Off Label Advice for Doctors- The Appeals Court is Dead On
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Off-label drugs-- those used for indications other than what the drug was originally approved for-- have been used for many years. Most of us have probably benefited from this practice, but despite this, it has been illegal for a pharmaceutical sales rep to even mention a possible off-label use of any drug to doctors.

That changed Monday, when the Court of Appeals for the Second Circuit in Manhattan curtailed the FDA's authority to limit what sales reps are allowed to say to doctors about their company's drugs, throwing out the conviction of a sales rep who was found guilty of selling a narcolepsy drug for off-label indications. The court's argument was based on First Amendment rights, and although I don't really know or care about the constitutionality of this. I just know a good idea when I see one.

I'm sure the anti-pharmaceutical activists will be howling about this one for quite some time. I can already see the headlines: "Big Pharma Money Buys Corrupts Courts" or "A Legal Win for Pharma; A Loss for Us."
And of course, there will also be countless analyses about how the First Amendment was not designed to permit sales reps to "illegally push" drugs that have not been approved for a particular use upon doctors and their patients. But until now, this was the law.

I never understood the law in the first place. It just doesn't make sense.

Once the FDA approves a drug for a particular use, a doctor can legally prescribe it for other indications. It happens all the time. It has been estimated than about 20 percent of all prescriptions are written for a non-approved indication. Given this, why should it be illegal to pass along information to doctors, letting them know about new treatments?

Well, it shouldn't. And there are good reasons for this.

First of all, drug reps are an important source of information for many doctors, who may not have the time to take courses or read medical journals. There are probably quite a few instances where the drug rep is the only source of new drug information for a physician. The rep supplies information. It is then up to the physician to decide whether to use the drug or not.

Since off-label use is already a common practice, doctors have either decided to try this on their own, or have gotten some information from somewhere else. Where? A colleague on the golf course? A medical journal? From the patient himself? Who knows? Why not a sales rep? If you believe that they simply lie about everything to meet their quotas (and I certainly don't), they can just as easily lie about the new approved drug that they are selling. I don't see much of a difference between the two, nor do I believe it is common.

As long as off-label information exists, why should it not be transmitted? It is the doctors who will determine what is best for their patients and they will decide what to do with the information that get. No one will force them to use anything they are not comfortable with.

Second, any off-label drug has already been approved for something else, meaning that it has already gone through an exhaustive safety review that was required for its approval in the first place (yes-- it is imperfect, so don't bother reminding me about Vioxx).

So, the use of an approved drug for condition X is not likely to be any more dangerous than using it for disease Y, since the FDA has already deemed it sufficiently safe to use in the first place. (Of course there are exceptions--no doctor wishing to hold onto his license will prescribe a cancer drug for a backache).

But that cancer drug may be very useful in treating noncancerous diseases, and this highlights some of the real benefits of off-label drug use--something most people are unaware of.

Certain chemotherapeutic agents are effective for treating autoimmune diseases, such as lupus, multiple sclerosis and rheumatoid arthritis--three god-awful diseases that may not respond to other therapies.

And there are many others. Singulair, originally approved for asthma is used off-label for chronic obstructive pulmonary disorder (COPD). Antidepressants are used to treat chronic neuropathic pain, as is Neurontin, originally an epilepsy drug. Seroquel, and anti-psychotic drug is used as an adjunct in treating depression.

The beta-blocker heart drug Inderal is also used for treating migraine headaches, stage fright and PTSD. And Zofran, which revolutionized cancer chemotherapy by significantly reducing nausea and vomiting is used off-label for treatment of hyperemesis gravidarum, a severe form of morning sickness, which put Kate Middleton in the hospital this week.

To me, the entire concept that providing information to doctors needs to be artificially constrained is based on the presumption that we need to be protected from greedy and dishonest drug reps and doctors. I don't buy it. Yes, I'm sure there are some bad apples out there (as there are in any profession), but on the whole I believe this decision will provide a substantial net benefit to patients.

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More on Caronia from PointOfLaw Forum on December 7, 2012 8:30 AM

Scott Gottlieb notes the chilling effect of current DOJ policy. I still think he underestimates the incentives facing prosecutors and pharmaceutical companies in hoping for internal reform or successful pharmaceutical-company challenges; reform is goin... Read More


Josh, I agree with you almost 100%. I believe drug reps should be able to provide scientific data on off label uses without any restriction, including published case reports from clinical practice. I'd be hesitant to allow drug reps to provide anecdotal unpublished information.

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