The Agency's drug approval and enforcement actions are falling through the cracks, while regulators are squandering time and resources on insubstantial trivia.
The agency's primary functions are ensuring food safety, regulating tobacco products rationally, and expeditiously approving new drugs and medical devices. It's failing. Instead, we're getting increasingly complex organizational structures and the commissioning of endless reports.
There's a new, proven treatment for COVID-19 called pegylated interferon lambda, but FDA won't approve it, even under Emergency Use Authorization. It's inexcusable.