How Trump's Federal Hiring Freeze Impacts Biotech and an Already Short-Staffed FDA

January 26, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – A freeze on hiring federal employees is expected to negatively impact biotech-related agencies and the U.S. Food and Drug Administration.

On Monday, the first day of President Donald Trump’s administration, the president signed a freeze on hiring federal employees, with exceptions for positions in national security, public safety and the military. Trump said the executive order was a way to curb the growth of the federal government. But, detractors of the administration’s plan say the hiring freeze, which includes new and existing openings, will actually create problems for the agencies affected. David Cox Sr., president of American Federation of Government Employees, said the freeze will be disruptive and actually cost taxpayers more because agencies will be forced to “hire more expensive contractors to do work that civilian government employees are already doing for far

"This hiring freeze will mean longer lines at Social Security offices, fewer workplace safety inspections, less oversight of environmental polluters and greater risk to our nation's food supply and clean water systems," Cox said.

Multiple federal agencies, such as the Department of Agriculture, the Department of the Interior and Department of Health and Human Services, hire for biotech positions.

One federal agency that has been looking to bring on more employees, particularly research scientists, is the FDA. In June FDA Commissioner Robert M. Califf posted a blog touting the mission of the regulatory agency and the need to hire additional staff to meet those needs. That posting at FDA.gov came four months after the federal agency submitted its budget requests to Congress that called for an 8 percent increase in hoped-for monies. The agency had plans to hire about 1,000 employees, but the freeze has halted that plan—which could lead to a slow-down in the approval of new drugs and medical devices. At this point it remains unclear how the freeze will affect the FDA, as public health concerns could fall under the administration’s idea of public safety.

Focus, the publication of Regulatory Affairs Professionals Society, said the freeze could cause delays in the FDA review of New Drug Applications. This year, the FDA is anticipating more than 1,500 ANDAs, Focus said, citing former FDA official Bob Pollock.

PhRMA, the public advocacy arm of the industry, told Focus in an email that it is crucial for the FDA to be able to hire the brightest employees to “keep pace with scientific advances in biopharmaceutical drug development while ensuring safe and effective medicines reach patients in a timely manner.”

It is possible the White House will address hiring concerns at the FDA after Trump selects a new commissioner, but that remains to be seen. It is likely Trump will not tap a new commissioner until Rep. Tom Price is confirmed as the new head of HHS. The FDA head reports to the HHS secretary.

Not only did Trump halt hiring at federal agencies, he has also blocked some agencies’ means of communication, including at the Department of Health and Human Services and the Environmental Protection Agency. That communication block includes the publishing of new regulations or guidance documents.