WASHINGTON, D.C. (April 21, 2023) – The Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President, General Counsel and Corporate Secretary, Jim Stansel, who leads PhRMA’s legal and regulatory advocacy teams, released the following statement today after the U.S. Supreme Court issued its latest decision in the U.S. Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine case:

“Today’s action by the Supreme Court is a welcome step. As we’ve said previously and explained in our amicus brief, Congress gave the FDA the authority to determine whether a medicine is safe and effective for patients to use. Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians. We will remain engaged to help ensure the concerns of our members are heard as the legal process unfolds.”