The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > If Sequester Takes Effect, Could Top FDA Brass Be Furloughed?

If Sequester Takes Effect, Could Top FDA Brass Be Furloughed?

Posted 26 February 2013 | By Alexander Gaffney, RAC

How, exactly, would budget sequestration affect some of the US Food and Drug Administration's (FDA) most senior officials? If a new report from The Washington Post is correct, some of FDA's most senior center leaders could be subject to the same furloughs as the rest of the regulatory agency.

The 22 February 2013 report from The Post notes that when it comes to equal application of budget sequestration, some workers might be lucky enough to escape furloughs. But those workers are likely ones you already know by name, and for good reason: They were directly appointed by the president of the United States.

For a sub-level agency like FDA, a department within the US Department of Health and Human Services (DHHS), this likely leaves only one employee exempt from the effects of a furlough: Commissioner Margaret Hamburg.

That would leave the heads of every other center-from the Center for Devices and Radiological Health's (CDRH) Jeffery Shuren, to the Center for Drug Evaluation and Research's (CDER) Janet Woodcock to the Center for Biologics Evaluation and Research's (CBER) Karen Midthun-and the thousands of FDA employees they lead to face the effects of the sequester head-on.

The exact effect of the furloughs is not yet clear. Some agencies have said they may furlough workers for up to a week, while others have said the cuts could go as deep as 20% of employees' yearly salaries.

The Alliance for a Stronger FDA, an advocacy group that argues on behalf of more resources for FDA, has noted that the agency is more staff-heavy than many agencies, and would thus be more prone to furloughs. "Furloughs and unfilled job vacancies are almost certain," the group wrote in a statement posted online. " Lay-offs cannot be ruled out if the sequester runs the entire seven months."

Other Effects of Sequester

The furloughs would be at least one reason behind the White House's conclusion, noted in reports detailing the state-by-state impact of sequestration cuts, that FDA would have a difficult time doing its job.

"The FDA's Center for Drug Evaluation and Research (CDER) would face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in new drug approvals," the White House wrote. "The FDA would likely also need to reduce operational support for meeting review performance goals, such as the recently negotiated user fee goals on new innovative prescription drugs and medical devices."

The other reasons, as noted last week by DHHS Secretary Kathleen Sebelius, include that the sequester will affect industry-paid user fees, now used to support FDA's operations, and in particular the speed with which it is able to review products. A shortage of funds could imperil some of its initiatives to approve drugs in just fraction of the time normally taken, and extend the review times for other drug products as well.

But even if Hamburg isn't forced to give up any of her pay-$153,000 a year as of 2009-she may feel some pressure to do so by example. The Post notes that Deputy Defense Secretary Ashton Carter will return some of his salary to the federal treasury as a "gesture of solidarity."

Hamburg could be in a better position than many other public officials to do so. According to Hamburg's 2010 disclosure form, the commissioner had a net worth of between $21.5 million and $24.1 million, a value The Wall Street Journal notes is partially the result of her husband, a hedge-fund executive.

We reached out to FDA for comment and to determine if any other FDA officials are exempt from potential furloughs, but did not hear back by press time.

Tags: Sequester

Regulatory Focus newsletters

All the biggest regulatory news and happenings.