Two manufacturers of the abortion pill mifepristone asked the Supreme Court on Saturday to immediately restore full access to the medication, putting the contentious issue of abortion back before the justices in a midterm election year.<\/p>\n
The requests came after a lower court on Friday temporarily restricted abortion providers<\/a> nationwide from prescribing the pills by telemedicine and sending them to patients by mail. That process is one of the main ways women seeking abortions have obtained the medication in recent years.<\/p>\n If the order on Friday by a federal appeals court is upheld, it could sow confusion and upend a major avenue for abortion access across the country \u2014 not just in states with abortion bans. About one-fourth of abortions in the United States are now provided through telemedicine.<\/p>\n Louisiana officials had sued the Food and Drug Administration to restrict access to mifepristone, saying the availability of the medication by mail had allowed abortions to continue in the state despite its near-total ban on abortion.<\/p>\n A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit on Friday sided with Louisiana and essentially reimposed an F.D.A. requirement that health care providers prescribe mifepristone only after seeing patients in person. That rule was first lifted in 2021<\/a>. The Fifth Circuit ordered that in-person dispensing of mifepristone be reinstated until the Louisiana lawsuit made its way through the courts.<\/p>\n The manufacturers, Danco Laboratories and GenBioPro, are also defendants in the Louisiana lawsuit. On Saturday afternoon, Danco filed an emergency request asking the Supreme Court to lift the lower court\u2019s order, which applied to patients across the country. GenBioPro filed a similar request Saturday evening.<\/p>\n \u201cThe Supreme Court must reject this unfounded and baseless attack on an essential medication,\u201d GenBioPro\u2019s chief executive, Evan Masingill, said on Saturday, adding: \u201cWe remain concerned that anti-abortion special interests are attempting to undermine the U.S. Food and Drug Administration\u2019s regulatory authority. This is why we are bringing our fight to the Supreme Court.\u201d<\/p>\n In its filing, GenBioPro said that \u201cpatients and clinicians have, for years, relied on dispensing mifepristone without an in-clinic visit, particularly for women from rural areas and those for whom transportation, child care or occupational constraints make it difficult to see providers in person.\u201d<\/p>\n It said that the Fifth Circuit\u2019s order \u201cis deeply unsettling to drug sponsors, health care providers, patients and the public \u2014 all of whom rely on F.D.A.\u2019s exercise of scientific judgment and orderly administration of the Nation\u2019s complex system of drug regulation.\u201d<\/p>\n In its filing, Danco said the Fifth Circuit\u2019s ruling \u201cinjects immediate confusion and upheaval into highly time-sensitive medical decisions,\u201d and requires Danco, providers, patients and pharmacies \u201call to guess at what is allowed and what is not.\u201d<\/p>\n In a motion filed on Friday night asking the Fifth Circuit to pause its order, Danco said that the ruling would cause \u201cchaos.\u201d The court had not responded to the request by Saturday evening.<\/p>\n The Trump administration has defended the F.D.A. in court, but has not said in this case, or in public statements, whether it supports keeping in place the regulations that allow for pills to be mailed. Rather, it has said that the F.D.A. is conducting a review of mifepristone. It has also asked the court to delay the lawsuit proceedings until that review is complete.<\/p>\n Administration officials recently told The New York Times that the review would not be finished until the end of this year, a time frame that would fall after the midterm elections.<\/p>\n The mifepristone case puts the Trump administration in a politically tricky position, given that many of President Trump\u2019s supporters oppose abortion. The Justice Department has not responded to requests for comment about whether it would appeal to the Supreme Court.<\/p>\n On Saturday, a spokesman for the Department of Health and Human Services, which oversees the F.D.A., declined to comment, citing \u201congoing litigation.\u201d<\/p>\n Following the Supreme Court\u2019s decision in 2022 to eliminate the nationwide right to abortion, Republican-led states like Louisiana imposed strict bans on abortion. In response, many Democratic-led states passed shield laws that protect abortion providers who prescribe pills by telemedicine and send them to patients in states with abortion bans.