WASHINGTON, D.C. (May 1, 2023) –Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed an amicus brief alongside other leading industry stakeholders in the U.S. Court of Appeals for the Fifth Circuit in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA).

“It is wrong for any court to replace the FDA’s expert scientific decision embodied in a drug approval with its own judgment. The FDA is authorized by Congress to evaluate the safety and efficacy of medicines – and the Agency is the gold standard for regulatory review. The district court’s ruling would upend the successful regulatory framework on which biopharmaceutical research and development depends,” said PhRMA Executive Vice President, General Counsel and Corporate Secretary Jim Stansel.

The brief largely focuses on two central arguments:

• First, the district court erred in replacing FDA’s scientific judgments with its own views on what information to consider and how to evaluate it. The district court further overstepped by imposing additional requirements not found in the statute. Specifically, the district court required that a medicine’s approved use conditions must match the supporting clinical trial conditions, and that a controlled clinical study and extra adverse event reporting must support modifications to Risk Evaluation and Mitigation Strategies (REMS). Importantly, Congress did not impose these requirements and for good reason: they run contrary to well-understood and accepted scientific methods and FDA’s proper use of its expertise.
• Second, the district court decision jeopardizes the certainty long afforded by FDA approval. The district court’s ruling makes it possible – if not probable – that any FDA approval decision for a medicine could be subject to unwarranted challenge in court. Under the district court’s reasoning, any health care provider could bring a lawsuit challenging any drug approval at any time, and a court could invalidate the approval without providing drugmakers the notice and hearing required by Congress as part of any suspension or withdrawal of an FDA approved drug.

For the complete filing, please see here.