Dec 4, 2023 - Health

Scoop: House panel investigating FDA's handling of decongestants

Photo: Joe Raedle/Getty Images

Republicans on a House oversight panel will investigate the Food and Drug Administration's handling of a common decongestant ingredient that the agency recently concluded was ineffective, the committee told Axios first.

Why it matters: The inquiry, the latest in an aggressive investigative agenda by House Republicans, seeks to understand why the FDA didn't take earlier action against a wide range of over-the-counter cough and cold drugs that accounted for nearly $1.8 billion in sales last year.

Driving the news: Rep. Lisa McClain (R-Mich.), chairwoman of the House Oversight subcommittee on health care and financial services, in a letter being sent today will request a briefing with FDA commissioner Robert Califf.

  • The FDA "relied upon outdated and insufficient evidence regarding phenylephrine's use as a decongestant for so many years, despite numerous appeals by the scientific community," she wrote.
  • "Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs."

Catch up quick: In September, an FDA advisory panel found that oral formulations of phenylephrine, which is in drugs like Sudafed PE and some versions of NyQuil, were ineffective.

  • There had been questions about the ingredient's effectiveness for years, and the FDA previously reviewed it about 15 years ago. Since then, there were several large studies that confirmed oral formulations were ineffective, agency scientists said in September.

CVS Health voluntarily removed common decongestants that contain phenylephrine as the only active ingredient from store shelves in October.

  • Doctors and other health experts have since raised skepticism about the efficacy of a large number of over-the-counter cold medications, NPR reported.

What we're watching: The FDA is expected to decide whether it will order products with oral phenylephrine be pulled from shelves.

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