The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC).

In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.

Claims, from Democrats and Republicans alike, that the FDA is, or isn’t, authorizing the emergency use of COVID-19 products because of political pressures rather than science do nothing but fuel the public’s distrust of the agency. And sudden, unexplained changes in CDC guidelines for testing create more confusion in an already chaotic environment.

Together, the distrust and confusion may have dire consequences in a pandemic that’s expected to surge, even as potential, and much-needed, vaccines loom on the horizon.

President Donald Trump’s frequently expressed hope of seeing a COVID-19 vaccine granted an emergency use authorization (EUA) before the November election has raised fears that the FDA will be pressured into granting an EUA before the agency is satisfied with the safety and benefit of a candidate. The political response, magnified by social media, reinforces those fears and will make it a reality even if it isn’t.

In an Aug. 24 letter to FDA Commissioner Stephen Hahn, Democratic leadership of the House Energy and Commerce Committee questioned whether the FDA, under Hahn’s leadership, would truly follow the science in ensuring a vaccine candidate is safe and effective before allowing its use.

“Given the time necessary to enroll and conduct phase III clinical trials as well as the duration of minimum safety monitoring requirements laid out in FDA’s [COVID-19 vaccine] guidance, licensure of a COVID-19 vaccine will be unlikely before spring 2021,” Reps. Frank Pallone (D-N.J.), Diana DeGette (D-Colo.) and Anna Eshoo (D-Calif.) said in the letter.

While the lawmakers acknowledged that an EUA could be granted earlier, the letter suggests that any such emergency authorization likely would be driven by political expediency, despite Hahn’s commitments to the contrary. Consequently, even if the science were to support an EUA, a vaccine allowed for emergency use this year will be tainted by politics. And what’s been a growing vaccine hesitancy will turn into vaccine shunning – not just for COVID-19 and this administration, but for other infectious diseases in future administrations.

Other actions this week that led to political mud slinging included an update in the CDC’s guidelines for COVID-19 testing and the grant of an EUA for convalescent plasma. The testing update, posted Aug. 24, clarifies when asymptomatic people should be tested for the coronavirus. Only those who have been referred for testing by their doctor or state health officials or those who have had close contact with someone with confirmed COVID-19 should be tested if they’re asymptomatic, according to the update. It defines “close contact” as being within six feet of an infected person for at least 15 minutes.

Posted with no explanation or justification, the CDC update has stirred considerable political controversy, with critics saying it raises the bar for testing, will lead to misleading reporting of COVID-19 cases and will help spread the coronavirus by interfering with track-and-trace efforts. It also was a reminder of a Trump quip awhile back at a media briefing that maybe the U.S. should slow down its testing program so there would be fewer new cases to report.

With the EUA for convalescent plasma coming just a few days after Trump wondered aloud if it were being held up for political reasons, the timing of it gave rise to more accusations that the FDA was serving political purposes rather than ensuring public health.

Along with the concerns over the EUA’s timing, the accusations themselves undercut the FDA’s integrity, second-guess its decisions and threaten its EUA authority, which was strengthened under the 2013 Pandemic and All-Hazards Preparedness Reauthorization Act.

Without EUAs that allow the emergency use of unapproved medical products or unapproved uses of approved medical products when there are no adequate, approved and available alternatives, the nation will be even less prepared for the next pandemic.

And without public confidence in the FDA’s decisions, the best science in the world will be useless. We cannot afford for the FDA and other government health agencies to become part of the political morass.

No Comments