Danco Laboratories LLC

Pictured: The U.S. Supreme Court building in Washington, DC/iStock, Mindaugas Dulinskas The U.S. Supreme Court on Thursday unanimously rejected a challenge to the FDA’s approach to approving the abortion pill mifepristone, preserving wide access to the drug based on procedural grounds. Justice Brett Kavanaugh, who penned the court’s opinion, noted that the anti-abortion plaintiffs do not have legal standing to sue the regulator for its loosening of the safety guidelines around the use of mifepristone. “Citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities—at least without the plaintiffs demonstrating how they would be injured by the government’s alleged under-regulation of others,” Kavanaugh wrote, noting that the plaintiffs in this case had failed to convincingly establish a direct causal link. Kavanaugh also argued that the plaintiff doctors’ argument—that relaxing the safety regulations around mifepristone use could injure their practice by diverting time and resources from other patients—is “highly speculative.” The doctors failed to provide evidence of such resource and time diversion, according to Kavanaugh, nor did the plaintiffs provide proof that they had been subject to higher costs or legal liability related to mifepristone treatment. Instead of petitioning the courts, “citizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions on certain activities,” Kavanaugh wrote in the opinion. In response to the ruling, several pharma players and groups applauded the Supreme Court, noting that the decision helps solidify the FDA’s expertise and authority. Jim Stansel, executive vice president and general counsel of the trade group Pharmaceutical Research and Manufacturers of America, said in a statement that the court’s ruling “provides innovative biopharmaceutical companies the certainty needed to bring future medicines to patients.” Abby Long, vice president of marketing and public affairs of Danco Laboratories, one of the petitioners in the lawsuit alongside the FDA, said that by rejecting the plaintiffs’ case against mifepristone the Supreme Court “reaffirmed longstanding basic principles of administrative law.” In doing so, the ruling “maintained the stability of the FDA drug approval process.” The recent legal tussle over the abortion pill started in November 2022 when the Alliance for Hippocratic Medicine sued the FDA, seeking to withdraw the approval of mifepristone. In April 2023, Texas federal judge Matthew Kacsmaryk issued a preliminary injunction to block the sales of mifepristone, which was only partially blocked by the U.S. 5th Circuit Court of Appeals a few days later. Thursday’s ruling did not impact the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which eliminated a constitutional right to abortion nationwide. Since then, dozens of states have banned or limited access to the procedure. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

NEW YORK, June 13, 2024 /PRNewswire/ -- Danco Laboratories, LLC Vice President of Marketing & Public Affairs Abby Long issued the following statement in response to today's U.S. Supreme Court's ruling in Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine: Continue Reading Photo courtesy of Danco Laboratories "We are pleased with the Supreme Court's decision in this incredibly important case. By rejecting the Fifth Circuit's radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law. In doing so, they maintained the stability of the FDA drug approval process, which is based on the agency's expertise and on which patients, healthcare providers and the US pharmaceutical industry rely. The decision also safeguards access to a drug that has decades of safe and effective use. As the sponsor of Mifeprex® (mifepristone) tablets, the first and only brand-name drug approved for use in medical abortion, Danco is proud to have led the way in obtaining FDA approval of this essential reproductive health option and of modifications to the conditions under which it can be used. We thank the Court for its careful analysis and remain committed to developing and bringing to market safe and effective products in this crucial area of public health." SOURCE Danco Laboratories

"The plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue," Justice Brett Kavanaugh wrote in the court's opinion. The Supreme Court unanimously sided with the Food and Drug Administration in a case that challenged the availability of mail-order abortion medications and regulatory authority. In a decision handed down Thursday morning, the top court wrote that the case’s plaintiffs—the Alliance for Hippocratic Medicine, a group of physicians ideologically opposed to providing abortion services—do not have standing to challenge the agency’s regulation. “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote for the court. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.” The ruling settles a legal battle in which the plaintiffs argued against FDA’s ability to expand the use of mifepristone to include mail-order prescriptions over a decade after its initial approval. U.S. District Judge Matthew Kacsmaryk had taken their side in early 2023 and ruled to invalidate the drug’s full approval, with an appeals court later adjusting the restrictions to telehealth and mail-order prescription. That decision was put on hold pending the Supreme Court’s input. Its decision today reverses the restriction, ensuring that mifepristone will remain available through telehealth and mail orders. Lawyers from the federal government, mifepristone manufacturer Danco Laboratories and trade groups from the pharmaceutical and healthcare industries had opposed the plaintiffs and the decisions of the lower courts. In briefs and in oral arguments made before the Supreme Court, they warned judiciary intervention could have disastrous impacts on the FDA’s authority to regulate drugs. Ultimately, the plaintiffs could not show that they were being harmed by the FDA’s regulations, which sunk their case. Echoing questions and comments from oral arguments, Kavanaugh wrote in the order that the FDA is not forcing individual providers with conscientious objections to abortion to provide services. “Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” he wrote. “Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue.” The court also shot down the “several complicated causation theories” the plaintiffs used to establish injury and standing, such as downstream economic injuries. Justice Clarence Thomas penned a concurring opinion affirming the court’s rejection of the case. Supporters of individuals’ right to an abortion said they are relieved by the court’s decision. Plan C, one such group, described the ruling as “a minor win on a baseless case that never should have made it past the initial filing. We’re relieved that the court did not take action to further restrict access to mifepristone, a very safe and effective medication that is already overregulated by the [FDA].” Health and Human Services Secretary Xavier Becerra celebrated the ruling on behalf of the administration and reiterated HHS' intention to expand reproductive health access where able.  "Mifepristone has been used safely and effectively for more than two decades since it was first approved by the FDA, one of our nation’s most critical public health agencies," Becerra said in a statement. "Today, this critical medication remains approved and available." Bobby Mukkamala, M.D., president elect of the American Medical Association, said in a statement that the "efforts to second guess the FDA’s scientific judgment and roll back access to mifepristone were based on a sham case that not only lacked standing, but relied on speculative allegations and ideological assertions to undermine decades of rigorous scientific review proving the drug is highly safe and effective for both termination of pregnancy and for medical management of miscarriage." Mukkamala also alluded to "substantial evidence" that "restricting access to needed abortion care without justification carries a psychological, physical, and economic toll." Mifepristone is used for about two-thirds of abortions in the U.S. Telehealth and mail-order use rose substantially during the COVID-19 pandemic and since the implementation of state-level abortion restrictions after SCOTUS overturned Roe v. Wade in 2022. The Supreme Court is currently weighing another case related to medical abortion and the Emergency Medical Treatment and Active Labor Act (EMTALA), which requires hospitals to treat patients with life-threatening health emergencies.