[ad_1]
Washington – A federal judge in Texas on Friday struck a blow to abortion rights advocates after the Supreme Court dismantled constitutional abortion rights by suspending approval of the abortion drug mifepristone by the U.S. Food and Drug Administration. Gave.
In a 67-page opinion, U.S. District Judge Matthew Kacsmaryk argued that the FDA’s 20-year-old approval violated federal rules that allow for the early approval of certain drugs, and that subsequent action by the agency has been ruled out. He put the decision on hold for seven days so the Biden administration could appeal to the Fifth Circuit Court of Appeals.
The Biden administration actually filed a notice of appeal late Friday night.
President Biden released a statement late Friday night strongly condemning the ruling, saying, “The court in this case has superseded the judgment of the FDA, the agency that approves drugs. If this ruling is valid, There will be virtually no prescription, and FDA approval would make it safe from this kind of political and ideological attack.”
“The lawsuit and judgment are an unprecedented step in depriving women of their fundamental freedoms and putting their health at risk,” Biden said.
Kacsmaryk’s injunction did not go as far as revoking or suspending FDA approval of mifepristone, as a group of medical associations advocating anti-abortion rights asked him to do. Such a move from Kaksmalik, appointed by former President Donald Trump, likely disrupted access to medicine for millions of women across the country, including in states where abortion is legal.
“The Department of Justice strongly disagrees with the Northern District of Texas District Court’s decision. Alliance for Hippocratic Medicine v. FDA Attorney General Merrick Garland said in a statement Friday night that he would appeal the court’s decision and seek a stay of the appeal.
But a legal situation that has been overturned since the Supreme Court has further disrupted access to abortion nationwide. reverse row vs wade June last year. Following decisions to roll back abortion rights under the U.S. Constitution, at least a dozen states have either nearly outright banned the procedure or imposed tighter restrictions.
Following Kacsmaryk’s decision, a federal judge in Washington ruled in a separate case involving mifepristone to temporarily block the Biden administration from changing the status quo in relation to drug availability. I went down. His two competing orders set up a stakes showdown that is likely to land in the Supreme Court.
The FDA approved mifepristone over 20 years ago. This drug is taken with a second drug, misoprostol, to terminate pregnancy until the 10th week of pregnancy. Since then, the FDA has approved a generic version of mifepristone in 2019 and has made several changes to its rules on abortion drugs, including removing the requirement to dispense the pill face-to-face in 2021. . Your provider will be emailed to you during your telemedicine appointment.
But it wasn’t until last November, 22 years after the FDA approved the abortion drug, that a group of doctors and medical associations filed a lawsuit seeking to revoke the FDA’s approval of mifepristone. , has been filed in federal district court in Amarillo, with Judge Kaksmalik alone in charge of the case.
Robin Beck/AFP via Getty Images
allegations in court last month
In a complaint filed by the conservative legal group Alliance Defending Freedom, doctors said the FDA determines the safety and effectiveness of abortion drugs and “promptly administers certain drugs that are serious or life-threatening.” Approved under federal regulations permitting approval.” dangerous illness. Opponents have asked the court to issue a preliminary injunction ordering the FDA to withdraw approval of mifepristone, alleging that the agency has exceeded its regulatory authority to approve mifepristone.
Kaksmalik held a public hearing to consider their request last month.
” [FDA] We must protect the health, safety, and welfare of all Americans by denying or restricting the use of dangerous drugs. But the FDA disappointed American women and girls when it approved the use of chemical abortion drugs in the United States,” doctors and medical associations against abortion said in court. related to their use. “
But the FDA asked the court to maintain approval of the drug, arguing that the plaintiffs had taken too long to contest approval of the abortion drug. The agency also alleges that the lawsuit involves expedited review of the FDA’s approval of mifepristone, but the drug has been out for more than four years since its maker, Danko Laboratories, filed an application. He also mentioned that he later received the FDA’s OK.
“Eliminating access to mifepristone would worsen the health outcomes of patients who depend on the availability of mifepristone to safely and effectively terminate their pregnancies,” the FDA said in court. The “sudden absence” of abortion, according to the report, “does significant harm to patients who choose to take abortion drugs out of medical necessity, either for real-life privacy or to avoid further trauma.”
The FDA also warned that eliminating medical abortion options would lead to overcrowding and delays at clinics already working to increase patients overcoming abortion restrictions in neighboring states.
