{"id":7742,"date":"2023-03-16T06:21:46","date_gmt":"2023-03-16T11:21:46","guid":{"rendered":"https:\/\/ustower.net\/?p=7742"},"modified":"2023-03-16T06:21:50","modified_gmt":"2023-03-16T11:21:50","slug":"long-used-american-abortion-pills-are-threatened-in-texas-lawsuits","status":"publish","type":"post","link":"https:\/\/ustower.net\/?p=7742","title":{"rendered":"Long-used American abortion pills are threatened in Texas lawsuits"},"content":{"rendered":"\n

A federal judge in Texas raised questions Wednesday about a Christian group\u2019s effort to overturn the decades-old U.S. approval of a leading abortion drug, in a case that could threaten the country\u2019s most common method<\/a> for ending pregnancies.<\/p>\n\n\n\n

Judge Matthew Kacsmaryk heard more than four hours of debate over the Alliance Defending Freedom\u2019s request to revoke or suspend the Food and Drug Administration\u2019s approval<\/a> of mifepristone. Such a step would be an unprecedented challenge to the FDA and its authority in deciding which drugs to permit on the market.<\/p>\n\n\n\n

Kacsmaryk said he would rule \u201cas soon as possible,\u201d without giving any clear indication of how he might decide and leaving open the possibility that the standard regimen for medication abortions might soon be curtailed throughout the country.<\/p>\n\n\n\n

Mifepristone, when combined with a second pill, was approved in 2000 and is used to end pregnancies until their 10th week. It has been increasingly prescribed since last summer\u2019s U.S. Supreme Court ruling overturning Roe v. Wade.<\/a><\/p>\n\n\n\n

The Texas lawsuit<\/a> has become the latest high-stakes legal battle over access to abortion since the question of its legality was returned to the states.<\/p>\n\n\n\n

Kacsmaryk, who was appointed by former president Donald Trump, saved some of his most pointed questions for attorneys representing the conservative group, which filed its lawsuit in Amarillo in anticipation of receiving a favorable ruling.<\/p>\n\n\n\n

\u201cExplain to me why this court has that sweeping authority?\u201d Kacsmaryk asked, in reference to the group\u2019s request for a preliminary order pulling mifepristone from the market.<\/p>\n\n\n\n

The judge also questioned whether the group had the legal standing to obtain a pretrial ruling on the drug, grilling both sides on U.S. Supreme Court cases that set out when such extraordinary relief is allowed.<\/p>\n\n\n\n

Still, the judge also posed questions suggesting he was considering how he might draft a preliminary injunction in the plaintiffs\u2019 favor, at one point asking the alliance\u2019s lawyers if the issue of standing had been addressed by appellate courts. At another point, he told them that their outline for the order of their arguments \u201ctracks the elements for an injunction nicely.\u201d<\/p>\n\n\n\n

Lawyers representing the FDA argued that pulling mifepristone would upend reproductive care for women across the U.S.<\/p>\n\n\n\n

\u201cAn injunction here would interfere with the interests of every state in the country\u201d said Julie Straus Harris of the U.S. Justice Department, which represented the FDA.<\/p>\n\n\n\n

Straus Harris and her colleagues also questioned whether the alliance \u2014 which filed its case on behalf of several anti-abortion doctors \u2014 had standing to bring the lawsuit, given that none of the plaintiffs could show the type of harm typically needed for such a legal action.<\/p>\n\n\n\n

One of the chief arguments leveled against the FDA in the case is that the agency misused its authority when it originally approved mifepristone.<\/p>\n\n\n\n

The FDA reviewed the pill under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it has been used to expedite drugs for cancer and other \u201cserious or life-threatening diseases.\u201d<\/p>\n\n\n\n

\u201cThe plain text is clear it applies to illnesses,\u201d argued Erik Baptist, the alliance\u2019s lead attorney. \u201cMifepristone is used to end pregnancies, and pregnancy isn\u2019t an illness.\u201d<\/p>\n\n\n\n

The FDA rejected the group\u2019s argument on multiple accounts. First, attorneys said FDA regulations make clear that pregnancy is considered a \u201cmedical condition\u201d that can be serious and life-threatening in some cases.<\/p>\n\n\n\n

Second, government attorneys said the terms of mifepristone\u2019s use were replaced more than a decade ago by subsequent FDA programs created by Congress, rendering the argument irrelevant.<\/p>\n\n\n\n

Finally, while the FDA reviewed the drug under its accelerated approval regime, it didn\u2019t expedite the drug\u2019s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone.<\/p>\n\n\n\n

Legal experts have been deeply skeptical of many of the arguments made by the alliance. And there is essentially no precedent for a lone judge overruling an FDA drug approval decision.<\/p>\n\n\n\n

At one point, Kacsmaryk asked the alliance\u2019s attorneys about the possibility of suspending mifepristone\u2019s approval, without withdrawing it completely.<\/p>\n\n\n\n

\u201cAny relief you grant must be complete\u201d and apply nationwide, Baptist said. \u201cThe harms of these abortion drugs know no bounds.\u201d<\/p>\n\n\n\n

Kacsmaryk gave each side two hours to make their arguments \u2014 with time for rebuttal \u2014 in the high-stakes case<\/a>. Mifepristone\u2019s manufacturer, Danco Laboratories, joined the FDA in arguing to keep the pill available.<\/p>\n\n\n\n

A ruling could come at any time. A decision against the drug would be swiftly appealed by the Justice Department, which would also likely seek an emergency stay to stop it from taking effect while the case proceeds.<\/p>\n\n\n\n

Members of the Women\u2019s March advocacy group rallied outside the courthouse, including one person dressed as a kangaroo to decry the proceedings as a \u201ckangaroo court.\u201d<\/p>\n\n\n\n

Ultimately, courthouse officials allowed 20 members of the media and 20 members of the general public to attend the hearing.<\/p>\n\n\n\n

If Kacsmaryk rules against the FDA, it\u2019s unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberations, which can take months or years.<\/p>\n\n\n\n

If mifepristone is sidelined, clinics and doctors that prescribe the combination say they would switch to using only misoprostol, the other drug used in the two-drug combination<\/a>. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies but is widely used in countries where mifepristone is illegal or unavailable.<\/p>\n\n\n\n

In addition to challenging mifepristone\u2019s approval process, the lawsuit takes aim at several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement<\/a> that women pick it up in person.<\/p>\n\n\n\n

Apnews<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

A federal judge in Texas raised questions Wednesday about a Christian group\u2019s effort to overturn the decades-old U.S. approval of a leading abortion drug, in a case that could threaten the country\u2019s most common method for ending pregnancies. Judge Matthew Kacsmaryk heard more than four hours of debate over the Alliance Defending Freedom\u2019s request to revoke or suspend […]<\/p>\n","protected":false},"author":7,"featured_media":7743,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1154],"tags":[3548,2381,3043,1298],"class_list":["post-7742","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-trending","tag-abortion-pill","tag-ban","tag-fda","tag-texas"],"_links":{"self":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/7742","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7742"}],"version-history":[{"count":1,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/7742\/revisions"}],"predecessor-version":[{"id":7744,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/7742\/revisions\/7744"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/media\/7743"}],"wp:attachment":[{"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}