In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does not work. I have written about this issue previously (here and here), explaining how the process works slowly and deliberately, like sap exuding from a tree or a snail traversing a football field. The seemingly never-ending process of decision-making can be vexing for certain, but that is the way of the government bureaucracy.

The final decision, that the ingredient as an oral decongestant does not work, did not present a safety issue but rather an efficacy problem. Consumers have been wasting money purchasing products that contain phenylephrine for a long time. But why was the original move to broadly include phenylephrine as an oral decongestant so swift? Well, it came shortly after the FDA and DEA required that pseudoephedrine, a very effective decongestant, be removed from on-the-shelf over-the-counter sales and be placed behind the counter at pharmacies, forcing companies to reformulate products that could still be on-the-shelf OTCs. Moving pseudoephedrine behind the counter was not due to a safety issue, but rather a diversion decision. As you all likely know, pseudoephedrine can be used as a precursor to making methamphetamine, and was being bought for this nefarious reason by the ton. In addition, the DEA required a nationwide computer system to track the sale of these still-OTC products with a strict quantity and time limit placed on their purchase.

The reason I now concentrate on this move and the removal of phenylephrine in one breath is that it is extremely concerning that the EU is now in the process of reviewing safety issues with pseudoephedrine (see EU February statement of inquiry here). As a historical note, I believe that there is no need dredge up the phenylpropanolamine saga when the FDA removed this very effective decongestant from the market for OTC and prescription use due to a documented safety issue. But as to options for effective decongestants, they are few and far between; pseudoephedrine, while having the diversion baggage, is widely accepted as a very effective medication alone or in combination with other ingredients, like antihistamines. If the EU finds a safety problem, akin to that of phenylpropanolamine, and removes it from the market and the FDA follows, then we are stuck with no real alternative for an effective decongestant, OTC or prescription.

Here we are at a juncture, where one decongestant has been found to clearly be ineffective, another has been removed for safety issues, and a third, and potentially last, of the effective decongestants is under investigation. The outcome is unknown; the timing will surely be long and drawn out, and the outcome might push cough and cold symptom relief to only antihistamines. So, while sometimes slow could be better, as far as risk-benefit assessment goes, give me pseudoephedrine every time as I have a keen nose for relief!