FDA needs to better support advanced manufacturing technologies, GAO says

When the COVID-19 pandemic hit, one thing that became immediately clear was the importance of readily available medical supplies. While U.S. drug supply chains largely proved resilient during the crisis, officials are continually looking at ways to improve reliability in the biopharma supply chain.

To that end, the Government Accountability Office (GAO) says the FDA has some work to do on its efforts around innovative manufacturing technologies. While the FDA has acknowledged the importance of advanced manufacturing tech, the agency needs to go further to ensure real-world uptake of alternative production technologies, GAO said in a new report (PDF).

After interviewing 15 industry stakeholders, GAO said that "regulatory challenges contributed to uncertainty about when and whether a drug manufactured using advanced manufacturing will be approved." GAO cited 3D printing and continuous manufacturing as two examples of advanced production technologies.

Between 2015—when the FDA first approved a drug based on advanced manufacturing tech—and October 2022, the agency signed off on only 16 drug applications using nontraditional production tech, GAO says.

Importantly, FDA officials said in their own GAO interviews that a range of factors, not only agency regulations, dictate whether companies pursue alternative production technologies.

The FDA has already prioritized industry outreach, policymaking and research surrounding next-gen production tech, GAO says. But many drug companies don't know the specifics behind how to get drugs approved using those production technologies.

The uncertainty "weakens the business case for and contributes to slow adoption of advanced manufacturing," the GAO report said.

In its conclusion, the GAO said the FDA should develop a set of advanced manufacturing goals and targets and that it should "regularly assess" its progress.