WASHINGTON, June 11 Christopher White, executive vice president and general counsel for the Advanced Medical Technology Association (AdvaMed), released the following statement regarding today's hearing at the Senate Judiciary Committee on the Food and Drug Administration's (FDA) federal preemption authority for certain medical devices approved through the agency's pre-market approval (PMA) process.
"More than 30 years ago, Congress approved a science-based approach to the regulation of medical devices. It decided the safety and effectiveness of medical devices should be determined by the scientists at the FDA rather than by an inconsistent patchwork of state regulations.
"Since 1976, the FDA's comprehensive PMA process, which subjects medical devices to the most rigorous scrutiny at every stage of development and marketing from clinical studies to real-world clinical use, has enabled patients to benefit from improved health outcomes and enhanced quality of life due to these life-saving technologies.
"Allowing state court lay juries to serve as secondary regulatory bodies would interfere with FDA's extensive oversight of medical devices, delay or deny patient access to life-saving treatments and increase the costs to the health care system.
"The Supreme Court's 8-1 decision in Riegel v. Medtronic re-affirmed the two previous lower court rulings in this case, consistent with a 30-year history of jurisprudence, and once again made clear that the Medical Device Amendments to the Federal Food Drug and Cosmetic Act expressly provide for FDA's ultimate regulatory authority in these matters.
"While Riegel addresses clear express preemption for PMA device approvals, Supreme Court Justice Stephen Breyer had it right when he queried in an earlier case related to implied preemption for drugs. To quote Justice Breyer: 'Now, who would you rather have make that decision as to whether a drug is on balance, going to save people or, on balance, going to hurt people? An expert agency, on the one hand, or 12 people pulled randomly for a jury roll who see before them only the people the drug hurt and don't see those people who need the drug to cure them?'"