FDA Oversight of Clinical Trials Has Fallen Drastically Under Trump Compared With Obama

Document Type

News Article

Publication Date

2020

Keywords

Food and Drug Administration, Clinical Trial Research, United States

Abstract

The U.S. Food and Drug Administration (FDA) reportedly sent fewer warning letters to scientists over how they were conducting clinical trials during the Trump administration when compared with the tenure of his predecessor, Barack Obama. Experts fear this may indicate the agency's authority is being undermined.

During the first and final three years of the Obama presidency, 99 and 36 warning letters were sent due to serious transgressions in clinical trials, according to an investigation by the journal Science. In contrast, 12 were sent in the first three years of the Trump administration.

Science reviewed 1,600 FDA inspection and enforcement documents for trials found to violate rules and the law. Most of the documents were obtained via FOIA requests. The report assessed the entirety of Obama's presidency and the first three years of President Donald Trump's term.

Comments

Professor Matthew Herder was interviewed for this news article. He is quoted at paragraphs 15-18.

Link to Full Text

Share

COinS