Straight to the point

ASPR and BARDA: Bureaucratic Dysfunction in Biodefense
by Randall Bock at Brownstone Institute

Introduction: A Broken System with a Vital Mission

In the complex world of U.S. pandemic preparedness and biodefense, the Administration for Strategic Preparedness and Response (ASPR) and its subdivision, the Biomedical Advanced Research and Development Authority (BARDA), hold crucial responsibilities. 

Established under the Pandemic and All-Hazards Preparedness Act of 2006, ASPR and BARDA were tasked with responding swiftly to bioterrorism, natural disasters, and pandemics. Yet, over the years, their structure has become a textbook example of government inefficiency, burdened by overlapping jurisdictions, regulatory bottlenecks, and internal power struggles between federal departments.

ASPR was originally formed as the Office of the Assistant Secretary for Preparedness and Response under HHS but underwent a significant transformation in 2022 when it was elevated from a staff office to an official operating division and rebranded as the “Administration for Strategic Preparedness and Response” (conveniently retaining its “ASPR” -acronym). Despite the reorganization, core bureaucratic challenges remain entrenched.

Under different, alternating political regimes, the agency’s permanent workforce, particularly unfireable, untouchable Senior Executive Service (SES) employees, can either facilitate or obstruct policies based on their own preferences. This tactic, often referred to as “slow-walking,” aligns with the natural human tendency to minimize workload, and results in delays and inefficiencies. These barriers undermine the agency’s ability to act swiftly in genuine emergencies—ironically defeating the very purpose for which it was created.

Historical Context: From Bioterror to Bureaucratic Overhaul

The 2001 anthrax attacks were a pivotal moment in U.S. biodefense strategy. The attacks heightened fears of bioterrorism and underscored the need for improved preparedness. However, they also exposed systemic dysfunction in government oversight.

Dr. Steven Hatfill, a scientist wrongly accused of orchestrating the attacks, became the focus of a media and FBI campaign. “The FBI was tailing him, running him off the road, harassing him day and night,” Dr. Robert Malone recounted. The investigation’s flaws underscored a pattern of political expediency over fact-based inquiry, a recurring issue in crisis management.

Bruce Ivins, the Army anthrax specialist later suspected, never faced trial (due to suicide). His early cooperation with investigators may have presented a false cover for his spores having the identical genome as the terror envelopes. Some theorize that Ivins, like a fireman who doubles as an arsonist, orchestrated the attacks to magnify society’s need for his expertise. This potential scenario foreshadows institutions’ ability, similarly, to exploit threats to underscore their own indispensability in managing them.

In the aftermath, Dr. Anthony Fauci lobbied Congress to transfer bioweapons oversight from the Department of Defense (DOD) to NIAID, arguing that DOD had failed in its responsibilities. “Fauci argued that DOD had allowed these bioweapons to leak and couldn’t handle the job,” Malone explained. This shift consolidated NIAID’s power, significantly expanding Fauci’s budget and influence over both military and civilian biodefense programs.

While this expansion did not involve a formal transfer of bioweapons oversight from the Department of Defense (DoD) to NIAID, it did signify a substantial broadening of NIAID’s mandate to include biodefense, complementing the DoD’s existing programs. In 2005 and 2006, Fauci’s salary saw a steep increase—likely elevating him to the status of the highest-paid federal employee, a position he definitely held in recent years.

In 2002, Fauci pushed for NIAID’s expanded role in biodefense, declaring, “Our goal within the next 20 years is ‘bug to drug’ in 24 hours,” He secured billions in funding, blurring the line between civilian and military research. NIAID-backed projects, including work at the Wuhan Institute of Virology and Fort Detrick (with DoD), played a direct role in the origins of Covid-19. The same “science” meant to prevent pandemics instead unleashed one, with devastating global consequences.

This NIAID/ DoD biodefense restructuring, coupled with the creation of BARDA in 2006, was meant to streamline the development of medical countermeasures. Instead, the process became sluggish and overburdened. Homeland Security assesses bioterror threats, but ASPR and BARDA often face long delays before receiving authorization to act. “It can take 18 months just to get a green light to develop a countermeasure,” Malone noted. The system is like a ring full of sumo wrestlers—big, bulky, and each trying both to absorb and exert as much power as possible. NIAID, DoD, DHS, and HHS’ ASPR and BARDA collide with overlapping responsibilities, bogging down critical decisions.

