House panel probes FDA’s handling of OTC cold medication

House Republicans query FDA delay in addressing OTC cold drug efficacy
FDA: Some oral phenylephrine ineffective; drug found in Sudafed, NyQuil
Despite report, health workers note meds can still alleviate other symptoms

Updated: Dec 5, 2023 / 05:49 AM CST

WASHINGTON (NewsNation) — Republican lawmakers are demanding answers regarding the U.S. Food and Drug Administration‘s delay in addressing some long-lasting popular cold medicines the agency deemed ineffective.

House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services Rep. Lisa McClain, R-Mich., sent a letter to FDA Commissioner Dr. Robert Califf urging him to provide a staff-level briefing on this matter, highlighting concerns about consumers wasting money and drug companies profiting nearly $1.8 billion in sales last year.

In September, an FDA advisory panel revealed that a key ingredient in many over-the-counter medicines, oral phenylephrine, doesn’t effectively relieve congestion. This ingredient is found in medications like Sudafed PE and some varieties of NyQuil.

Despite this, health workers note that these medications may still alleviate other symptoms such as sore throats. The ingredient has reportedly been under scrutiny by researchers for years.

“It is concerning that the NPDAC, and thereby the FDA, relied upon outdated and insufficient evidence regarding phenylephrine’s use as a decongestant for so many years, despite numerous appeals by the scientific community. Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs,” McClain wrote in her letter to Califf.

“I think what we saw then was kind of a slow grinding of the wheels, then between 2006 and 2016, we started to present the first bit of robust data to say phenylephrine may not be as efficacious as we thought it was, said Dr. Jayne Morgan. “In other words, looking at new available and more modern research techniques it may not be that phenylephrine doesn’t actually do what we say it’s going to do.”

CVS voluntarily removed products with phenylephrine as the main ingredient from shelves. Health workers suggest opting for behind-the-counter cold medicine. Notably, nasal sprays with phenylephrine are not under review — only oral medications.

NewsNation contacted the FDA for comment.