Today’s Federal Register pre-publication page contains a notice that is likely the final punch before the oral decongestant phenylephrine lies knocked out on the canvas. The notice (here) states in regard to the “proposed revision of the proposed order OTC000036 to amend the requirements for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter (OTC) human use, as currently described in Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (OTC Monograph M012) if finalized, will amend the conditions described in OTC Monograph M012 as set forth in the Final Administrative Order OTC000026 to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage from OTC Monograph M012 as nasal decongestant active ingredients because they are not effective.”
While there is a 180-day comment period on the proposed Monograph revision before it is finalized, it has been a long and arduous journey for the FDA to recognize phenylephrine’s lack of effect and take action to remove it as an oral decongestant from the OTC market. We have posted here, here, and here regarding the proposed action. In the Fierce Pharma article cited above, it is noted that “In September, (of 2023) 16 panelists on the Nonprescription Drugs Advisory Committee (NDAC) agreed to the ineffectiveness of phenylephrine after reviewing data that showed it performed no better—even at high doses—than placebo in relieving congestion.” However, they also point out that “In 2007, the NDAC came to a similar conclusion on the ineffectiveness of phenylephrine, which first hit the market in 1938.”
Well, now the last gasp of phenylephrine as an oral decongestant will soon be at the end of its life. One always wonders why some decisions take so long to make. Sometimes the answers are clear and sometimes they are not. But at least now consumers won’t be wasting their money on an ineffective product any longer. The lack of suitable oral decongestant products is an issue, with pseudoephedrine really the other real option. It works great but there are barriers to its access – the product is only sold behind the counter, the purchaser needs to present a Driver’s License or other official government ID in order to purchase the product, and can only be obtained in limited amounts because of potential diversion issues associated with its use as a precursor in methamphetamine manufacture. Maybe the lack of alternative decongestants contributed to the long delay in action, but ineffective is ineffective and perhaps the Agency should have moved with greater speed.
