What are FDA's 2016 Priorities?

Recommendation

7/8 February 2023
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

Janet Woodcock M.D., Director of FDA's Center for Drug Evaluation and Research (CDER), has published an overview on the forthcoming priorities of the center (CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs).

Most of the priorities listed in this short presentation CDER 2016 Priorities don't have a direct GMP impact. So what would be the most important ones for the readers of this newsletter? The overall mission does not come as a surprise. It is to ensure "an accessible supply of safe and effective drugs, and preventing introduction of unsafe, ineffective or counterfeit drugs". The outlook itself starts with a review on what was achieved in 2015, like for example the completion of the standup of an Office of Pharmaceutical Quality.

As one of the "front burner priorities" for 2016, the implementation of FDA's track and trace program should be continued with the implementation of statutory provisions related to the drug supply chain and track and trace. At least an important project is the whish to make "significant progress on FDA-EU mutual reliance initiative". However FDA is clearly not in favour of an MRA (Mutual Recognition Agreement) to automatically rely on EU inspections.

A little bit more information is given on the Quality Metrics initiative. FDA sees that metrics are already widely used in quality management in many manufacturing sites and they are already often used to "alert management to impending problems". The FDA wants to collect Quality Metrics from production sites supplying APIs, medicinal products, Biotech, OTC etc. to the US to schedule inspections based on risk assessment. Now it is time to make sure metrics "represent the same measure across various groups". This will certainly be a pre-requisite to compare data.