprex in 2000 and mifepristone, a generic version, in 2019. The drug, which blocks a hormone called progesterone needed for a viable pregnancy, is usually taken in combination with a medicine called misoprostol to end a pregnancy during the first 10 weeks. Numerous studies have found the pills to be safe and effective.

    Republican lawmakers have outlawed most abortions in about a quarter of the country in the nine months since Roe v. Wade was overturned, often threatening doctors who perform abortions with jail. But a recent FDA decision, allowing the pills to be mailed and taken at home, offered a way around some of those laws and made the pills a prime target for anti-abortion advocates and conservative lawmakers.

    Can I still obtain abortion pills?

    Yes. U.S. District Court Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, delayed the effect of his ruling for one week, and the Biden administration on Friday appealed the decision.

    What was this case really about?

    The most important implications of this ruling have to do with abortion. But the legal arguments centered on procedure and whether mifepristone received proper scrutiny from the FDA more than two decades ago.

    The Alliance Defending Freedom, a conservative Christian legal group that brought the case on behalf of providers who oppose abortion, argued that the FDA went beyond its authority when it approved the medication. Their lawyers also argued that a 19th century anti-obscenity law, the Comstock Act, prohibits the mailing of any medication used for abortion.

    What did the judge say?

    Kacsmaryk ruled that both the initial approval of the pills in 2000 and a more recent decision to allow them to be prescribed via telemedicine were unlawful.

    “The Court does not second-guess FDA’s decision-making lightly,” he wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion — which was the ‘whole idea of mifepristone.’”

    The judge also agreed that mailing the pills likely violates the Comstock Act, writing the plaintiffs have a “substantial likelihood of prevailing on their claim that defendants’ decision to allow the dispensing of chemical abortion drugs through mail violates unambiguous federal criminal law.”

    Why did the judge allow this to happen 23 years after a medicine was approved?

    “Simply put, FDA stonewalled judicial review — until now,” Kacsmaryk wrote in his ruling. “Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within ‘180 days of receipt of the petition.’ … Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.”

    How can a federal judge in Amarillo, Texas, prohibit access in blue states like California and New York?

    Kacsmaryk issued a nationwide injunction, meaning the ruling will take effect across the country in a week unless a higher court issues a stay. These types of rulings have become increasingly common over the last 20 years, and judges have used them to halt former President Barack Obama’s plan to offer quasi-legal status to certain undocumented immigrants and former President Donald Trump’s ban on travelers from certain countries. The Department of Justice during the Bush, Obama and Trump administrations, argued that nationwide injunctions are overused and “inconsistent with constitutional limitations on judicial power.”

    What will happen next?

    The Department of Justice quickly appealed the ruling Friday night to conservative-leaning 5th U.S. Circuit Court of Appeals in New Orleans.

    Kacsmaryk’s ruling came out the same day as a federal judge in Washington state ruled that the FDA is placing overly burdensome regulations on mifepristone. This will also likely be appealed to the more liberal-leaning 9th U.S. Circuit Court of Appeals in San Francisco and possibly set up dueling circuit court rulings, teeing up a case over abortion pills for the Supreme Court.

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    ( With inputs from : www.politico.com )

  • Wyoming governor signs measure prohibiting abortion pills

    Wyoming governor signs measure prohibiting abortion pills

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    Wyoming’s ban on abortion pills would take effect in July, pending any legal action that could potentially delay that. The implementation date of the sweeping legislation banning all abortions that Gordon allowed to go into law is not specified in the bill.

    With an earlier ban tied up in court, abortion currently remains legal in the state up to viability, or when the fetus could survive outside the womb.

    In a statement, Gordon expressed concern that the latter law, dubbed the Life is a Human Right Act would result in a lawsuit that will “delay any resolution to the constitutionality of the abortion ban in Wyoming.”

    He noted that earlier in the day, plaintiffs in an ongoing lawsuit filed a challenge to the new law in the event he did not issue a veto.

    “I believe this question needs to be decided as soon as possible so that the issue of abortion in Wyoming can be finally resolved, and that is best done with a vote of the people,” Gordon, a Republican, said in a statement.

