Biden’s Goals for the 1st 100 Days from the Lens of US Technology Policy

Published in UDN
(Taiwan) on 18 April 2021
by Lu Hsinchang (link to originallink to original)
Translated from by Pinyu Hwang. Edited by Elizabeth Cosgriff.
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.


在橢圓形辦公室內掛上富蘭克林總統肖像的美國總統拜登,標榜要以科學治國的態度來對抗新冠疫情;同時,藉重科研實力來改善各地區和產業的技術含量,發展成美國大未來。

僅從他2022年度的預算草案,提議擴增近二成的預算給相關的科研單位,內容包括:由國家衛生研究院成立專責單位,全力在癌症、糖尿病、艾罕默症等等,與壽命延長和族群權益攸關的疾病防治;由疾病管制局負責帶動社會弱勢的投入,讓低社經階層參與醫護產業與在地養老。此外,國家科學委員會、美國海洋與氣象局,以及長年叫窮的太空總署也取得相當的預算增加,可以從國家安全與氣候變異的角度,繼續推進研究與作成政策性的技術移轉。

另外頗引人側目的政策立場,自然是不取消由川普所開徵的鋼、鋁關稅,即使面臨到經濟復甦,而讓製造業與營造鋼鐵的需求,大幅增加;同時,更撤銷了石油輸送的拱心石管道(Keystone Pipeline)建設許可。這些對高耗能或是高汙染產業的抑制,既是拜登的競選政見、也是回歸到全球氣候峰會的美國,重新確認與盟邦減碳的立場一致,必要有的付出。

再就是廢止在川普下台前的最後一周,由當時的衛生部長阿查爾(Alex Azar)所親下指令,進一步放寬對於83種醫療器材、醫療應用軟體和個人防護裝置等的銷售,做510(k)的程序申報。誠然,將人工智慧(AI)與深度學習(DL),應用於醫療產業的軟體開發,本來就是生醫科技於晚近做創業或投資時的大熱點。

有趣的是,除了羅氏藥廠之外,各大藥廠和包括美國醫學會、放射科學會與醫療影像組織,都群起反對這項行政命令的執行。

根據美國醫藥與食品管理法令,但凡1976年以前即已在市面上流通,或是現成合規、有效、且已被降低安全分級要求的醫療產品,那麼新推產品的競爭廠家,並不需經由食品藥物管理局做審核。但必須進行在銷售前的申報程序,以及有義務在日後,接受不定期查驗和提供相符的成效資料。

由於2020年間面臨到的新冠疫情,當時因為缺乏呼吸器與個人防護裝置的大震撼,本來在審核與通報程序已有暫時性的放寬。但詭異的是,這批永久放寬的清單,卻並未與國家級的研究機構做過意見諮商;何況還夾帶相當數量的新開發器材,尤其是人工智慧的醫療軟體與在尖端影像設備上的變相放行。

就在上周,拜登內閣一方面是撤銷前衛生部長的命令,放寬重大前沿醫材可以不做申報;在另一方面,於川普時期禁止以聯邦補貼款,來進行使用到胚胎的相關研究,這項禁令也一併被廢止。

從內政管理、疫苗注射進度與擴大基礎建設計畫,一路到要壯大北約、盟邦外交與自阿富汗撤軍的全面開展,拜登總統的百日維新,有如千絲萬縷的霧裡穿梭,卻有著極其明確的拆解與目標定位。

何況更有在人心帶動、信賴互助,以及科技研究與經濟整建的良好企圖,四月底之前的第一個一百日,拜登總統或許老邁,但仍然是意氣風發。
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