FDA and off-label use

What is off-label use?  Basically, drug manufacturers have to submit approvals to the FDA for new drugs they wish to sell in the US.  Usually, most drugs go under the approval process for a specific indication, or what the drug is actually used to treat.  For example, Neurontin (gabapentin), is approved by the FDA (or indicated) to treat epilepsy.  However, most people I know use it for neuropathic pain (pain originating from the nerves themselves, usually without outside stimulus).  This is an off-label use, or a use differing from the original indication of a drug (the epilepsy).  So, is this dangerous?  Yes and no.  If the FDA approves a drug, it is lawful for a doctor to prescribe it for any reason s/he sees fit.  Some off-label use comes with research backing it up, others do not.  If it works and has few side effects, why not?

So, what’s the fuss now?  Originally, the FDA did not allow drug companies to promote drugs for off-label uses.  But, in 1997, the FDA granted a temporary exemption to pharmaceutical companies to allow them to promote proven research to physicians and representative agencies to promote off-label uses.  ”Proven research” meant that companies had to submit the research to the FDA prior to promoting the research themselves.  The problem?  It expired in 2006.  Now, the FDA is looking again at the issue.  Now the FDA wants to limit its ties to off-label uses of drugs and devices even more.  Under the new plan, drug companies would be able to promote off-label uses of their drugs as long as the research was done well and that the companies were not the ones funding the studies. 

So why doesn’t pharmaceutical manufacturers get additional indications for their drugs?  Money.  It costs millions or even billions for the drugs to get approval from the FDA, even if the drugs are on the market, since the approval process basically starts over again.  So, say you have a drug that is used to treat Blood Pressure in males ages 20-55.  Can doctors write it for a female, aged 65?  Sure, but it’s an off-label use.  Research may support it, but in reality, the FDA has not approved its use for this purpose.  Why should the company spend the money to get it approved when the doctor’s are writing prescriptions anyway?  This happens more often then you think.  More than 50% of stents (a procedure where a blood vessel is reopened in the heart via a “tube”) are done with off-label uses. 

So, what does the ruling mean to you?  Not much, unless you take a drug for an  off-label use.   The U.S. Supreme Court has now ruled that you the patient cannot sue for a medical device (including stents) that is defective if you use it as an off-label use.  That’s right.  If you have a stent and it breaks, or it breaks off as you put it in, and you are one of the 50% of people that use it as an off-label use, you are out of luck.  For now, this only applies to medical devices, not drugs, but I bet that ruling is not far off.  Pair that with the fact that the FDA is trying to get more lenient with their ability to control the marketing of off-label use, and we have a problem on our hands.  Imagine if the drug companies could soon promote a drug with an off-label use without sending the research by the FDA (assuming they didn’t fund the study of course, well, at least not out-right…), and then couldn’t get sued if it harmed you for that use?  I hope it never gets that bad…

Flu vaccine, what happened?

Here I am, a noble pharmacist giving out flu vaccines like candy back in October, when, what do I hear?  This year, only about 40% of the strains of the flu were covered by the flu shot.  That means that if you got the flu shot and some flu-invested snob sneezes in your face, you had a 60% chance of getting the flu.  Usually, the FDA (the governing body who decides which 3 strains, that’s right only 3 strains, of the flu are covered by the vaccine each year) has been doing pretty well the past 19 years.  However, this year, with major outbreaks coming in January, the FDA needs to take action.  And, well, it’s done their best…

For the first time in history, the FDA has changes all 3 of the strains for the following year’s flu vaccine.  See, the FDA meets now, in February, to plan for next year’s flu vaccine.  It picks 3 strains of the ever changing flu to stop dead in its tracts for next year.  Why decide so soon?  Well, the manufacturing process of vaccines is tedious, and requires millions of eggs.  Basically, one egg equals one dose of vaccine.  The egg is inoculated with the strains of flu, the flu is harvested from the eggs, killed off and injected into you.  Ok, it’s a little more complicated then that, but a tedious process no doubt.  (Hopefully your pharmacist asks you if you are allergic to eggs before giving you the shot.  This is why.  However, most if not all of the egg has been filtered out, since the egg is basically used only as a petri dish.  If you can eat cake, you can take a flu shot.)  And, of course, a very volatile process.  Remember, back in 2006, with the flu vaccine shortage?  One bad egg spoils the bunch…

What can we do now?  Not much.  Tamiflu only works if you can get treatment within 24-48 hours of symptoms.  Hopefully in the future we will have newer technology to be able to make vaccines quicker, and therefore get a better picture of the following flu season.  Better luck next time, FDA.