April 26, 2017

Senators Seek Clarification from FDA Commissioner Nominee Regarding Hiring Freeze

A copy of the letter can be found here (PDF)

Washington, D.C. - Today, United States Senators Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), Robert Casey (D-Pa.), Sheldon Whitehouse (D-R.I.), and Tammy Baldwin (D-Wis.) sent a letter to Food and Drug Administration (FDA) Commissioner-Designate Scott Gottlieb, seeking clarification on his plans to ensure the FDA will have the necessary resources and capacity to protect the health and safety of the American people.

In January, President Trump signed an executive order imposing a hiring freeze on federal agencies, including the FDA, prompting a letter from the senators to Acting Commissioner Ostroff, expressing concern about how the freeze would impact the FDA's capabilities. The inquiry did not receive a response. Despite the recent OMB announcement lifting the hiring freeze, and around 1,000 current vacancies at the FDA, the Department of Health and Human Services (HHS) has reportedly opted to maintain the freeze. Federal agencies have also been directed to reduce their workforces in line with President Trump's Fiscal Year 2018 budget blueprint, which promises steep cuts across HHS.

"The Trump Administration has failed to present a clear view about hiring policies at the FDA and whether the agency will be prepared to meet its commitments," wrote the senators. "Given its crucial public health role, it is imperative that the FDA remain a strong regulatory agency equipped with sufficient, reliable funding and a robust workforce," they continued.

While the senators were encouraged by some of Dr. Gottlieb's statements during his confirmation hearing, and a recent response to a question for the record that the "FDA's ability to fulfill its mission to protect and promote public health depends on its world-class workforce of talented and dedicated public servants," they requested that he answer additional questions before the upcoming Senate floor vote on his confirmation.

The senators asked Dr. Gottlieb to explain how he would work to ensure the FDA has sufficient funding and personnel to carry out its mission, whether or not he agrees that positions not funded by user fee dollars are critical to ensuring the agency can fulfill commitments made in user fee agreements negotiated with the medical products industry, what steps he would take to implement the hiring authority provisions under the 21st Century Cures Act, and how his ability to lead the FDA would be hampered by a hiring freeze or reduction in overall workforce.