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.

• The Fifth Circuit faulted FDA for failing to rely on a controlled study when it modified the REMS requirements in 2016. However, no controlled study requirement exists in statute. Congress already has made clear FDA may require a REMS modification based on a number of factors, including to “minimize the burden on the health care delivery system.” The Fifth Circuit ruling misinterprets the REMS statute. 

• The Fifth Circuit criticized FDA for making a safety-related determination in 2021 based on the absence of non-fatal adverse event reports, citing the FDA’s 2016 decision to eliminate a REMS reporting requirement for health care providers. However, biopharmaceutical manufacturers are required to submit adverse event reports. Moreover, FDA maintains a reporting database for monitoring adverse event reports from multiple different sources — including these mandatory reports from biopharmaceutical manufacturers — as well as voluntary reports from health care professionals and patients.   

• The Fifth Circuit endorsed a sweeping theory of standing, or the ability to sue the FDA, which would seemingly permit doctors to challenge FDA-approval based on claims that they will at some point in the future treat patients for complications related to a drug. This could invite unlimited court challenges to FDA-approved medicines based on the mere possibility of future purported harms.

For the filing, please see here.