An FDA advisory panel unanimously ruled Sept. 12 that the ingredient, oral phenylephrine, does not alleviate nasal congestion.
The House Oversight Subcommittee on Health Care and Financial Services sent a Dec. 3 letter to FDA Commissioner Robert Califf, MD, asking why it took the FDA so long to conclude that the decongestant was ineffective, despite existing evidence.
“It is important that the American people have confidence in the FDA’s approvals and trust that the drugs they purchase are not only safe, but also effective,” reads the letter, which was obtained by The Hill.
Lawmakers are requesting more information on the FDA’s decision by Dec. 11. Axios first reported news of the probe.
The FDA plans to review the letter and respond to lawmakers directly, a spokesperson told Becker’s.
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