Abortion producer of pills enters into a legal fight for FDA principles

The largest manufacturer of abortion tablets wading to the first sedate legal battle for the abortion of the second term of President Trump.

The company, Genbiopro, on Tuesday asked the court in Texas to add it to the list of accused in a lawsuit submitted in October by three republican general prosecutors. This movement was a significant offensive action in terms of perceived as an avant -garde in the fight for access to abortion.

The lawsuit was filed by the Prosecutor General from Missouri, Idaho and Kansas and asks the Federal Court to reverse a series of provisions on food administration and medicines that significantly increased access to the MifePriston abortion pill.

According to the administration of Biden, the Department of Justice defended the rules of the Agency and the approved by FDA 25 years ago. However, many supporters of the rights to abortion provide that Trump’s administration will refuse to defend the agency, effectively on the part of general prosecutors and using the case to limit access.

If the judge gives Genbiopro’s application, the maneuver will allow the company to direct the Mifepristone defense. The company is represented by Democracy Forward, a legal organization non -profit, which filed several lawsuits and won many court orders against Trump’s administration.

“The basis of the arguments of these extreme politicians is rather purely political, and not based on scientific evidence,” said Skye Perryman, president and director of the democracy. “A threat that this case brings access to abortion throughout the country cannot be underestimated.”

Abortion pills are prescribed up to 12 weeks for pregnancy and are used in almost two -thirds of abortion in the United States. In states where abortion is criminalized or very restricted, shipping drugs have become the main way to receive the procedure.

From the time when the Supreme Court has eliminated the constitutional right to abortion in Dobbs against Jackson Women’s Health Organization, the service providers in the states where abortion is legal, they claim that they sent over 10,000 abortion tablets per month to patients in these states.

Opponents of abortion turned to the administration to withdraw the rules that allow the tablets to be rewritten by teether meetings and sent by post. They claim that personal medical visits are necessary to protect patients. Such efforts are part of their mission to end all abortion. Over 100 scientific studies, conducted for decades, were found that the pills are safe and sound and rarely cause sedate complications.

Genbiopro, which produces only abortion drugs, controls about two -thirds of the drug market. The only other manufacturer of Mifepristone in the country, Danco Laboratories, is already called the defendant in the lawsuit.

“We are concerned about the attempts of extremists and special interests of undermining the American regulatory body for food and medicine,” said Evan Masingill, General Director of Genbiopro. “All people have the right to access safe and sound, inexpensive health care based on evidence, and Genbiopro remain involved in the utilize of all legal and regulatory tools to protect Mifepriston for millions of patients and suppliers throughout the country.”

Whether Mr. Trump takes action to limit the tablets remains unclear. During his presidential campaign last year he promised to leave the regulation of abortion to individual countries. After winning the White House, Mr. Trump said that this is “unlikely, very unlikely”, that he would allow additional steps to limit access to the abortion pill. But he refused to completely exclude the idea, telling the interviewer that people “feel demanding in both directions.” He faces intensive public and private pressure on the part of his party’s anti -abortion wing to criminalize drugs.

Senator Josh Hawley, a Republican from Missouri, said that he specially asked Mr. Trump in a private conversation to restore rules that require patients personally to pick up abortion drugs. This movement would seriously limit access to women in the United States with prohibitions of abortion.

“These requirements have never been controversial until Joe Biden decided that this is a good way to get around Dobbs,” Hawley said in an interview last month. “It is simple to restore personal dosing requirements and I hope that the administration will do it.”

The legal struggle for the pill began only a few months after Dobbs’ ruling, when the coalition of organizations dealing with the rights against abortion and doctors asked the court Texas to annul the approval by FDA tablets in 2000.

The Supreme Court finally rejected its argument, saying that the groups lacked the defendant’s legal position because they could not show evidence that the pills were hurt.

The latest lawsuit is a corrected and extended version of this case. Directly questions the approval of Genbiopro to the general Mifepriston, which was awarded in 2019, and aims at a wider range of principles aimed at increasing access to tablets.

The claim asks the court to prohibit medicines for each under 18 years of age, restore the requirements of a personal meeting, a fine that only doctors can prescribe tablets and reduce the ability of retail pharmacies, such as CV and Walgreens, to issue medicines.

The complaint also criticizes the provisions regarding the shield, which have been adopted in eight states that protect doctors and other healthcare providers who prescribe and send abortion tablets to patients in the United States with prohibitions or restrictions. Court lawsuits brought by conservatives in Louisiana and Texas question the protection offered by such provisions.

Instead of submitting a case in one of their home states, general prosecutors brought her before the judge Matthew J. Kacsmarka, from the American District Court for the Northern Texas district, appointed by Trump, who opposes access to abortion and who heard the original process.

In April 2023, Judge Kacsmaryk ruled in favor of anti -abortion groups, issuing a wide preliminary order, annuling the initial approval by FDA Mifepristone. His decision was finally rejected by the Supreme Court.