H.R. 5663, the Safeguarding Therapeutics Act, passes the House E & C Committee with full support

Low angled view of the U.S. Capitol East Facade Front in Washington, DC.

July 15, 2020 – Today, H.R. 5663, the Safeguarding Therapeutics Act, was marked up and passed favorably out of the full House Energy and Commerce Committee.

The markup included a minor technical amendment to the bill to define “counterfeit device,” which mirrors the definition of “counterfeit drugs” already defined by current law.

The bi-partisan bill, introduced by Rep. Brett Guthrie (R-KY) and Rep. Eliot Engel (D-NY), would amend the federal Food, Drug and Cosmetic Act to add “counterfeit device” to the list of items that can be refused entry into the United States. Additionally, the bill provides the Food and Drug Administration (FDA) the authority to destroy medical devices worth $2,500 or less that they deem counterfeit. While the FDA has the current authority to destroy counterfeit medicines, they lack the authority to destroy counterfeit medical devices. H.R. 5663 would remedy this oversight.

PSM applauds the House Energy and Commerce Committee for its unanimous support of H.R. 5663, and urges the swift passage of H.R. 5663 by the full House.