The US Supreme Court has unanimously rejected the petition seeking to restrict the FDA’s approval and relaxed regulation of the medical abortion pill mifepristone, granting nationwide access to the controversial drug.
In the unanimous ruling rendered on Thursday by Justice Kavanaugh on behalf of the court, the judges determined that the anti-abortion doctors, petitioners, and associations did not have the legal right to file the petition, maintaining a status quo on access to mifepristone.
Concerns about FDA’s Under-regulation of Mifepristone
The plaintiffs in the abortion case mainly focused on two main grounds, which they cited to pose potential risks of the drug’s widespread use across the United States.
The first point focused on FDA approval and regulations. Citing the regulation’s breach, petitioners argued that the federal regulator had no authority to approve the drug in the first place, arguing that the federal body did not adequately consider its effectiveness and safety before approval.
The petitioners also faulted the FDA for the drug’s initial clearance in 2000 and changes that followed due to the 2016 and 2021 federal actions, arguing that the changes led to relaxed rules on the access and use of the pills. This could result in its widespread use, according to petitioners.
However, the SCOTUS did not discuss the regulatory issues due to a lack of standing, which formed the basis of the petition’s rejection.
Conscience Clause Concerns
The second point for the petition focused on conscience clause concerns, arguing that the ease of access to Mifepristone pill may lead to “downstream conscience injuries” as many women may seek emergency abortions after using the pill, with some ending up in their clinics.
According to the plaintiff, this influx of abortion-related patients could lead to time and resource diversion from other patients, a claim that was watered down by the SCOTUS as “highly speculative” since the plaintiff did not provide sufficient evidence to back their arguments.
Major Pharmaceutical Players Applauded the Ruling
The landmark ruling comes two years after the apex court rescinded guarantees to abortions across the United States. Many pharma players and groups applauded the decision, stating that it reaffirms the FDA’s authority while setting a precedent for drug regulations in the United States through a stable FDA drug approval process.
Responding to the ruling on the access to Mifepristone pill , Pharmaceutical Research and Manufacturers of America (PhRMA), through its Corporate Secretary, Jim Stansel, expressed its satisfaction in a press release, noting that the decision gives the pharmaceutical industry the certainty to develop advanced medicines for patients.
