Our 25 organizations, representing patients with serious health conditions and providers who care for them, urge the Supreme Court to reverse the Fifth Circuit’s decision in Alliance for Hippocratic Medicine et al. v FDA et al. because it threatens patients’ and providers’ ability to rely on Food and Drug Administration (FDA) decisions about drug safety.
As explained in our amicus brief filed today, the ruling threatens the unique and critically important role of the FDA in ensuring Americans’ access to safe, effective drugs and treatments.
If the Supreme Court fails to reverse the ruling, patients may face dangerous, unnecessary barriers to a safe and effective FDA-approved drug or treatment. Moreover, a decision to uphold the lower court’s ruling sets a dangerous precedent that not only impacts access to the drug at the heart of this case but jeopardizes patients’ ability to rely on FDA approval of any drug or conditions of a drug’s use.
The Fifth Circuit’s ruling has created uncertainty about where the ultimate authority for decisions about drug safety rests in our country. As groups representing patients and providers, we firmly believe that authority must continue to sit with the medical and scientific experts at the FDA. Those experts, not judges, are best equipped to determine the safety and efficacy of drugs and medical treatments.
Patients and medical providers rely on the FDA’s oversight of approved drugs, and its subsequent modifications to FDA-approved uses, which often evolve as more clinical data become available. This science- and data-based evolution of drug use is essential to medical innovation. Any ruling that undermines or dilutes the authority of FDA experts in science and medicine to determine the safety and efficacy of drugs and treatments would be dangerous — and unprecedented.
We condemn the Fifth Circuit ruling in Alliance for Hippocratic Medicine et al. v FDA et al., and we unequivocally urge the Supreme Court to reverse that decision. 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.