By this Wednesday, the US Supreme Court is expected to rule on whether it will be possible to continue using the abortion pill Mifeprison, also known in Israel as Mifegin, in the US. The drug was approved for use in 2000 by the FDA, the American Food and Drug Administration, and has been widely used since then. Most abortions in the US are performed through it, about 5 million abortions to date.

But a federal judge from Texas ruled at the beginning of last week that the pill is not safe, and that the approval for its use was improperly received, in complete contrast to the FDA’s position on the matter. His ruling is valid for the entire American market, and if it is not canceled, the pill will not be available even in countries where abortions are legal today.

Meanwhile, following an appeal by the Biden administration and the FDA, the Supreme Court issued a stay order, and the drug is still on the market, as of today. The Supreme Court asked all parties concerned to submit their position on the issue by next Tuesday, and the freeze order for the ruling ends on Wednesday, so according to estimates, the decision will be made on Wednesday at the latest.

The ruling is of course critical to the issue of the right to abortion in the US, a burning issue in itself, but it also has implications beyond that. Following the ruling, officials in the pharmaceutical industry fear for the independence of the FDA. To date, a court has never overturned a drug approval decision by the FDA .

The FDA: stand behind the original decision

The administration is indeed considered a body that can be sued, and there have been cases where courts have found the FDA guilty of improper approval procedures. However, these criticisms often appeared after the administration itself revoked approval for the drug, following the accumulation of information about its harms, and the legal issue was how it happened that it was approved in the first place. In these cases the court judged the confirmation procedure. He never pretended to judge instead of or better than the FDA whether a drug is safe or effective.

In response to the ruling, the FDA claimed that it stands behind its original decision, which stood the test of two decades, during which five heads of the authority appointed by both parties changed. According to the FDA, all the evidence shows that the drug is safe to use. Sources in the industry claim that the judge Mati Kashmirak who invalidated the drug, on a double claim – both that the approval process was flawed, and also that the drug is indeed unsafe – relied on controversial studies, and that he lacked the knowledge and training to make this decision contrary to the FDA’s opinion.

The concern of pharmaceutical industry officials now is that more drugs will be challenged through the court in an FDA bypass route. In a letter issued on behalf of the Bio organization, the organization of American biotech companies, signed by Pfizer CEO Albert Burla and Biogen CEO Christopher Weibacher, along with many other senior executives, they claimed that it would now be possible to challenge through a court whose judges are political appointees, the approvals for vaccines as well, and not only the corona vaccine, also medicines based on fetal stem cells, studies of which were previously prohibited in the US for reasons related to opposition to abortions, also contraceptives and “morning-after” pills, also supportive treatments for gender change, and it is not known which Other drugs will prove to be controversial.

Former CEO of Teva: “This situation will affect the whole world”

Dr. Jeremy Levin, former CEO of Teva, now CEO of Ovid and a member of the board of the Bio organization, together with the Sisterhood organization, an organization of women CEOs of biotech companies in the USA, is leading the pharmaceutical companies’ fight against the ruling. These parties initiated the letter signed by the heads of the biotech industry, and which will be submitted to the Supreme Court.

“The FDA received from the American Congress the authority to be the first and last body to decide on the issue of drug safety and effectiveness. We are now faced with the possibility of two paths for drug approval – the professional path, and the legal path influenced by political considerations, in which the decision is made by a judge who has no training in the field, instead of by panels of experts. This situation will affect the whole world, as many countries are affected by their decisions to approve drugs, by the FDA’s decision.”

The federal judge claimed that the drug was unsafe. Couldn’t there really be something to it?
“Federal judges, like Judge Cashmirk who issued the ruling, are appointed by the government. When Cashmirk was appointed, his views on abortion were well known, as well as his views on the LGBT community and other views that caused Democrats to oppose his appointment. He stated at the time that he would stay away from any discussion where he was in a conflict of interest, but that is not what he actually did. Not only that, but the associations that wanted to get a ruling against the drug, deliberately set out to find a judge who would agree with their opinion, and then filed their petition precisely in his court. In other words, they did ‘legal tourism’ to achieve the result they wanted.”

Levin claims that there was no evidence in the trial that the drug was unsafe. “According to the data available to the FDA, it is considered safer than paracetamol,” says Levin. “The most fundamental issue here is who has the authority to confirm that a medicine is safe for use, and on what basis. Is the approval based on a scientific basis? This is a critical question for the question of innovation in the pharmaceutical industry.”

According to him, “anti-vaccination elements connected to American politicians are already starting to talk about how this ruling might serve them.”

Levin, who is also active in opposing the legal reform in Israel, says that “for Israel there is a lesson here: what happens when politicians appoint judges, and these make decisions that are very political.”

Meanwhile, the drug is approved for use until Wednesday

Meanwhile, an appeals court overturned part of the Kashmir ruling, but upheld part of it. The legal issues are, among other things, whether the plaintiffs even had the right to file their lawsuit, considering that they are not doctors who prescribe the drug, nor patients who were treated with it.

The doctors’ claim, which has meanwhile been accepted by the first appeals court and will have to be examined by the Supreme Court, is that they are doctors who will be forced to treat those suffering from the side effects of the drug. Another issue is whether it is possible to invalidate an approval given by the FDA, so many years after it was given, based on the detection of flaws in the original approval process (if indeed there were any), and this despite the fact that a great deal of real information regarding the use of the drug has been accumulated since then.

In the meantime, the aforementioned drug is approved for use until Wednesday at least. Abortions are currently legal in some US states. If the ruling is not overturned, Mifeprison will become illegal even in states where abortion is completely legal. It will also not be possible to purchase the drug elsewhere, and use it in the US.

Mifeprison, in combination with another drug called Misoprostol, is also used to terminate pregnancies in which the fetus is already dead or definitely cannot develop. It would be more difficult to perform this procedure without mifeprison.

The drug Misoprostol is still considered legal in the US, and an abortion can be performed using this drug alone, but it is considered a less effective and less safe procedure. Also, in countries where abortion is legal, it can still be performed surgically. This procedure is more invasive, although in some cases it is It is better for various reasons. It is certainly a more demanding process in terms of the health system, compared to a pill that the patient takes herself at home.

Revoking the FDA’s approval of a drug in the US does not cancel its approval in Israel, and today there are no parties calling for the cancellation of its use. However, in recent years more voices have been heard from the opponents of abortion in Israel, after for most of the years of the country’s existence this was not a significant issue in Israeli politics.