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30 Patient and Provider Groups Warn that Mifepristone Ruling Threatens All FDA-approved Drugs

April 11, 2023

WASHINGTON, D.C. – Our organizations, representing patients with serious health conditions, condemn Judge Kacsmaryk’s 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, sets a dangerous precedent that erodes an institution critical to Americans having access to the care they need.

For decades, the FDA has ensured the safety of drugs and treatments in the United States. The FDA’s processes for assessing a drug’s or treatment’s 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 – not judges – are best equipped to determine the safety and efficacy of drugs and treatments.

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.

Generations of Americans have trusted the FDA’s expertise. If this judge’s ruling is allowed to stand, patients may no longer have the security of knowing that determinations about drug safety ultimately lie with the experts.

We support the FDA's role in safeguarding patients and urge the Fifth Circuit Court of Appeals to act swiftly to reverse the judge’s decision.

 

ALS Association

American Cancer Society Cancer Action Network

American Diabetes Association

American Kidney Fund

American Society of Hematology

Arthritis Foundation

Association for Clinical Oncology

Asthma and Allergy Foundation of America

CAL Rare (California Action Link for Rare Diseases)

Cancer Support Community

 CancerCare Chronic Disease Coalition

Crohn’s & Colitis Foundation

Cystic Fibrosis Foundation

Epilepsy Foundation

EveryLife Foundation for Rare Diseases

HealthyWomen

Lupus Foundation of America

Muscular Dystrophy Association

National Alliance on Mental Illness (NAMI)

National Coalition for Cancer Survivorship

National Health Council

National Hemophilia Foundation

National Multiple Sclerosis Society

National Organization for Rare Disorders

National Psoriasis Foundation

RESOLVE: The National Infertility Association

Susan G. Komen

The Mended Hearts, Inc.

The Leukemia & Lymphoma Society

WomenHeart  

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Media Contacts

Alissa Crispino
Senior Vice President, Advocacy Communications & Policy
Trista Hargrove
Director, Media Advocacy - Health Equity