{"id":666,"date":"2024-03-27T12:04:50","date_gmt":"2024-03-27T12:04:50","guid":{"rendered":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/27\/supreme-court-medication-abortion-case-threatens-seismic-shift-in-fda-drug-approval-process-experts-warn\/"},"modified":"2024-03-27T12:04:50","modified_gmt":"2024-03-27T12:04:50","slug":"supreme-court-medication-abortion-case-threatens-seismic-shift-in-fda-drug-approval-process-experts-warn","status":"publish","type":"post","link":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/27\/supreme-court-medication-abortion-case-threatens-seismic-shift-in-fda-drug-approval-process-experts-warn\/","title":{"rendered":"Supreme Court medication abortion case threatens \u2018seismic shift\u2019 in FDA drug approval process, experts warn"},"content":{"rendered":"
\n

In 1937, a drugmaker called S.E. Massengill Co. came up with what seemed like an improvement on an effective medicine <\/strong>for sore throats: a liquid formulation that tasted like raspberry. <\/p>\n

The only problem: The new formulation of the drug, called sulfanilamide, used diethylene glycol, which is essentially poison. More than 100 people, many of them children, died after taking it. <\/p>\n

The company didn\u2019t know that diethylene glycol would be so dangerous, but it hadn\u2019t been required to run toxicity studies before releasing a new product, and so it hadn\u2019t done so, according to a US Food and Drug Administration account of the disaster. <\/p>\n

The deaths led Congress the next year to pass the Federal Food, Drug and Cosmetic Act, which empowered the FDA to require drugs to be proven safe before they can be marketed. In 1962, Congress further expanded the FDA\u2019s authority after the drug thalidomide was shown to cause severe birth defects \u2014 this time, to require that drugs be proven effective. <\/p>\n

That dual mandate, in place for more than 60 years, has created a trusted drug approval process that could be upended by a case about the medication abortion drug mifepristone that\u2019s being argued Tuesday in front of the US Supreme Court, according to doctors, former FDA commissioners, legal scholars, and pharmaceutical industry executives and investors. <\/p>\n

\u201cIf the court ends up \u2026 ruling in any way in favor of the plaintiffs, it says that basically, anybody who may be ideologically opposed to medication approved by the FDA could try to go to court and overrule the scientific determination of the experts,\u201d said\u00a0Dr. Daniel Grossman, a professor at the University of California San Francisco and director of the university\u2019s Advancing New Standards in Reproductive Health program. <\/p>\n

The case at hand Tuesday focuses on mifepristone, one of two medicines in a regimen used for medication abortion \u2014 which accounted for 63% of abortions in the US <\/strong>in 2023, according to data from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health. <\/p>\n

Last year, a district court judge in Texas agreed with the plaintiffs, a group of doctors opposed to abortion, that the FDA inappropriately approved mifepristone in 2000 and expanded how it could be used starting in 2016. <\/p>\n

That decision would have removed mifepristone from the market, but the ruling was stayed as an appeals process began; the US 5th Circuit Court of Appeals found that the 2000 approval was too long ago to be overturned but agreed with the challenges to the expansions to the approval that began in 2016. <\/p>\n

If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. <\/p>\n

\u201cThat would be a significant change and restriction on access,\u201d Grossman said. <\/p>\n

But the prospects of a broader undermining of the FDA\u2019s authority, he and others argue, is also on the line. <\/p>\n

In addition to opening up any drug to challenges on ideological grounds, weakening the FDA\u2019s authority could enable challenges from drug companies trying to remove a competitor\u2019s product or to reverse the agency\u2019s judgment about their own rejection, a group of former FDA commissioners wrote in a friend-of-the-court legal brief. <\/p>\n

\u201cThis new paradigm would take a significant toll on public health,\u201d they wrote. <\/p>\n

The pharmaceutical industry and its investors also warned that a shakier regulatory system could lead to less investment in developing new medicines. <\/p>\n

\u201cBiopharmaceutical research and development is expensive, time consuming, and risky,\u201d the Pharmaceutical Research and Manufacturers of America, or PhRMA, wrote in a brief. \u201cNevertheless, drug developers invest in new medicines because, if their investments succeed, FDA\u2019s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. <\/p>\n

