I was serving in the U.S. Senate when, one week after the September 11, letters containing anthrax spores were mailed to several news media offices and two Democratic U.S. Senators, exposing more than 30,000 people, killing five of them, and costing the U.S. Government more than $1 billion to clean up Capitol Hill buildings.
We were unprepared. We received a wake-up call fifteen years ago, and immediately began addressing our vulnerabilities in this area.
Now, the alarm clock is ringing once again. With the outbreak of the Zika virus and other biological threats that weren’t on most Americans’ radar until recently, the definition of emergency preparedness in the U.S. has expanded exponentially to include virus outbreaks and biohazards that have the potential to cause devastating harm to our national security.
In 2004, Congress passed the Project BioShield Act. I am proud to have been the lead sponsor of this bill, which created a ten-year $5.6 billion set-aside, known as the Special Reserve Fund (SRF). The SRF was established to incentivize the research, development and stockpiling of medical countermeasures (MCMs) such as medicines, vaccines, and diagnostics for chemical, biological, nuclear and radiological threats.
These threats are identified by the Department of Homeland Security in consultation with our intelligence officials. The government decides what the MCM requirements are, and asks companies to partner in developing the products needed to protect Americans.
Because there is no commercial market for many MCMs – anthrax antibiotics and smallpox vaccines are not sold at your local pharmacy, for example – a public-private partnership is required. Between 2004 and 2013, the money allocated to the SRF was successful in stimulating companies to invest in MCMs. The Department of Health and Human Services reports that twelve MCMs were completed and stockpiled during this period, and the pipeline of MCMs in late-stage development now exceeds 200 products.
The BioShield SRF was successful because it provided a guaranteed market for companies – they could be guaranteed that their investments in these critical products would pay off, if their product proved successful. There was a promise of procurement at the end of the decade-long development cycle.
We have made significant progress in preparing for an attack in some instances, such as with anthrax or smallpox, but we remain unprepared for many other high-risk pathogens such as plague or tularemia.
Today, Congress has the opportunity to strengthen our ability to respond to an expanding array of biohazards and threats.
When the original $5.6 billion expired, Congress reauthorized the SRF with a $2.8 billion sum over five years. However, rather than providing the funds as a lump-sum reserve, Congress has funded the SRF through annual appropriations, diminishing the certainty that the SRF originally provided. In both 2014 and 2015, only $255 million was appropriated each year – far below what was authorized and what is needed for drug development.
It was encouraging to see Congress increase funding for the SRF to $510 million in 2016, but disheartening to see only $350 million requested in the President’s 2017 Budget. This is especially true when you examine the HHS Multi-Year Budget provided last year, in which the Administration estimated that they would spend $870 million on procurement of life-saving MCMs in 2017.
In 2017 and 2018, Congress must provide a robust level of funding for the SRF if they want to inspire the confidence necessary for companies to put their time and money into the development of urgently needed MCMs.
Furthermore, Congress must ensure that the SRF remains focused on the national security threats identified by DHS. Unconscionably, the Obama Administration recently proposed to open up the SRF to buy anything HHS wants, thereby eliminating the required focus on DHS identified national security threats. This dangerous proposal comes at a time when ISIS and other bad actors are on the move and our intelligence officials are warning that biological and chemical weapons capabilities are widespread.
With two years left in the BioShield SRF authorization, there is still $1.78 billion to be appropriated. It is imperative that funding for the SRF continue to increase, and remain focused on national security threats, in order to meet the remaining gaps in our preparedness and ensure that the products currently in the pipeline can complete the development process.
We still face biological threats today – both manmade and naturally occurring. America shouldn’t be forced to pick and choose which biological threats to prepare for. Our national security depends on preparing for every known threat, and this shortfall makes it difficult, if not impossible, to do so.