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


Dr. David Gortler

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. …


Dr. David Gortler is a senior policy advisor to The Heartland Institute. He’s a professor of pharmacology and biotechnology and former White House appointee who served as Senior Advisor to the FDA Commissioner and the HHS/FDA Senior Executive Leadership Team.


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