This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill for fiscal 2014, which would, among other things, allow the Food and Drug Administration (FDA) to access $85 million in user fees sequestered in 2013.
In addition, BIO supports the agreement’s overall funding for: FDA, NIH, the biodefense enterprise; and improved program oversight of the important 340B program. BIO also strongly supports the language in the bill providing the Department of Energy transfer authority to the Defense Production Act program for the development of cleaner drop-in aviation and marine biofuels.
The absence of funding in the bill for vital Farm Bill energy programs emphasizes the need to get a Farm Bill completed with mandatory funding levels for energy title programs. The Farm Bill would give these programs funding in the immediate term and would ensure funding of the programs into the future.
Jim Greenwood issued the following statement:
“Through this agreement, the House and Senate recognize the importance of restoring FDA access to the portion of user fees denied them under sequester. Unfortunately, the sequester restricted FDA’s ability to access the full amount of all of their user fees, including the user fees our companies pay to provide resources for expeditious review of new drug applications.
“User fees represent no cost to American taxpayers, while benefiting patients and caregivers immensely through timely availability of safe and effective treatments.
“It makes no sense to subject private company-paid user fees to sequestration. Having privately-paid user fees subjected to sequestration does not lower our nation’s deficit.
“Instead, the only real effect is that FDA has not been able to access all PDUFA user fees, thus inhibiting the ability of the Agency to fulfill its mission of ensuring patient access to safe, effective new drugs and biologics.
“We firmly believe that freeing the user fees so that FDA can fully access them will greatly benefit public health.”