Coordination and Goals for Domestic Pharmaceutical Manufacturing Initiatives

Executive Summary

The medicines that Americans rely on every day are often products of complex global supply chains, with manufacturing sites in many different countries handling different stages of production. While global supply chains can enable specialization, efficiency, and access to global capabilities, they come with challenges as well:

• Geopolitical risks associated with concentration of production in higher-risk countries.
• Negative impacts to local U.S. economies that could benefit from high-paying manufacturing jobs.
• Issues with regulatory oversight in some foreign countries.

Supporting a robust domestic pharmaceutical manufacturing base is a bipartisan priority for policymakers. Absent effective planning and well-defined goals, though, policy efforts to support domestic manufacturing could be expensive and generate limited benefits to public health and the U.S. economy. This policy brief describes the benefits and challenges associated with domestic pharmaceutical manufacturing, including an overview of relevant recent and ongoing policy efforts. The policy brief also outlines three high-level goals that domestic pharmaceutical manufacturing efforts can help to achieve (Figure 1). We then propose several SMART (Specific, Measurable, Attainable, Relevant, Time-bound) objectives that support each goal. Establishing SMART objectives can help to illuminate the policy steps that can most effectively and efficiently achieve desired goals, and SMART objectives can also be used to measure progress over time.

We recommend that the Office of Management and Budget’s (OMB) Made in America Office (MIAO) and other White House offices, in partnership with HHS, DoD, VA, DOC, and other relevant agencies, direct the establishment of a National Strategy for Bolstering Domestic Production of Critical Pharmaceuticals and Associated Ingredients. We recommend that the OMB MIAO consider incorporating the goals and SMART objectives proposed in this policy brief into the National Strategy.

Read the full paper here.