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Congress’s Biotech Unicorn – WSJ

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There’s enough private innovation if the feds don’t fix drug prices.

Photo: Getty Images

It’s hard to recall a greater triumph of private innovation and failure of public health bureaucracies than the pandemic. So it’s bizarre, to say the least, that Members of Congress now want to launch a government healthcare startup to develop technologies that are supposedly too cutting-edge for private industry.

The House last week passed legislation by a 336-85 vote that would establish the Advanced Research Projects Agency for Health (ARPA-H) within the Health and Human Services Department to invest in biomedical research. Isn’t that what Congress gave the National Institutes of Health $45 billion this year to do?

Congress says NIH is slow, bureaucratic and risk-averse. They have a point. A Johns Hopkins study last year found that only 2% of the NIH’s 56,169 grants in 2020 went to Covid-19 research. That’s because the agency dithered on grant applications and required multiple reviews by as many as 20 scientists.

Some researchers compare the NIH grant application process to college admissions—secretive, often arbitrary and occasionally nepotistic. The NIH grant process needs streamlining. But the solution isn’t to create a new agency that could supplant some private investment.

The House bill gives the agency wide discretion to “foster the development of new, breakthrough capabilities, technologies, systems, and platforms to accelerate innovations in health and medicine that are not being met by Federal programs or private entities” and “promote high-risk, high-reward innovation.”

But private industry is taking enormous risks, such as mRNA technology. Biotech startups and drug makers are spending billions of dollars to adapt the mRNA platform to produce personalized cancer vaccines, regenerative medicines (rebuilding damaged tissue) and autoimmune treatments, among other uses.

Large drug makers invest more than $90 billion annually in research and development. Last year life sciences venture-capital funding—which is what most small biotech startups rely on—hit a record $33 billion. Some 260 vaccines are in the pharmaceutical pipeline, and more than 1,300 gene and cell cancer therapies are under development.

There’s no shortage of private risk-taking. But there is a substantial risk that government policies could squash private investment by reducing the rewards for innovation—i.e., profits. Democrats are threatening drug price controls. Progressives are calling for the feds to strip patents from drugs they deem too expensive. This could include mRNA treatments.

The Centers for Medicare and Medicaid Services set an ominous precedent this spring when it refused to cover Biogen’s novel Alzheimer’s drug Aduhelm—the first treatment shown to slow disease progression—outside of a randomized controlled trial. This was the first time CMS contradicted a Food and Drug Administration drug approval.

Let’s hope the opposition to high-priced drugs like Aduhelm doesn’t cause the FDA to revert to its old, risk-averse habits. Canada this month approved an experimental amyotrophic lateral sclerosis (ALS) drug that slowed disease progression by 25% over six months in a clinical trial. But the FDA is wavering on approval after critics trivialized these benefits.

The U.S. doesn’t need another bureaucracy to fund new technologies. We need the existing bureaucracies to encourage private innovation. Politicians on both sides of the aisle nowadays seem to think that the U.S. needs to use industrial policy to compete with China. But China’s only pandemic innovations were lockdowns and surveillance.

Congress allotted $1 billion in the omnibus spending bill for seed funding for the new government healthcare startup, but it doesn’t have to sink more.

Journal Editorial Report: Joe Biden supports expanding the central bank’s mandate. Images: AP/Getty Images/Reuters Composite: Mark Kelly

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Appeared in the June 27, 2022, print edition.



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