Can The President Override The FDA In Emergencies?

"I want a new drug," said Huey Lewis. But Americans increasingly demand an older medicine, Hydroxychloroquine, while coronavirus enfeebles victims across America. 'Chloroquine' is one of the oldest and best-known anti-malarial drugs and appears effective against COVID-19. President Trump advocates chloroquine. Since the drug is US Food and Drug Administration approved for humans, and effective in China, why not offer it to Americans? Because it is not approved for use outside malaria. Wait. What?!!

This embargo is silly.  Can we challenge the FDA's moratorium to quickly help coronavirus patients? Presidents do not have direct control over the decision making of administration agencies.  Despite effectiveness of chloroquine, the FDA initially stated, "There are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19." Then, FDA Commissioner Dr. Steve Hahn changed course, stating: "The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19." But the FDA wants a big clinical trial to determine "effectiveness, right dosage and administration." How much longer will such testing take?  Newt Gingrich called the FDA the nation's top job-killer and a "prison guard" stopping a "healthcare breakout." But Obama's FDA chief Robert Califf stated: "Unfortunately, too many of the decisions made today about health and health care are not supported by high-quality evidence, because there is such a limited amount available." So could Trump just overrule the FDA? He might, but at what cost? We know Trump doesn't want another political war in the mid-coronavirus crisis.  The FDA explains its own legal authority on its website, by powerpoint summary:

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. 

---

Describing the agency, the Heritage Foundation states: 

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

---

So, what can President Trump do to rein in the FDA permanently? First, explain to Americans that the FDA is an active member of the DC swamp. Second, get behind the RESULT Act and push it related to coronavirus. Third, recall this agency is political and that his office has oversight duties. Specifically, via Office of Management and Budget (OMB), the president must oversee regulatory agencies.  The president has the duty to examine "the  most  significant agency rule making actions" of the administrative agencies, and "this form of presidential oversight  of  rule making  is  now  well  established." The crucial question is whether medicines  can be quickly approved in a fast-developing and unprecedented health crisis. This question cannot just belong to a subsidiary agency, but must be subject to the democratic process and unitary presidency. In fact, some even argue governors have the power to defy the FDA. Christian Perronne, department head of infectious diseases, University Hospital Raymond Poincaré, Garches, Paris, was optomistic: 

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? 

---

I Want A New Drug