> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Industry Defense Shows FDA is ‘Politically Impaired’: Column
- URL: https://www.fdaweb.com/industry-defense-shows-fda-is-politically-impaired-column/
- Published: 2020-09-10T12:00:00.000Z
- Updated: 2026-09-14T16:28:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147622

New York University School of Medicine professors **J. Russell Teagarden** and **Arthur Caplan** say the recent joint statement from nine leading drug and biotechnology companies that they will not distribute a Covid-19 vaccine before its safety and effectiveness have been firmly established means “there’s no question that FDA is politically impaired.” Writing online in a *Stat* opinion [column](https://www.statnews.com/2020/09/10/hell-has-frozen-over-pharmaceutical-industry-stands-in-for-politically-impaired-fda/?ref=fdaweb.com), the two say that FDA leaders have done little to convince the public they will not capitulate to pressure from the Trump administration.

They describe the questions that arose with approval and subsequent revocation of an emergency use authorization of hydroxychloroquine and chloroquine, Operation Warp Speed on vaccine development, and the administration’s public display of pressure of FDA leaders to approve a vaccine before the 11/3 presidential election.

“Trust in FDA is an essential ingredient in introducing new drug therapies and successful vaccination programs,” Teagarden and Caplan write. “People won’t have confidence in medicines or vaccines that have not been evaluated by a credible and independent source.”

With FDA being damaged, they say, it is the long-term reputational risks and business motives of the pharmaceutical industry that are left to prevent a collapse in public trust. With vaccine makers sensing this could be an issue as large numbers of Americans express hesitancy about Covid-19 vaccines in development, companies are pledging to withhold their vaccines from commercial distribution until they are satisfied they can be used “with the confidence FDA is otherwise expected to generate,” the article says.

Teagarden and Caplan say that despite their combined eight decades of healthcare experience, “we never would have expected to see the pharmaceutical industry feel compelled to step into the role FDA is mandated to fill. It is ironic and tragic at the same time.”

They say the situation could be reversed. “Leadership at FDA strong enough to withstand pressure from an administration attempting to bend the agency to its political will, or an administration that would not pressure the agency to bend in such a way, could eventually win back public confidence,” they conclude. “The American people should have confidence that FDA will protect us from half-baked or potentially harmful therapies. It’s unconscionable that we must rely for that instead on protection fueled in part by the business objectives and reputations of pharmaceutical and biotech companies.”