GAO Report Hits FDA on Advanced Manufacturing Tracking
A new Government Accountability Office (GAO) report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt advanced manufacturing. The report was mandated by the CARES Act to report on the federal pandemic response, particularly FDA’s efforts to support advanced manufacturing as a means to “enhance the resiliency of the drug supply chain by increasing domestic manufacturing capabilities, improving drug quality, and enabling a faster response to (or even avoiding) drug shortages.”
The GAO report notes that relatively few drugs on the market today are produced using advanced manufacturing. “While there are many factors — including those outside of FDA’s control — that contribute to this, work by the National Academies of Sciences, Engineering, and Medicine and interviews with industry stakeholders show that regulatory challenges contribute to uncertainty for industry stakeholders, weakening the business cases for adoption of such technology,” it says. “Given these challenges, FDA’s efforts to encourage advanced manufacturing of drugs are important.”
The report’s only recommendation is for FDA to “document and finalize performance goals and measures related to its advanced manufacturing program efforts and regularly assess program progress.” It says HHS concurred with the recommendation. Specifically, as the agency continues its efforts to encourage advanced manufacturing, GAO says it needs more information on the extent to which its Emerging Technology Program and its Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative are successful.
“Through FRAME, CDER is examining its statutory authorities, regulations, and guidance to identify changes that may need to be made to facilitate its review of applications that use advanced manufacturing technologies,” the report explains. “As part of this initiative, CDER plans to seek stakeholder input by issuing discussion papers and holding workshops on advanced manufacturing technologies; may issue new or updated advanced manufacturing guidance; and plans to work to harmonize international guidelines to ensure global regulatory practice is clear to stakeholders implementing advanced manufacturing.” The GAO report also says FDA is developing an action plan for its FRAME Initiative.
Additionally, the report says FDA’s advanced manufacturing efforts should include “documenting goals, formalizing means to measure progress, and conducting regular assessment of progress toward these goals. This information will help CDER make informed decisions about which efforts 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. Going forward, this information could also give FDA insight into whether its actions are helping to address stakeholder concerns, and thus facilitating stakeholders’ adoption of advanced manufacturing technology.”