Accordingly, the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) was formed in 2006 to coordinate these efforts; not unexpectedly, bureaucratic overlap and indecision still stifle progress. Biopharmaceutical companies face delays, canceled contracts, and confusing directives, discouraging them from producing life-saving countermeasures. In emergencies, these layers of bureaucracy take the “emergency” out of the response.

Structural Issues: Senior Executive Service and Regulatory Burdens

Malone highlighted the entrenched power of SES employees, who serve as gatekeepers within agencies like ASPR. “Presidents come and go; they stay,” Malone observed, emphasizing how these career bureaucrats can obstruct initiatives they oppose. Ironically, the roots of modern civil service reform go back to President Garfield’s assassination, at the hands of an office-seeker angered by his failure to secure a spoils-system patronage job. The ensuing Pendleton Civil Service Reform Act of 1883 (turbocharged by Jimmy Carter in 1978) aimed to create a stable, professional bureaucracy. These Acts succeeded in establishing stability, but by benefiting now-entrenched, unaccountable, and unresponsive poobahs.

Further complicating matters are the cumbersome requirements of Federal Acquisition Regulations (FAR). Government contracts impose strict compliance rules, including detailed timecards for all employees, which Malone described as “an endless La Brea tar pit.” To bypass these obstacles, agencies have turned to Other Transaction Authorities (OTAs). Yet, during Covid-19, OTAs were misapplied to mass-produce vaccines, raising questions about oversight and legality.

BARDA and the Challenge of Bio-Preparedness

BARDA’s mission involves acquiring and stockpiling countermeasures like vaccines for anthrax and smallpox. However, this work exists in a paradox: if successful, these preventive measures remain unseen and underappreciated. My father used to joke he was ‘the tiger catcher for the Bronx’. When kids said ‘There are no tigers in the Bronx’, he’d reply, ‘See what a good job I’m doing?’”

The business model for biodefense is inherently flawed. Unlike businesses that adapt to market demand, BARDA develops products for crises that may never occur. This leads to what Malone called “psychological bioterrorism,” where fear is stoked to sustain funding. He cited the example of bird flu: “The CDC itself says bird flu is not a major threat to human health right now. Yet, we’re funneling hundreds of millions into it.“

Duplicative Efforts? ASPR, BARDA DHS, NIAID vs. Department of Defense

The Department of Defense (DOD) operates a parallel biodefense infrastructure, historically investing more in bioweapons research than in thermonuclear weapons. Projects at Fort Detrick and other facilities have blurred the line between defensive and offensive capabilities. Meanwhile, NIH funding—driven by NIAID’s expanded role in biodefense—nearly tripled from the late 1990s to the early 2000s. By 2018, NIH’s overall budget had reached over $36 billion, fueled by billions allocated to bioterrorism research under civilian oversight.

Whether this surge was justified by genuine security threats or opportunistic budget expansion is debatable, especially given the systemic inefficiencies and the overlapping efforts between civilian and military programs. ASPR’s budget had been (under Biden) set to explode, both for BARDA and for the Strategic National Stockpile (ASPR SNS). 

Moreover, the SNS budget itself had massively grown after the anthrax attack and scare;

However, those amounts are projected to grow even more massively. To put that red graph in context: we have this prospective 500% increase by fiscal year 2027 (per Biden administration).

ASPR’s Strategic National Stockpile (SNS) is pushing for a multi-billion increase—about a 500% hike over previous funding levels—to transition 13 medical countermeasures (MCMs) by FY 2027. These include therapeutics for Ebola, radiation/nuclear exposure, and smallpox. However, the need for such funding is dubious. Ebola, while deadly, has never posed a widespread threat because people naturally isolate during/after outbreaks, limiting transmission; reinforcing that diseases with high danger/ fatality rates rarely spread widely. Similarly, replenishing MCMs for the mpox response feels like bureaucratic padding for an exaggerated threat. Without clearer justification for the massive budget hike, this looks more like pocket-lining than prudent preparedness.

