Pink Sheet
June 30, 2022

U.S. Supreme Court’s EPA Ruling Expected To Have Limited Impact on FDA Regulations (Pink Sheet)


Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say. William Jay, head of Goodwin's Appellate and Supreme Court Litigation practice who has represented clients in cases against the FDA, said the decision could impact the agency to the extent it moves into an area it hasn’t regulated before. “Any agency that does something like what EPA did here would run into the same reasoning,” he said. But the issue “will not come up in the drug, device and food context unless the agency were to regulate something really new.” Read the Pink Sheet article here.