WASHINGTON, D.C. – U.S. Sens. Mike Enzi, R-Wyo., and Maggie Hassan, D-N.H., have introduced legislation that would help protect patients from counterfeit medical products that could cause serious harm.
The Safeguarding Therapeutics Act would give the Food and Drug Administration authority to seize and destroy counterfeit medical devices and products, including vaccines and combination products like EpiPens. It is a Senate companion to legislation introduced by Reps. Brett Guthrie, R-Ky., and Eliot Engel, D-N.Y., which is included in the latest coronavirus relief package passed by the House.
“As we continue to combat the coronavirus pandemic, it is critical to ensure that vaccines, COVID-19 tests and other medical products are safe and reliable,” Enzi said in a news release. “This bill would allow the FDA to destroy counterfeit medical products that could be dangerous to patients while strengthening our health care supply chain at a time when we need it most.”
“Amid the COVID-19 pandemic, ensuring that people have access to safe and effective medical products is more essential than ever,” Hassan said. “This bipartisan legislation to allow the FDA to destroy counterfeit medical products will protect public health and keep the American people safe.”
This legislation builds on the 2012 Food and Drug Administration Safety and Innovation Act, which gave the FDA the ability to seize and destroy counterfeit drugs, but not medical devices.