“This will lead to a series of delays in medical services as providers and resources are unnecessarily diverted to surgical abortion,” the agency said.
In its ruling, Kacsmaryk stated that the group’s challenge to FDA’s actions from 2000 approval to 2021 was likely to succeed on the merits and that the FDA exceeded its authority in approving mifepristone. discovered.
“The FDA manipulated and misunderstood the text of Subpart H to authorize elective chemical abortion on a large scale,” he wrote, referring to federal regulations under which abortion drugs were approved.
Kacsmaryk also said in his ruling that “the FDA has so far impeded judicial review,” and accused the agency of ignoring petitions seeking approval of mifepristone for 16 years.
“The court did not take FDA’s decision lightly. But here, in violation of its statutory duty, FDA acquiesced to legitimate safety concerns. Plainly unsound reasoning and , based on studies that do not support that conclusion,” he wrote. “There is also a serious political urge for the FDA to withhold the proposed safety measures in order to better advance its political objective of increasing access to chemical abortion, the ‘mifepristone big picture’. There is also evidence to suggest that they have faced political pressure.”
But the FDA said it approved the abortion drug in 2000 based on a “comprehensive evaluation of scientific data.” It reviewed separate clinical trials and found that they “provided substantial evidence of efficacy and demonstrated a low incidence of serious adverse events.”
The FDA summary also noted that additional studies, including data on “well over 30,000 patients,” found that serious mifepristone-related complications were rare, accounting for only a fraction of cases. says.
Medical abortions are becoming more common each year, accounting for more than half of all abortions in the United States in 2020, according to the Centers for Disease Control and Prevention. The American College of Obstetricians and Gynecologists says her more than three million women in the United States have used medical abortion since her FDA approval in 2000, and that it is “safe and effective.” increase.
Access restrictions and challenges
Doctors have warned of the far-reaching impact the verdict could have on patients.
Dr. Kristyn Brandi, an obstetrician and gynecologist in New Jersey, said: told CBS News At the beginning of this year, drug bans will be “catastrophic.”
“A lot of people rely on this drug,” she said. “This has been the standard of care for over 20 years.”
Democrats and abortion rights groups lashed out at Kaksmalik’s ruling and reiterated their commitment to protecting abortion rights.
“This ruling by an activist judge is a gross violation of the law and sets a dangerous new precedent,” Senate Majority Leader Chuck Schumer said in a statement. “Democrats in the Senate are working relentlessly to defend women’s right to choose from this extreme MAGA Republican agenda.”
Alexis McGill Johnson, president of Planned Parenthood, called the decision “angry,” but said mifepristone is still available for now.
“This decision has the potential to threaten the FDA’s role in the country’s public health system and, if left unchecked, will have far-reaching and unprecedented consequences far beyond abortion,” she said. said in a statement. “Let’s be clear: those who oppose abortion are not happy with it. Law vs Wade And by pursuing such lawsuits that undermine medical expertise and harm patients, they actively seek to undermine access to sexual and reproductive health care. “
The abortion drug challenge is the latest effort by anti-abortion rights advocates to limit access. In addition to banning abortion by gestational age and method, Republican-led states have also enacted laws restricting medical abortion.
Nearly total abortion bans have replaced drug abortion restrictions in 12 states, and medical abortions are mandated in 15 states. According to the Guttmacher Institute, a research group that supports abortion rights, six states require patients to see their practitioners in person.
At the federal level, the Biden administration is taking steps to expand the availability of abortion drugs. FDA in January Confirm rule change This will allow more retail pharmacies to dispense drugs to patients with prescriptions, increasing drug availability. Walgreens and his CVS stated: they are going to sell Mifepristone.
The Department of Justice’s Office of General Counsel also found that the U.S. Postal Service had given the green light to mailing mifepristone and misoprostol, and that the Comstock Act of 1873 did not prohibit the mailing of drugs.
The lawsuit targeting Mifepristone has attracted a great deal of interest and scrutiny from Kaksmalik, primarily focusing on his conservative views and motivations behind the lawsuit filed in Amarillo.
Critics of anti-abortion rights groups have accused them of engaging in forum shopping.Kaksmalik too criticized After delaying notice of the hearing on March 15.
Read the full decision here:
[ad_2]
Source link
