Claudio Gallina

The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States. This is essential to enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

The pharmaceutical industry is in a continuous state of change and constant scrutiny from health insurers, consumers, and the government, who require greater transparency and accountability. In recent times, industry challenges have been numerous as global health fears and economic regression due to the Covid-19 pandemic have taken center stage. Pharmaceutical companies are grappling with unfolding challenges arising from supply chain disruption and the need to change business processes. As the impacts of Covid-19 continue to unfold, pharma companies need to respond accordingly in order to recover, compete, and even thrive, depending on their current situation.