FDA decongestant move shows agency does more harm than good

POLITICS: FDA decongestant move shows agency does more harm than good

Why should Americans trust the Food and Drug Administration at all anymore?

The FDA’s latest bungle: One of its advisory panels just announced that phenylephrine — the active ingredient widely used in over-the-counter cold and flu meds — works no better orally than a placebo. 

Hmmmmm. That’s odd: In the 1970s, that very same agency said phenylephrine was effective. 

So — a useless drug has been majorly on the market for five decades and the federal agency tasked with making sure drugs are safe and effective not only gave its imprimatur to the stuff initially but then somehow failed for half a century to notice it didn’t really work. 

This when Americans by the millions rely on Sudafed, Benadryl and other products centered on phenylephrine.

Why did phenylephrine find its way into everything in the first place? 

Because Congress in 2005 passed a law making it harder to buy drugs containing an effective decongestant, pseudoephedrine, to curtail its illicit use in meth production. 

Meth makers adapted, of course, getting raw materials in other ways: The law powered up the Mexican cartels to supply those — without cutting meth deaths and addiction stateside. 

So sure, the FDA doesn’t deserve all the blame for the miserable cold season we’re about to have. 

But if, way back when, the agency had spoken up about phenylephrine’s flaws (as a pill, not an inhaler, by the way), Congress might have thought twice about depriving Americans of pseudoephedrine if there’d been no FDA-approved alternative on hand.

And keep in mind, the agency’s record on other recent issues has been subpar (to say the least).

There was the baby formula shortage of 2022, caused mainly by absurd FDA policies restricting the import of high-quality European formula. 

Then there’s the FDA’s role in the Great American COVID Test Shortage of 2020.

The Centers for Disease Control and Prevention got that debacle started by outlawing any tests except the one it had designed — which turned out not to work.

But then the FDA fumbled massively on expedited OKs for all the labs developing rapid at-home COVID tests during the worst of the pandemic: By one account, the agency’s backlog in processing emergency-use applications hit 3,000. 

Consider the Kafkaesque saga of morning-sickness drug Benedictin, whose maker pulled it off the US market in the ’80s over claims it caused birth defects.

Baseless claims: The drug stayed on the market in Canada for decades — and the FDA finally re-approved it under a different name in 2013. 

More madness: The agency regulates sunscreen as though it were a drug, leaving US beachgoers with far fewer options than in Europe or Asia. 

Heck, the current FDA head, Robert Califf, is still banging the drum about the need for government regulations against misinformation. (No prizes for guessing which agency he’d like to see doing the enforcement.) 

As with so many other federal agencies, the FDA is a sclerotic, bureaucratic nightmare — and it seems, based on its numerous flubs, to be doing more harm than good. 

So while you sniffle and cough your way through the upcoming winter, remember to “thank” the FDA. 

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