By Kelly O'Connell ——Bio and Archives--March 23, 2020
American Politics, News | CFP Comments | Reader Friendly | Subscribe | Email Us
About the legal framework. FDA does what it does because they have the authority to do it, and that authority comes from the United States Constitution...Under the Constitution, there is the authority to enact laws, also called statutes. Congress makes the laws. FDA, as an agency, can then issue regulations and guidance documents as part of the implementation of the laws.
The FDA is a division of the Public Health Service, itself an agency of the U.S. Department of Health and Human Services (HHS). It is the largest consumer protection agency in the world, with regulatory authority over food, drugs, cosmetics, and medical devices. In fact, the FDA's vast authority covers approximately one-third of all items consumed in the United States. Some 25 cents out of every dollar spent in America is spent on products regulated by FDA.Here, the FDA claims to follow the Constitution. Not everyone agrees. For example, the FDA changes its interpretive rules, but pretends it's nothing. Philip Hamburger, in Is Administrative Law Unlawful, disputes the FDA acts constitutionally, claiming administrative agencies are "dangerous and unlawful in ways not conventionally recognized." (See also "Tyranny of the Administrative State" (The Wall Street Journal) and "Unelected Bureaucrats Are Running Our Lives" (USA Today)). Recall the FDA is the 1906 child of Progressivism, pushed by Pulitzer Prize winner Upton Sinclair's novel, The Jungle, an expose of disgusting slaughter house conditions. This work helped bring in truly innovative and necessary standards. But the FDA is now politically motivated, not simply a bureaucracy run with pure intentions on clear scientific standards. One author states, "The FDA is an executive branch agency, the beneficiary of vast legislative powers delegated to it by Congress, a repository of powers not delegated by Congress that FDA has usurped beyond the limits of its enabling statute throughout its 68 year history." The FDA was challenged by Congress, when Senators Ted Cruz and Mike Lee offered the RESULT Act, or Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388) in December 2015. The act allowed drugs already accepted and used in first world countries a much faster 30-day window for FDA approval. Especially for dire public health need. This act failed to pass. It was reintroduced by Sen Cruz in July 2019. Now, TX Rep Chip Roy reintroduces the RESULT Act, with a coronavirus addition.
Support Canada Free Press
I believe in hydroxychloroquine. It's a fascinating drug, used for decades. There were positive results in an in-vitro study and a preliminary Chinese study in 100 patients which showed hydroxychloroquine reduced the viral load, the symptoms lasted less time, and not as severe. This could reduce the number of carriers, which I find interesting from an epidemiological perspective.President Trump, in an epic crisis, must quickly determine if an already approved drug is available. But, playing the devil's advocate – we should not encourage bureaucrats devoid of science or medical training to simply make gut decisions. Yet, the US president has a right to access other non-FDA medical experts to choose if we should send in chloroquine. After all, it wouldn't be irrational to say the gains outweigh the risks. Further, why not let the afflicted choose whether they want to try it during their terrible ordeal, especially in those groups abandoned to die?
View Comments
Kelly O’Connell is an author and attorney. He was born on the West Coast, raised in Las Vegas, and matriculated from the University of Oregon. After laboring for the Reformed Church in Galway, Ireland, he returned to America and attended law school in Virginia, where he earned a JD and a Master’s degree in Government. He spent a stint working as a researcher and writer of academic articles at a Miami law school, focusing on ancient law and society. He has also been employed as a university Speech & Debate professor. He then returned West and worked as an assistant district attorney. Kelly is now is a private practitioner with a small law practice in New Mexico.