Pharma industry urges reversal of judge’s decision to halt mifepristone approval

USA — More than 300 executives from the biotech and pharmaceutical industries have signed an open letter calling for the reversal of a federal judge’s decision to halt the approval of mifepristone by the US Food and Drug Administration (FDA).

The letter asserts that the judge’s decision disregards science and undermines the FDA’s role in ensuring the safety and efficacy of medicines for the public.

The signatories include ReCode Therapeutics CEO Shehnaaz Suliman, Blackfynn co-founder Amanda Banks, and Ovid Therapeutics CEO Jeremy Levin.

The decision was made by US District Judge for the Northern District of Texas, Matthew Kacsmaryk, on April 7.

Kacsmaryk halted the FDA’s two-decade-old approval of the abortion drug Mifeprex (mifepristone) and a generic version of the drug, stating that the FDA’s approval violated a federal rule allowing for accelerated approval of certain drugs and was unlawful.

The judge accused the FDA of acquiescing on its legitimate safety concerns in violation of its statutory duty, based on unsound reasoning and studies that did not support its conclusions.

The FDA has appealed the decision to the 5th Circuit Court of Appeals, emphasizing that its approval of the drug in 2000 rested on a comprehensive evaluation of the scientific data.

The agency conducted three clinical trials involving more than 2500 pregnant patients and found substantial evidence of effectiveness, with a low rate of serious adverse events.

Following Judge Kacsmaryk’s decision to halt the FDA’s approval of mifepristone, the Biden administration also filed a notice of appeal.

President Joe Biden stated that the court had overruled the FDA, which is considered the expert agency for approving drugs.

Biden expressed concern that if the decision were allowed to stand, it could open the door to political and ideological attacks on other FDA-approved drugs.

Attorney General Merrick Garland also spoke out against the ruling, stating that the DOJ strongly disagreed with the decision.

According to Garland, the ruling overturns the FDA’s expert judgment from over two decades ago, which determined that mifepristone is safe and effective.

Mifepristone is a medication used with misoprostol to end early pregnancies up to 10 weeks gestation.

The FDA approved a generic version of the drug in 2019 and removed the requirement for in-person dispensing.

This permits healthcare providers to prescribe the medication during telemedicine appointments and have it delivered by mail.

The drug was initially approved by the FDA in 2000 under a special accelerated approval process. The special accelerated approval allows for drugs to be approved based on preliminary data, with the condition that the drug’s efficacy and safety will be confirmed in further studies.

Since then, the FDA has continued to monitor and evaluate the drug’s safety and efficacy. According to the FDA, the plaintiffs in the lawsuit challenging the approval of mifepristone waited too long to take action since challenges to agency actions are subject to a six-year statute of limitations.

Additionally, the agency stated that the drug was approved more than four years after the manufacturer Danco Laboratories submitted its application, despite claims that the drug received an accelerated review.

The FDA argued that removing access to mifepristone would lead to worse health outcomes for patients who depend on the drug for safe and effective pregnancy termination.

The lawsuit was filed in late 2022 by a group of doctors and medical associations in Amarillo, Texas, seeking to reverse the approval of mifepristone and subsequent agency decisions that eased access to the drug.

The doctors claimed that the FDA erred in determining the safety and efficacy of mifepristone and exceeded its regulatory authority by approving it under a federal rule that allows accelerated approval of drugs that treat “serious or life-threatening illnesses.”

They requested a preliminary injunction from the court to order the FDA to undo its approval of the drug. The complaint was filed by the Alliance Defending Freedom on behalf of the doctors.

An opposing ruling

In contrast to the ruling by Judge Kacsmaryk, a district judge in Washington state has granted an injunction sought by a group of Democratic attorneys-general.

The lawsuit aimed to support the FDA’s original conclusion that mifepristone is a safe and effective drug for terminating early pregnancies.

District Judge Thomas Rice ordered the FDA not to alter the availability of mifepristone, preventing the drug from being removed from the market.

The injunction applies to 17 states and Washington, DC, that petitioned for the FDA to be stopped from taking mifepristone off the market.

The case centres on the Risk Evaluation and Mitigation Strategy (REMS) that the FDA applies to mifepristone, which mandates that the benefits of the drug outweigh the risks.

The attorneys-general argued that the REMS had no scientific basis and imposed burdensome requirements on prescribing and dispensing the medication.

In his ruling, Rice stated that the plaintiffs had demonstrated a balance of equities in their favor and that the public interest favored a preliminary injunction.

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