There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just a breadcrumb system that forces companies in the supply chain to retain standardized documentation of supply chain events, “just in case”. Very few drug packages will ever get “verified” at any point in their existence in the supply chain. And that’s by design.
Last month the US Department of Health and Human Services (HHS) published a new notice of proposed rulemaking (NPRM) related to the importation of finished drugs from foreign supply chains–initially, only Canada but expandable in the future to other countries. The proposal is the result of President Trump’s initiative to lower the price of some medicines and it would invoke Section 804 of the Food, Drug and Cosmetics Act (FD&C)–inserted in the early 2000s–that envisions importation programs, under certain strict conditions. Programs under Section 804 can only be implemented if the Secretary of HHS certifies that the they will pose no additional risk to the public’s health and safety, and will result in a significant reduction in the cost of covered products to the American consumer (see “Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?” and “Here We Go Again. Florida Flirts With Opening Door To Counterfeits“). Those are high bars. So high, that no Secretary of HHS has been willing to pursue Section 804 Importation Programs (SIPs) until the current one. Will the HHS proposed rule result in programs that pose no increased risk to American consumers? Let’s take a look and see if we can find the answer.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.
