Ethics & Public Policy Center

The FDA Under Biden – Here’s How Drug Safety, Public Health Issues Are Being Compromised

Published in Fox News on March 20, 2021


As a former FDA drug safety expert during the Trump and Obama administrations, I’m worried about the safety of our public health in 2021. And I’m not talking about COVID-19.

Thanks to the Donald Trump administration’s brilliant endeavor to collaborate with Pfizer and Moderna, and extraordinary efforts of every scientist at Operation Warp Speed, we will soon have the horrible Wuhan, China, pandemic in our rearview mirror. (I find it sad and offensive that Barack Obama glibly dismissed the massive efforts that led to the novel ingenuity behind the COVID vaccine development as “not rocket science.”)

Most politicians like Obama only vaguely understand pharmacology and drug development. As a scientist, I’m therefore concerned today because along with scores of other political appointees, I was abruptly shown the door the minute Joe Biden was sworn into the White House, even though he didn’t – and still doesn’t – have an FDA commissioner or senior advisor replacement for us.

That’s hard to believe, but it’s true. As a result, the critical and nonpartisan public health projects that we’d been working on under the Trump White House came to an unceremonious, grinding halt.

The Biden administration didn’t care about our epidemiology and drug safety initiatives – they just wanted us gone. This was profoundly unfortunate and has adversely affected America’s public health.

As a pharmacist, I had conceived of and founded the world’s first “analytical pharmacy,” which measured the milligram strength and purity of our pharmaceutical products, and was hoping to implement this strategy at the FDA. That could have benefited all Americans.

Alarmingly, our nation has become dependent on China and India to produce many of our pharmaceuticals over the past decade. Overseas labor is cheap, quality is a mystery, FDA inspections are rare and aggressively unwelcome, and the falsification of quality control data by bad actors is much too easy.

That is why I’d been working on requiring independent analytical “release testing” for imported pharmaceuticals as the new safety standard at the FDA. Right now, nobody is comprehensively testing the quality of our drugs from China and India. It’s outrageous, right? Yet such work is critical to ensuring the safety of the American public.

For over a year, and with assistance of others I’d been laboring on advancing the following tasks – which have been dissolved and are no longer underway thanks to the Biden administration:

  • Advancing state-of-the-art human tissue micro-plating research to expedite drug discovery. This technology could also eventually eliminate outdated and cruel animal testing that’s currently mandated by the FDA. All Americans love their pets – and animal testing has never been all that enlightening with regard to human drug safety, despite the massive kill rate.
  • Clearly labeling pharmacy bottles so that each drug’s country of origin is identified, giving consumers transparency and a choice about where their pharmaceuticals come from.
  • Returning pharmaceutical production back here to the U.S., so that it can be better monitored for safety and quality control and we can bring back high-paying jobs for pharmaceutical scientists.
  • Implementing outside ethics oversight at the FDA. Accountability must be a cornerstone of public service – and right now, at the FDA, when bad decisions are made, there is noaccountability.

This partial list represents a mere 20% of the FDA initiatives that were ongoing during the Trump administration.

The Biden administration’s instant political dismissal of key public health and FDA safety programs, without any reasonable transition, not only dissolved great ideas and threw away decades of expertise and insight – it wasted taxpayer money. The protection of public health should never be regarded as “conservative” or “liberal,” red or blue, Republican or Democrat.

Specialized FDA drug development training and understanding takes decades to cultivate. You can’t just bring in someone “new” of your own political persuasion to handle it, with zero transition of ongoing projects.

The safety of Americans’ health isn’t – and shouldn’t be – a polarizing issue. It’s not in any way similar to such issues as taxes, immigration policies, guns or military spending, where there are differences of policy and opinion.

Who out there can argue against having the safest pharmaceuticals we can possibly have? Who can argue against verified and transparent quality control of the drugs we need for our health? Who can argue against knowing exactly where, and from what countries, our medications originate?

These are urgent issues of decency, practicality and just plain old good sense. They should have been treated as such by the Biden administration.

The safety of American citizens is at stake right this minute.

Dr. David Gortler is a former Yale University professor of pharmacology and biotechnology, who previously served as an FDA medical officer/analyst and FDA drug, device and vaccine safety expert. He was appointed by the White House to the FDA Senior Executive Leadership Team and served as senior adviser to FDA Commissioner Dr. Stephen M. Hahn. Dr. Gortler is now a senior FDA safety analyst at www.FormerFDA.com.

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