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Dennis v. United States, 341 U.S. 494 (1951), was a United States Supreme Court case relating to Eugene Dennis, General Secretary of the Communist Party USA.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified ...
- The Pre-History of EUA
- The Enactment and Early Years of EUA
- EUAs Against Covid-19
- Historical Reflections
- Beyond Covid-19
The first event to foreshadow the major themes surrounding FDA’s EUA power was the Thalidomide tragedy of the mid-20th century. In the 1950s, a new drug called Thalidomide was put into circulation in West Germany and other countries as a treatment for morning sickness. The next decade would reveal that the drug resulted in severe birth defects, wit...
Ultimately, it was the War on Terror that would give rise to emergency use authorization. After the events of September 11, 2001 and subsequent anthrax mail attacks, Congress enacted the Project Bioshield Act of 2004. The act called for billions of dollars in appropriations for purchasing vaccines in preparation for a bioterror attack, and for stoc...
Then came COVID-19. In February 2020, HHS Secretary Alex Azar declared the pandemic a national health emergency warranting emergency use of in vitro diagnostics, followed by subsequent declarations in March warranting emergency use of other countermeasures. Since then, FDA has issued nearly 400 EUAs for personal protective equipment, medical equipm...
Looking back through the history of EUA, two key themes emerge. The first concerns the influence of the President on FDA decision making: sometimes in ways that seem motivated by the public interest, other times by political or personal interest. As the swine flu affair of 1976 demonstrates, President Trump is not the first president to have presse...
Lawmakers and policymakers place great value in precedent, whether written or historical. There is almost no precedent to guide FDA’s use of this relatively new power, let alone during the greatest public health crisis the agency has ever faced. On the contrary, the history of EUAs points up essential dilemmas that aren’t going away, and that will ...
Dennis v. United States, case in which the U.S. Supreme Court on June 4, 1951, upheld the constitutionality of the Smith Act (1940), which made it a criminal offense to advocate the violent overthrow of the government or to organize or be a member of any group or society devoted to such an advocacy.
- The Editors of Encyclopaedia Britannica
Aug 28, 2021 · The purpose of an EUA is to allow for the use of unapproved medical countermeasures (MCMs) to diagnose, treat, or prevent serious or life-threatening disease or condition in response to a public health, military, and domestic emergency [ 3 ].
- Allan Tran, Theodore J. Witek
- 2021
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the...
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats...
