Statement of the Alliance on Today's OMB Budget Release

In response to inquiries, the Alliance for a Stronger FDA issued the following statement earlier today:The President and OMB’s budget proposal recognizes that FDA’s process for reviewing medical products needs resources at least as great as the current level of funding. FDA provides basic public health and consumer protections that are essential to the American public, who expect that their routine, everyday use of countless products (both food and medical products) are safeguarded by the agency.

However, 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.As the Congress engages in the appropriations process over the next several months, we are hopeful legislators will see the importance of both strong continuing funding of FDA’s medical product and food safety responsibilities and the value of sustaining current levels of public funding.