What we have learned from trying to remove oral phenylephrine from the market

Abstract

A 2023 United States Food and Drug Administration (FDA) Nonprescription Drug Advisory Committee unanimously voted that oral phenylephrine is not Generally Recognized As Safe and Effective (GRASE). This decision resulted, in part, from our nearly 20 years as clinical pharmacists advocating for patients with nasal congestion. As a result, the FDA recently posted a proposal to remove oral phenylephrine from the market, and the American College of Clinical Pharmacy (ACCP) has been a key stakeholder supporting the removal of oral phenylephrine from the market. ACCP members are encouraged to submit comments to the FDA regarding the market status of oral phenylephrine. In this article, we describe the role of a Freedom of Information request for unpublished data, our systematic review and meta-analysis of the data upon which the FDA relied to approve oral phenylephrine, our two Citizen Petitions, and modern data, including an unpublished study from clinicaltrials.gov.