    In a statement, Wyoming ACLU advocacy director Antonio Serrano criticized Gordon’s decision to sign the ban on abortion pills, which are already prohibited in a number of states that have total bans on all types of abortion.

    “A person’s health, not politics, should guide important medical decisions — including the decision to have an abortion,” Serrano said.

    Of the 15 states that have limited access to the pills, six require an in-person physician visit. Those laws could withstand court challenges; states have long had authority over how physicians, pharmacists and other providers practice medicine.

    States also set the rules for telemedicine consultations used to prescribe medications. Generally that means health providers in states with restrictions on abortion pills could face penalties, such as fines or license suspension, for trying to send pills through the mail.

    Women have already been traveling across state lines to places where abortion pill access is easier. That trend is expected to increase.

    Since the reversal of Roe last June, abortion restrictions have been up to states and the landscape has shifted quickly. Thirteen states are now enforcing bans on abortion at any point in pregnancy, and one more, Georgia, bans it once cardiac activity can be detected, or at about six weeks’ gestation.

    Courts have put on hold enforcement of abortion bans or deep restrictions in Arizona, Indiana, Montana, Ohio, South Carolina, Utah and Wyoming. Idaho courts have forced the state to allow abortions during medical emergencies.

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    ( With inputs from : www.politico.com )

  • Conservative Texas judge weighs challenge to abortion pills

    Conservative Texas judge weighs challenge to abortion pills

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    Mifepristone, when combined with a second pill, has become the most common method of abortion in the U.S. and has been increasingly prescribed since Roe was overturned.

    Acknowledging the significance of the case, Kacsmaryk, who was appointed by then-President Donald Trump, asked Baptist if he could cite a prior example of a court removing an FDA-approved drug after many years on the market.

    Baptist acknowledged that there are no prior examples, but he blamed the drug’s longevity on the FDA’s “stonewalling” of his group’s prior requests to remove the drug. The group petitioned the FDA in 2002 and in 2019 seeking to curb access to the pill.

    Lawyers for the FDA are expected to argue that pulling mifepristone would upend reproductive care for U.S. women and undermine the government’s scientific oversight of prescription drugs.

    Kacsmaryk gave each side two hours to make their arguments — with time for rebuttal — in the high-stakes case. Mifepristone’s manufacturer, Danco Laboratories, will join the FDA in arguing to keep the pill available.

    A ruling could come any time after arguments conclude. A decision against the drug would be swiftly appealed by U.S. Department of Justice attorneys representing the FDA, who would also likely seek an emergency stay to stop it from taking effect while the case proceeds.

    One of the alliance’s chief arguments against the FDA is that it misused its authorities when it originally approved the pill.

    The FDA reviewed the drug under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it’s been used to expedite drugs for cancer and other “serious or life-threatening diseases.”

    The alliance, which was also involved in the lawsuit that led the Supreme Court to overturn Roe, argues that pregnancy is not a disease and therefore mifepristone should not have been considered for accelerated approval.

    “The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be more stark,” Baptist told Kacsmaryk.

    But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.

    Second, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone, including requiring physicians to be certified before prescribing it.

    The hearing is the first in the case and is being closely watched by groups on both sides of the abortion issue in light of the reversal of Roe. Removing mifepristone from the market would curtail access to abortion even in states where it’s legal.

    If Kacsmaryk rules against the FDA, it’s unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberations, which can take months or years.

    If mifepristone is sidelined, clinics and doctors that prescribe the combination say they would switch to using only misoprostol, the other drug used in the two-drug combination. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies but is widely used in countries where mifepristone is illegal or unavailable.

    In addition to challenging mifepristone’s approval process, the lawsuit takes aim at several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.

    Lawyers for the FDA have pointed out that serious side effects with mifepristone are rare, and the agency has repeatedly affirmed the drug’s safety by reviewing subsequent studies and data. Pulling the drug more than 20 years after approval would be “extraordinary and unprecedented,” the government stated in its legal response.

