White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar user fees.  The White House statement calls for “Congress to provide for 100 percent user fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”  This follows the Administration’s budget proposal for FY2018, which called for the elimination of federal funding for FDA pre-market review activity.

As reported by RAPS, however, there is still “bipartisan agreement that FDA should not be entirely funded by industry fees and that the agreements forged over the last two years between industry and FDA should be what is included in the reauthorization.”

The Senate has not voted on H.R. 2430, although it is on the Senate Legislative Calendar.  Without reauthorization, the FDA’s user-fee programs will sunset on September 30, 2017.