Tag: pill

Ignore the courts? Some Democrats say Texas abortion pill ruling demands it.

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Now, senators, representatives, state officials and advocacy groups are calling on President Joe Biden to defy the U.S. District Court judge and use his executive powers to protect the drugs’ availability even before the case is heard by the conservative-leaning 5th U.S. Circuit Court of Appeals.
“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Sen. Ron Wyden (D-Ore.) said Friday. “The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America. If they don’t, the consequences of banning the most common method of abortion in every single state will be devastating.”
Rep. Alexandria Ocasio-Cortez (D-N.Y.) backed Wyden’s call in a CNN interview Friday, arguing that the “deeply partisan and unfounded nature” of the court’s decision undermines its own legitimacy and the White House should “ignore” it.
But the Biden administration is afraid any public defiance of the Friday-night ruling could hurt its position while the case moves through the appeals process.
A person who is advising the White House on legal strategy, granted anonymity to discuss the ongoing litigation, said administration officials think it would be “premature” and “pretty risky” to take the step Wyden is calling for, because it’s possible a higher court would reverse the decision by Texas U.S. District Court Judge Matthew Kacsmayrk.
“They’re able to present themselves right now as the adults in the room who care about the rule of law,” the person said. “But that posture would come under pressure if they jumped out of the gate and said they wouldn’t abide by the ruling.”
The person added that the White House sees limited benefit in publicly defying the court’s ruling at this juncture for three reasons:
First, ignoring a lower court ruling stripping FDA approval of the pills wouldn’t stop GOP-controlled states from imposing their own restrictions and prosecuting those who violate them. Second, a future Republican president could reverse any decision on enforcement discretion and choose to aggressively prosecute those who sell or prescribe the pills. And third, even in the short term, the president defying the court could leave doctors across the country afraid to dispense the pills.

“It’s a very, very loose Band Aid that wouldn’t actually ensure access to medication abortion,” the person said. “And when you have another option on the table like the appeals process, it’s a pretty risky strategy.”
Additionally, the person said, because the Texas judge put his ruling on hold for one week to give the Biden administration time to appeal, the pills can still be legally prescribed in much of the country, limiting the urgency to take such a drastic action.
Sen. Patty Murray (D-Wash.) told reporters on a call Saturday that while she is sympathetic to Wyden’s position, she doesn’t endorse anything that could jeopardize the administration’s fight to overturn the district court ruling.
“I get the sentiment, because this is a truly infuriating situation,” she said. “This outrageous decision had nothing to do with the facts or science or the law. But the key thing that needs to happen right now is making sure this decision is quickly appealed and reversed in court.”
Murray and Senate Majority Leader Chuck Schumer on Saturday signaled their intent to use the decision to mobilize their base in the 2024 elections — arguing that flipping the House and passing a law restoring Roe v. Wade is the best path to achieving more permanent protections for the pills than whatever temporary protections the Biden administration could offer through executive actions.
“This battle is going to be fought with public opinion and with our votes at the ballot box, from here until we move forward in 2024,” Murray said.
Schumer suggested Democrats will force votes in Senate in the coming months that “put Republicans on the record” on the issue.
“The American people will see for themselves the stark contrast between Democrats who are relentlessly fighting for women’s rights, to make decisions about their own bodies and MAGA Republicans who will stop at virtually nothing to enact a national abortion ban with no exceptions,” Schumer told reporters on Saturday.
Biden himself appeared to endorse this strategy in the hours after the ruling, saying in a statement that while the administration was appealing the case, “The only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade.”
Even some abortion-rights leaders who have previously criticized the Biden administration for not doing enough to protect access say they support the wait-and-see strategy given the current judicial threats to the pills.
“They do tend to be cautious,” NARAL President Mini Timmaraju told POLITICO. “But with stakes like this, with these courts, they should be. They’re the defendant. We want them to be careful. Also, it has served them well in the past. So I feel confident the administration is doing what they need to do.”
Some legal experts are also warning the administration against defying the decision this early in the process, saying doing so could create a precedent that gives future presidents cover to ignore “future orders that would be more firmly rooted in the law.”
“It would not be advisable for the FDA to disregard a court order even if they believe it’s wrong,” said Joanne Rosen, an attorney and senior lecturer at the Johns Hopkins Bloomberg School of Public Health. “They could appeal. They could re-initiate the approval process of mifepristone all over again to get it back on the market.”
Yet others in the legal community are urging the administration to play hardball, arguing that the FDA was given enforcement discretion by Congress and previous court rulings and the agency should use those to the fullest extent if it is ultimately ordered to rescind its approval of abortion pills.
Those in this camp are pointing to another court ruling Friday night out of Washington State ordering the FDA to maintain the status quo for abortion pills and forbidding the agency from rolling back access in the dozen blue states that brought the challenge. Those clashing decisions, they say, give the Biden administration cover to maintain access to the drugs in defiance of the Texas court if that ruling stands.
“These are not radical,” said David S. Cohen, a professor at the Drexel University Thomas R. Kline School of Law. “These are real strategies within the law.”
Other Senate Democrats, anticipating this ruling, have called on the Biden administration to “use every legal and regulatory tool in its power” to keep abortion pills on the market. Sens. Elizabeth Warren (D-Mass.) and Mazie Hirono (D-Hawaii) recently petitioned the White House to use “any existing authorities, such as enforcement discretion, to allow mifepristone to remain available.
“FDA has previously used its authority to protect patients’ access to treatment and could do so again,” they wrote.
Timmaraju sees the mounting pressure from Democratic officials to ignore the court ruling as meaningful — even if they don’t ultimately goad the Biden administration into sweeping action.
“The senators are doing their jobs — it’s their job to push the White House and agencies like the FDA,” she said. “We need lawmakers from blue states getting out there and calling public attention to this case and raising awareness. For us, the biggest point people need to understand is that there is no state that is safe from these tactics.”
Adam Cancryn contributed reporting.
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( With inputs from : www.politico.com )

