{"id":124403,"date":"2023-04-11T15:26:41","date_gmt":"2023-04-11T19:26:41","guid":{"rendered":"https:\/\/rarediseases.org\/?p=124403"},"modified":"2023-04-24T15:58:17","modified_gmt":"2023-04-24T19:58:17","slug":"mifepristone-ruling-threatens-fda","status":"publish","type":"post","link":"https:\/\/rarediseases.org\/es\/mifepristone-ruling-threatens-fda\/","title":{"rendered":"Why the Mifepristone Ruling Threatens All FDA-Approved Drugs"},"content":{"rendered":"

UPDATE:<\/span> April 24, 2023 \u2014 33 Patient and Provider Groups Applaud Supreme Court Ruling, Urge Courts to Preserve FDA\u2019s Authority<\/h3>\n

Our 33 organizations, representing patients with serious health conditions, applaud the Supreme Court\u2019s decision to pause new restrictions that would have limited access to the FDA-approved drug mifepristone while litigation about the drug works its way through the courts.<\/p>\n

Unfortunately, the threat facing patients continues as the case of Alliance for Hippocratic Medicine et al. v FDA et al.<\/em> has been sent back to the lower court. The litigation jeopardizes access to FDA-approved medications and other treatments by shifting decisions about drug safety to judges. For the time being, however, patients will continue to have access to mifepristone and other FDA-approved drugs and treatments without court-imposed limitations.<\/p>\n

Generations of Americans have trusted the FDA\u2019s expertise which, over time, has yielded rigorous, science- and data-based approval of tens of thousands of lifesaving and life-changing medications for people with acute or chronic serious health conditions. Experts in science and medicine are best equipped to determine the safety and efficacy of drugs and treatments, and it is dangerous to eviscerate or dilute their authority.<\/p>\n

We strongly support the FDA’s role in safeguarding patients and urge the Fifth Circuit Court of Appeals to reverse the U.S. District Court\u2019s decision.<\/p>\n

Read our full statement here.<\/a><\/p>\n

 <\/p>\n

April 11, 2023 \u2014 33 Patient and Provider Groups Warn that Mifepristone Ruling Threatens All FDA-approved Drugs<\/h3>\n

WASHINGTON, D.C. \u2013 Our 33 organizations (updated<\/em> 4\/24\/23<\/em>), representing patients with serious health conditions, condemn Judge Kacsmaryk\u2019s decision which threatens to restrict access to a Food and Drug Administration (FDA)-approved medication and other treatments. We believe the ruling, in the case of Alliance for Hippocratic Medicine et al v FDA et al<\/em>, sets a dangerous precedent that erodes an institution critical to Americans having access to the care they need.<\/p>\n

For decades, the FDA has ensured the safety of drugs and treatments in the United States. The FDA\u2019s processes for assessing a drug\u2019s or treatment\u2019s benefits and risks are rigorous, involving extensive lab and clinic testing. The results are reviewed by experts in science and medicine before a drug or treatment is approved. Those experts \u2013 not judges \u2013 are best equipped to determine the safety and efficacy of drugs and treatments.<\/p>\n

This ruling sets in motion a process to block access to mifepristone, which is used in the treatment of several diseases, including cancer. However, the implications of this ruling go far beyond mifepristone. This decision risks emboldening other courts to block access to FDA-approved drugs and treatments for reasons having nothing to do with their safety or efficacy.<\/p>\n

Generations of Americans have trusted the FDA\u2019s expertise. If this judge\u2019s ruling is allowed to stand, patients may no longer have the security of knowing that determinations about drug safety ultimately lie with the experts.<\/p>\n

We support the FDA’s role in safeguarding patients and urge the Fifth Circuit Court of Appeals to act swiftly to reverse the judge\u2019s decision.<\/p>\n

Read our full statement here.<\/a><\/p>\n

American Cancer Society Cancer Action Network<\/em>
\nAmerican Childhood Cancer Organization<\/em>
\nAmerican Kidney Fund<\/em>
\nAmerican Lung Association<\/em>
\nAmerican Society of Hematology<\/em>
\nArthritis Foundation<\/em>
\nAssociation for Clinical Oncology<\/em>
\nAsthma and Allergy Foundation of America<\/em>
\nCancer Support Community<\/em>
\nCancerCare<\/em>
\nChronic Disease Coalition<\/em>
\nCrohn’s & Colitis Foundation<\/em>
\nCystic Fibrosis Foundation<\/em>
\nEpilepsy Foundation<\/em>
\nEveryLife Foundation for Rare Diseases<\/em>
\nFriends of Cancer Research<\/em>
\nHealthyWomen<\/em>
\nHemophilia Federation of America<\/em>
\nInfusion Access Foundation<\/em>
\nLupus Foundation of America<\/em>
\nNational Coalition for Cancer Survivorship<\/em>
\nNational Health Council<\/em>
\nNational Multiple Sclerosis Society<\/em>
\nNational Organization for Rare Disorders<\/em>
\nNational Patient Advocate Foundation<\/em>
\nNational Psoriasis Foundation<\/em>
\nPulmonary Hypertension Association<\/em>
\nResearch!America<\/em>
\nRESOLVE: The National Infertility Association<\/em>
\nSusan G. Komen<\/em>
\nThe Leukemia & Lymphoma Society<\/em>
\nThe Mended Hearts, Inc.<\/em>
\nWomenHeart<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

UPDATE: April 24, 2023 \u2014 33 Patient and Provider Groups Applaud Supreme Court Ruling, Urge Courts to Preserve FDA\u2019s Authority Our 33 organizations, representing patients with serious health conditions, applaud … <\/p>\n

Continue reading “Why the Mifepristone Ruling Threatens All FDA-Approved Drugs”<\/span><\/a><\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"categories":[232],"tags":[],"class_list":["post-124403","post","type-post","status-publish","format-standard","hentry","category-advocacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/124403","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/comments?post=124403"}],"version-history":[{"count":0,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/124403\/revisions"}],"wp:attachment":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/media?parent=124403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/categories?post=124403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/tags?post=124403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}