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    ( With inputs from : www.politico.com )

  • Democratic senators, led by Elizabeth Warren, are demanding answers from Walgreens on abortion pills. 

    Democratic senators, led by Elizabeth Warren, are demanding answers from Walgreens on abortion pills. 

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    The senators are asking the company to disclose the list of states where they will seek certification to dispense the medication.

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    ( With inputs from : www.politico.com )

  • Biden administration braces for ruling that could ban abortion pills

    Biden administration braces for ruling that could ban abortion pills

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    While the Biden administration plans to swiftly appeal any ruling against the pills — which could come any time after lawyers for both sides submit their briefs on Friday — advocates say they are not counting on federal leaders to take the sweeping actions they believe are needed to deal with the potential loss of the country’s most-used method of abortion.

    “We don’t hold our breath for government action,” said Elisa Wells, the founder of the organization Plan C that helps patients order the pills online. “We know that in the absence of political support and leadership, this is what we have to do. We have to provide for ourselves and our community.”

    Bracing for a decision that cuts off access to the drugs, abortion-rights supporters are giving patients and providers a crash course on a workaround that uses just the second pill in the two-pill regimen — misoprostol — and contemplating expanding clinic capacity should patients need to switch from pills to a surgical procedure. Advocates will also hold an “emergency mobilization” on Saturday near the Texas courthouse hearing the case on Saturday to draw more attention to it and pressure political leaders to act.

    Since anti-abortion medical groups sued the FDA in November, Planned Parenthood, Plan C, the Women’s March, the Center for Reproductive Rights and other advocacy groups have pleaded with government officials to do more to prepare for a potential ruling blocking the sale of the pills — holding briefings with lawmakers, governors, attorneys general and health leaders.

    The Biden administration has, so far, rebuffed the groups’ calls for declaring a public health emergency for abortion. And top Biden administration health officials have downplayed the prospect that the pills may be banned, with HHS Secretary Xavier Becerra telling reporters last month that he’s “very confident” the court will side with the FDA.

    “The FDA took an action based solely on its statutory authority and the science — the data in front of it and the evidence behind it,” Becerra told reporters in late January. “FDA did not take this under consideration lightly. We’ve had more than 20 years of the use of this medication abortion. So we feel very confident that the work that FDA has done will stand the test — whether it’s time or the courts.”

    The White House and abortion-rights groups meet regularly and are mostly aligned on policy, and advocates have praised the administration for defending abortion rights and rolling out policies in recent weeks protecting patients’ access to the pills through the mail and at retail pharmacies. But there is also an undercurrent of frustration with the scope and pace of the administration’s response to the myriad threats to abortion access around the country.

    That tension was evident in reactions to Biden’s State of the Union address on Tuesday — the first since Roe v. Wade was overturned. Planned Parenthood and NARAL Pro-Choice America praised the president for pledging to veto any ban Congress passes, while other abortion rights groups like We Testify and All* Above All said they were disappointed the speech didn’t include a mention of the looming court decision on pills or details on how the administration might handle it.

    “The President continues to not meet the moment with his words,” said Renee Bracey Sherman, the executive director of the advocacy group We Testify. “He’s not showing up for people who have abortions the way we need. We’re relieved to know that he is willing to veto a national abortion ban, but what will he do to make abortion accessible for everyone? We deserve a real plan.”

    The White House defended its efforts to protect abortion access, pointing to a six-point strategy that HHS published in January detailing the various steps it’s taken since Roe v. Wade was struck down. Biden himself has repeatedly emphasized the only way to fully guard abortion access is for Congress to codify Roe.

    The lawsuit from the anti-abortion legal powerhouse Alliance Defending Freedom, representing a group of doctors and conservative medical groups, targets the FDA’s two-decade old approval of mifepristone, arguing that the agency didn’t adequately study the safety risks of the drug.

    The challenge, ADF Senior Counsel Julie Marie Blake said, is “seeking to protect girls and women from the documented dangers of chemical abortion drugs.”

