The Obama administration on Thursday announced an overhaul of the federal government's strategy for preparing for natural and man-made public health emergencies.
Health and Human Services (HHS) Secretary Kathleen Sebelius proposed a five-pronged approach for ensuring that the nation has the vaccines and other supplies it needs in the event of an emergency. The plan in particular calls for the department to establish and sponsor an "independent strategic investment firm" that would partner with small "innovator" companies and private investors to develop needed vaccines and other products.
The new strategy comes as the Obama administration has questioned the effectiveness of the existing BioShield program, which some lawmakers have proposed cutting by $2 billion. BioShield aims to spur development of new drugs and vaccines that protect against biological, chemical and radiological weapons by ensuring that the federal government will purchase what the private sector develops.
"Taken together," Sebelius said Thursday, "these five initiatives will add more life-saving products to the pipeline, enabling critical programs like BioShield to work the way they are supposed to."
The new plan calls for:
- making a "significant investment" in the Food and Drug Administration so federal regulators can more quickly review — and approve — new discoveries;
- establishing "Centers of Innovation for Advanced Development and Manufacturing" that would create "manufacturing platforms" to help innovators produce their medications or vaccines;
- helping young companies get their product to market, in particular by creating "sherpa teams" at the National Institutes of Health to "identify promising research and facilitate its translation into vaccines, drugs and treatments that keep Americans safe";
- upgrading flu vaccine manufacturing;
- and creating a strategic investment fund that would help small companies attract investors.
Sebelius ordered a review of the nation's "medical countermeasures" system last December after the government faced challenges in its response to the H1N1 (swine) flu.
The new strategy calls for a $2 billion investment over the next few years, most of which Sebelius said was already appropriated last year in response to the H1N1 flu. In addition to moving money around, the administration will seek congressional authorization for the creation of the strategic investment fund, Sebelius said.
Sebelius added that while the BioShield program "will remain as the entity for purchasing a developed product," many innovative companies are too small to get that far along without upfront support.
"What we know is that some of these great ideas are going to come from very small companies who don't have the capital and the wherewithal to get a product from microscope to market," Sebelius said. "So the investment early in that pipeline can really not only ensure that the great idea becomes a product, but will help spur that development.
Coincidentally, the President's Council of Advisers on Science and Technology on Thursday released its plan to improve the nation's vaccine response in the event of pandemic influenza or other outbreaks.
The report calls for investments of $1 billion or more every year for several years and identifies five areas for improvement:
- surveillance of newly emerging pandemic viruses;
- development of stock viral "backbones" (seed viruses) to allow faster production of specific vaccine strains;
- developing faster and better tests to ensure sterility during vaccine production;
- developing faster and more reliable tests to document vaccine potency;
- and enlarging the capacity and modernizing machinery used in the final stages of vaccine production, including filling vials.