The Drug Competition Plan and the FDA's steps to facilitate efficient generic drug review

By Dr Nicola Davies

Many patients struggle to gain access to low-cost medications, motivating the US Food and Drug Administration to develop the Drug Competition Plan, which aims to broaden access to generic drugs, notes Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. This plan has three major components:1

1. Reducing the number of review cycles and the overall approval time for new generic medicines, promoting efficiency in the FDA’s generic review process;
2. Addressing scientific and regulatory hurdles to the approval of generic versions of complex drugs; and,
3. Diminishing branded drug makers’ ability to delay a generic drug’s market entry.2