    The Biden administration has told the court these charges are baseless and politically motivated, and presented evidence that the drug has safely been used by millions of people over the last 23 years.

    Yet, White House officials are privately worried about the far-reaching implications if the FDA’s mifepristone approval is struck down and what they see as the limited options they have for responding, according to three people familiar with internal discussions. Biden’s Gender Policy Council and intergovernmental affairs office have huddled repeatedly with White House lawyers to plan for the various possible outcomes, said one of the people familiar with the internal discussions.

    The Department of Justice is also poised to quickly appeal should Kacsmaryk rule against the government, in hopes of staving off a temporary ban on the pill’s use, said another person familiar with the internal discussions. That appeal, however, would go to the right-leaning 5th U.S. Circuit Court of Appeals and then the Supreme Court — an outcome advocates fear given the high court’s ruling last year overturning Roe v. Wade.

    The White House is also planning a messaging response, officials said, that would likely frame the ruling as further proof of its argument that Republicans are determined to ban abortion everywhere, part of a plan to refocus national attention on an issue that’s proven politically potent.

    Democrats in Congress, meanwhile, said they’re alarmed by the case but at a loss on how to prepare for a decision given the partisan divisions on the issue.

    “I’m really worried about what this means for women across the country,” said Rep. Pramila Jayapal (D-Wash.), the head of the Congressional Progressive Caucus who has spoken about her own abortion. “But obviously, you know, that a legislative response requires Republicans to be with us. So we’re going to keep looking for ways that we can try to do things administratively, but unfortunately, the options on legislation are blocked.”

    Because the case targets the regulation of the drugs at the federal level, there is also little state officials can do to respond to the ruling, legal experts and advocates said. Abortion-rights groups say that they’re mainly urging states that support abortion rights to lobby their federal counterparts “and tell them that this can’t be allowed to stand.”

    “There are lots of lawmakers and state leaders who want to be helpful right now,” said Kirsten Moore, the director of the Expanding Medication Abortion Access (EMAA) Project. “But this is about the willingness of the administration to be expansive in this moment, and they haven’t always shown a willingness to lean in and be forceful on this issue.”

    Under pressure from progressive lawmakers and advocates to take more decisive action on the issue, Biden officials in recent months revisited the idea of declaring abortion access a public health emergency.

    The move, supporters argue, could make it easier to dispatch federal health workers to help women obtain abortions and free up money for blue states facing higher demand from those who have to travel across state lines for the procedure.

    But the White House remains deeply skeptical — unconvinced it’d be helpful practically or politically. Sending federal workers into GOP-led states to aid abortion access would likely spark a political uproar that risks backfiring, two of the people familiar with the internal discussions said, and officials doubt the flexibilities granted through a health emergency would be significant enough to make a difference.

    “At this point, we don’t believe that declaring a public health emergency would provide meaningful new resources in this fight,” Jennifer Klein, who co-chairs Biden’s Gender Policy Council, told reporters last week.

    The move would also invite an immediate legal challenge, with unpredictable results. The courts could strike down the declaration, potentially limiting the government’s future ability to declare emergencies for a wider set of issues, the people familiar with the internal discussions said. And even if it was upheld, a future Republican administration could conceivably use that precedent to justify declaring a public health emergency aimed at constraining abortion access.

    “You’re begging for trouble,” said one adviser to the White House. “Republicans might later declare an emergency for the fetus.”

    Abortion-rights groups say the high stakes of a ruling against the pills and the uncertainty around a federal response has motivated them to take matters into their own hands.

    Aid Access and Plan C — two groups that help patients order pills from overseas no matter where they live in the U.S. — have made videos encouraging people to buy the medication before they are pregnant just in case they need it in the future, saying “abortion pills can be in our hands no matter what the courts and politicians decide.”

    The FDA has spoken out against stockpiling — known as advance provision — arguing that it prevents doctors from assessing whether a patient is within the first 10 weeks of pregnancy when the pills are approved for use and whether there’s a risk of an ectopic pregnancy. But advance provision is something advocacy groups had been encouraging even before the lawsuit against the pills emerged, and a tool they now argue is one of the only ways to prevent the anticipated court ruling from wiping out access in much of the country.

