President Barack Obama announced in his State of the Union address “a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”
Eight months later, Health and Human Services Secretary Kathleen Sebelius has come out with a report launching the initiative. It does not just call for additional spending, as most federal initiatives seem to do, but for a reconsideration of our life science development process, with a specific call for clearing up bottlenecks that hold up new countermeasures to combat a host of biological threats.
In trying to move the report from paper to policy, the administration may find that some of its most implacable opponents are its staunchest allies, while putative allies may cause the administration heartburn.
“The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers seeking to enter the MCM arena,” the report found. In other words, companies looking to create new lifesaving products find the product development process both intimidating and difficult.
To address this, according to the accompanying HHS press release, “HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”
There is little doubt that bureaucratic hiccups and “bottlenecks,” as the report calls them, make the development process for new medical products — including drugs, vaccines, biologics and devices — longer than it needs to be. It takes about 10 years and $1 billion to bring a new pharmaceutical product to market, making such an investment only available to large or well-funded entities. One longtime career staffer told me while I was HHS deputy secretary that he never understood why industry complained about the Food and Drug Administration until he began working on trying to develop and acquire new countermeasures through BARDA, the Biomedical Advanced Research and Development Authority, which manages Bioshield.
Two years ago, I produced an HHS report detailing strategies to approach bottlenecks in the life science development process, which I shared with the incoming administration.
It is noteworthy, however, that a Democratic administration is coming up with these findings, as criticizing pharmaceutical companies has become a staple Democratic attack. Both John Kerry in 2004 and Barack Obama in 2008 sent barbs their way, and congressional Democrats such as Henry Waxman have long been critical of the companies as well.
Many congressional Democrats, as well as other Pharma critics on the left, will not want to embrace Sebelius’ drive to clear up FDA bottlenecks — and they may be uncomfortable with the funding for the countermeasure enterprise as well.
The new administration initiative calls for $2 billion in funding as “Democrats on Capitol Hill have tried repeatedly to cut funding for the BioShield program to pay for other domestic priorities,” according to Congressional Quarterly’s Julian Pecquet. If the House succeeds in its efforts to cut $2 billion out of this area, the new initiative could be scuttled before it even gets off the ground.
It also is interesting that the report somehow fails to acknowledge the administration that made the greatest strides in encouraging the development of our current countermeasures.
The report notes that “the federal government began work over a decade ago, during the Clinton administration, to develop and stockpile medical countermeasures against biological threats.” Although the report acknowledges Bill Clinton by name, things that happened in the most recent decade are characterized by a sentence saying that “events after Sept. 11, 2001 led to an acceleration of those efforts.” These efforts included, as the report acknowledges, a new smallpox vaccine, the purchase of anthrax antibiotics and vaccine, and countermeasures against botulinum toxin.
Other important developments recognized by the report include the creation of Project Bioshield for development and procurement of countermeasures and the creation of the pandemic flu preparedness plan. Both were major achievements of the Bush administration, as were the creation of a new HHS office of preparedness and response, as well as BARDA itself.
The report’s inartful and passive “after Sept. 11” construction appears to be a kind of Soviet method for referring to actions undertaken by the Bush administration without actually mentioning George W. Bush’s name. The Obama administration may be loathe to acknowledge this, but in calling for clearer regulatory pathways and more funding for developing and acquiring medical countermeasures, it may be angering some key allies, as well as embracing an important part of the Bush legacy.