{"id":33572,"date":"2025-03-01T20:32:51","date_gmt":"2025-03-01T20:32:51","guid":{"rendered":"https:\/\/cincinnatirighttolife.org\/?p=33572"},"modified":"2025-03-02T20:52:04","modified_gmt":"2025-03-02T20:52:04","slug":"abortion-pill-maker-enters-legal-fight-over-f-d-a-rules","status":"publish","type":"post","link":"https:\/\/cincinnatirighttolife.org\/abortion-pill-maker-enters-legal-fight-over-f-d-a-rules\/","title":{"rendered":"Abortion Pill Maker Enters Legal Fight Over F.D.A. Rules"},"content":{"rendered":"\n

By: Lisa Lerer, originally published February 25, 2025, The New York Times<\/a><\/em><\/strong><\/p>\n\n\n\n

The country\u2019s largest manufacturer of abortion pills is wading into the first major legal battle over abortion of President Trump\u2019s second term.<\/p>\n\n\n\n

The company, GenBioPro, on Tuesday asked a Texas court to add it to the list of defendants in a lawsuit filed in October by three Republican state attorneys general. The move was a significant offensive action on an issue seen as a vanguard in the fight over access to abortion.<\/p>\n\n\n\n

The lawsuit was\u00a0filed<\/a>\u00a0by the state attorneys general from Missouri, Idaho and Kansas, and asks a federal court to reverse a series of Food and Drug Administration regulations that have greatly expanded access to the abortion pill mifepristone.<\/p>\n\n\n\n

Under the Biden administration, the Justice Department defended the agency\u2019s rules and F.D.A.\u2019s approval of the medication 25 years ago. But many abortion rights advocates anticipate that the Trump administration will decline to defend the agency, effectively siding with the state attorneys general and using the case to limit access.<\/p>\n\n\n\n

If the judge grants GenBioPro\u2019s request, the maneuver will allow the company to lead the defense of mifepristone. The company is being represented by Democracy Forward, a legal nonprofit that has filed more than a dozen lawsuits and won multiple court orders against the Trump administration.<\/p>\n\n\n\n

\u201cThe foundation of these extreme politicians\u2019 arguments are purely political, rather than based in scientific evidence,\u201d said Skye Perryman, the president and chief executive of Democracy Forward. \u201cThe threat this case brings to abortion access nationwide cannot be understated.\u201d<\/p>\n\n\n\n

Abortion pills are prescribed up to 12 weeks into pregnancy and are used in nearly two-thirds of abortions in the United States. In states where abortion is criminalized or heavily restricted, mail-order medication has become the central way to receive the procedure.<\/p>\n\n\n\n

Since the Supreme Court eliminated the constitutional right to abortion in the 2022 case of Dobbs v. Jackson Women\u2019s Health Organization, health care providers in states where abortion is legal say they have sent\u00a0more than 10,000 abortion pills per month<\/a>\u00a0to patients in those states.<\/p>\n\n\n\n

Abortion opponents have asked the administration to roll back rules that allow the pills to be prescribed by telehealth appointments and sent through the mail. They argue that in-person medical visits are necessary to safeguard patients. Such efforts are part of their mission to end all abortions. More than 100 scientific studies, conducted over decades, have found the pills\u00a0to be safe<\/a>\u00a0and to rarely cause serious complications.<\/p>\n\n\n\n

GenBioPro, which manufactures only abortion medication, controls roughly two-thirds of the market for the drug. The only other mifepristone manufacturer in the country, Danco Laboratories, is already named as a defendant in the suit.<\/p>\n\n\n\n

\u201cWe remain concerned about extremists and special interests\u2019 attempts to undermine the U.S. Food and Drug Administration\u2019s regulatory authority,\u201d said Evan Masingill, the chief executive of GenBioPro. \u201cAll people have a right to access safe, affordable, evidence-based health care, and GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone for millions of patients and providers across the country.\u201d<\/p>\n\n\n

\n
\"\"<\/figure><\/div>\n\n\n

Whether Mr. Trump will take action to restrict the pills remains unclear. During his presidential campaign last year, he promised to leave abortion regulation to individual states. After winning the White House, Mr. Trump said it was \u201cunlikely, very unlikely\u201d that he would authorize additional steps to limit access to the abortion pill. But he refused to rule out the idea completely, telling an interviewer that people \u201cfeel strongly both ways.\u201d He faces intense public and private pressure from the anti-abortion wing of his party to criminalize the medication.<\/p>\n\n\n\n

Senator Josh Hawley, Republican of Missouri, said he specifically asked Mr. Trump in a private conversation to reinstate rules that require patients to pick up abortion medication in person. The move would severely curtail access for women in states with abortion bans.<\/p>\n\n\n\n

\u201cThose requirements were never controversial until Joe Biden decided that this was a good way to get around Dobbs,\u201d said Mr. Hawley in an interview last month. \u201cIt\u2019s an easy call to put the in-person dispensing requirement back in place, and I hope that the administration will do that.\u201d<\/p>\n\n\n\n

The legal fight over the pill began just months after the Dobbs ruling, when a coalition of anti-abortion rights organizations and doctors asked a Texas court to invalidate the F.D.A.\u2019s approval of the pill in 2000.<\/p>\n\n\n\n

The Supreme Court eventually rejected their argument, saying that the groups lacked legal standing to sue because they could not show evidence of being harmed by the pills.<\/p>\n\n\n\n

The latest lawsuit is a revised and expanded version of that case. It directly challenges GenBioPro\u2019s approval for generic mifepristone, which was granted in 2019, and takes aim at a wider range of rules intended to expand access to the pills.<\/p>\n\n\n\n

The lawsuit asks the court to outlaw the medication for anyone under 18, reinstate the in-person appointment requirement, mandate that only doctors can prescribe the pills and limit the ability of retail pharmacies, like CVS and Walgreens, to dispense the medication.<\/p>\n\n\n\n

The complaint also criticizes\u00a0shield laws<\/a>, which have been passed in eight states, that protect doctors and other health providers who prescribe and send abortion pills to patients in states with bans or restrictions. Lawsuits\u00a0brought by conservatives in Louisiana and Texas<\/a>\u00a0are challenging the protections offered by such laws.<\/p>\n\n\n\n

Rather than file the case in one of their home states, the state attorneys general brought it before Judge Matthew J. Kacsmaryk, of the U.S. District Court for the Northern District of Texas, a Trump appointee who\u00a0opposes abortion access<\/a>\u00a0and who heard the original lawsuit.<\/p>\n\n\n\n

In April 2023, Judge Kacsmaryk ruled in favor of the anti-abortion groups, issuing\u00a0a sweeping preliminary injunction<\/a>\u00a0invalidating the F.D.A.\u2019s initial approval of mifepristone. His ruling was eventually rejected by the Supreme Court.<\/p>\n\n\n\n

Lisa Lerer\u00a0is a national political reporter for The Times, based in New York. She has covered American politics for nearly two decades.<\/em><\/strong><\/p>\n\n\n\n

Image: Justin Rex\/Associated Press.<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

By: Lisa Lerer, originally published February 25, 2025, The New York Times The country\u2019s largest manufacturer of abortion pills is wading into the first major legal battle over abortion of President Trump\u2019s second term. The company, GenBioPro, on Tuesday asked a Texas court to add it to the list of defendants in a lawsuit filed…<\/p>\n","protected":false},"author":2,"featured_media":33574,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-33572","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"\nAbortion Pill Maker Enters Legal Fight Over F.D.A. 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