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Off Label

Last month I wrote about how the FDA has been fining pharmaceutical companies billions of dollars for marketing their drugs to doctors for non-approved (“off label”) uses. Earlier this month, a pharmaceutical company (Amarin Pharma) took a novel preemptive strike – they are suing the FDA over violation of freedom of speech, claiming that they have a constitutional right to share information about such products. Amarin feels that if they are truthful with the information, there should be no restrictions imposed on how they disseminate this information.

The problem is that not all speech is protected – it’s not an absolute right. Our Courts have long held that there are limits on the 1st amendment right of free speech. We recognize the Government’s right to restrict speech that incites violence or harm, is false, obscene, threatening or speech that is owned by others.The classic example they teach you in law school is that you cannot yell “Fire” in a crowded theater. Why? Because there is an overriding societal concern that would override an individual’s right to scream fire in a theater. Other examples would include slander. You can not just say whatever you want. In fact, if you say something that is false and damages another person you could be held accountable for their damages in a slander lawsuit.

Those who side with the FDA feel that it’s critical for consumer safety to limit confusion and information on non-approved uses for drugs. In other words, just like screaming “Fire” in a crowded movie house, there is a counterveiling interest in not allowing drug companies to use their well funded marketing budgets to convince doctors to use their drugs for unapproved “off label” uses as it is a end around the FDA testing and approval process. The interest in keeping the public safe from the possible dangers of “off-label” uses outweighs the companies 1st amendment right to free speech. This could be a slippery slope if Amarin wins the lawsuit and could have major implications for drug safety and the drug approval process. On the other hand, Amarin takes the position that doctors need MORE information (not less) about the many uses of a particular drug. They argue that not allowing them to educate physicians on other possible uses causes physician and consumer confusion.

The FDA is considering some new guidelines that may allow additional drug information to be shared with doctors. We’ll be watching to see where this goes. In the meantime, it’s more important than ever to be a concerned consumer and an aware patient.

  1. Make sure the prescribing physician is aware of all medications you are currently on. (And for that matter, let all of your doctors know what you are taking and combining.)
    2. Ask your doctor if the drug is approved for use in your diagnosis, or if this is an off-label prescription. Regardless of what your physician says, do some research on your own as to approved uses and side effects. Ask your pharmacist, look online and definitely read the package insert.
    3. If you are taking a medication for off-label use, find out if the use is supported by strong trial data for people with a similar condition. Also, ask your doctor why he or she didn’t consider a medication approved for your illness.
    4. Talk to your insurance company to see if they will cover payment for an off-label use. Don’t assume they will.
    5. When adding a new drug, find out if it’s possible to discontinue use of another drug you are taking. Many adverse drug reactions have been caused by continuing to use drugs beyond when they are needed.
    6. When you leave your doctor’s office, make sure the instructions for taking a new medication are clear to you AND to one other person (a family member or friend). Medications can cause confusion and memory loss, so you want to inform another person about possible adverse drug reactions.