Moore, Wenstrup, Pfluger, and Green Release Request for Information on Policy Solutions to Secure and Enhance Domestic Medical Supply Chains

September 11, 2024

Moore, Wenstrup, Pfluger, and Green Release Request for Information on Policy Solutions to Secure and Enhance Domestic Medical Supply Chains

WASHINGTON-Yesterday, Representatives Blake Moore (UT-01), Brad R. Wenstrup, D.P.M. (OH-02), August Pfluger (TX-11), and Mark Green, M.D. (TN-07) released a Request for Information (RFI) to solicit feedback on strengthening and enhancing domestic medical supply chains.

As Congress continues its important duty to ensure the safety and security of our nation through strengthening our medical supply chains, this RFI seeks feedback from independent experts, stakeholders, industry leaders, and coalition groups to inform how Congress may best achieve this goal.

Building off earlier efforts from the 118th Congress, the House voted this week on the BIOSECURE Act, a bill to ensure American patient data and taxpayer dollars do not fall into the hands of foreign adversaries' biotechnology companies of concern by prohibiting federal contracting with these companies.

U.S. supply chains must be free from dependency on foreign adversaries - we cannot rely on the Chinese Communist Party for genomic testing or basic pharmaceutical ingredients nor depend on Russia for fine chemical production. The BIOSECURE Act is an important first step, but Congress must take a multi-faceted approach to fortify national health security by working to bolster domestic medical manufacturing and ensuring our supply chains are free of interference and manipulation by foreign adversaries.

To that end, this RFI will allow Congress to hear from individuals and organizations who can provide feedback and ideas to incentivize, support, and strengthen domestic medical manufacturing and supply chains with trusted allies and partners. Responses may address, but are not limited to, the following:

1. Economic obstacles you currently face in bringing medical supply chains onshore?

a. Where would your costs increase by bringing operations onshore?

b. What other factors/barriers are preventing you from onshoring?

c. What incentives could facilitate the transition?

d. What kinds of ongoing support could help offset these costs?

2. Lessons learned, challenges, and opportunities with respect to efforts to diversify supply chains, address for potential global vulnerabilities, and onshore key operations.

3. Feedback on the scope and priority level of medical products and services in need of onshoring, friendshoring, or increased diversification (ex. PPE, generics, devices, ingredients, pre-clinical or clinical services, etc.)

4. Insight into any elements of the global supply chain on which your company is dependent on suppliers in foreign adversary countries.

5. Perspectives on how much time would it take to onshore, friendshore, or diversify such supply chains.

6. Insight into the main barriers to domestic production (ex. environmental or FDA regulations, permitting barriers, workforce challenges, etc.) and what policy options Congress has to alleviate them.

a. How do current U.S. regulations impact your ability to onshore or diversify your supply chain? Are there specific regulatory changes or flexibilities that could facilitate these efforts?

b. What are the primary workforce challenges your company or industry faces in expanding domestic production?

7. To what extent are upstream inputs into natural and synthetic API production, including fine chemicals, sourced from adversarial countries? If API production were onshored to the US or friend-shored, what legislation would be needed to ensure there will be sufficient diversity of inputs to offset a sustained supply disruption from China?

8. Current programs that can be utilized to assist in catalyzing new innovative technologies for advanced manufacturing.

9. What types of public-private partnerships could be most effective in accelerating the onshoring of pharmaceutical manufacturing?

10. Policies that promote alternative approaches to securing medical supply chains such as near-shoring and friend-shoring (ex. comprehensive trade agreements or plurilateral agreements with foreign partners).

11. What long-term strategies should Congress consider to ensure the sustainability and competitiveness of domestic pharmaceutical manufacturing over the next 10-20 years?

All responses should be submitted to [email protected] no later than October 4, 2024.

To download the RFI, click here.

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