The Dry Eye Zone

Rebecca's Blog


Allergan's lawsuit

Allergan Files Federal Lawsuit to Allow It to Share Relevant Information with the Medical Community on the Safe Use of BOTOX(R) for Common Therapeutic Off-Label Treatments

Did I ever do a double-take when I saw THAT headline. It sounds just too delectably, archetypically appropriate to our times.

First, allow me to translate: Allergan (the company that sells Restasis as well as Botox) is suing the US government for the right to market Botox for uses for which it has not been approved but which doctors use it for anyway.

Now, for those of you who aren't familiar with the concept of "off-label": Drugs and devices are approved by the FDA for specific indications - that is, for a very carefully defined use in treating a disease or other condition. The company can only market it for the specified indication(s) - however, doctors are not restricted in what they can choose to prescribe or use it for. Once approved, the product gradually gets used more and more by doctors and as they gather more clinical experience with it often it gets used for different purposes than that for which it was approved. Some of these remain relatively rare, and some become commonplace. Some companies seek a new approval for the new use that it's showing good results in, if they're able to prove those results objectively. Some don't. And now, apparently, some sue the FDA instead.

An example of how 'off-label' works is excimer lasers, used to perform LASIK and PRK. Individual companies' excimer lasers were originally approved for PRK, but when LASIK was developed, they began using it for that, as far back as 1995 - while the very earliest laser to actually be approved for LASIK received its approval in 2000. (Or was it 99? Anyway, at least a 4-year gap.) Likewise, though excimer lasers are approved for LASIK and have been used for repeat LASIK procedures for more than a decade (procedures typically called 'enhancements' or 'touch-ups', the lasers themselves were never approved for anything but a primary treatment. What this means in practice for those using the lasers is that (among other things) they cannot advertise these 'off-label' procedures and they must inform the patients that the procedure is an off-label procedure. So if you've ever had a LASIK 'enhancement', and are scratching your head over the idea that it was not an approved procedure, if you go back and look at your paperwork you'll probably find the phrase "off-label" tucked away in there somewhere.

Anyway, the same holds true for drugs. Azasite, for example - the new bleph wonderdrug du jour. It was approved for treating bacterial conjunctivitis. Lo and behold, it's been found to be so helpful in many cases of meibomian gland dysfunction that it's being Rx'd left and right. On the other hand, Inspire, instead of suing the government, are simply applying for FDA approval to sell Azasite for more uses than the originally approved use (indication).

Now I'll try my best to stop pontificating and just report the news straight from the horse's mouth.

IRVINE, Calif., Oct 01, 2009 (BUSINESS WIRE) -- Allergan, Inc. (NYSE: AGN) today filed a declaratory relief action in the United States District Court for the District of Columbia seeking a ruling that would allow Allergan to proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of BOTOX(R) (onabotulinumtoxinA) for certain "off-label" therapeutic uses. Some of these off-label uses are medically accepted and commonly prescribed but currently unapproved by the United States Food and Drug Administration (FDA). In the lawsuit, Allergan contends that the Government's legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act. The lawsuit does not involve BOTOX(R) Cosmetic.

My heart bleeds for all the innocent sales reps anxious to proactively share truthful and relevant information - or even conscientiously sharing said truthful and relevant information and causing their company to be wrongfully investigated by the FTC or FDA....

I shudder at the thought of a pharma being deprived by our very own government of its first amendment rights and the potential to turn a ten digit annual revenue into an eleven digit annual revenue without a two-year delay to definitively establish safety and efficacy for an additional indication. Surely someone somewhere has written a folk song about that....

After all, what reasonable individual would expect a multinational pharmaceutical company to put their drug through clinical trials and the FDA approval process a second time, when we all know it's probably more or less safe and effective for the additional indication anyway? I mean honestly. There is just something too utterly twentieth-century about that whole process.

Oops. Well, I said I'd try.

So, by now you think I'm way too far gone in anti-pharma prejudice and cynicism to have any reasonable opinion to share on the subject. I do have some understanding of the counter arguments. And here's an op-ed piece in the Washington Examiner which presents a decent case for lifting the ban on offlabel marketing. I know off-label usages are the norm these days, and I know there are benefits. But there are also tradeoffs - which will increase if Allergan win this thing.