
Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things. Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here). A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act