FDA Should Quickly Finalize Proposed Order to Remove Ineffective Oral Phenylephrine
FDA scientists have proven oral phenylephrine does not work
WASHINGTON, D.C. — This week, Public Citizen submitted comments to the Food and Drug Administration (FDA) strongly supporting the agency’s proposed order that would remove orally administered phenylephrine from the over-the-counter (OTC) monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use because they are ineffective for relief of nasal congestion.
In September 2023 an FDA Nonprescription Drugs Advisory Committee unanimously voted (16-0) that the current dosage of orally administered phenylephrine is not effective for nasal congestion relief. The committee’s decision was based on consistent and compelling scientific evidence presented by FDA scientists that oral phenylephrine does not work.
Azza AbuDagga, Ph.D., Public Citizen Health Research Group health services researcher, who urged the 2023 advisory committee to vote against the effectiveness of oral phenylephrine, said the it is deeply concerning that the FDA has long maintained the “generally recognized as safe and effective” (GRASE) status of oral phenylephrine for nasal congestion despite compelling research evidence against its effectiveness.
“The FDA should act quickly in finalizing the proposed order, banning oral phenylephrine,” said AbuDagga. “The decades-long availability of oral phenylephrine products on shelves has been a huge disservice to the American people because it had misled countless patients and delayed their access to effective relief of nasal congestion while wastefully enabling drug companies to profiteer from these placebo drugs. The oral-phenylephrine saga is unacceptably reminiscent of the snake oil era. The FDA should seek to uphold the statutory standards of efficacy and safety by expanding its nonprescription drug review process to include evidence supporting other potentially ineffective or unsafe products that have been grandfathered into OTC monographs.”