FDA commissioner Margaret Hamburg told Senate appropriators 4/18 that no furloughs are expected at the agency as a result of the $209 million in sequester-related cuts this fiscal year. “Of course, the sequestor is a significant concern to us due to expanded responsibilities,” she said, adding that “these cuts will come at a cost.”
The sequester cuts $126 million in budget authority and $83 million in user fees, Hamburg told a Senate appropriations subcommittee FY 2014 budget hearing. “At the present time, we are trying to absorb the impact of the sequester in ways that will have the least impact on public health and our ability to move forward with critical programs,” she said. “We are decreasing travel, conferences and training programs, while also cutting back on consulting contracts and grants.”
Asked about the agency’s inability to use all of the user fees, Hamburg told the hearing that this will be “reflected in a slowing of our ability to build up key programs, and to advance medical product review programs in critical ways, and I do think that this is a set of concerns for all of us.” She said the agency would support any measure that would protect the user fees from being calculated into future budget cuts.
In her testimony, Hamburg told the hearing that it is critical to fully fund FDA. “Although FDA continues to be an effective and efficient investment, our job has become increasingly demanding,” she said. “We are in the midst of dramatic technological and market-based changes in the way that foods, drugs, biologics, and devices are produced — from personalized medicine and nanotechnology to the globalization of our food and medical product supplies. Congress has also continued to pass new laws and expand our responsibilities. While we welcome these new responsibilities, they don’t always come with added resources. These changes force us to stretch our limited resources, while finding ways to ensure the safety of a global supply chain. Our scientists must also adapt to, and even drive, new science and technology so that we can accelerate medical product innovation rather than impede it.”
A fully funded FDA will also allow the agency to advance regulatory science, Hamburg said. “It is well known that advances in biomedical research are not being translated into real world products as swiftly and surely as we all would hope,” she told the hearing. “The time and costs of developing new drugs has been increasing. Yet despite increases in research and development, the pipeline of new, innovative drugs remains disturbingly limited. Serious public health needs, such as treatments for autism and Alzheimer’s disease, are not yet being met, despite years of research and investment. And many drugs are not revealed to be unsafe or ineffective until the last stages of development, wasting valuable time and resources. Through its regulatory science programs, FDA is committed to helping to develop new knowledge and tools that can help translate basic scientific discoveries and approaches into life-saving medicines, and reducing the time, complexity, and cost of drug and device development.”
Full funding is needed to support innovation through a range of activities, according to Hamburg, including:
The Innovation Pathway, which cuts the time and cost of developing and reviewing breakthrough device technologies — the first to benefit from this was a robotic arm controlled by a microchip in the brains of patients with spinal cord injuries or amputations;
Greater use of genetic data to advance personalized medicine, especially in cancer therapies;
New scientific tools and partnerships to learn earlier in development whether a drug or device will work and be safe, saving time and money now wasted on late-stage product failures;
More guidance to industry early in technology development to help bring important new products, like the artificial pancreas, to market more quickly; and
More collaboration with companies earlier in development, which has been shown to shave up to five years off their development time.