April 8, 2023
Texas judge halts FDA approval of abortion pill

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Meanwhile, a Washington State federal judge issued a conflicting order Friday night that blocks the FDA from rolling back access to the pills in the dozen blue states that brought the lawsuit.
The ruling from U.S. District Court Judge Thomas O. Rice, an appointee of former President Barack Obama, clashes with Kacsmaryk’s in that it orders the FDA to maintain the status quo, raising the likelihood that the issue could go before the Supreme Court.
Kacsmaryk’s decision, for its part, is a sweeping endorsement of arguments brought by anti-abortion groups and disputed by the government and major medical groups that the FDA failed to adequately consider the safety risks of the pills.
Hitting back at arguments that it was inappropriate to allow a challenge to a medication that have been approved for decades, he also wrote that “the FDA stonewalled judicial review” and “ignored” petitions from anti-abortion organizations to revisit the pill’s approval.
The judge’s decision includes language commonly used by anti-abortion advocates, describing the intent of the pill as one “to kill the unborn human,” referring to abortion providers as “abortionists,” and describing the “intense psychological trauma” of people who use the pills and then see “the remains of their aborted children.”
Roughly a quarter of states have banned nearly all abortions in the eight months since Roe v. Wade was overturned but this decision has the potential to affect pregnant people across the country — including in Democratic-controlled states that have prioritized abortion access.
The pills, which the FDA approved for use in the first 10 weeks of pregnancy more than two decades ago, recently became the most common method of abortion in the United States, and a way many people have circumvented state bans since the Supreme Court overturned Roe v. Wade last June.
Both abortion-rights supporters and opponents have focused intensely on the pills in recent months — leading to clashes in state legislatures, regulatory agencies and the courts.

