WASHINGTON, D.C. (April 14, 2023) – The Pharmaceutical Research and Manufacturers of America (PhRMA) today filed an amicus brief with the U.S. Supreme Court in the U.S. Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine case.
Arguing in support of the FDA, the PhRMA brief supports the U.S. Fifth Circuit Court of Appeals’ (Fifth Circuit) decision to leave in place the 2000 FDA approval at issue in the district court. Importantly, the amicus brief also argues the Fifth Circuit should also have left in place the other challenged actions, including the 2016 FDA-approved changes to the relevant risk evaluation and mitigation strategy (REMS).
“Our brief aims to protect the FDA’s long-standing authority to determine whether a medicine is safe and effective for people to use, as Congress has authorized them to,” said Jim Stansel, who leads PhRMA’s legal and science and regulatory advocacy teams as Executive Vice President, General Counsel and Corporate Secretary. “By allowing the courts to substitute their own opinion for the FDA’s, biopharmaceutical manufacturers, prescribers and patients would all face significant uncertainty. At a time when medical innovation has never been more promising, it is vital we have a legal and policy environment that fosters the development of new treatments and protects patients’ access to innovative medicines.”
PhRMA’s amicus brief focuses on three concerns that, if unchanged, could have significant negative consequences for patients and the biopharmaceutical industry’s ability to bring new treatments and cures to patients.
For the filing, please see here.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Over the last decade, PhRMA member companies have more than doubled their annual investment in the search for new treatments and cures, including nearly $101 billion in 2022 alone.