In 2013, US Customs & Border Protection seized more than 2,350 parcels containing counterfeit medical devices and pharmaceutical products valued at $83 million, according a new report from the U.S. Department of Homeland Security. Over the past two years, US and European governments have passed legislation and introduced regulations that would help protect global supply chains. This paper discusses the implications of each, along with processes for securing pharmaceutical and medical device supply chains.
FDA Legislation – Supply Chain Security Background
In the fall of 2013, the US Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fee amendments paid by manufacturers of drugs, medical devices, and biologics for product licensure applications. The law also contains additional provisions, the most important of which are Supply Chain Provisions that empower the FDA to protect medical device and drug supply chains. Although an attempt to add a nationwide track & trace requirement to the bill failed to become law, a number of significant supply chain security elements became law with the enactment of FDASIA. These are “Title VI —Medical Device Regulatory Improvements. Sec. 614. Unique Device Identifier” and “Title VII—Drug Supply Chain” which define changes that enhance FDA’s inspection authority and the drug supply chain. Similar to the medical device UDI system, FDASIA requires FDA to create a Unique Facility Identifier (UFI) system and to maintain an electronic database containing the registration and listing information of drug facilities.
For more, please download our report.