‘A dangerous precedent’
The Justice Department quickly appealed the case to the right-leaning 5th U.S. Circuit Court of Appeals Friday night, and top members of the Biden administration said that defending the FDA’s authority and maintaining access to the pills is a top priority.
“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” President Joe Biden said in a statement Friday night, referencing widespread concerns among medical providers that the decision would spur other legal challenges to long-approved medications, including vaccines and contraception. “My Administration will fight this ruling.”
Attorney General Merrick Garland also weighed in Friday evening, saying that while the Justice Department “strongly disagrees” with the Texas decision and is appealing it, the DOJ is still reviewing the Washington State ruling. In both cases, he stressed, the administration “is committed to protecting Americans’ access to legal reproductive care.”
The anti-abortion groups that brought the challenge, meanwhile, cheered Kacsmaryk’s ruling Friday night, calling it a “significant victory” and insisting on a call with reporters that if higher courts don’t intervene over the next week, the two pharmaceutical companies that make the pills “should cease production of this drug.”
Erik Baptist, a senior counsel with the Alliance Defending Freedom, who argued the case in Texas on behalf of anti-abortion medical groups, declined to comment on the ruling out of Washington State that protects access to the drugs, but said the issue “may be inevitably going to the Supreme Court.”
Baptist also pushed back on accusations that his organization engaged in “judge shopping” by filing the case where the group knew it would come before Kacsmaryk who — before being confirmed to the federal bench in 2019 — was an attorney for the First Liberty Institute, a conservative Christian legal advocacy group. He argued that some of the doctors he represented in the case are based in Amarillo, Texas, and have recently been impacted by the pills by having to divert resources to patients who took them and needed follow-up care.
At oral arguments in the case in March, the anti-abortion medical groups and individual doctors Baptist represented claimed that the FDA erred in its approval of the drug and didn’t adequately consider its safety risks — a position Kacsmaryk cited in his ruling.
“The adverse events from chemical abortion drugs can overwhelm the medical system and consume crucial limited medical resources, including blood for transfusions, physician time and attention, space in hospitals and medical centers, and other equipment and medicines,” the American Association of Pro-Life Obstetricians & Gynecologists, Christian Medical & Dental Associations and other organizations claimed in their suit. “The more patients suffering emergency complications from chemical abortion drugs or seeking to reverse the effects of the drug regimen, the less time and attention Plaintiff doctors have to treat their other patients.”
The Justice Department asked Kacsmaryk to dismiss the case, saying the doctors and medical groups have no standing and are attempting to “upend [the FDA’s] longstanding scientific determination based on speculative allegations of harm.” The DOJ also argued that the groups are well past the statute of limitations for challenging the 2000 approval of the pills, saying they can only legally go after the more recent agency actions that have loosened restrictions on how patients obtain them.
The 2021 and 2023 rule changes that allowed patients with a prescription to receive the pills by mail and pick them up at retail pharmacies were based on “multiple studies that showed that administration of the drug was associated with exceedingly low rates of serious adverse events,” DOJ argued to the court. The FDA first allowed telemedicine prescription of the pills just for the duration of the Covid-19 pandemic and later moved to make the rules permanent based on new safety data.
Danco, the maker of the drug, has also intervened as a party in the case, arguing that the suit threatens “the company’s economic health.” The company said it would immediately appeal the ruling, calling it “a dark day for public health.”
Democratic state attorneys general joined forces with the Biden administration in the Texas case but a dozen of them faced off with government lawyers for the FDA in the Washington State case, arguing that the remaining federal restrictions on the pills are unsupported by science and hamper states’ ability to care for patients who need the medication.
Washington’s Bob Ferguson and Oregon’s Ellen Rosenblum co-led the lawsuit, joined by the Democratic attorneys general representing Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
Judge Rice has not yet ruled on their challenge of the REMS — or Risk Evaluation & Mitigation Strategies — that the FDA places on a narrow class of drugs, including requirements that patients sign a “Patient Agreement Form” acknowledging the risks of the medication and that health care providers who prescribe the drug first obtain certification and prove they can accurately date pregnancies, diagnose ectopic pregnancies and provide or arrange for a follow-up care if needed.
Potential impact of Texas ruling
If the ban ordered by Kacsmaryk ultimately takes effect, some parts of the country could be hit particularly hard. An analysis by the Guttmacher Institute, an abortion-rights think tank, found that abortion clinics in 2 percent of U.S. counties only offer abortion pills and don’t have a procedural option. Some of the states set to be most impacted — including Colorado, Pennsylvania and New Mexico — are serving their own residents and a large influx of patients from neighboring states with more restrictions. Guttmacher estimates the decision could impede access for at least 2.4 million people.
Some abortion providers have announced that they plan to pivot to prescribing just the second pill in the two-pill regimen — misoprostol — in the event that mifepristone is banned. The drug is subject to fewer restrictions because it’s used for many non-abortion purposes, including treating stomach ulcers. Misoprostol-only abortions are also common in other countries, but they have a slightly higher rate of patients requiring follow-up surgery to complete the abortion than the two pills used together.
“We’ve been preparing for the last few weeks, putting together updated policies and procedures that will go into effect should the ruling make mifepristone unavailable,” Ashley Brink, the director of the Trust Women abortion clinic in Wichita, Kansas, told reporters in February. “We’ve held trainings for our doctors on how to counsel patients on what to expect and we’ve met with our attorneys about our legal exposure.”
“However,” she stressed, “not every clinic may be able to pivot as quickly to a misoprostol-only protocol.”
If the decision banning mifepristone is allowed to stand, the FDA could move to approve it again if it receives a new application from the pharmaceutical company — a process that could take months if not years.
Abortion-rights advocacy groups also warn the decision could open the door to a wide range of ideologically motivated challenges to anything from birth control to vaccines.
“It basically puts at risk people’s access to medication that they rely on,” Carrie Flaxman, an attorney for Planned Parenthood, said in an interview. “This would allow anyone to come back decades later and claim a medication is unsafe.”
Josh Gerstein contributed to this report.
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( With inputs from : www.politico.com )

