Health and Human Services review of countermeasure enterprise is welcome, but limited

On August 19, Health and Human Services released its Public Health Emergency Medical Countermeasures Review, entitled “Transforming the Enterprise to Meet Long-Range National Needs.” 

The announced policy initiatives are meant to speed MCM research and development, approval, and production and, in brief, include: 1) Strengthening the FDA’s legal and regulatory framework and its capacity to conduct regulatory science; 2) establishing Centers for Innovation in Advanced Development and Manufacturing primarily to speed MCM production and provide assistance to smaller market participants; 3) identifying product concepts and assisting in their translation from basic science through a “Sherpa” program; 4) Upgrading and modernizing U.S. vaccine production infrastructure, and; 5) creating a strategic investment firm for MCM innovation, which will differ from current BioShield efforts by focus on holistic support for the health of small companies themselves rather than just providing support for single products.

Funding for these measures is expected to come from an estimated $1.9 billion dollars of unused money originally appropriated to fight the H1N1 pandemic. 

The International Security & Biopolicy Institute applauds these measures and the thoughtful and collaborative manner in which they were conducted.  However, there are at least two critical concerns that these measures fail to address: 1) None of the announced $2 billion worth of programs addresses problems associated with distributing MCMs, even those products which we already posses; and, 2) announced measures to examine legal and regulatory frameworks do not seek what should be critical goals of harmonizing legal regimes and standards at the international level. The legal, regulatory and logistical efforts needed in each of these areas are nascent or nonexistent, and leaving them unaddressed continues to leave the U.S. vulnerable to an epoch-changing rupture.

Even the most successful abilities to develop and produce new products will be nullified if we cannot deliver and dispense needed MCM’s with corresponding speed and coherence once we have them. The H1N1 pandemic showed critical gaps in this country’s capacity to execute a threat-specific dispensation strategy. As a first order priority, we must simply assure that we have adequate stockpiles of existing medical countermeasures to meet the government's already identified need to protect our citizens and service men and women. Relatedly, dispensation plans should be properly prioritized to protect the vital members of our Emergency Services Sector.  A biological attack is likely to disrupt our security, hospital, public health, critical infrastructure and emergency services; a countermeasure program that does not seek to protect the critical actors within them is patently insufficient.

Moreover, our dispensation efforts entirely ignore scenarios outside the U.S. Disease knows no borders; threats that originate from afar will reach our airports within hours and days. The most effective response strategies may be those that proactively contain threats in foreign locations.  Further, even assuming all Americans can be protected from an outbreak, the effects that even a moderately severe disease event would have on trade, finance, diplomacy and transportation, could be devastating to our way of life. Our ability to distribute needed MCM’s to strategically sensitive areas of the world is a national security concern of the highest order. The recent floods in Pakistan provide a graphic illustration.  

Legal and regulatory frameworks governing the global MCM enterprise are also chaotic, limiting the effective market for MCM’s and thereby serving as a crippling drag on overall development. This most recent report – indeed our entire decade long struggle to get MCM’s from microscope to market – demonstrates the complexity of the legal and regulatory maze within the U.S. alone. If market participants have been hesitant to enter the U.S. market, one can be imagined how they view the prospect of entering an even more dysfunctional global system. Currently, MCM producers face countless foreign “FDA’s” with unknown rules and conflicting processes.  Approval and licensing protections are uncertain or nonexistent in foreign jurisdictions. Efforts to harmonize these systems between even our closest allies, would serve as a far greater multiplying effect on industry’s willingness to participate than anything countenanced by the recent U.S.-centric review.  

While ISBI accepts that the current review was consciously confined to issues related to MCM research, development and production, undoubtedly a more fundamental review of the medical countermeasure enterprise is warranted. At a time when there is no “front line,” when all parts of the globe are potential targets, a subsequent review should address these described gaps with an approach that adopts an international perspective, examines the needs and expected roles of emergency services sector personnel, and focuses on real world gains in security. 

The International Security & Biopolicy Institute is a Washington, DC, based think-tank that focuses on preventing and preparing the globe against the threat of epoch-changing bioviolence.

Brent Davidson is the director of program development at the International Security & Biopolicy Institute.