Judge halts FDA's approval of mifepristone
10 Apr 2023
Drug ApprovalPatent Infringement
A federal judge in Texas halted the FDA's two-decade-old approval of Danco Laboratories' abortion drug Mifeprex (mifepristone) and a generic version of the drug. US District Judge for the Northern District of Texas Matthew Kacsmaryk said the FDA's approval violated a federal rule that allows for accelerated approval of certain drugs and was unlawful. "The court does not second-guess FDA's decision-making lightly. 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," Kacsmaryk said.
The FDA appealed the decision to the 5th Circuit Court of Appeals, noting that its approval of the drug in 2000 rested on a "comprehensive evaluation of the scientific data." The agency explained it reviewed three clinical trials involving more than 2500 pregnant patients and found the trials provided "substantial evidence of effectiveness and showed a low rate of serious adverse events."
Plaintiffs waited too long
The FDA further argued that the plaintiffs waited too long to fight its approval of mifepristone, as challenges to agency actions are subject to a six-year statute of limitations. Additionally, the agency noted that while the lawsuit claims its approval of mifepristone involved an accelerated review, the drug received the FDA's approval more than four years after its application from manufacturer Danco was submitted. "Removing access to mifepristone would cause worse health outcomes for patients who rely on the availability of mifepristone to safely and effectively terminate their pregnancies," the FDA said.
The lawsuit was filed in late 2022, when a group of physicians and medical associations sued the FDA and Health and Human Services department in federal court in Amarillo, Texas, seeking to undo the approval of mifepristone as well as subsequent agency decisions easing access to the drug. In their complaint filed by the Alliance Defending Freedom, the doctors claimed the FDA erred in determining the safety and effectiveness of mifepristone and approving it under a federal rule that allows accelerated approval of certain drugs that treat "serious or life-threatening illnesses." They claimed the agency exceeded its regulatory authority to approve mifepristone and requested the court to issue a preliminary injunction ordering the FDA to undo its approval of the drug.
Mifepristone is taken together with misoprostol to terminate a pregnancy through 10 weeks gestation. Since its approval, the FDA approved a generic version of mifepristone in 2019 and later lifted a requirement that the pills be dispensed in-person, allowing the drug to be prescribed by a provider during telemedicine appointments and sent by mail. In January, the FDA allowed retail pharmacies to offer abortion drugs in the US for the first time.
Shortly after Kacsmaryk's ruling, the Biden administration filed a notice of appeal, with President Joe Biden noting that the "court in this case has substituted its judgment for FDA, the expert agency that approves drugs. 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." Attorney General Merrick Garland said that the Justice Department "strongly disagrees with the decision," which it said "overturns the FDA's expert judgment, rendered over two decades ago, that mifepristone is safe and effective."
Danco to appeal
"Today's decision is wrong on the medicine and science, wrong as a matter of public health policy, wrong as a matter of reproductive rights, and wrong as a matter of law," said Jessica Ellsworth, lead counsel for Danco in the case, adding that "we will appeal this to the Fifth Circuit and to the Supreme Court, if necessary, while working hard and creatively with FDA, state authorities, healthcare providers, reproductive rights organisations and others to maintain access and do all we can to make Mifeprex available legally."
Opposing ruling
Meanwhile, an opposing ruling in Washington state followed a lawsuit filed by a group of Democratic attorneys-general who sought to affirm the FDA's original conclusion that mifepristone is safe and effective." District Judge Thomas Rice barred the FDA from "altering the status quo and rights as it relates to the availability of mifepristone." Rice's injunction applies to 17 states plus Washington, DC, that requested that the FDA be prohibited from removing mifepristone from the market. The case centres on the Risk Evaluation and Mitigation Strategy (REMS) applied to mifepristone by the FDA. The programme is required by the agency for any drugs that may have serious safety concerns and is meant to ensure that the benefits outweigh the risks of use. The attorneys general claim that the REMS applied to mifepristone has "no basis in science" and enforced onerous requirements on who can prescribe and dispense the drug.
"Based on the public health and administrative considerations at issue in this case, Plaintiffs have shown the balance of the equities sharply tip in their favour and the public interest favours a preliminary injunction," Rice said in his ruling.
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