Short-term Budget Deal Opens FDA

Furloughed FDA employees are expected to return to work early next week under a 1/25 tentative agreement reached between President Trump and Congress to re-open the government for three weeks while negotiations continue on border security issues. A short term budget resolution gives FDA some breathing room, according to the Alliance for a Stronger FDA. It has been reported that 95% of CFSAN and 70% of ORA are still furloughed, and the agency continues to order rolling callbacks for inspectors to perform high-risk inspections. Additionally, drug user fee carryover funds were expected to last only until mid-February, and compounding funds are no longer available, the group says. “There is enough carryover funding for the generics and medical device process for the foreseeable future, but new applications requiring a fee cannot be accepted,” it says. “This will create a backlog of product reviews once FY 19 funds become available.”