Dean M. Harris, J.D., Associate Professor (Retired), Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, USA, Dean_Harris unc.edu

In the US, many public health functions are decentralized to the governments of the 50 states, and the authority (or “competence”) of the federal government is limited by the US Constitution. The interaction between the US federal and state governments is an ever-present source of political and legal conflict, especially on issues such as reproductive health, immigration, the environment, and government regulation.

The official bulletin from the Florida state Surgeon General

In the US State of Florida, the politically-appointed state Surgeon General issued an official bulletin on 3 January 2024. The Florida state Surgeon General, who is appointed by the state Governor and confirmed by the state Senate, is the State Health Officer with responsibility to monitor all aspects of public health in that state. In that official bulletin, state Surgeon General Joseph A. Ladapo called for a stop (a “halt") in the use of mRNA vaccines for COVID-19. That bulletin is available online. On its own, the bulletin of Florida’s state Surgeon General does not have the legal effect of prohibiting the sale or use of mRNA vaccines, either in Florida or elsewhere, and it is not binding on private parties or the federal government. 

According to that state bulletin, the federal Food and Drug Administration (FDA) failed to provide evidence that it had performed an evaluation of "the risks of contaminant DNA integration into human DNA." In addition, the Florida bulletin states that "If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings." 

At the federal level, the FDA had already responded to explain the mistakes in the Florida Surgeon General’s argument. The federal FDA's letter on this issue, dated 14 December 2023, is also available online. As the FDA explained in that letter, “with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.” Other scientists have strongly rejected any concern about DNA in mRNA vaccines.

Although he has degrees as a medical doctor and a PhD, Florida Surgeon General Ladapo has repeatedly taken extreme positions that are outside the mainstream of scientific consensus and global strategy for public health. During an interview on a right-wing podcast on 4 January 2024, Dr. Ladapo described those vaccines as “the Antichrist of all products ….”

Why does this dispute matter?      

Some people might wonder why a controversy in one US state should matter to people who live in other states or other nations. There are several reasons why this dispute could have much broader consequences. First, a significant reduction in the use of effective mRNA vaccines in Florida could have the effect of increasing the spread of COVID-19 within Florida and to other states and nations. With almost 23 million residents, Florida is the third most populous state in the US (after California and Texas). In 2022, almost 10 million people visited Florida from countries outside the US, and presumably returned from Florida to their home countries. Thus, an increase in COVID-19 in Florida could have an adverse effect on other countries.

Second, the extreme type of vaccine skepticism that was expressed by the Florida Surgeon General could easily spread to other states and nations, either by social media or by other means. Like infectious diseases, conspiracy theories do not stop at international borders, and the worldwide marketplace for information includes a worldwide marketplace for misinformation. In its response to the Florida Surgeon General on 14 December 2023, the FDA wrote that “The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake.” 

Third, the Florida Surgeon General and other people might be laying the groundwork for future litigation in US federal courts to challenge the FDA’s approval of mRNA vaccines or the conditions under which the FDA allows those vaccines to be used. It might be part of a broader strategy that could involve filing a lawsuit against the FDA, in an effort to block the use of mRNA vaccines for COVID-19 throughout the entire US (either permanently or at least while a lawsuit is pending). It is difficult to imagine all the consequences of even a temporary stop in the distribution and use of those COVID-19 vaccines, including boosters and updated vaccines, in all 50 US states. According to US government data as of 11 May 2023, only about 70 percent of the US population had completed a primary series of COVID-19 vaccination, and only 17 percent had received an updated (bivalent) booster dose. As of 10 January 2024, the US Centers for Disease Control and Prevention (“CDC”) is recommending the 2023-2024 updated vaccines for COVID-19. As discussed below, some groups and individuals have already filed that type of lawsuit against the FDA about the FDA’s approval of a drug for abortion (mifepristone) and the conditions under which the FDA allows that drug to be used.

The ongoing lawsuit against the FDA about mifepristone

Under the authority granted by Congress, the FDA has the power to approve drugs that are safe and effective. The FDA approved mifepristone for medication abortion under specific conditions, and it made changes to those conditions over time.

