Patient and Provider Groups Continue to Urge Courts to Preserve FDA’s Authority

UPDATE: WASHINGTON, D.C. (April 5, 2024) — On March 26, 2024, the U.S. Supreme Court heard oral arguments in a critical case related to the Food and Drug Administration’s (FDA) authority in the drug review and approval process. The case revolves around challenges to the FDA’s responsibility to determine the safety and efficacy of new drugs before they are marketed publicly. 

Preserving the FDA’s authority is crucial to ensuring that medications are not only effective but also safe for patient use. The FDA’s comprehensive review process plays a vital role, and an erosion of this authority may make it harder for patients and providers to access the medications they need or compromise trust in the safety of those products. The established regulatory framework is essential to maintaining high health and safety standards, as well as support for the level of credibility and reliability of the health care system overall. 

The Arthritis Foundation filed an amicus brief, along with several other patient and provider organizations, to provide information on how patients would be affected by a decision, and we encouraged the Supreme Court to reverse the lower court’s decision. We anticipate a final ruling in early summer. 

UPDATE: WASHINGTON, D.C. (January 30, 2024) — The Arthritis Foundation strongly urges the U.S. Supreme Court to reverse the Fifth Circuit Court’s decision in Alliance for Hippocratic Medicine et al. v FDA et al. This decision could jeopardize the Food and Drug Administration’s authority and make it harder for patients and providers to rely on FDA determinations about drug safety and effectiveness.
 
The Arthritis Foundation, along with several other organizations that represent people with serious medical conditions and health care professionals, filed an amicus brief Jan. 30, 2024, asking the Supreme Court to reverse the lower court’s decision. This legal matter could affect access to and trust in FDA-approved medications and treatments by giving judges more say in deciding if drugs are safe.

Generations of Americans have trusted the FDA’s expertise to proceed with lifesaving care and treatment. For the health and safety of patients, we urge the Supreme Court to act in their interest and preserve the authority of the Food and Drug Administration.

UPDATE: WASHINGTON, D.C. (September 6, 2023) — A 3-judge panel of the Fifth Circuit Federal Court of Appeals upheld (in part) a lower court’s decision that found that the FDA used an improper process to approve mifepristone back in 2000. This decision does not revoke the FDA’s approval of the drug. It remains available. Due to the U.S. Supreme Court’s April order, mifepristone will remain available until the final decision is determined presumably by the U.S. Supreme Court at some point probably next year. If it is upheld by SCOTUS, the Biden Administration is very likely planning to appeal. (The medication would still be approved but only in the form it was FDA-approved before 2016.)

WASHINGTON, D.C. (April 24, 2023) – 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.
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