Better Breathing Through Bureaucracy: The FDA’s Half-Century Phenylephrine Saga

In September 2023, a Food and Drug Administration (FDA) advisory panel informed the agency that, 50 years after the FDA certified phenylephrine hydrochloride as a safe and effective oral decongestant, the evidence suggests it works no better than a placebo. The advisory report came several years after a couple of academic pharmacists had reviewed the research behind the 1970s FDA claims and determined the evidence of efficacy sorely lacking. As I wrote in a blog post that month and a month later in a USA Today column, stomach and intestinal juices break down ingested phenylephrine, rendering it inactive. I hypothesized that, despite the pharmacists' warnings, the FDA dragged its feet reviewing phenylephrine's efficacy because it didn't want to undermine another federal agency's efforts to wage war on methamphetamines.