Posted 25 January 2017
By Zachary Brennan
On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals.
What’s unclear right now is whether the order, which stipulates 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,” includes FDA.
A White House spokesman told Focus via email: “The federal hiring freeze has exemptions for public safety, which certainly could include public health.”
Understanding how the freeze impacts FDA will be key for drug, generic drug and medical device companies that rely on FDA staff to review and approve their products in a timely manner.
A spokesman from the industry group PhRMA also told Focus: "While we are still reviewing the administration’s
executive order, patients deserve the best and brightest minds to be able to
review the medicines they need. The U.S. Food and Drug Administration (FDA) is
the gold standard, and a stable and sustainable workforce is crucial to
Agency’s ability to keep pace with scientific advances in biopharmaceutical
drug development while ensuring safe and effective medicines reach patients in
a timely manner.”
The Generic Pharmaceutical Association (GPhA) also said in a statement that with more than 4,000 pending generic drug applications and more than 850 open positions at FDA, including more than 150 vacant generic drug reviewer positions, a "fully-resourced FDA is critical to reducing the backlog."
As former FDA official Bob Pollock noted on a Lachman Consultants blog yesterday, FDA’s Office of Generic Drugs is expecting more than 1500 abbreviated new drug applications (ANDAs) in 2017, and it remains unclear how the freeze will impact the timely review of these ANDAs.
BioCentury also noted in an article yesterday that there’s a possibility some open FDA jobs could be filled under an exemption to Trump's executive order, and the order does seem to prevent FDA from exempting positions funded by user fees.
In addition to the hiring freeze, FDA and other federal agencies were also told by Trump’s administration not to publish any new regulations, rulemakings or new guidance documents.
That order coincides with FDA’s rush to release almost 20 new draft or revised draft guidance documents since the election, some of which were long-awaited, like the one on biosimilar interchangeability, in addition to more than 20 final guidance documents, a measured explanation of off-label marketing, and an interim policy on drug compounding, and the launch of a new oncology center.
Editor's note: This article was updated on 1/26 with comment from GPhA.