Sens. Marco Rubio (R-FL) and Angus King (I-ME) have told the FDA that “considerable work” needs to be done to address how advanced manufacturing technologies can be used to improve US domestic supply chains.
“The lack of domestic medical manufacturing has created dangerous vulnerabilities for American public health and national security,” the senators wrote in a letter to FDA Commissioner Robert Califf on Tuesday.
Rubio and King outlined eight questions for the agency, urging clearer advice for manufacturers following the FDA’s launch in December of the Advanced Manufacturing Technologies Designation Program, which was meant to improve domestic manufacturing in the US.
Rubio and King have demanded the FDA up the ante on finalizing the program and have requested information on how the agency is encouraging manufacturers to partake.
The US has struggled with multiple shortages of APIs and drugs, such as the ADHD medication Adderall and key cancer therapies, causing temporary drug imports and consistent supply issues.
One key issue lies within manufacturing woes and quality issues uncovered during inspections of overseas facilities, with the FDA regularly handing out warnings to foreign factories supplying the US. In particular, the US is very reliant on outsourcing manufacturing to China, the lawmakers emphasized.
Meanwhile, the FDA has made other recent efforts to support the use of new technologies in manufacturing and released a new draft guidance last week on adopting advanced tech in drug production.