Access to Abortion Pills Preserved by US Supreme Court: What Was the Case All About?

It was June 13 when the US Supreme Court rejected a petition by anti-abortion groups that demanded the disapproval of mifepristone, an easily available abortion pill. The approval of the pill has been given by the Food and Drug Administration (FDA).

According to the court, the petitioners did not hold a direct stake in the matter and therefore the petitioners could not sue the Food and Drug Administration. The ruling was authored by Justice Brett M Kavanaugh. Justice Kavanaugh expressed that the plaintiffs were not the ones who prescribed or used mifepristone. Moreover, the FDA has not asked the plaintiffs to do something or refrain from doing something. Justice Kavanaugh said that to make any drug less available for others as the desire of the plaintiff does not actually establish a stand to sue.

What exactly is the verdict of the US Supreme Court in the matter?

For now, the court has preserved the access of mifepristone. Two years ago, the Supreme Court of the United States overturned the case of Roe . Wade, which repealed the right to abortion.

Take a look at what the present case is all about.

The case, the arguments, the contentions

It was in the year 2022 when the Food and Drug Administration (FDA) was sued by some individual doctors and four pro-life medical associations. The suit was filed in the US District Court, Northern District of Texas. The petitioners were against the FDA's assent to the mifespristone pills. They also challenged the changes made by the federal agency in the conditions of use of the pill and the provision of providing the pills to remote areas through telemedicine and mail.

According to the plaintiff, the mifepristone pills are unsafe. The plaintiffs also argued that the approval process of the FDA was actually flawed.

In the month of April last year, it was held by Matthew J Kacsmaryk that the approval of the drug by the FDA should be suspended. It was held that mifepristone should be suspended from the market.

The ruling was partially overturned by an appeals court in New Orleans. The court put certain restrictions on the distribution of the pill.

The Supreme Court, however, put the ruling of the appeals court on hold. The Supreme Court assented to hear the case.

Finally, how does FDA approve drugs?

As per the official website of FDA, the FDA goes through a comprehensive process involving many checkpoints and steps.

First things first, a drug is developed by a drug maker for the purpose of treating a disease or medical ailment. Tests for the same medicine is done in laboratories.

Once these preliminary tests go good, submitting an Investigational New Drug Application to the FDA is what the drug maker does next. The application elaborates the ways the drug maker intends to test and investigate the drugs via clinical trials done on volunteers. The clinical trials are followed based on a set of regulations and laws. These laws are designed to safeguard the rights and ensure welfare of the volunteers.

Once the clinical trials are conducted and enough information is gathered in support of the drug, the drug maker can now submit the New Drug Application to get it approved by the agency.

Now, the ball is in the court of the FDA. An unbiased FDA team comprising of experts analyze the clinal trial research. They make use of scientific date to assess if the drug meets the rigorous standards of the FDA.

If the FDA analyzes that the drug is safe to use, it inspects the facility where it will be manufactured.

If the FDA finds the research, date and the evidence in favor of the drug, it approves the drug.

However, even after the drug is approved and is out for public to use, the agency continues to monitor the safety, effectiveness, and quality of the drug for years.