UPDATE: April 24, 2023 — 33 Patient and Provider Groups Applaud Supreme Court Ruling, Urge Courts to Preserve FDA’s Authority
Our 33 organizations, representing patients with serious health conditions, applaud the Supreme Court’s 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.
Unfortunately, the threat facing patients continues as the case of Alliance for Hippocratic Medicine et al. v FDA et al. 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.
Generations of Americans have trusted the FDA’s 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.
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’s decision.
April 11, 2023 — 33 Patient and Provider Groups Warn that Mifepristone Ruling Threatens All FDA-approved Drugs
WASHINGTON, D.C. – Our 33 organizations (updated 4/24/23), 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.
American Cancer Society Cancer Action Network
American Childhood Cancer Organization
American Kidney Fund
American Lung Association
American Society of Hematology
Association for Clinical Oncology
Asthma and Allergy Foundation of America
Cancer Support Community
Chronic Disease Coalition
Crohn’s & Colitis Foundation
Cystic Fibrosis Foundation
EveryLife Foundation for Rare Diseases
Friends of Cancer Research
Hemophilia Federation of America
Infusion Access Foundation
Lupus Foundation of America
National Coalition for Cancer Survivorship
National Health Council
National Multiple Sclerosis Society
National Organization for Rare Disorders
National Patient Advocate Foundation
National Psoriasis Foundation
Pulmonary Hypertension Association
RESOLVE: The National Infertility Association
Susan G. Komen
The Leukemia & Lymphoma Society
The Mended Hearts, Inc.