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:
For the complete 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.