    “Why not just have it on hand so you can use it when you need it?” Wells said, noting that the pills can be stored for up to two years at room temperature. “If you’re in a state with a six-week ban, for example, having it in advance makes a lot of sense. You can take it within the six weeks very easily. But if you wait to order them until you know you’re pregnant, you could run up against that limit.”

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    ( With inputs from : www.politico.com )

  • Pair of lawsuits kick off state-federal battle over abortion pills

    Pair of lawsuits kick off state-federal battle over abortion pills

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    The cases come as both supporters and opponents of the right to terminate a pregnancy are increasingly focusing on abortion pills — which recently became the most popular method of abortion in the United States and a common way patients are circumventing state bans on the procedure.

    Anti-abortion advocates and their allies in state and federal office are pushing more states to adopt laws like North Carolina’s — including states that already have near-total bans — hoping to prevent patients from ordering the pills online.

    The North Carolina case, filed in federal district court in Greensboro, challenges the state’s law requiring that abortion pills may only be provided in person by a physician in a certified surgical facility after a mandatory counseling session and a 72-hour waiting period.

    Eva Temkin, the lead attorney in the suit, said those restrictions are hampering physicians, including her client Amy Bryant, as they attempt to serve patients in the state and those coming from other southeastern states that have implemented near-total bans on abortion since the Supreme Court overturned Roe v. Wade last summer.

    “The restrictions in North Carolina that our plaintiff and medical providers generally are grappling with have created a lot of inflexibility and inefficiency,” she said. “Since Dobbs there has been a significant increase in the number of patients needing abortion care and these rules impose unnecessary delays and travel costs. Because of these restrictions, providers can’t see the number of patients they’d like to see, for instance, by telehealth.”

    A spokesperson for Democratic Attorney General Josh Stein, who recently announced his bid for governor, told POLITICO the office is reviewing the lawsuit, declining to comment further.

    The case has echoes of a previous legal fight between the FDA and Massachusetts over that state’s efforts to restrict an opioid medication, Temkin noted, a battle in which federal rules prevailed.

    “It’s a well-settled principle that a state can’t implement a policy that conflicts with and frustrates the objectives of a federal law,” Temkin said.

    “But in some ways, this is the first case of its kind,” she added. “And that’s because this is the first drug on which states have imposed restrictions on access that the FDA has determined are not appropriate.”

    The FDA lifted the in-person dispensing requirement for the drugs in 2021 — at first, just for the duration of the Covid-19 pandemic and then permanently after determining the pills were safe to prescribe via telemedicine and send-by-mail. The agency loosened its rules for the medication again earlier this month, allowing them to be dispensed by certified retail pharmacies to patients with a prescription.

    In West Virginia, GenBioPro, the company that manufactures the generic version of the abortion pill, is arguing in federal court that the state cannot impede the regulation or sale of a federally approved medication without violating the supremacy and commerce clauses of the Constitution.

    The drugmaker’s lawsuit also challenges the state’s previous restrictions on medication abortion — including a ban on telehealth prescription of the drug, mifepristone. Those restrictions were superseded by the September 2022 prohibition on the procedure at all stages of pregnancy.

    The state laws “constrict GenBioPro’s ability to market its FDA-approved product to West Virginians who need it,” the company said in the lawsuit. “West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime.”

    Meanwhile, anti-abortion groups, which filed a lawsuit in Texas in November are challenging the FDA’s two-decade old approval of the abortion pill, mifepristone, a case that could halt access to it nationwide.

    Anti-abortion groups are also mounting a campaign to pressure Walgreens and CVS pharmacies not to carry the drugs in states where they are legally allowed to do so, with lawsuits, protests and boycotts planned for the coming weeks.

    Over the weekend, marking what would have been the 50th anniversary of Roe v. Wade, President Joe Biden signed a memo directing his health secretary to “consider new guidance to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone — no matter where they live.”

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    ( With inputs from : www.politico.com )