President Joe Biden, who has a portrait of President Franklin Roosevelt hanging in the Oval Office, has made it a mission to fight the new pandemic by adopting a scientific approach to governing. At the same time, he is focusing on scientific research to improve the technological capability of various regions and industries to develop a great future for the United States.
In his draft budget for 2022, he proposes increasing the budget for scientific research agencies by nearly 20%, including: the establishment of a special entity by the National Institutes of Health to focus on cancer, diabetes, Alzheimer’s disease and other diseases related to extended life expectancy and the rights of various ethnic groups; as well as the commitment of the Centers for Disease Control to promote the health care of the socially disadvantaged, allowing lower socioeconomic classes to participate in the health care industry and local elderly care. In addition, the National Science Foundation, the National Oceanic and Atmospheric Administration and perennially impoverished NASA have also received considerable budget increases to continue to advance research and policy-oriented technology transfer related to national security and climate change.
Another policy stance that draws attention is Biden’s decision not to cancel the steel and aluminum tariffs imposed by Donald Trump, even in the face of economic recovery, which has led to a significant increase in the demand for manufacturing and fabrication of steel. Biden has also revoked the permit for the construction of the Keystone XL pipeline for oil transport. These curbs on energy-intensive or highly polluting industries were part of Biden’s campaign, and are necessary for the U.S., newly returned to the Paris Agreement, to reaffirm its position on carbon reduction.
Biden has also halted the relaxations on the 510(k) reporting process for the sale of 83 medical devices, medical applications and personal protective devices, personally issued during the last week of Trump’s presidency by then-U.S. Secretary of Health and Human Services Alex Azar. It is clear that the application of artificial intelligence and deep learning to software development in the medical industry has been a hot spot for biomedical technology startups and investments in the recent past.
What is interesting is that, in addition to Roche, major pharmaceutical companies and organizations, including the American Medical Association and various radiology and medical imaging organizations, have rallied against the implementation of the executive order.
Under the U.S. Federal Food, Drug and Cosmetic Act,* competing manufacturers of newly introduced products that were commercially available before 1976 or that are currently in compliance, effective and have had their safety classification requirements reduced are not subject to Food and Drug Administration review. However, they must undergo a premarket approval process and are obliged to submit to testing and to provide consistent efficacy information in the future.
Due to the outbreak of COVID-19 in 2020, the review and approval process was temporarily relaxed due to the lack of respirators and personal protective equipment at the time. Curiously, however, the list of permanent relaxations has not been subject to any consultations with national research institutions, not to mention that they include a significant number of newly-developed devices — especially the release of medical software relying on artificial intelligence and cutting-edge imaging equipment.
Just last week, Biden’s Cabinet rescinded the former secretary of health and human service’s order relaxing the exemption for major new kinds of medical equipment, and at the same time repealed the Trump-era ban on federal subsidies for research using embryos.
From internal administration, vaccination progress and expanded infrastructure programs, all the way to strengthening NATO, diplomacy and the full-scale withdrawal of troops from Afghanistan, Biden’s 100-day plan may seem to be wrapped in fog, but is actually a very clear dismantling and target positioning.
In addition, Biden has made efforts to motivate the public, build trust and mutual assistance, as well as in scientific and technological research and economic consolidation — all during these first 100 days ending before the end of April. Biden may be old, but he is still in high spirits.
*Editor’s note: The original Federal Food, Drug and Cosmetic Act was passed by Congress in 1938, and has been amended many times since then.