Three months after an FDA panel declared a popular cold remedy no more effective than a sugar pill, a House oversight panel wants to ask FDA leadership a pointed question: What took you so long?
The Subcommittee on Health Care and Financial Services, chaired by Rep. Lisa McClain (R-Mich.), sent a letter announcing the probe to FDA Commissioner Robert Califf Dec. 3.
The letter points out that the drug, phenylephrine, has been used by millions of Americans since its branding as an oral decongestant in 2006. It’s the active ingredient in everything from Sudafed and Theraflu to DayQuil and NyQuil.
In fact, the drug’s pedigree is much older. It was patented 90 years ago and has been used for medical purposes since 1938.
Phenylephrine became a commercial hit in 2006 when its OTC cousin, pseudoephedrine, came under fire because criminals were using it to cook methamphetamine.
“Prior to and since phenylephrine became the preferred alternative to pseudoephedrine, scientific support for the effectiveness of phenylephrine has been consistently weak, showing that the drug administered orally provides no better symptom relief than a placebo,” McClain and colleagues state to Califf.
The authors add that they find it “concerning” that the FDA’s Non-Prescription Drug Advisory Committee, and thereby the FDA, “relied upon outdated and insufficient evidence regarding phenylephrine’s use as a decongestant for so many years, despite numerous appeals by the scientific community.”
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“Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs.”
McClain and fellow subcommittee members request facetime with Califf, asking him to schedule a briefing no later than Dec. 11.
Axios points out that the inquiry is the “latest in an aggressive investigative agenda by House Republicans” and notes that OTC cough-and-cold drugs rang up close to $2 billion in sales last year.
Scripps News reports that CVS has so far been the only major retailer to pull products with no active ingredients except phenylephrine.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.