ASPR BARDA, under the Biden administration, is projecting a staggering >$10 billion budget increase through 2027, aimed at developing medical countermeasures: 86 FDA approvals of pandemic vaccines and novel therapeutics; yet, this sudden end-of-term push feels like a last-ditch attempt to lock in regulatory-capture rewards and promises. It’s reminiscent of a whole life insurance’s estate-tax wormhole: securing interests before political handover. Much like USAID’s boondoggles currently under scrutiny, BARDA’s efforts appear more geared toward cementing pet projects than achieving genuine biodefense preparedness.

With the 2024 election’s shifting leadership to Trump, drastic cuts and reorganizations are on the horizon, targeting (what he may view as) overfunded bureaucracies. Stockpiling critical countermeasures is essential, to some degree, but the current model is unwieldy and exorbitant. Contracts for niche products like anthrax vaccines lock out competition, resulting in bloated costs to sustain companies that exist solely to serve these contracts. The SNS resembles the Romanov czar’s hemophiliac heir—precious, fragile, endlessly protected, yet uncertain to deliver when truly needed.

Without reforms to streamline operations and encourage innovation, this strategy risks leaving us overprepared for yesterday’s threats and underprepared for the crises of tomorrow.

Emergent BioSolutions landed two big contracts for anthrax vaccines—$50 million from ASPR BARDA and a separate $235.8 million deal with the Department of Defense, both in 2024, highlighting a concerning overlap.

Emergent is essentially the sole supplier, with significant leverage, while different federal agencies foot the bill for similar stockpiling efforts. Shouldn’t there be a smarter, more cost-effective balance? “We’re stuck in an artificial market where survival depends on taxpayer dollars, not need,” Malone concluded.

From “Warp Speed” to Long-Term Strategy: Turning Misguided Investments into Biodefense Reform

The U.S. government’s response to Covid-19, particularly its unprecedented push for mRNA vaccine technology, reflects a colossal gamble with long-term consequences. Despite the existence of more erstwhile-proven alternatives (adenovirus-vector vaccines and purified protein-based options by China, India, and Russia), American health authorities placed (nearly) all their chips on the experimental mRNA platform. This was a technology that had never passed full Phase II or Phase III trials, yet it was rushed through under the guise and perceived necessities of “Warp Speed,” sidelining therapeutics and other prophylactic approaches.

The costs of this decision were staggering. Trillions of dollars were spent, while the American public endured unprecedented restrictions: lockdowns, mask mandates, and the closure of schools and businesses. Social and economic repercussions—rising crime, drug abuse, and mental health crises—were compounded by the misuse of vaccines on populations at minimal risk, such as children. In essence, we conducted a nationwide experiment with society as the unwitting subject.

Given this immense investment and the societal upheaval it caused, critics argue that we must extract lasting benefits from this misadventure. Dr. Fauci’s vision of rapid “bug to drug” solutions—intended to achieve effective countermeasures within 24 hours—remains unfulfilled. However, the mRNA platform, flawed as its deployment may have been, offers a potential tool for future pandemics if the infrastructure and production chains can be refined and fortified.

This should prompt a re-evaluation of stockpiling strategies. While a robust Strategic National Stockpile (SNS) remains necessary to guard against critical supply chain failures, the mRNA technology offers the possibility of just-in-time manufacturing. Properly implemented, this approach could reduce our reliance on vast, expensive, and sometimes obsolete reserves. The challenge lies in balancing preparedness with flexibility—ensuring the capacity for both innovation and immediate response without repeating the overreach and inefficiencies seen during Covid-19.

After the forced sacrifices endured by the public, the nation deserves more than a metaphorical “lousy T-shirt” for its troubles. If we cannot mold these hard-learned lessons into a streamlined and effective biodefense system, we risk repeating the same costly errors in the next crisis.

Reform Recommendations: Ending Bureaucratic Turf Wars

The dysfunction in U.S. biodefense stems from overlapping mandates across multiple agencies. ASPR, BARDA, the Department of Defense (DoD), and the Department of Homeland Security (DHS) function like contentious, intermixed step-and divorced parents—fighting for control rather than coordinating efforts. Dr. Fauci’s 2002-5 successful lobbying for NIH/NIAID’s expanded role in biodefense only exacerbated this fragmentation, creating multiple fiefdoms’ vying for dominance.

