September 11, 2023
My name is Sophia Phillips and I am a Health Policy Associate speaking on behalf of the National Center for Health Research. Our nonprofit think tank scrutinizes research on the safety and effectiveness of medical products, and we do not accept funding from companies that make those products. Therefore, we have no conflicts of interest.
The National Center for Health Research appreciates the opportunity to testify on the lack of efficacy surrounding orally administered phenylephrine (or PE) as a nasal decongestant and the need to reclassify both phenylephrine hydrochloride and phenylephrine bitartrate as not Generally Recognized as Safe and Effective.
Our position is simple: oral PE should not be on the market if it doesn’t work. The public needs to trust the FDA to take products off the market that are proven to not work, especially in this case when it is ineffective for all patient groups.
There are a number of potential benefits that would stem from changing the GRASE status of oral PE.
- The avoidance of a delay in care of taking a drug that has no benefit and to prevent missed opportunities for use of more effective treatments (including seeing a doctor if needed).
- The avoidance of the risks of potential allergic reactions or other side effects related to use of PE in combination products.
- The avoidance of the inherent risks (especially for combination therapies) of taking more in order to seek some benefit.
- The avoidance of the risks of medication use in children.
- The avoidance of the unnecessary costs for consumers and lowering of overall healthcare costs.
Millions of dollars have been wasted by consumers on a product that has been shown in research to act similar to a placebo. If people want a placebo for a cold, they can other products such as vitamin C, which are inexpensive and not making FDA-approved claims to be a cold medicine.
With that said, we recognize that there will need to be efforts to educate consumers regarding alternatives to PE (including both oral and intranasal products), how to obtain PSE alternatives from behind-the-counter, and education of consumers with a preference for PE regarding why it is being removed from the market. These efforts will be necessary and essential to an efficient transition away from PE.
Lastly, FDA stated that potential impacts on industry will not be discussed at this AC meeting. We support this measure and would like to emphasize that any potential to hurt industry profits is irrelevant when making decisions that directly impact public health.