Over its 114-year history, the U.S. Food and Drug Administration has become a global paragon when it comes to drug regulation. In the most consequential year of its existence, however, the agency—and its rookie director—was besieged and almost swallowed by all manner of Trump cronies pushing pet projects, according to new interviews and previously undisclosed documents. A special report.
As Dr. Stephen Hahn, commissioner of the Food and Drug Administration, stepped to the White House lectern on March 19, for his first star turn in the Trump administration’s pandemic response, he seemed alert to the risks of serving as the president’s “miracle cure” consigliere. That day President Trump was touting an old malaria drug, hydroxychloroquine, for showing “tremendous promise” against COVID-19, lavishing praise on Hahn as “fantastic” for moving swiftly and slashing red tape to make the drug more widely available. Beaming from the acclaim, and introducing himself to a panicked nation, the affable former oncologist spoke of his own medical background. “One thing that was really important is to provide hope,” he said. “What’s also important is not to provide false hope…. And as a doctor, that’s the way I come to this.”
He then made a point that he’d repeat throughout the coming months: The FDA would rigorously follow data in approving only safe and effective treatments. In other words, despite the frantic search for COVID-19 remedies, there would be no back door to FDA approval: Every product would get the same scrupulous scientific vetting, regardless of who was pushing it.