April 8, 2023
Dem AGs clash with Biden admin over abortion pill restrictions

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Should the judge rule in their favor, the case could eliminate restrictions in those states — broadening access to the drug for tens of millions of people. But the oral arguments also come as a federal judge in Texas is set to rule on whether to ban the pills entirely, and the potential for clashing federal court decisions could push the issue to the U.S. Supreme Court, which overturned Roe v. Wade in June.
The Biden administration has repeatedly criticized GOP officials and corporate entities in recent months for moving to curb access to abortion pills — noting that they have been deemed safe and effective by the FDA for nearly 25 years and have become the most popular way of terminating a pregnancy in the U.S.
Yet it is also in court fighting to maintain restrictions on the pills known as REMS — or Risk Evaluation & Mitigation Strategies — that the FDA places on a narrow class of drugs. Namely, Biden administration is defending requirements that patients sign a “Patient Agreement Form” acknowledging the risks of the medication and that health care providers who prescribe the drug first obtain certification and prove they can accurately date pregnancies, diagnose ectopic pregnancies, and provide or arrange for a follow-up care if needed.
The FDA declined to comment on the case, citing the ongoing litigation.
Oregon Attorney General Ellen Rosenblum is co-leading the lawsuit with Ferguson, and they are joined by the Democratic attorneys general representing Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
The pill restrictions, the group claims, are burdensome for both patients and doctors and the documentation requirements put them at risk for harassment or violence.
The Justice Department, meanwhile, is arguing that the attorneys general challenging the FDA rules waited too long to do so, didn’t follow the proper procedure and have failed to prove the remaining pill restrictions are harming patients in their states.
“They cannot credibly claim to be irreparably harmed by FDA’s decision to retain two 22-year-old requirements,” Biden administration attorneys wrote in a brief filed earlier in March. “Their delay shows that any harm is not so significant as to justify a preliminary injunction that would upset the status quo.”

Even as the Democratic officials and the FDA face off in Washington State on Tuesday, they’re on the same side in the Texas case, arguing that the anti-abortion groups suing the agency have no standing, haven’t proved the pills are causing harm and are infringing on the FDA’s authority to regulate the drugs. The same group of Attorneys General, plus several others, submitted amicus briefs in the Texas case backing the FDA rules around abortion medication.
When the FDA originally approved mifepristone for market in 2000, after many years of debate, the agency said the pills could only be dispensed in person by a certified physician. The Biden administration has acted multiple times to loosen those restrictions. In 2021, soon after Biden took office, the FDA allowed the drugs to be prescribed via telemedicine and delivered by mail — at first only for the duration of the Covid-19 pandemic and then permanently. Then, this January, the FDA announced that retail pharmacies could dispense the pills to patients with a prescription and the Justice Department reaffirmed that mailing the pills is not considered a federal crime under the Comstock Act.
Still, Ferguson and his fellow attorneys general argue the remaining restrictions on the pills are not justified given their well-documented safety record and lower rate of complications compared to many other over-the-counter medications. They also say the restrictions prevent providers in their states from serving both their own residents and the high volume of patients coming in from states with abortion restrictions.
“The FDA has approved over 20,000 drugs without limitations. So why is mifepristone listed along with fentanyl as one of only 60 drugs that have limitations?” he said. “It doesn’t make sense from a science perspective. And that’s why we think we’re going to prevail.”
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( With inputs from : www.politico.com )

March 28, 2023
12 US states sue to expand access to abortion pill

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Washington: A total of 12 states in the US have launched a lawsuit saying that the Food and Drug Administration (FDA) is hampering access to a popular abortion pill, the media reported.
Mifepristone, part of a two-drug regimen that induces abortions was approved in 2000, with restrictions to assure its safe use. reports the BBC.
The combination of mifepristone and another drug, misoprostol, is considered safe and highly effective in terminating pregnancies within the first 10 weeks.
But while misoprostol is freely available, the FDA tightly controls who can prescribe and dispense mifepristone.
The states of Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont launched the lawsuit on Thursday at a federal court.
The lawsuit has claimed that the limits on the drug were not supported by evidence, adding that thus has created “burdensome restrictions” on a drug that is the “gold standard” for abortions and has a high safety profile.
“The availability of medication abortion has never been more important,” wrote the plaintiffs, noting that approval of the drug was “based on a thorough and comprehensive review of the scientific evidence”.
But restrictions on the drug have made it “harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome… to dispense”, the BBC reported citing the lawsuit as saying.

Medication abortion is the most common method of the procedure in the US.
Now accounting for more than half of all abortions in the country, it has become the focus of growing political attacks since the US Supreme Court overturned the constitutional right to an abortion last year.
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( With inputs from www.siasat.com )

February 25, 2023