Senate bill targets FDA powers on fake medical devices

A bipartisan bill has been introduced in the Senate that seeks to protect the US public from counterfeit medical devices.

The Safeguarding Therapeutics Act was introduced this week and if passed would extend the powers of the FDA to seize and destroy “counterfeit medical devices and products, including vaccines and combination products like EpiPens,” according to its sponsors Senators Mike Enzi (R-Wyo), and Maggie Hassan (D-NH).

The legislation builds on the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which gave the FDA the ability to seize and destroy counterfeit drugs, but not medical devices.

It is a Senate companion to HR 5663, which was introduced by Representatives Brett Guthrie (R-KY) and Eliot Engel (D-NY) in January and 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,” said Enzi. “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,” added Hassan. “This bipartisan legislation to allow the FDA to destroy counterfeit medical products will protect public health and keep the American people safe.”