On Jan. 29, 2020, the House Energy & Commerce Committee Subcommittee on Health held a hearing on multiple bills related to improving safety and transparency around food and medical products. Among the bills considered during the hearing was the Safeguarding Therapeutics Act (H.R. 5663). Introduced on Jan. 21, 2020 by Representatives Eliot Engel (D-N.Y.) and Brett Guthrie (R-Ky.), the legislation , which passed through the subcommittee markup March 11 without amendment, would also allow the Department of Health and Human Services (HHS) to destroy any drug or medical device valued at under $2,500 found to be counterfeit. The legislation would also allow HHS to promulgate regulations to ensure a system of due process for the medical product in question as well as an opportunity to submit testimony and appear before HHS officials concerning any potential destruction of a counterfeit device.
Medical products, including drugs and devices, make up the largest swath of the illicit trade market representing over $200 billion annually. Certain multi-national operations have worked to purge the market of counterfeit medical products and related websites, including a multi-year operation organized by Interpol that recovered over $50 million in counterfeit products across 123 countries and shut down over 3,500 related websites. Examples include the recall of $7 million of intra-aortic pumps due to counterfeit components, and, in the United States a series of lawsuits related to counterfeit spinal hardware in California in 2014. The legislation is seen as a positive step towards creating a more established response to counterfeit medical devices and their components. The legislation has not yet been considered by the full House Energy & Commerce Committee.
To date, heart valves have not been a target of counterfeiters but Heart Valve Voice US will remain vigilant to ensure patient safety.
