WASHINGTON—U.S. Senator Chris Murphy (D-Conn.) and U.S. Senator Mike Braun (R-Ind.), both members of the U.S. Senate Health, Education, Labor and Pension Committee, on Thursday introduced bipartisan legislation to get counterfeit medical devices out of the domestic supply chain. Since the start of the pandemic, the Food and Drug Administration (FDA) has seen thousands of counterfeit devices including face masks, test kits and other personal protective equipment (PPE). While U.S. Customs and Border Patrol have seized more than 34 million counterfeit face masks and the FDA has new authorities to destroy imported counterfeit devices, some still make it into the United States. The Protecting Patients from Counterfeit Medical Devices Act takes the FDA’s existing authorities that crack down on counterfeit drugs and apply them to counterfeit medical devices.

“Anyone trying to sell fake medical devices—especially during a global pandemic—deserves to face the full consequences of the law. I’m glad to team up with my colleague from Indiana to get these dangerous devices out of our domestic supply chains and provide the FDA with the authority to crack down on counterfeit medical devices just as we crack down on counterfeit drugs,” said Murphy.

"The number of counterfeit medical devices have been on the rise during the pandemic, posing a serious risk to the safety and health of Americans. This legislation would bring greater protection for patients and consumers of medical devices by increasing enforcement penalties against fraudulent medical device manufacturers," said Braun.

The Protecting Patients from Counterfeit Medical Devices Act specifically:   

  • Raises the statutory cap for counterfeiting conduct from three years to ten years;
  • Raises the cap on sentencing from 36 months to up to 120 months, which would have a significant deterrent effect;
  • Allows FDA to present additional evidence at criminal trials to help successfully prosecute cases; and
  • Removes a requirement for an interstate commerce violation such that mere possession of a counterfeit device with intent to sell would be a criminal act under the Federal Food, Drug, and Cosmetic Act.

You can read more about the bill here.