Oral phenylephrine (PE) has been relied upon as a beneficial nasal decongestant by American families for decades, and FDA has repeatedly concluded the ingredient is safe and effective. This determination, established by multiple double-blind, placebo-controlled trials and supported by two previous FDA advisory panels, has also been validated by a meta-analysis of relevant clinical studies.
Considering the data from multiple clinical trials demonstrating effectiveness and decades of in-market experience, CHPA urges the panel to recognize PE’s clear benefits and critical role in public health. We further urge the panel to be mindful of the significantly negative unintended consequences associated with removing PE from the OTC monograph, considering consumers would instead need to find time to seek help from a pharmacist, doctor, or clinic for an oral decongestant for a minor ailment they could otherwise self-treat. Additionally, some consumers indicate they might delay or forgo treatment, which could lead to worsened clinical outcomes such as progression to acute sinusitis and increased demand for doctor and clinic visits over time.
Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications.
When it comes to consumers’ needs, a recent national survey revealed that American adults repeatedly rely on oral PE because they recognize its benefits when they use it. In fact, 83% of consumers who used a product containing PE in the past year agreed the medicines helped relieve their nasal or sinus congestion. Respondents also reported PE further relieves their symptoms and overall ability to sleep, work, and get through their day. Additionally, actual retail sales data contradicts the assertion made in FDA’s briefing book that consumers have "gradually stopped purchasing these products," as it shows that more than half of all U.S. households purchased an OTC medicine containing oral PE within the past year, and 68% of those households repurchased medicines containing the ingredient.
PE is the only oral nonprescription medicine for nasal congestion available without purchase restrictions. The "behind-the-counter" option, pseudoephedrine (PSE), is not as accessible for all consumers due to sales restrictions and varying purchase laws on PSE-sales from state to state. This poses unequal burdens for consumers living in areas with limited access to traditional retail options based on geography, schedules, or socioeconomic factors. According to data collected through the real-time tracking system for PSE in 40 states, less than 20% of retail stores that sell OTC medicines also sell PSE, and medicines containing PSE are not available in convenience or dollar channels. If PE were taken off the market, more than 80% of stores would not have an OTC oral decongestant available to consumers.
Additionally, because the U.S Drug Enforcement Agency (DEA) limits the annual amount of PSE available to manufacturers, supply may not be able to keep up with demand if PE were no longer available, a point which is especially relevant given our nation’s recent attention to preventing future drug shortages. Along with access and supply issues, the behind-the-counter areas are not equipped to include the large number of products which may be needed, nor are pharmacy areas staffed or designed to manage the high volume of people who may need access to products.
As scientific techniques and methodologies progress, it is important to integrate new data within the broader framework of existing evidence rather than viewing it as a complete substitute for the previous body of evidence, particularly when assessing a well-established and globally used ingredient like PE for its safety and efficacy. It’s also important to note that an FDA advisory committee does not make determinations on whether an ingredient’s use is "Generally Recognized as Safe and Effective (GRASE)." Rather, any future GRASE determination would be made by FDA after considering all relevant data, including input from the advisory committee and industry.
As the committee prepares to evaluate an ingredient relied on by millions of Americans, CHPA looks forward to helping interpret the totality of evidence supporting the effectiveness of oral PE, by presenting the benefits of this ingredient, as well as the significant risks associated with any access restrictions. Following our discussion, we urge the panel to recognize the high acceptance and critical need for consumers to have continued unrestricted access to this ingredient.