Post-regulatory

As a fascinated observer of the pharmaceutical industry, I have to confess that I was disappointed to hear that an FDA advisory committee had unanimously voted against approval of Sanofi-Aventis's Zimulti (née Acomplia)—and not just because I could afford to lose a few pounds myself. Acomplia promised to be the most interesting drug launch in several years, the first real chance to see how an old-fashioned write-it-for-everybody blockbuster would fare in the post-Vioxx era. Would Sanofi try to stave off liability by reining in off-label and marginal use of the drug? Would it push actively to consumers? And, most interesting of all, how would the company and FDA cope with the vast amount of unofficial information circulated about weight-loss products on the Internet? It was easy to imagine a scenario in which unofficial grassroots promotion of Acomplia could overwhelm the official, FDA-approved message.

Patrick Clinton

Well, unless something very surprising has happened in the few weeks between when I wrote this and when you read it, we're not going to see that scenario just yet. The advisory committee's thumbs-down is likely to be the end of Acomplia in the United States until at least 2010, when a 50-month clinical trial, currently under way, is scheduled to conclude.

Instead, we're going to see a different scenario, one just as interesting—and potentially revealing—as the one I'd been looking forward to. Instead of the conflict between official and unofficial sources of information and on-label and off-label uses of drug, we'll get to observe a truly global commotion, as authentic and counterfeit versions of Acomplia are marketed by legitimate and illegitimate suppliers across national boundaries. In short, we'll get a taste of the post-regulatory world, where patients are truly consumers—buying and using more or less whatever they want—doctors and FDA be damned.

The basic pieces are all in place. If you'd typed buy Acomplia into Google 18 months ago, you'd have found a few hundred sites, most of which were designed to steer you to other products. Try it today, and you'll get close to 70,000 hits, mostly links to online stores willing to sell you something Acomplia (who knows? maybe even real Acomplia) for anything from $3 a pill to almost $10. Some are coy, advising you to talk to your doctor and use the drug correctly. Others drop broad hints about off-label uses and offer to replace packages seized by American customs.

The big Mexican-border pharmacies are stocked up (and, according to some news accounts, selling out to American tourists whose eagerness to buy has apparently been piqued by the advisory committee's disapproval).

And there's going to be plenty of product out there, even if the European Medicines Agency pulls its approval. The Indian generics companies have announced their intention to keep cranking out tablets. And the counterfeiters will have a field day.

I'm making a big assumption: that for all that the public squawks about drug safety, people still want what they want, and they think that what happens to other people won't happen to them. That attitude has been the bedrock of a lot of misery and foolishness, and I don't really expect it to fail now. And unless it does, we're going to have to start facing up to the idea that controlling the drug supply has become a new and much more complex task. We'll need new systems to cope, and industry needs a seat at the table as those systems are planned.

Patrick Clinton

Editor-in-chief

pclinton@advanstar.com