Whether it’s 3D drug printing, or a process known as continuous manufacturing, advanced manufacturing is a key new tool to get more drugs on the market.
Now a new watchdog report is highlighting challenges that remain for getting advanced manufacturing approved for drugs in the U.S.
After the start of the pandemic, the U.S. Food and Drug Administration (FDA) approved advanced manufacturing for two drugs to treat COVID-19, according to the report from the U.S. Government Accountability Office (GAO).
But the report says few drugs are actually using this process.
In fact, the report said the federal government has only approved 16 drugs for advanced manufacturing from 2015 to October 2022.
“There is a lot of uncertainty around this given it is a new technology,” said Mary Denigan-Macauley, a Director of Public Health for GAO.
The report highlights the benefits from this technology, including getting some drugs on the market faster.
“Traditional ways of producing drugs for example can be much slower,” said Denigan-Macauley. “They’re producing batches and they can take months to do but if you can do an advanced technology called continuous manufacturing, you can be able to produce them in a few days. So, if you end up with supply problems like you saw in COVID-19, this can be pretty revolutionary.”
The report said regulatory barriers are getting in the way of more drugs using advanced manufacturing technology.
“The 15 industry stakeholders GAO interviewed reported that regulatory challenges contributed to uncertainty about when and whether a drug manufactured using advanced manufacturing will be approved,” the report said. “This uncertainty weakens the business case for, and contributes to slow adoption of, advanced manufacturing.”
It points to drug companies having trouble navigating the approval process and a need for more guidance,
The report said the FDA has focused on industry engagement and research on advanced manufacturing.
But it points out the agency doesn’t know if all of its efforts to increase the use of this technology are actually working because it isn’t documenting or finalizing things like performance goals and progress.
The report calls on the Department of Health and Human Services (HHS), which oversees the FDA, to better document the advanced manufacturing processes.
In response, HHS said it agrees with the recommended changes.
“We want to say to FDA, this is great all these different efforts that you have underway, but we want you to make sure that you know which of these efforts are most effective,” said Denigan-Macauley.
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