\u201cIf endorsed by this Court,\u201d PhRMA continued, \u201cthe Fifth Circuit\u2019s attenuated standing analysis threatens to subject every drug approval and later action to a substantial risk of litigation, reducing revenues that drive investment and thereby diminishing the incentives to innovate in the first place.\u201d <\/p>\n

A separate brief from pharmaceutical companies, executives and investors warned of a \u201cseismic shift in the clinical development, drug approval, and post-approval processes\u201d if the Supreme Court allows the appeals court\u2019s decision to stand. <\/p>\n

\u201cThis additional uncertainty would make the already high degree of risk in these investments intolerable,\u201d they wrote. \u201cAnd without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.\u201d <\/p>\n

Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. <\/p>\n

GenBioPro, which manufactures the generic version of mifepristone, said in its own friend-of-the-court brief that the company wouldn\u2019t be able to sell the drug until it made \u201csignificant changes to its product and marketing practices that would be necessary to comply with the pre-2016 conditions and obtain FDA approval of those changes.\u201d <\/p>\n

\u201cAcross all of GenBioPro\u2019s current customers and partners, the Fifth Circuit\u2019s opinion creates a cloud of uncertainty over the legal status of existing inventory, especially inventory in the hands of distributors, dispensers, and patients,\u201d the company said. \u201cThe utterly unprecedented nature of court-ordered changes to an approved drug label and products that are already in the stream of commerce threatens confusion and turmoil for all entities that purchase, distribute, prescribe, and use mifepristone.\u201d <\/p>\n

\n
    <\/ul>\n<\/div>\n

    Cohen said that he expected the court to \u201cthrow out the case\u201d because the plaintiffs lack standing to challenge the FDA\u2019s decisions to expand access but that if the court instead upholds the appeals court decision, the FDA could seek to essentially redo the process of broadening access to the medicine. But, he said, it could be an uphill battle, and the agency\u2019s willingness to do so could depend on the outcome of the US presidential election. <\/p>\n

    \u201cIt is both my hope and my \u2018bet\u2019 that the court doesn\u2019t uphold the 5th Circuit on the standing argument,\u201d Cohen wrote. \u201cBut I have learned the Supreme Court is hard to predict much of the time.\u201d <\/p>\n<\/p>\n

    This post appeared first on cnn.com<\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"

    In 1937, a drugmaker called S.E. Massengill Co. came up with what seemed like an improvement on an effective medicine for sore throats: a liquid formulation that tasted like raspberry. The only problem: The new formulation of the drug, called sulfanilamide, used diethylene glycol, which is essentially poison. More than 100 people, many of them …<\/p>\n","protected":false},"author":1,"featured_media":667,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"loftocean_post_primary_category":0,"loftocean_post_format_gallery":"","loftocean_post_format_gallery_ids":"","loftocean_post_format_gallery_urls":"","loftocean_post_format_video_id":0,"loftocean_post_format_video_url":"","loftocean_post_format_video_type":"","loftocean_post_format_video":"","loftocean_post_format_audio_type":"","loftocean_post_format_audio_url":"","loftocean_post_format_audio_id":0,"loftocean_post_format_audio":"","loftocean-featured-post":"","loftocean-like-count":0,"loftocean-view-count":547,"tinysalt_single_post_intro_label":"","tinysalt_single_post_intro_description":"","tinysalt_hide_post_featured_image":"","tinysalt_post_featured_media_position":"","tinysalt_single_site_header_source":"","tinysalt_single_custom_site_header":"0","tinysalt_single_custom_sticky_site_header":"0","tinysalt_single_custom_sticky_site_header_style":"sticky-scroll-up","tinysalt_single_site_footer_source":"","tinysalt_single_custom_site_footer":"0","footnotes":""},"categories":[35],"tags":[],"class_list":["post-666","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/666","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/comments?post=666"}],"version-history":[{"count":0,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/666\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media\/667"}],"wp:attachment":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media?parent=666"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/categories?post=666"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/tags?post=666"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}