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The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein

Q&A with FDA Podcast | Transcript

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Dr. Roach: Welcome to “Q&A with FDA”. In this podcast series, we answer some of the most frequently asked questions that we have received from the public.

My name is Dr. Sara Roach, and today we are discussing a recent FDA advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant. Oral phenylephrine is an active ingredient found in several over-the-counter cough and cold products. It is indicated for the temporary relief of nasal congestion and is used both in single ingredient products and in combination with other active ingredients directed at other symptoms such as headache, fever, or cough.

With me today is Dr. Theresa Michele from the Office of Nonprescription Drugs within the FDA’s Center for Drug Evaluation and Research. Also joining is Dr. Ilisa Bernstein, Senior Vice President for Practice, Policy and Partnerships from the American Pharmacists Association, or APhA. Welcome, Dr. Michele and Dr. Bernstein. Thank you both for speaking with us today on this important and timely topic!

Dr. Michele: My pleasure!

Dr. Bernstein: Certainly!

Dr. Roach: Our focus today is FDA’s meeting of the Non-prescription Drugs Advisory Committee held on September 11th and September 12th, 2023, as well as a statement the agency released on September 14th subsequent to that meeting, which generated a significant influx of questions and comments from the public. Dr. Michele, can you provide some background on why the agency convened this particular advisory committee meeting for the oral phenylephrine nasal decongestant?

Dr. Michele: So, in 2007 the Advisory Committee recommended that more clinical data were needed to evaluate the safety and effectiveness of oral phenylephrine as an OTC nasal decongestant for patients 12 years of age and older. Fast forward to September of 2023, that AC meeting was convened to discuss whether data generated since the 2007 recommendation on the effectiveness of oral phenylephrine as a nasal decongestant warrants reconsideration of its status as an ingredient that is generally recognized as safe and effective (or “GRASE”) when used as directed on the product labeling. "GRASE" is the standard FDA uses to decide if an active ingredient is appropriate for inclusion in an OTC monograph.

For those of you who are not familiar with the role of advisory committees, the primary purpose is to provide independent expert advice to FDA on a particular topic. AC meetings, as they’re often referred to, are convened to solicit independent advice, scientific expertise, and knowledge from those outside the agency. They often include a non-binding vote on a scientific, technical, or policy question.

It should be noted that the advice provided by the AC is not binding, and FDA will make the final decision on phenylephrine.

Dr. Roach: Thank you for that background. Can you talk more about the outcome of the AC meeting and the statement FDA issued shortly thereafter?

Dr. Michele: Yes, the AC meeting discussed the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the dosage of orally administered phenylephrine in the OTC cough-cold monograph is effective as a nasal decongestant. However, neither the FDA nor the committee had concerns about the safety of taking oral phenylephrine at the dose in the OTC cough-cold monograph.

CDER also released a Statement on the 14th of September that was intended to clarify the scope of the AC meeting, the impact of the recommendations, and the next steps if FDA agrees that oral phenylephrine is no longer considered generally recognized as effective.

Dr. Roach: And FDA still needs to conduct its own review and make a final decision.

Dr. Michele: Exactly. So as I mentioned earlier, yes, AC meetings may result in a voting question on recommendations to the agency. However, FDA will make the final decision. Generally, the agency follows the recommendations received from the Advisory Committee, but we are not legally bound to do so.

Dr. Roach: Dr. Bernstein, what is APhA’s take on this issue?

Dr. Bernstein: Thanks. As background, APhA represents our nation’s pharmacists, and pharmacists are experts in medication management and medication use, including OTC drug products such as oral phenylephrine. And we appreciate that FDA placed these issues of oral phenylephrine efficacy for discussion before the Advisory Committee. APhA submitted comments in advance of the meeting to share the position of our members, which is in support of removal of oral phenylephrine from the Final Monograph due to its ineffectiveness.

Pharmacists are often the consumer’s only health care professional available and accessible for advice on OTC drug product selection. In fact, 90% of Americans live within five miles of a pharmacy. So, it’s important that pharmacists have a complete understanding of the concerns that FDA and the Advisory Committee discussed.

And pharmacists often receive feedback from consumers who are seeking relief from nasal congestion. And they often hear from patients that complain that oral phenylephrine products aren’t working and not effective to treat nasal congestion. In fact, I am a pharmacist, and I can share first-hand that I’ve experienced the same feedback. These consumers rely on the information that’s on the package labeling. They look at the outside of the package, and it says that oral phenylephrine products will relieve their symptoms. And so our pharmacists, our members, our nation’s pharmacists, are interested to know the steps that FDA plans to take next.

Dr. Roach: It’s important to note that the questions about efficacy discussed at the AC meeting and supported by APhA are specific to oral phenylephrine products and not for other dosage forms of phenylephrine such as nasal sprays, and that the meeting was not convened because of safety concern.

Dr. Michele: That’s a great point. Neither the FDA nor the advisory committee had safety concerns about the use of oral phenylephrine in both single ingredient or combination products at the OTC monograph dose. They also didn’t have issues with safety or efficacy of topical phenylephrine products, such as nasal sprays. Now remember that FDA’s role is to help ensure that drug products are both safe and effective for the American public.

Dr. Roach: As we heard from Dr. Bernstein, pharmacists generally accept that oral phenylephrine is ineffective as a nasal decongestant, but they want to know what happens next and consumers want to know if products they currently use are going to be discontinued. I’ll start with the first question, Dr. Michele, what are the next steps?

Dr. Michele: Well at this time, the status of oral phenylephrine products remains the same – they are considered generally recognized as safe and effective as OTC nasal decongestants under the conditions of the OTC cough-cold monograph.

