“The FDA Is Not a Physician!”

By

Julio Gonzalez, M.D., J.D.

In an opinion addressing whether physicians have the right to sue the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”), a panel from the Fifth Circuit Court of Appeals pithily declared that “The FDA is not a physician,” last Friday.  The Fifth Circuit is the same appellate body that ruled the FDA needed to reevaluate the drug authorization amendments it issued regarding mifepristone, agreeing with the arguments made by the USMA in its amicus brief.

This present case arose from the public treatment by the FDA of physicians prescribing ivermectin for the treatment and prevention of COVID-19.  Drs. Robert L. Apter, Mary Tally Bowden, and Paul E. Marik contended that official comments made by the FDA advising patients not to take ivermectin for COVID-19 represented illegal actions on the part of the FDA.  These comments included social media posts stating, “You are not a horse.  You are not a cow.  Seriously, y’all.  Stop it,” referring to the use of ivermectin in livestock.  The physicians alleged that, through their comments, the FDA and HHS caused reputational harms to them and interfered with their abilities to practice medicine.  According to the physicians, although the FDA has the authority to regulate drugs, it cannot interfere with a physician’s ability to prescribe medications in an off-label manner.  Additionally, the physicians aver, the FDA and HHS purposely misled the public by concealing the fact that ivermectin, although used in livestock, is also available for human consumption. 

However, in order to sue the government, the physicians needed to pierce the normal restrictions protecting the government from litigation.  In this case, the plaintiffs were trying to use a legal exemption to the sovereign immunity rule called ultra vires allowing one to sue the government when it overstepped its legal bounds.  Of course, Dr. Apter et al. argued that they did have the ability to sue the FDA and HHS in this case because the agencies were acting outside of the scope of their legal authorities when they tried to regulate physicians’ off-label use of ivermectin.  The lower court disagreed and held that the physicians were prohibited from doing so.  In a stunning reversal Friday, the Circuit Court overturned the lower court’s decision and mandated that the case move forward.  The development was a major win for the physicians in their efforts to seek restitution and injunctions against the agencies.

Regardless of the court’s ruling in this case, physicians are indeed the victims of an intellectual and administrative pandemic that still grips the country, namely the erroneous malediction infesting agencies, government officials, and third-party payers inappropriately convincing them that they have the authority to interfere with a doctor’s judgment in treating patients. 

The problem is not limited to non-physician agencies, as it has also infected our major national accrediting boards.  In one ongoing case, Dr John Littell, a Florida family practice physician, had his board certification revoked because of his positions regarding the treatment of COVID-19 and vaccinations.  Dr. Littell is otherwise in excellent standing in the State of Florida but has been brutally attacked by the American Board of Family Medicine (“ABFM”) only because he vehemently disagrees with that organization’s positions regarding the treatment of COVID-19.  Earlier in 2023, the ABFM revoked Dr. Littell’s board certification causing significant harm to his abilities to practice medicine, particularly in hospitals.  However, Dr. Littell fought back, and On September 3, it was reported that his credentials had been reinstated by the Board. 

The tribulations experienced by Drs. Littell, Apter, Bowden, and Malic stand as evidence of the surprising ease with which government agencies and even some organizations supposedly run by our colleagues coerce physicians into compliance with those issues they feel are politically expedient.  Never in the history of American medicine has such deceitfully guised political persecution been launched against American physicians.  It is time for this assault on independent thought and scientific inquiry to stop. 

Please join the USMA and help us effectively check the war being waged against scientific freedoms and physician autonomy. 

Visit the USMA by going to usmedicalassocation.org, or our sister organization, USMAAction.org and join us.  Let us save our profession for ourselves, our patients, and our posterity. 

Dr. Julio Gonzalez is an orthopaedic surgeon practicing in Venice, Florida, and a former Florida State Representative.  He is President of the United States Medical Association.