(Scypre.com) – The Supreme Court on Friday granted a full stay in a case concerning the FDA’s approval of the widely used abortion pill. The Biden administration and the pill’s manufacturer are appealing a lower court ruling that would impose restrictions on the drug.
“The administration and manufacturer are not entitled to a stay because they have not shown that they will suffer irreparable harm in the interim,” according to Alito’s dissent. The White House applauded the stay and vowed to fight the restrictions on the abortion pill. “As a result of the Supreme Court’s stay, the FDA’s evidence-based approval of Mife remains in place,” President Joe Biden said in a statement.
The Supreme Court gave itself more time to decide if it would wade into the legal battle over a Texas judge’s ruling suspending the FDA’s approval of the drug more than 20 years ago. The Supreme Court’s decision to overrule abortion access was the new focus of legal battles.
A coalition of anti-abortion doctors and associations, represented by the conservative legal group Alliance Defending Freedom, filed a lawsuit in Amarillo, Texas, challenging the FDA’s assessment of the safety and effectiveness of the drug.
On April 7, Matthew Kacsmaryk ruled in favor of the group. The drug was approved by the FDA in 2000.
The order of Kacsmaryk was partially blocked by the 5th Circuit Court of Appeals.
If the federal agency’s expertise were to be second-guessed, the Biden administration and Danco Labs warned of possible wide-ranging consequences. “If allowed to take effect, the lower courts’ orders would undermine FDA’s scientific judgment and undermine widespread reliance on a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and intrusive surgical abortions,” Prelogar told the Supreme Court.
The administration’s concerns amounted to a “sky-is-falling-argument” according to Alliance Defending Freedom. “If this litigation involved any other drug, there would be no debate as to whether this Court should intervene mid-litigation stream with extraordinary relief,” attorneys for the Alliance Defending Freedom wrote in a filing to the court.
The case has divided the nation. The conservatives are supported by Republican lawmakers. Democrats and leading medical associations have pushed for the continued availability of the drug. As the legal battle plays out, some states and abortion providers have been stocking up on abortion drugs.
The case will be argued in the 5th Circuit Court of Appeals on May 17.
The Supreme Court on Friday protected access to a widely used abortion drug by freezing lower court rulings that placed restrictions on its use. While appeals play out, the US Food and Drug Administration’s approval of the drug will remain in place.
The Friday night move is a victory for the Biden administration and its allies in the abortion rights community, who suffered a defeat at the Supreme Court last year. The Wade precedent protected abortion rights nationwide.
The court didn’t explain why it granted the request by the Biden administration and the manufacturer of the drug. The votes of the other justices weren’t disclosed.
The most important abortion-related dispute to reach the high court is the case. Wade caused conservative states to either ban or severely restrict the procedure. Even in the states that still allow it, the dispute over medication abortion could make it more difficult for women to get an abortion.
The scope of FDA’s authority to regulate a drug that the medical community deems safe and effective is at issue. Mifepristone has been used by millions of women across the country for more than two decades.
A hearing in front of a New Orleans-based federal appeals court will be the next step in the litigation. The case could come back to the justices once the Fifth Circuit rules, but nothing will change until the court takes the case on the merits and sides with the challengers.
The order was praised by President Joe Biden. As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts, Biden said in a statement Friday evening.
Biden urged Americans to use their vote as their voice, and toelect a Congress who will pass a law restoring the protections of abortion. The lawyer for the group of doctors downplayed the order. The case seeking to put women’s health above politics continues on an expedited basis in the lower courts.
Alito said he voted against the request for a stay because the 5th Circuit had scheduled an expedited hearing on the merits of the case.
He said that allowing the restrictions to remain in place would not cause any real harm.
“The stay would restore the circumstances that existed when the FDA passed new regulations to ease access to the pill,” Alito wrote. Alito wrote that the Government has not dispelled legitimate doubts that it would obey an unfavorable order in these cases, much less that it would choose to take enforcement action to which it has strong objections.
The other justice did not join his dissent.
The Friday order for preserving “crucial access to a drug relied on by millions of patients” was cheered by the manufacturer of the drug. The lower courts’ reversal of longstanding FDA approvals has caused chaos.
Jessica Ellsworth, Danco’s attorney, said in a statement that the order provided continuity to all concerned.
The FDA’s approval of the generic version of the abortion pill would have been suspended had the Supreme Court left the lower court rulings in effect. Evan Masingill, the company’s CEO, said in a statement that the Supreme Court ruling was lawful and available.
The order was an important step in the right direction as the administration fights to defend the FDA’s independent authority to review, approve, and regulate a wide range of prescription drugs. He said that they were confident the law was on their side and that they were focused on prevailing in court.
The Justice Department didn’t say anything.
The legal controversy began last November when a group representing doctors who oppose abortion filed suit, arguing that the FDA hadn’t done enough to ensure the safety of the drug. US District Court Judge Matthew Kacsmaryk issued a broad ruling on April 7 that blocked the approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible. The effective date of his ruling was delayed by seven days to give time for an appeal.
Rejecting the consensus of the medical community, Kacsmaryk raised questions about the safety of the drug, peppering his opinion with jargon that’s often used by opponents of abortion. He labeled doctors who perform the procedure “abortionists” and explained that he’d reject the term “fetus” in favor of the more inflammatory “unborn human.” Instead of referring to the procedure as a “medication abortion,” he insisted on calling it a “chemical abortion.”.
At one point, the FDA was accused of violating its statutory duty by acquiescing on its legitimate safety concerns, based on plainly unsound reasoning and studies that didn’t support its conclusions.
His assertions about the dangers of the drug have been rebuked by the medical associations.
On a key threshold issue, the judge insisted that the doctors who don’t use or prescribe the drug had the legal right to be in court because they alleged that the use of the drug could overwhelm the medical system.
The appeal was filed with the 5th US Circuit Court of Appeals by the Biden administration and Danco.
The appeals court agreed with Kacsmaryk that access to the drug could be limited. A divided three-judge panel ordered a return to the stricter pre-2016. The FDA regime around the drug prevents mailing the pill to patients who obtained it through virtual visits with their providers, rather than traveling to a clinic or hospital to obtain the drug in person. The generic version of the drug was approved in 2019. The window for obtaining the pill to seven weeks into pregnancy is shortening because of the restrictions.
It’s possible that some providers could continue to prescribe the drug even after the ruling is in effect.
The FDA’s rules for the drug created an exceedingly unusual regime, and the anti-abortion doctors had the right to file a lawsuit because they would be injured by the FDA’s decision to cut out doctors, according to the 5th Circuit.
The appeals court said that the statute of limitations probably barred the plaintiffs from challenging the 2000 approval, but that they were likely to succeed in their claims against the FDA’s recent moves to adjust the rules around the drug.
The lower courts had handled the case. He thinks that the court is going to overrule the FDA on whether something is safe or not.