<\/p>\n Nearly two-thirds of abortions in the United States are now carried out with abortion pills, typically used through the first 12 weeks of pregnancy. The medication abortion regimen usually involves taking mifepristone, which blocks a hormone necessary for pregnancy to continue, followed 24 to 48 hours later by a second medication, misoprostol, which causes contractions similar to a miscarriage. The Louisiana case targets mifepristone, which the F.D.A. approved for abortion in 2000. Misoprostol, which is also used for other medical conditions, is not affected by the Fifth Circuit ruling. <\/p>\n During the coronavirus pandemic, the F.D.A. lifted its requirement that patients visit a medical provider in person to obtain mifepristone. That decision was made permanent in 2023 and led to the creation of numerous telemedicine abortion services.<\/p>\n Louisiana has claimed in its lawsuit that the F.D.A.\u2019s decision to remove the in-person dispensing requirement was based on inadequate or flawed data \u2014 an assertion medical organizations dispute, pointing to more than 100 studies<\/a> that have found that mifepristone is safe, and that serious complications from taking it are rare.<\/p>\n In addition, Louisiana said that the regulations had resulted in numerous illegal abortions in the state, and that it had paid thousands of dollars in Medicaid bills for women harmed by mifepristone.<\/p>\n In its Supreme Court filing, GenBioPro said Louisiana\u2019s \u201cnarrative is demonstrably false,\u201d adding that the F.D.A.\u2019s regulation change allowing telemedicine prescribing and pills by mail \u201cdoes not require anyone to prescribe mifepristone, require anyone to dispense mifepristone or prevent Louisiana from creating or enforcing its abortion prohibitions. It simply removes a federal in-person dispensing requirement.\u201d<\/p>\n In April, a district court judge in Louisiana said the state was likely to win its challenge to the regulation, but declined to pause the availability of pills by mail. Instead, the judge gave the F.D.A. time to complete the safety review of mifepristone.<\/p>\n In its ruling Friday, the Fifth Circuit sided with Louisiana, echoing the state\u2019s arguments that the F.D.A.\u2019s regulations were \u201cundermining its laws protecting unborn human life\u201d and also \u201ccausing it to spend Medicaid funds on emergency care for women harmed by mifepristone,\u201d according to the order written by Judge Stuart Kyle Duncan, a Trump appointee. He was joined by Judge Kurt D. Engelhardt, another Trump appointee, and Judge Leslie Southwick, an appointee of President George W. Bush.<\/p>\n Other litigation over access to abortion medication has been making its way through the federal courts.<\/p>\n In 2024, the Supreme Court declined to limit access to mifepristone in a case brought by anti-abortion doctors and groups that sought to have its approval revoked. The court unanimously sided with the Biden administration and the manufacturer of mifepristone, and said the plaintiffs did not have legal grounds to bring the challenge.<\/p>\n The case was revived later that year<\/a>, and is pending before a federal court in Missouri<\/a>. Another similar case was filed against the F.D.A. last year by Texas and Florida<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Two manufacturers of the abortion pill mifepristone asked the Supreme Court on Saturday to immediately restore full access…\n","protected":false},"author":2,"featured_media":217956,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[39],"tags":[85962,1452,54296,85963,17074,81829,85964,9,24,63,134,136,135,17080,68592,1069,1876],"class_list":["post-218001","post","type-post","status-publish","format-standard","has-post-thumbnail","category-staten-island","tag-danco-laboratories","tag-donald-j","tag-drugs-pharmaceuticals","tag-duncan","tag-federal-courts-us","tag-food-and-drug-administration","tag-kyle-1972","tag-new-york","tag-new-york-city","tag-nyc","tag-staten-island","tag-staten-island-headlines","tag-staten-island-news","tag-supreme-court-us","tag-telemedicine","tag-trump","tag-united-states-politics-and-government"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts\/218001","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/comments?post=218001"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts\/218001\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/media\/217956"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/media?parent=218001"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/categories?post=218001"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/tags?post=218001"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}