The Partnership for Safe Medicines (PSM) applauds the passage of H.R. 5663 – the Safeguarding Therapeutics Act. The bipartisan bill, introduced by Congressman Brett Guthrie (KY-02-R) and Congressman Eliot Engel (NY-16-D), was passed via unanimous consent in the Senate on December 8th.
Counterfeit medicines and medical supplies are not a new phenomenon. Over the years, PSM has witnessed individuals and criminal groups not only traffic in a wide array of counterfeit prescription medicines, but counterfeit medical supplies and devices, including counterfeit glucose tests, blood pressure cuffs and substandard syringes. While the United States Food and Drug Administration (FDA) may deny and/or destroy counterfeit medicines attempting to enter into the United States, they lack the authority to do so with counterfeit medical devices.
H.R. 5663 remedies this situation by amending 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 FDA the authority to destroy medical devices, worth $2,500 or less, they deemed counterfeit.
The COVID-19 pandemic highlighted the need to provide FDA counterfeit device destruction authority. Since the onset of the pandemic, U.S. law enforcement have been reporting a proliferation of shipments containing fake cures, vaccines and testing kits. As such, the passage of H.R. 5663 was urgently needed and more important than ever to ensure the FDA has the ability to prevent the entry of and destroy fake COVID-19 testing kits and other counterfeit devices before they get into the hands of an unsuspecting American public.
PSM believes that counterfeit medical devices are dangerous to American patients and that the FDA and other U.S customs authorities should have the unequivocal power to seize and destroy these dangerous products whether they are found in interstate commerce or in transit to enter America. Additionally, where the law is not clear, we support granting the FDA seizure and destruction authority to protect American patients from counterfeit medical devices in any venue it operates.
PSM strongly supported H.R. 5663 and thanks the Senate for recognizing the importance of, and passing, this vital bill before the cessation of the 116th Congress. We now call upon the White House to swiftly sign this key bill into law.