Trump hiring freeze may stall FDA drug approval
An executive order signed by president Donald Trump to freeze all federal government hiring could negatively affect the US Food and Drug Administration’s (FDA) progress towards approving new drugs, medical devices and generic drugs.
The agency is currently lacking over 700 positions and it is unclear how the order will affect the FDA. The executive order states that “the head of any executive department or agency may exempt from the hiring freeze any positions that it deems necessary to meet national security or public safety responsibilities.”
Whilst it seems that the FDA would be exempt, it appears that even the White House aren’t sure about where the agency stands in regards to the order. According to Focus a White House spokesman said: “The federal hiring freeze has exemptions for public safety, which certainly could include public health.”
Hopefully this is the case but until further guidance is provided it will be unclear how the freeze impacts the FDA.
However, if the freeze does affect the FDA then the agency will be subject to the rules of the order and the 21st Century Cures Act which provides the FDA with $500 million over a decade, most of which is used to hire new staff.
The act also obliges the FDA to implement new programmes and to meet user fee goals for medical product reviews. The User Fee programme was implemented to accelerate innovation in the industry through funding provided by the Office of Financial Management. The implementation of the freeze, coupled with the 21st Century Cures Act will place the FDA in a position where it is likely to let targets slip.
In addition to the hiring freeze, the Trump administration has also told federal agencies not to publish any new regulations, rulemakings or new guidance documents.
Under the 21st Century Cures Act the FDA needs to implement a number of new programmes, including a new pathway for reviewing antibiotics and a system for designating regenerative advanced therapies.