"The regulations for phenylephrine (PE) remain unchanged, and there is no change in the availability of products containing PE on store shelves. The NDAC vote was a non-binding suggestion for the FDA to consider. Consumers can maintain their confidence in the fact that these medicines continue to be recognized as safe and effective by FDA.”
(See FDA's public statement clarifying the results of the recent advisory committee meeting)
“We are disappointed by the outcome of today’s FDA Advisory Committee meeting because its non-binding recommendation is at odds with the numerous clinical trials and previous regulatory determinations affirming oral PE as a safe and effective decongestant at its labeled dose,” said CHPA President and CEO Scott Melville. “As stated in the FDA briefing document and highlighted by the committee chair, FDA has not identified any safety issues with orally administered PE. The meeting was a scientific review of recent research on PE efficacy.”
“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status. While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted. We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers.”
