Rubio Writes to FDA, Warns of America's Dependence on Foreign Pharmaceuticals

Senator Marco Rubio (R-FL), alongside Senator Angus King (I-ME), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, calling for clear standards and industry guidance to “strengthen America’s domestic pharmaceutical supply chain.”

This surrounds Sens. Rubio and King’s concern about the FDA’s failure to develop clear regulatory guidelines for manufacturing technologies of medicines fully.

For example, Sen. Rubio released a statement regarding this letter, emphasizing that the United States depends on foreign adversaries for pharmaceutical manufacturing.

Moreover, the senators’ letter begins by saying that “greater action is needed” for programs manufacturing Active Pharmaceutical Ingredients (APIs) using advanced manufacturing technologies (AMTs).

“We commend the FDA’s work to issue industry guidance for considerations specific to continuous manufacturing of APIs, but greater action is needed to promote a resilient domestic API supply chain,” wrote Sens. Rubio and King. They continued by pushing for domestic AMTs. “We are concerned that the FDA has not yet created a feasible pathway for stakeholders to invest confidently in domestic AMTs … we urge you to prioritize domestic manufacturing facilities and commit to frequent engagement with industry and patient stakeholders, ensuring a clear and efficient approval process for AMTs and their products.”

Furthermore, Rubio and King highlighted the notion that the COVID-19 pandemic “exposed” America’s dependence on foreign pharmaceuticals.

“For several years, the United States has grappled with a concerning uptick in shortages of key APIs and medications. Quality issues resulting from weak manufacturing standards abroad are the most common cause for shortages … The COVID-19 pandemic exposed the U.S.’ heavy reliance on foreign entities, particularly China, for our drugs and medical supplies. The lack of domestic medical manufacturing has created dangerous vulnerabilities for American public health and national security,” said Rubio and King.

They concluded their letter by urging the FDA to prioritize the domestic supply chain and “enforce clear guidelines” for American manufacturers. They also requested answers to the following questions:

1. What strategies has the FDA implemented to encourage greater investment by domestic drug manufacturers into AMTs, such as continuous manufacturing?
   • How has the FDA engaged with industry to further refine its regulations and expand opportunities for approval?
2. How is the FDA ensuring that the AMT Designation program will benefit more domestic manufacturing facilities than foreign-based facilities?
3. Based on the current application pool for AMTs seeking FDA approval through currently active pathways, what is the ratio of domestic versus foreign-based facility applications that the FDA has received?
   • What is the ratio of domestic versus foreign based facilities that have been approved?
4. Has the FDA received any new continuous manufacturing applications for generics, especially among pharmaceuticals experiencing domestic shortages?
   • Will the FDA consider a drug or API’s risk for shortage when evaluating applications for the AMT Designation program?
5. How is the FDA communicating about the AMT Designation Program to eligible entities and the public?
   • How is the FDA ensuring the drug manufacturers of all sizes are aware of the program and understand the requirements to apply?
6. How is the FDA ensuring the timely approval of continuous manufacturing technologies?
7. Has the FDA seen continued growth in the number of approved continuous manufacturing products since 2022?
8. What is the implementation status of the AMT Designation Program?
   • Has the FDA made progress on implementing the required program since the draft guidance period, which closed on March 13, 2024?
   • Has the program accepted any designation requests for new technologies?

Rubio and King did not ask for a specific date for a response, but expect a “prompt response.”