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, secured inclusion of their bill to get counterfeit medical devices out of the domestic supply chain in the broader bipartisan pandemic response package released by Chairman Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.).

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) enter the market. 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 extends the FDA’s existing authority to crack down on counterfeit drugs to counterfeit medical devices.

“Getting counterfeit medical devices off the marketplace is essential to our COVID-19 response. I’m glad to see HELP Committee leadership prioritize our legislation to bring the full weight of the law against fraudulent actors trying to exploit the pandemic for personal gain. This will help us get fake N95s and the like out of our domestic supply chains,” said Murphy.

“We must take swift action against the prevalence of counterfeit medical devices being sold in the marketplace by unscrupulous vendors. Our bill would amend the Food, Drug, and Cosmetic Act to raise the sentencing cap on these crimes and create the tools to tackle these counterfeit medical devices in American supply chains,” said Braun.

The Protecting Patients from Counterfeit Medical Devices Act specifically:  

·       Raises the cap on sentencing from 36 months 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.

 

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