GAO to FDA: Do more to encourage drug manufacturing innovation
The Government Accountability Office on Friday released a report calling on the FDA to better encourage the adoption of advanced drug manufacturing practices, particularly as interviews with 15 stakeholders from industry said delays in adopting advanced tech are related to regulatory uncertainties.
In addition to not encouraging more advanced manufacturing practices, like continuous manufacturing, GAO found that the FDA “lacks information on the extent to which its industry engagement and policy and guidance efforts encourage adoption of advanced manufacturing.” What’s more, the FDA has not even defined or documented its goals in this area, GAO found.
“FDA data show that relatively few drugs manufactured using an advanced manufacturing technology are currently approved for marketing,” the new report says, noting that between 2015 (when CDER first approved a drug that used advanced tech) and last October (the most recent data available), CDER had approved just 16 applications or supplements that used advanced manufacturing tech.
FDA officials, meanwhile, told GAO that part of the problem is that companies’ decisions to adopt advanced manufacturing is based on multiple factors, and hard to make a business case for, but most of those are outside the scope and control of the FDA.
Even still, the agency and former acting commissioner Janet Woodcock have made clear that advanced manufacturing tech is a high priority and can help shore up the supply chain and drug quality concerns during public health emergencies like the pandemic. GAO also noted that earlier in the pandemic, the FDA signed off on two Covid-19 drugs that are made using advanced manufacturing processes.
Earlier this month, the agency joined with its European regulatory colleagues in adopting a new quality-related ICH guideline on continuous manufacturing, known as Q13.
On the other side of the coin, the 15 industry stakeholders that GAO interviewed said that most of the reason they were slow to adopt new manufacturing tech was because of the FDA, explaining that
regulatory challenges contributed to uncertainty about when and whether a drug manufactured using advanced manufacturing will be approved. This uncertainty weakens the business case for, and contributes to slow adoption of, advanced manufacturing. For example, according to stakeholders, the unfamiliar[ity] of FDA application review staff with advanced manufacturing may lead to delays in approval.
The report, which GAO conducted as part of a CARES Act provision requesting more info on the federal pandemic response, ultimately concluded that the FDA needs to make more informed decisions on which of its initiatives “should be continued or expanded or whether corrective actions are warranted, thus contributing to the larger federal focus on increasing the use of advanced manufacturing for drugs.”