Miniscule increases for FDA and the National Institutes of Health in President Obama’s proposed FY 2015 budget were attacked by stakeholders of each agency as soon as the $3.9-trillion document hit the streets on March 4.
Although Congress is certain to dismember and recast large sections of the budget ahead of the mid-term elections in November, only minor tinkering is expected for NIH (up 0.7% to $30.4 billion), where a focus on basic research makes it widely unpopular on Capitol Hill.
At FDA (up 1% to $2.6 billion from taxpayers), which has a more broadly based and potent constituency than NIH as well as substantial user-fee revenues from regulated industry ($1.8 billion expected), more fruitful negotiations are likely. In past years, Congress has regularly boosted parts of the agency’s appropriations much higher than the administration of the day proposed.
Commenting on the president’s budget, Pharmaceutical Research and Manufacturers of America said it “would jeopardize medical advances and economic growth by reducing the incentives to invest in the development of new biologic medicines. Perplexingly, the president would undercut forward-looking incentives that were strongly bipartisan, adopted in the House and Senate and continue to be supported today.
“The president’s budget also proposes to restrict patent settlements that allow generics to reach the market before innovator patents expire. These settlements contain complex legal issues recently reviewed by the Supreme Court. The President’s proposal to restrict such settlements creates an uncertain business environment and could lead to higher healthcare costs.”
The Biotechnology Industry Organization (BIO) complained that the budget proposal would reduce the period of regulatory data protection for innovative biologics manufacturers and would discourage biotech innovation.
And the broadly based Alliance for a Stronger FDA expressed disappointment that the budget request falls far short of what the agency needs to fulfill its responsibilities.
“This budget proposal would actually weaken the FDA in certain areas, which we think the American people will regard as unacceptable,” the Alliance said. “FDA’s funding needs to be increased further—well above the FY 14 level—to reflect the agency’s vast public health responsibilities and continually increasing workload.”
Under the president’s budget request, food programs are proposed to grow nearly 2.5%, the Alliance noted, while drugs would grow about 2% and the rest of FDA would lose about 1.5%, including a $3-million decrease for medical device programs.
NIH-focused science groups expressed alarm that federal investment in biomedical research in inflation-adjusted dollars has decreased every year since 2003 and warned that if cuts continue, the US is in danger of losing its place as a global leader in scientific innovation.
According to NIH’s Biomedical Research and Development Price Index, which calculates its purchasing power, the cost of research work in FY 2015 is likely to increase 2.9%, far outpacing the agency’s paltry 0.7% budget hike.