22 January 2019 - Recently, two fundamental aspects of the US FDA’s pharmaceutical market oversight have become controversial. 

First, the FDA created and increasingly uses expedited development and approval pathways, emphasising greater reliance on post-marketing drug data. Some argue that approval standards are becoming inappropriately low and post-approval evaluation too lax.

Second, a court decision and state and federal legislation have chipped away at rules blocking advertising of drugs for non–FDA-approved indications (“off-label promotion”), which leads to patient harm by permitting manufacturers to encourage use of inadequately vetted medications. We surveyed a national sample of primary care internists and medical specialists to characterise physicians’ attitudes on these topics.

Read JAMA Internal Medicine article