Zyrtec-D Approved For OTC Use By the FDA
Anyone who knows me or my writing knows that I'm very much in favor of free markets. I strongly believe that most economic environments serve people better when government regulation is low or minimal.
In fact at Harbor-UCLA, situated as it is in southern California and having a largely poor and minority patient base, I'm surrounded by very idealistic housestaff and faculty who think I'm an apologist for big pharma, big corporations, and every other "big" thing with negative connotations.
But am I really? Am I a libertarian? No. And here's why.
I see classic libertarians as being almost completely averse to all government functions except for a few things such as minting money, protecting our borders, maintaining a military, and I believe maintaining a civil and criminal judicial system. My attitude is far too hands-on to support such a laissez-faire approach.
Call me hypocritical but there are many government intrusions I whole-heartedly embrace. I don't think, for example, that people should be allowed to lie or make unsubstantiated claims in advertising and I applaud laws preventing such transgressions. But truthfully, such a stance puts me at odds with many"true believers". Likewise, I'm perfectly content to have the government oversee things generally helpful to communities as a whole, such as street cleaning. Why should I pay for street cleaning like most of my neighbors but allow the occasional cheapskate on the block ride for free yet enjoy its benefits? Does that make me a hypocrite? I yam what I yam.
Likewise, I'm also in favor of government intervention when it comes to public safety. Rather than accept a purely libertarian position, I recognize the existence of circumstances in which the government has an overiding public interest.
So what does this all have to do with OTC Zyrtec-D?
I admit that I haven't done a complete review of the world literature on the subtleties of the different non-sedating antihistamines/decongestants on the market. However, no one has ever demonstrated to me (or even suggested) that cetirizine is any better than the others. So why do we need yet another "me too" drug to be approved for OTC use? Why should the FDA want to clog up the market with Zyrtec-D when there are other drugs already out there that do the exact same thing?
Now a true libertarian would welcome the added patient autonomy that OTC's provide (I've heard libertarians argue that there shouldn't be such a thing as the FDA in the first place). To me however, keeping the pharmacy lean and mean and not allowing medications that solve no new clinical problems is beneficial to society and falls under the category of the overiding public concern I mentioned above.
When the market for a particular clinical purpose is fractionated among several different drugs, there is an unfortunate consequence. Adverse reactions and serious side-effects become much harder to monitor. It will be harder to detect truly harmful drugs and remove them from the market. This is so because when smaller numbers of patients are taking them, bad outcomes are more likely to make it under the radar than with more commonly used drugs.
For this reason, I would vote for a more active FDA that demands improved efficacy before approving (or in the case of Zyrtec-D, simply expanding its market to OTC).
I do understand that when more companies are allowed to compete, prices inevitably come down and obviously, this benefits the consumer. But in an era where there are tremendous pressures on the FDA to act on drug applications faster and faster, after-market monitoring becomes increasingly important for safety. To me this concern should take precedent and me-too drugs shouldn't be allowed to expand their markets without real demonstrated advantages over what's already out there.
The one caveat to this would be if a company would formally agree to market a new drug at a substantial discount compared to existing drugs performing the same function. Again, this would result in a substantial benefit to the consumer.
I realize that my positioning of the dividing line that separates the public interest from unfettered free trade is arbitrary and derives from my own personal opinion. I'm willing to live with a certain degree of inconsistency.
And if I were emperor of the world, you would have to as well.