
By STEVEN ZECOLA
In its Strategy for Artificial Intelligence (V.3), the Department of Health and Human Services (“HHS”) acknowledges that: “For too long, our Department has been bogged down by bureaucracy and busy work.” HHS promises that it will accelerate artificial intelligence (“AI”) innovation, including “accelerating drug and biologic approvals at the FDA.”
History shows that well-intended but cumulative regulatory intervention – more so than scientific complexity – is the primary deterrent to rapid technological progress. If AI is subject to the typical pattern of regulatory creep, its potential to accelerate drug discovery and development will be significantly reduced. To avoid this outcome, HHS should develop a plan that is premised on a zero-based regulatory approach. That is, each new technology such as AI should start with a clean slate and only the minimum requirements deemed necessary to show effectiveness and safety should be applied in the approval process for that technology.
The Pace of Innovation
Medical innovation has lagged the pace in the other sectors of the economy. As Dr. Scott Podolsky of Harvard Medical School observed: “Medicine in 2020 is much closer to medicine in 1970 than medicine in 1970 was to medicine in 1920.” Podolsky points to breakthroughs such as antibiotics, antihypertensives, antidepressants, antipsychotics, and steroids that have not been met with same impact as innovations in the later 50 years.
Two explanations have been offered for this phenomenon: 1) the inherent complexity of biological processes; and 2) the regulatory approval process.
As a benchmark for comparison to the following case studies, the development of 4G communications spanned less than a decade, with discussions starting around 2001, technical specifications being released in 2004, and the first commercial networks launching in 2009.
Regulatory Intervention in New Technologies
- The Human Genome (Great Science Leads to Regulatory Paralysis)
The Human Genome Project (HGP) ran from 1990 to 2003, and has been lauded as one of the world’s greatest scientific achievements. The project identified the specific location of genes and DNA, creating a “roadmap” of the human genetic code and facilitating the identification of disease-related genes.
The HGP focused on balancing rapid scientific progress with ethical safeguards. Oversight was primarily managed through internal ethical programs and international data-sharing agreements rather than a single overarching legislative or regulatory body.
Under this structure, the HGP beat its target date by two years. That is to say that the complexity of the problem did not cause any delays, and progress was not impeded by the standard drug-approval bottleneck.
However, once the genetic roadmap was handed off for drug discovery and development, progress slowed dramatically.
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