President Donald Trump's FY 2018 budget proposal for the US Food and Drug Administration (FDA), leaked late Monday, seeks a last-minute renegotiation of user fee deals forged over the last two years to make up for about a 30% decrease in the agency’s budget.
The call for more than $1 billion in new user fees to replace appropriations comes as both the House and Senate have advanced their versions of the user fees reauthorization legislation with the previously negotiated user fee levels agreed to by FDA and the pharmaceutical, medical device, generic drug and biosimilar industries.
As the proposal notes, currently user fees cover an average of 60% of FDA premarket review costs, ranging from 30% for animal drug review to 70% for prescription drugs. All of those costs would fall on industry under the budget plan.
Newly confirmed FDA commissioner Scott Gottlieb also falls in line with the Trump administration, echoing the calls for the re-calibrated funds in FDA's budget justification, despite also noting the previously crafted goals letters for PDUFA VI, MDUFA IV, GDUFA II and BsUFA II.
The budget proposal mirrors what HHS Secretary Tom Price wrote in letter to senators last week, when Sen. Lamar Alexander (R-TN) told him that it’s "way too late" for the Trump administration to have an impact on this year's user fee reauthorization bills.
Representatives from industry groups BIO, AdvaMed and AAM (formerly the Generic Pharmaceutical Association) reiterated to the Senate HELP committee in April what FDA officials told the House Energy & Commerce Committee in March: A failure to act on the already-agreed-to reauthorizations would be devastating.
The Alliance for a Stronger FDA also noted late last week that this supposedly modest increase in budget for FDA is actually a massive cut in budget authority for the agency.
Alliance President, said in a statement on Tuesday: "We
are especially concerned because the Congress has made clear that these
additional user fees will not be adopted ... Thus,
the Administration has not proposed a viable pathway for the agency to avoid a
31% cut in FDA’s BA [taxpayer-funded budget authority] appropriation."
What remains unclear is whether this persistence from the Trump administration to try to forge its own deals for FDA and these industries means he might veto a bill that passes both the Senate and House if it strays too far from this plan.
Part of the new deal Trump is trying to single-handedly forge would see the bulk of FDA's budget ride on the back of the industries it regulates, as well as by "increasing the allowable fee amount for the export certification fee, and additional increases in all currently authorized user fee programs."