FDA Postpones User Fees Meetings, Pending White House Review

The FDA has had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump administration directed agencies to halt correspondence with members of Congress.

A memo sent to the heads of HHS agencies and centers Jan. 20, including the FDA, said that there would be no official communication with Congress before at least Feb. 3, unless specifically authorized by White House appointees.

It also states that no proposed or final regulation, notice or guidance document can be published until it has been reviewed by the acting secretary of HHS, Norris Cochran. Trump’s pick for secretary, Rep. Tom Price (R-Ga.), is currently waiting to be confirmed by the Senate.

The actions largely implement the government-wide freeze on new regulations and guidances, handed down on President Donald Trump’s first day in office.

Before the end of the Obama administration, HHS Secretary Sylvia Burwell informed Congress of the FDA’s recommendations for user fees covering medical devices. Congress’ deadline to pass legislation reauthorizing MDUFA IV through 2022 is Sept. 30.

The HHS memo is available here: www.fdanews.com/01-27-17-HHSMemo.pdf. — Conor Hale