Omnibus Threatens Public Health (Commentary)

The glut of pork and woke spending loaded into the lame-duck omnibus spending bill included $1.5 billion in taxpayer funding for something called the Advanced Research Projects Agency—Health (ARPA-H).

ARPA-H didn’t exist before March 2022. But this obscure agency cannot be ignored because it was supercharged by the omnibus bill President Biden signed into law on December 29, and could have deadly consequences for public health.

By statute, ARPA-H’s mission includes “promot[ing] high-risk, high-reward innovation for the development and translation of transformative health technologies” by “supporting … acceleration of transformational health technological advances in areas with limited technical certainty.”

Most competent health authorities will agree the words “high risk” and “limited technical certainty” should never be considered positive features when discussing public health, but ARPA-H embraces them with gusto.

It is precisely this sort of reckless thinking that got us into funding “gain of function” experiments with deadly viruses—including, it appears, high-risk research that might have led to the creation and escape of the COVID-19 virus at the National Institutes of Health-supported Wuhan Institute of Virology.

New Runway

Under the omnibus bill, ARPA-H will be plucked out of the National Institutes of Health (NIH), where it currently resides and established as “an independent operating division within the Department of Health and Human Services” (HHS).

This is clearly meant to allow ARPA-H to operate outside the purview of HHS’s other operating divisions—including the NIH, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Indian Health Service (IHS), and the Centers for Medicare and Medicaid Services (CMS).

All in all, ARPA-H is designed to sidestep over a dozen different agencies and almost 100,000 scientists, researchers, nurses, pharmacists, physicians, and support staff. ARPA-H is purposely hostile to existing structures, so much so, the omnibus all but bars it from hiring future staff from NIH.

Additionally, the ARPA-H director will have a renewable, four-year term of office and, in a move of dubious constitutionality, would be insulated from any requirement to submit “for approval or review” any personal recommendations to Congress regarding ARPA-H’s activities, whether or not they conflict with presidential policies.

Silicon Valley Imitator?

But to what end is all this independence?

It is to empower ARPA-H to mimic Silicon Valley “disruptors” and jam its risky ventures through or around existing public health safety structures. The bill sets up an advisory committee that includes FDA, CDC, NIH, and others, but clarifies that the committee will have no authority whatsoever over ARPA-H’s activities.

Although the law grants the FDA—America’s premier agency in charge of drug approval and medical device safety—the ability to meet separately with ARPA-H, it specifies that it must be only to discuss “actions that may be taken to facilitate the development of medical products and projects that are the highest priorities to ARPA-H.”

If that isn’t enough pressure on FDA to do ARPA-H’s bidding, the law further requires ARPA-H to “reimburse” the FDA for any activities it conducts as a result of these prioritization meetings. In short, FDA is expected to regularly meet with ARPA-H to get its marching orders and then get paid every time it completes them.

This structure so erodes the independence of the FDA as to be laughable if it weren’t so dangerous.

COVID Shots, Lesson Learned

As extensively cataloged by our Ethics and Public Policy Center colleague Aaron Kheriaty, public health authorities shamefully lowered standards and hid relevant safety information for the sake of political expediency when it came to the COVID-19 vaccines, and the last thing we should do is make such cutting of corners a permanent feature of our public health apparatus.

One can only imagine the deadly dangers to be unleashed when an ARPA-H director pushes for “high-risk” approvals of drugs or vaccines in an environment of “limited technical certainty,” such as during a pandemic. Under the omnibus bill passed by Congress, ARPA-H will have a $1.5 billion budget to play with as a non-emergency baseline.

Yes, FDA can and should improve its drug safety record and its speed of approvals. But injecting ARPA-H’s gotta-break-some-eggs-to-make-an-omelet ethos into the mix is not a solution but a recipe for disaster, much like the rest of the omnibus bill.

David Gortler, Pharm.D. (dgortler@eppc.org) is a pharmacologist, pharmacist, FDA, and health care policy scholar at the Ethics and Public Policy Center. Roger Severino is vice president of domestic policy and The Joseph C. and Elizabeth A. Anderlik Fellow at The Heritage Foundation.

A version of this article appeared in The Daily Signal on December 21, 2022. Reprinted with permission.