Expanded Access Program Improving, But Sponsor Concerns Linger

11 Sep 2019

• By Michael Cipriano

Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.

Can the FDA make everyone happy with expanded access?

Several drug makers believe the US Food and Drug Administration has made improvements to the expanded access program, but concerns persist that the agency may use adverse event data from the program against their products, according to a report from the Government Accountability Office.

Seven of the 10 different manufacturers interviewed by the GAO believe that the FDA's updated October 2017 guidance on how...