The abortion pill mifepristone puts the US drug authorization system in check

• Health United States authorizes the dispensing of abortion pills in pharmacies

On Monday, March 6, the governor of California,

announced that his state "will not do business with the Walgreens pharmacy chain or with others that do not distribute medications for the termination of pregnancy."

That is, with those that do not provide the

Mifepristone together with misoprostol - without sale restrictions because it has other medical indications - is used in pregnancy interruptions during the first trimester and is the path behind more than half of the abortions that occur in the US.

"California will not do business with Walgreens or any company

and endangers women's lives. We are done," the California Democratic Party representative tweeted.

Mifepristone

has been at the center of the legal, political and ethical battle that the US is experiencing with access to abortion, since this summer the decision of the Supreme Court that left the regulation of this right in the hands of the states was known

A right that until now was protected by the case law of

and that had federal effect.

have promoted regulatory changes to prohibit or make it difficult to terminate a pregnancy.

Access to pharmacological abortion is open through products authorized by the US Food and Drug Administration (FDA),

But the most conservative factions in the country are now attacking this path, and they are doing so from various fronts and with worrying side effects, since they are questioning the Agency's drug authorization process and the linkage of its decisions at the federal level.

In the midst of this setback in the right to abortion,

the FDA has made a decision -or rather, two- that have been key.

On the one hand, regarding

or morning-after pill, the FDA

that could limit the use of this medication in this new context.

To the same end, the Regulatory Agency

So now it can be purchased

and is available at certified community pharmacies, including big chains like Walgreens and CVS.

The FDA's decision dates from January 3 and, in principle, large companies showed their intention to request special certifications to offer mifepristone.

Meanwhile, the employers' association of community pharmacies in the US declared that they would act prudently so as not to jeopardize their dispensing certificates in each of the states.

It may have been

by several pro-abortion states that

In a statement, Walgreens, the second largest US retail pharmacy chain behind CVS Health

reported that "as a certified pharmacy,"

Prior to this decision, the attorneys general of about twenty states came together to send a letter to Walgreens Corp. in which they threatened legal action if they continued to allow the sale of the abortion pill in states such as Alabama, Alaska, Arkansas, Florida , Georgia, Iowa, Kentucky, Louisiana, Missouri, Mississippi, Montana, Texas, and Utah, among others.

The lawsuit dance begins in Texas

In November 2022, a definitive element emerged at the beginning of this controversy, when Texas Judge

-

- received a lawsuit from an anti-abortion group against the FDA's decision to facilitate access to said pill.

The appellants intend to prevent the dispensing of mifepristone throughout the country, questioning the safety of the drug.

Something that is now in the hands of Judge Kacsmaryk.

To counteract the possible ruling by Texas, 12 states have filed an appeal, signed by the attorneys general of each of them, against the FDA's decision to maintain extraordinary requirements for the sale of mifepristone.

Because, although in the recent review of the dispensing of this drug, the FDA facilitated its acquisition, it maintained requirements that, in light of certain groups,

.

That is, the pill remains within the

, where the drugs that need to comply with extraordinary procedures for their delivery are located.

This means that

while the supplying companies appear in a registry of drug dispensers for which they must first be accredited.

Kristin Beneski, Washington State's

has said that the goal of the lawsuit is to "protect and expand access to medical abortion."

It further argues that the certification requirements and the agreement that patients must sign to obtain the pill "are burdensome,

, and have discouraged many providers from prescribing mifepristone, limiting the access to medical abortion.

The prosecutor adds that, in addition, it forces providers to appear on a list, with the requirement of certification, which "makes the chains worry about their privacy" in a political environment in which, she said,

"They are really worried about being subjected to violence and harassment."

The appellants also recall that mifepristone is also indicated for

and, in these cases, women are still obliged to sign the official consent document

.

lawsuits continue

But these two cases -

are joined by other appeals that have been presented in recent weeks and that show to what extent pharmacological abortion has become in the following objective of the most conservative groups in the country, after knocking down the

GenBioPro

, one of the two pharmaceutical companies that market mifepristone in the United States, has filed a lawsuit in the Federal Court of the State of West Virginia against the regulations of the states that prohibit the dispensing of its abortion pill against the federal regulation that allows his dispensation.

The company maintains that federal regulations take precedence over restrictive state regulations.

Also so far in 2023, an OB-GYN has sued authorities in

, which still allows abortion, challenging the state's requirements for mifepristone use because they "go beyond what the FDA lays out."

It is necessary to wait for these judicial resolutions to find out what

will be - and other implications in the approval of medicines, about which several experts warn -

but there are scientists and lawyers who have left their opinion on the confrontation between federal and state regulations in the field of medicines that can help to glimpse the final meaning of the judicial resolutions.

Patricia Zettler

, a professor of law, and

, a professor of medicine, signed an article in

a year ago now, noting that "federal law trumps state law when the two collide."

To support their argument, they cite the case of the opioid

(hydrocodone), in Massachusetts, in 2014, when the state wanted to ban it despite having

.

Then a federal judge ruled in favor of the pharmaceutical company Zogenix, arguing that "if the state were able to overturn the FDA's determinations and substitute its own requirements, it would undermine the regulatory agency's ability to

drugs available to promote and protect public health".

A judgment that takes

In any case, the resolution of Texas judge

on the appeal of a group of anti-abortionists against the dispensing of mifestropin is taking time to wait.

And the importance of the case that he judges unsettling.

"Everyone thought that by now we would have a ruling on the case,"

told

.

And he has warned that if Kacsmaryk annuls the approval of mifepristone,

threats to abortion access: "If the court decision ends up withdrawing the abortion pill,

for approving drugs and would invade the authority of the FDA.

In de Becerra's opinion, "Kacsmaryk (the Texas judge) is realizing that it can be dangerous for much more than mifepristone.

at the FDA," says the Secretary of Health and Human Services, adding that "the approval decision was based on evidence, with scientific data collected over 20 years. And guess what? The FDA did it right," Becerra said.

And it is that, indeed, the judicialization that the dispensation of mifepristone has acquired -which has been approved by the FDA for more than 20 years- can have consequences

.

Although the pharmaceutical industry in general has remained silent on the issue during these weeks, there are some exceptions.

Thus,

, has left his opinion in a podium in

signed at the end of February, in which he ended by saying: "While the new majority of the Supreme Court weighs the dismantling of half a century of progress We, CEOs, C-level executives and other leaders

must do our duty:

, uphold the jurisdiction of the FDA, and publicly support the right of pregnant women to make their own medical decisions."

According to the criteria of The Trust Project

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