WASHINGTON, D.C. – U.S. Senators Tina Smith (D-MN) and Roger Marshall (R-KS) introduced bipartisan legislation to clarify the Food and Drug Administration’s (FDA) authority to regulate “combination products” – products that meet both the definition of drugs and devices. The bill would eliminate unnecessary confusion and turmoil in the industry and free up valuable time and resources within the FDA.
“Our regulatory process around medical products should be clear and transparent,” said Senator Smith. “This bipartisan legislation would help clarify the FDA’s authority to regulate things like sunscreen, eye drops, and other ‘combination products’ so the agency can focus on important work like bringing low-cost products to market and improving public health.”
“For decades, the FDA’s regulatory framework has provided appropriate oversight of drugs,” said Senator Marshall. “Unfortunately, this court decision has a far-reaching impact on the future of certain essential products physicians rely on to detect cancer, treat eye conditions, and more. I’m proud to join Senator Smith in introducing bipartisan legislation that reinforces the FDA’s longstanding processes that have made it a global leader in approving safe and effective medical products.”
The FDA has long taken the view that they have the discretion to regulate combination products including radioactive drugs, eye drops, and sunscreen as drugs. However, under a court decision – Genus Medical Technologies v. FDA – the agency is required to regulate these products as devices, which is a different and potentially more burdensome process. Transitioning to this new regulatory standard will take valuable time and resources away from other activities, like bringing low-cost products to market, that would have a more meaningful impact in lowering out-of-pocket costs, advancing public health, and improving patient outcomes.
Senators Smith and Marshall’s Consistent Legal Evaluation And Regulation of Medical Products Act (CLEAR Act) would clarify FDA’s authority to regulate certain combination products as drugs. This would ensure the FDA does not have to divert time and resources towards an unnecessary regulatory transition that does not benefit public health.
The CLEAR Act is endorsed by the American Academy of Ophthalmology, the Medical Imaging & Technology Alliance (MITA), GE Healthcare, the American Glaucoma Society, the American Society for Radiation Oncology, Lantheus Holdings, Giskit Pharma, Bracco Diagnostics, Glaukos, the American Society of Echocardiography, the Council on Radionuclides and Radiopharmaceuticals, and the American Society of Cataract and Refractive Surgery (ASCRS).
“We applaud Senator Smith and Senator Marshall for their leadership in introducing the Consistent Legal Evaluation and Regulation of Medical Products Act,” said David Glasser, M.D., secretary for Federal Affairs for the American Academy of Ophthalmology. “Restoring the strong regulatory framework for ophthalmic drugs that has been in place for 40 years will go a long way to ensure patients continue to have timely access to new ophthalmic treatments.”
“The American Society of Cataract and Refractive Surgery (ASCRS) is grateful to Senators Smith and Marshall for introducing the CLEAR Act (S. 4333),” said David F. Chang, M.D., ASCRS Executive Board member. “This legislation will maintain the safe and effective oversight of ophthalmic drugs and biologics that has existed at the FDA for nearly 40 years. Without this legislation, these ophthalmic products will be burdened with unnecessary and duplicative regulations that could stifle innovation and ultimately lead to higher costs for patients.”