H.R. 5663 would extend the Food and Drug Administration’s (FDA) authority to destroy certain imported products (known as administrative destruction authority) to include medical devices. Administrative destruction authority allows FDA to destroy certain imports when FDA believes such products are adulterated, misbranded, or unapproved and may pose a threat to public health. Under current law, FDA's destruction authority is limited to counterfeit drugs imported into the United States that are valued at $2,500 or less.
Based on information provided by FDA, CBO projects that about five full-time equivalent positions at an average cost of $300,000 each would be required each year to revise regulations, expand the agency’s capacity to investigate counterfeit device cases, and exercise its administrative destruction authority. In total, CBO estimates that implementing H.R. 5663 would cost $7 million over the 2021-2025 period, reflecting both increased staffing and contracting expenses. Such spending would be subject to the availability of appropriated funds.
Following the implementation of the H.R. 5663, a reduced volume of counterfeit device imports may result in lower collections of customs duties. CBO expects any change in revenues to be insignificant.