In 2022, some anti-abortion groups and individuals filed a lawsuit before a federal district judge in Texas to challenge the FDA’s approval of mifepristone and other FDA actions related to that drug. [1] The federal district court and the federal Court of Appeals for the Fifth Circuit ruled against the FDA on some issues, but the US Supreme Court has allowed that drug to be used while the case is pending.[2] Subsequently, on 13 December 2023, the US Supreme Court agreed to hear that case.[3]

The pharmaceutical industry is very concerned about the possible effects of the mifepristone case on drugs that have nothing to do with abortion. In fact, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) filed an amicus curiae (“friend of the court”) brief in that case to urge the Supreme Court to reverse the decision of the Fifth Circuit Court of Appeals. The industry is worried that a court decision against the FDA in that case could discourage development of new drugs for other uses, because FDA decisions in the past could be challenged easily after drugs have been approved. That is a serious concern, and the US Supreme Court might reverse or modify the decision of the Fifth Circuit for that reason. The current US Supreme Court is not likely to make a decision in that case for the purpose of promoting access to abortion. However, it is likely that the Supreme Court would want to protect the longstanding process for development, approval, and distribution of all pharmaceutical products in the US.

When someone requests a court to review an action by an administrative agency (such as the FDA), it is difficult to convince a court to disagree with an agency’s judgment about a technical issue that is within the scope of the agency’s expertise. In contrast, it is easier to convince a court to reject the decision of an agency if that agency went beyond the limits of its authority or failed to follow proper procedure in making its decision.

In the mifepristone case, one of the grounds on which the Fifth Circuit ruled against the FDA was the alleged failure by the FDA to evaluate an important risk in the use of that drug.[4] In effect, the Fifth Circuit was not directly challenging the FDA’s judgment or technical expertise. Rather, the Fifth Circuit was criticizing the FDA for allegedly failing to consider a different risk or go through the procedural step of explaining why it was not necessary to do so.

In regard to mRNA vaccines for COVID-19, the bulletin from the Florida Surgeon General appeared to emphasize the FDA’s alleged failure to evaluate the risk of DNA integration. Rather than directly challenging the FDA’s judgment or technical expertise, the Florida Surgeon General might be trying to fit his argument about vaccines into the legal analysis and precedents that were relied upon by the Fifth Circuit in the mifepristone case. Of course, the Fifth Circuit opinion will not be the final word on the issues in that case, and we will need to wait for a final decision from the US Supreme Court.

Conclusions

This controversy demonstrates that the conflict between science and politics about COVID-19 is continuing. It also reminds us that politicians are using doctors from the fringes of their fields, in an effort to give the appearance of legitimacy to theories that are far outside the scientific consensus. 

Commentators have noted that some politicians and officials in the US have been  relying on so-called “alternative facts.”[5] This is not simply a disagreement about the truth of particular facts, but rather it is an attack on the basic concept of truth. As Peter Wehner wrote in 2020, “It was to annihilate the distinction between truth and falsity, to make sure that we no longer share facts in common, to overwhelm people with misinformation and disinformation.”  Therefore, it is useful to remember the words of the late US Senator Daniel Patrick Moynihan, (https://www.washingtonpost.com/wp-dyn/content/article/2010/10/01/AR2010100105262.html) who said that "Everyone…is entitled to his own opinion, but not to his own facts."

[1] Zettler, P,  et al, “Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation,” New England Journal of Medicine, (March 9, 2023), 388;10, e29(1)-e29(3).

 [2] Alliance for Hippocratic Medicine v. FDA, 78 F.4^th 210, 2023 U.S. App. LEXIS 21630 (5^th Cir. 2023).

 [3] 2023 U.S. LEXIS 4917 (2023).

 [4] 78 F.4^th at 245-47; 2023 U.S. App. LEXIS at 66-72.

 [5] Pugh, S, et al, “Not without a fight: standing up against the Global Gag Rule,” Reproductive Health Matters, (2017), 25(49):14-16.