Increasing pharmaceutical manufacturing capacity in the United States is a central interest of U.S. policymakers and the wider health care industry. In a new insight, Health Care Policy Analyst Jack Leimann reviews key policies intended to create a supportive regulatory environment and analyzes how Food and Drug Administration (FDA) initiatives may impact domestic manufacturing investment and success.

Key Points:

• FDA policy initiatives, such as the PreCheck Pilot Program, seek to reduce the regulatory burden in operationalizing manufacturing facilities.
• This and other initiatives are intended to advance policies that support regulatory transparency, strong supply lines, enhanced inspections, and the adoption of innovative technology to bolster increased domestic manufacturing capacity.
• While there are strengths in the U.S. market, improving the consistency of decisions from federal regulators will provide a stable regulatory environment for manufacturers operating on long-term plans.

Read the analysis.