The advisory committee discussed the new data and concluded that the data do not support the efficacy of oral phenylephrine at its currently recommended dose as an oral nasal decongestant. The committee also discussed if a higher dose would be effective but concluded that no clinical studies had shown a safe and effective dose.

If FDA determines that oral phenylephrine is not GRASE as an OTC nasal decongestant, we intend to initiate a multistep process that will require a proposed order, a 180-day comment period, and then issuance of a final order. The public would have the opportunity to comment on the proposed order.

Dr. Roach: Can you describe that process in more detail?

Dr. Michele: Sure. If FDA issues a proposed order that proposes to remove phenylephrine as an active ingredient from the OTC monograph for oral nasal decongestants, the public will have an opportunity to comment on the proposed order, including the opportunity to provide additional data. During this time, the marketing status of oral phenylephrine would not change.

Now if, after we consider the comments on the proposed order, FDA concludes that phenylephrine is not generally recognized as safe and effective as an OTC oral nasal decongestant under the conditions of the relevant OTC monograph, the agency would then issue a final order removing this ingredient from the monograph. Only after FDA issues a final order would manufacturers be required to reformulate or remove OTC monograph products containing oral phenylephrine.

Dr. Roach: Thanks for walking us through the next steps. Dr. Bernstein, what are your thoughts about certain pharmacy chains discontinuing single-ingredient phenylephrine sales prior to a final order?

Dr. Bernstein: So there have been reports that - and I’ve actually heard that some community pharmacies have chosen, to remove single ingredient oral phenylephrine nasal decongestant products from their shelves, based on that recommendation from the Advisory Committee. That’s a business decision. I can’t really comment on it, but it is aligned with our support of the removal of oral phenylephrine products from the monograph and market.

Dr. Roach: To that point, there is a wide range of products that are available for temporary relief of congestion symptoms due to allergies or a common cold. Dr. Bernstein, what products have pharmacists heard that consumers are worried about being removed from the shelves?

Dr. Bernstein: There is confusion about what might happen to their choices at the pharmacy regarding cough and cold products, including that single ingredient vs. combination products - because some products in the cough and cold aisles only contain oral phenylephrine as a single ingredient but other products are in combination, and it contains oral phenylephrine plus other active ingredients that are effective for their symptoms.

So, consumers may rely on these combination products for both nasal congestion relief and to treat those other symptoms, such as headache. But they’re concerned about the effects that this might have on the availability of these other products.

Dr. Michele: I’m glad you brought that up. The important thing to know is that if FDA issues a final order finding oral phenylephrine to be not GRASE as a nasal decongestant, oral drug products containing only phenylephrine as the single active ingredient would need to be reformulated or removed from the market. Whereas combination products containing phenylephrine and other active ingredients would also need to be reformulated to remove the phenylephrine, or they could be removed from the market.

And just to emphasize again, this only applies to oral products – the availability of phenylephrine-containing nasal sprays will not be affected.

Dr. Roach: Thank you for emphasizing that point.

Dr. Bernstein: I’ll add that pharmacists are in a unique position to educate consumers on the status of oral phenylephrine containing products and how to make those informed decision on which OTC drug products to take. As pharmacists we know there are many other OTC products that are safe and effective for treating congestion such as oral pseudoephedrine, and intranasal decongestants, steroids, and other intranasal antihistamines.

And there is, there is pseudoephedrine, but there are some hurdles accessing it. Since 2006, Federal law requires that cold medicine containing pseudoephedrine has to be limited to behind the counter, it requires a photo I.D., you have to purchase the medicines in certain amounts. So, although pseudoephedrine is effective, those hurdles make it difficult and so having other choices in the marketplace is really important.

Pharmacists are a great resource for consumers who are wondering what options are best for them and can provide that guidance, despite the federal and state sales restrictions.

Dr. Roach: Thank you! It is great to have both FDA’s and APhA’s perspective on this important topic. As we wrap up this discussion, do either of you have any last comments?

Dr. Michele: I’d also like to thank Dr. Bernstein for joining this conversation today. And as we’re now kind of wrapping up cough and cold season, I do want to remind listeners that they should read product labels carefully. This is especially true for children’s cough and cold products as there are different age limits for different products. In addition, it’s important for consumers as well as for pharmacists and other health care professionals to read the label as there may be overlap in the active ingredients among different products.

One of the problems with this space is that many cough and cold products may have similar brand names with different active ingredients. So, knowing the active ingredients in the products you take is really very critical to avoid accidentally taking more than the recommended dose of a particular ingredient. This is especially important for acetaminophen, where overdose can be fatal.

Now if the product contains phenylephrine, that should be listed in the “Active Ingredients” section of the Drug Facts label. But because manufacturers of OTC medicines sometimes make product formulation changes (for example, they may have new ingredients, new dosages, or there may be new warnings added to the label), it’s essential for consumers to read the label each and every time they purchase that OTC drug product, even if they’ve purchased what they think is the same product before.

Dr. Roach: Dr. Bernstein, any last comments?

Dr. Bernstein: Well, first let me say thank you so much for inviting me to share the conversation with you all and Dr. Michele, and FDA, about this important topic. So, I agree, consumers should always read the Drug Facts label for that critical information about products they take, and ask your pharmacist or other health care professional any questions that you have about the drug or other choices. And as front-line health care professionals, pharmacists are available and accessible to help you choose the right medication for your needs so, thanks so much!

Dr. Roach: Thanks for listening to “Q&A with FDA.” The full podcast and transcript of this recording is available at www.fda.gov/qawithfda. Many of our episodes offer continuing education credits for health care professionals, so be sure to visit this webpage for more details. If you are looking for additional learning or continuing education credit opportunities, including live and home study webinars, you’ll also want to check out fda.gov/CDERLearn and fda.gov/DDIWebinars. And if you have questions about this episode, or anything drug-related, email us at druginfo@fda.hhs.gov.


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