To address these issues, the following reforms are essential:

1. Unified Oversight and Interagency Coordination:
   Agencies must collaborate instead of duplicating efforts. DHS assesses bioterror threats but lacks the authority for medical countermeasure production, while ASPR and DoD manage parallel programs with limited cross-communication. A consolidated strategic framework would allow one hand to know what the other is doing, reducing waste and ensuring that preparedness aligns with both civilian and military needs.
2. Resource Pooling and Shared Procurement:
   DHS, ASPR, and DoD’s competing biodefense portfolios create inefficiencies and redundant stockpiling. Leveraging shared resources and procurement strategies would allow better bulk purchasing power and reduce reliance on sole-source suppliers like Emergent BioSolutions. A competitive supplier network is critical to drive down costs and prevent monopolistic pricing.
3. Contracting Reform:
   Current biodefense contracting often relies on restrictive Federal Acquisition Regulations (FARs) or loosely monitored Other Transaction Agreements (OTAs), leading to either bureaucratic delays or underregulation. A balanced approach would expedite procurements while maintaining accountability, ensuring taxpayer dollars are better spent.
4. Term Limits for SES Employees:
   Senior Executive Service (SES) members often act as entrenched gatekeepers, obstructing reforms to protect their power. Imposing term limits or abolishing the SES system altogether would reduce this risk, allowing for fresh leadership focused on improving efficiency and innovation.
5. Mission Clarification:
   ASPR must maintain its reactive capabilities, but the current stockpile-heavy approach should be better integrated with a forward-looking strategy focused on prevention and rapid response. The mRNA platform deployed during Covid-19—despite its controversial and rushed implementation—highlighted the potential for rapid-response research and scalable production. While maintaining strategic reserves is essential, this should be paired with nimble manufacturing and research pipelines capable of swiftly developing and distributing new countermeasures. A dual approach—combining preparedness with just-in-time innovation—would optimize both readiness and resource allocation.

By eliminating bureaucratic rivalries and consolidating biodefense efforts, the U.S. can better safeguard against future threats without the current bloated, disjointed infrastructure. Dr. Malone emphasized, “If we stop disease before it develops, we don’t need all the therapeutics and prophylactics.”

The Road Ahead

ASPR and BARDA illustrate a troubling trend in American security policy: bureaucratic sprawl that hinders efficiency and responsiveness. While there are genuine bioweapon threats from nations like Iran and China, et al.—our systems, bogged down by overlapping military and civilian agencies, remain ill-prepared to respond swiftly. The Biological Weapons Convention of 1972, which limits lethal bioweapon research, leaves us vulnerable by disallowing the development of effective countermeasures. Meanwhile, adversaries with no such constraints continue to build and refine their arsenals. On “our team,” there remains Israel, which was never a signatory.

This pattern mirrors other treaties and agreements away from which the U.S. has stepped, such as the SALT nuclear treaty and the Paris Accords. These agreements often limit our capabilities while failing to check hostile actors’. The U.S. may still pursue non-lethal incapacitating agents like viruses that could induce temporary but debilitating symptoms (e.g., headaches, fever, or exhaustion) into opposing armies. This strategy aims to neutralize threats without triggering mass casualties, a workaround in line with international conventions.

Interestingly, as something of an end-around (during the Cold War), the U.S. developed the neutron bomb designed to kill soldiers while sparing infrastructure—allowing the U.S. and its allies to reclaim cities and equipment after a potential rapid Soviet advance across Western Europe. In essence, it was a form of lethal biological warfare by other means.

These examples underscore the relentless human ingenuity in both threat creation and countermeasure development. Unless the U.S. can streamline its biodefense system and balance security with diplomacy, we will continue to play a costly game of catch-up—spending billions only to be left in a precarious position when the next true biothreat materializes.

Special thanks to Dr. Robert W. Malone, whose insights from both private conversations and podcast appearances have greatly informed this analysis– and to Dr. Jill Malone, as well.

ASPR and BARDA: Bureaucratic Dysfunction in Biodefense
by Randall Bock at Brownstone Institute – Daily Economics, Policy, Public Health, Society

Source: Brownstone Institute Read the original article here: https://brownstone.org/