The Food and Drug Administration (FDA) is getting back the $85 million industry-paid user fees that fell victim to sequestration in 2013.
The agency is also getting a hefty 8% raise with an additional $91 million above 2013 funding levels from Congress in the recently passed $1.1 trillion spending bill. The passage of the new federal budget also removes the threat of another government shutdown for the next nine months. The President is expected to sign the bill.
Pharmaceutical and medical device companies pay the fees directly to the FDA. The fees amount to about 35% of the agency’s budget; the rest is supported by taxes. The bill allocates $2.55 billion for the FDA. That total is augmented by $1.79 billion in user fees charged to industry.
AdvaMed President and CEO Stephen Ubl said the association has long maintained that user fees paid by industry to FDA should not be treated the same way as taxpayer appropriated dollars. “User fees are part of an agreement between industry, FDA and Congress under which industry agrees to supplement FDA’s appropriated budget, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process. Restoring these user fee funds upholds that agreement.”
For food safety, the FDA is due to receive $882 million. Sandra Eskin, director of food safety at the Pew Charitable Trusts, said that marks a $53 million increase and a victory for public health, according to a Food Safety News story.
The bill says the FDA should provide a “comprehensive training program” for federal and state inspectors on the requirements of the Food Safety Modernization Act and what kinds of observations are proper to include on inspection reports.
However the legislation slashes spending for hospital disaster preparedness, and it shrinks the U.S. Department of Agriculture’s (USDA’s) food safety funding slightly But it provides a big boost for science programs at the Department of Homeland Security (DHS), including a new lab to study plant and animal diseases.
The new budget also restores some of the public health and disease-prevention funding that was lost in last year’s sequestration.
In addition to more money for the FDA, the bill provides increases for the Centers for Disease Control and Prevention (CDC) and the first appropriation for pandemic influenza preparedness at the Department of Health and Human Services (HHS) since 2011, according to congressional documents.
NIH (National Institutes of Health) would receive the biggest increase from 2013 spending levels, boosting funding by $1 billion, to $29.9 billion, for 2014. The spending package also would provide $115 million for mental health programs through the “Now is the Time” violence-prevention initiative. The spending package also contains a provision that would allow HHS to transfer up to $305 million out of trust funds to program management for Medicare
The bill would keep spending levels for Centers for Medicare and Medicaid Services (CMS) at $3.7 billion, which is its funding level under sequestration. However, it would cut the Affordable Care Act’s Prevention and Public Health Fund by $1 billion and the Independent Payment Advisory Board’s funding by $10 million.
