Constituencies Oppose Trump’s Proposed FDA Budget Cuts
President Trump’s just-released fiscal year 2018 budget blueprint is meeting significant resistance from FDA constituencies over a proposed doubling of FDA user fees on regulated industry’s medical product marketing applications, to about $2 billion annually. Such a jump “replaces the need for new budget authority to cover pre-market review costs,” the budget plan says. “To complement the increase in medical product user fees, the budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.”
But, Energy and Commerce Committee ranking member Frank Pallone (D-NJ) said the budget proposal could “endanger our nation’s pipeline of innovative drugs and medical devices by endangering funding for the Food and Drug Administration (FDA). And Alliance for a Stronger FDA said the “president’s proposed funding mechanism — cutting more than a third of the agency’s appropriation and offsetting it with an enormous increase in medical product industry user fees — is neither wise nor realistic. Not wise because FDA’s core responsibilities — safe and effective medical products and safe foods — need to be supported in large measure by the public, who is the primary beneficiary. Not realistic because the drug and device industries have recently completed user fee agreement negotiations with FDA, concurring upon an appropriate amount of industry fees to support agency improvements. User fees have always been intended to supplement the agency’s appropriation, never to replace it.”
Pallone added that the Trump budget proposal “could threaten the agency’s ability to hire and train medical product staff, carry out critical activities to ensure the safety and effectiveness of our drug supply, and effectively implementing the Food Safety Modernization Act which works to ensure a safe food supply. This blueprint is not a serious proposal. President Trump should stop wasting time on budget proposals that cannot pass a Republican Congress, and instead put forward sensible budget and policy proposals that do more than cut taxes for the rich at the expense of everyone else.”
While not discussed directly in the budget blueprint, the larger industry-paid portion of FDA’s budget would probably spare FDA significant cuts that many other agencies are facing. For example, the blueprint calls for a $5.8 billion cut in the National Institutes of Health’s (NIH) spending relative to the 2017 CR level. The budget proposal would also seek a major reorganization of NIH’s institutes and centers “to help focus resources on the highest priority research and training activities, including: eliminating the Fogarty International Center; consolidating the Agency for Healthcare Research and Quality within NIH; and other consolidations and structural changes across NIH organizations and activities.” It would also reduce administrative costs and rebalance federal contributions to research funding.
The current user fee programs expire 9/30. Negotiated reauthorization proposals are currently working their way through Congress, and it is unclear how these will be received by the Trump administration.
PhRMA spokesperson Nicole Longo told FDA Webview 3/16 that the group will continue to work with president Trump and Congress “to improve American competitiveness and protect American jobs... The negotiated user fee agreements are an important step toward ensuring innovative medicines are delivered to patients in a timely and safe manner. We remain committed to ensuring that policies support innovation and value to deliver this new era of medicines to patients.”