By: Chloe Clifford, Staff Writer
Photo courtesy of unsplash.com
In the United States, it is estimated that individuals suffer from over one billion colds each year.[1] With so many people suffering from colds, it is important to be able to rely on pharmacies and the medications that they sell you. As the flu and cold season begins, and more and more people look for cold medicine, the ineffectiveness of these products has become the source of numerous lawsuits.[2]
In early September, the FDA advisory committee issued a 16-0 decision that one of the most common ingredients in cold medicine is ineffective.[3] The committee found that phenylephrine is not effective when ingested orally and, in fact, there was evidence that phenylephrine was no more effective than a placebo.[4] Phenylephrine was designed to reduce swelling in blood vessels in order to assist in decongestion.[5] Evidence presented to the committee showed that when Phenylephrine was ingested orally, instead of through a nasal spray, there was not enough of the drug reaching the nasal passages to be effective.[6]
The FDA will next decide whether to ban the sale of over-the-counter oral medications containing Phenylephrine.[7] If it decides to do so, it could affect up to 250 products which generated approximately $1.8 billion in sales in 2022.[8] Some such popular products include Sudafed, Nyquil, Benadryl, Tylenol, and Mucinex.[9] Medications containing Phenylephrine became increasingly popular after the Combat Methamphetamine Epidemic Act of 2005 was passed and signed by President Bush in early 2006.[10] The act banned over-the-counter sales of cold medicines that contained pseudoephedrine.[11] This ban came after evidence showed that individuals were able to illegally produce methamphetamine by using pseudoephedrine.[12]
In response to the FDA advisory committee decision, several lawsuits have been filed against pharmacies and pharmaceutical companies for deceptive advertising.[13] The first lawsuit was filed against Johnson and Johnson and Proctor and Gamble.[14] The lawsuit claimed that the companies should have known by at least 2018 that their marketing claims were “false and deceptive” due to the products containing Phenylephrine.[15] Similar lawsuits were filed against the makers of Theraflu, GSK, Mucinex Sinus Max, Reckitt Benckiser, and Walgreens, which makes a generic decongestant.[16]
While many pharmacies continue to sell over-the-counter oral products containing Phenylephrine, CVS decided to pull all such products from their shelves.[17] A representative for the company stated, “We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores. . . We are aware of the FDA Advisory Committee’s position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations.”[18] The representative ensured that CVS would continue to sell other oral cough and cold products in order to meet consumer needs.[19]
Before deciding if they will further regulate, or possibly even ban, the production and sale of Phenylephrine, the FDA Advisory Committee is looking for public comments.[20] For those who want to comment, there are two main ways in which to do so. The first is to submit a written comment to the FDA Division of Dockets Management at 5630 Fishers Lane, Rm 1061, Rockville MD 20852.[21] The second way is to go to www.regulations.gov and submit the comment electronically.[22]
[1] https://www1.villanova.edu/university/health-services/health-wellness-resources/common-illnesses.html#:~:text=In%20the%20course%20of%20a,have%20more%20colds%20than%20men.
[2] https://www.fiercepharma.com/pharma/johnson-johnson-and-gsk-are-among-several-companies-facing-lawsuits-over-marketing
[3] https://www.fiercepharma.com/pharma/its-unanimous-fda-panel-says-decongestant-drug-phenylephrine-does-not-work
[4] Id.
[5] Id.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] https://www.fda.gov/drugs/information-drug-class/legal-requirements-sale-and-purchase-drug-products-containing-pseudoephedrine-ephedrine- and#:~:text=The%20Combat%20Methamphetamine%20Epidemic%20Act,commonly%20used%20to%20make%20methamphetamine.
[11] Id.
[12] Id.
[13] https://www.reuters.com/legal/jj-pg-sued-after-fda-panel-ruling-cold-medicine-decongestant-2023-09-14/
[14] Id.
[15] Id.
[16] Id.
[17] https://abc7chicago.com/rite-aid-cold-flu-medicine-stays-on-shelves-allergies/13946299/
[18] Id.
[19] Id.
[20] https://nypost.com/2023/09/15/fda-to-hear-public-comments-on-pulling-sudafed-off-shelves/
[21] https://www.fda.gov/patients/guide-submitting-comments-fda
[22] Id.
