US Pharm. 2014;39(10):1.

For the nearly 45 years that I have been a licensed pharmacist, and likely for many years before, promoting a drug based on its off-label use has been hotly debated, contested, and considered illegal. The issue of off-label use was driven home for me the very first week following my graduation from the Rutgers University pharmacy school. In New Jersey, where I lived, pharmacy graduates had to intern for a year in a practice setting of their choice before taking the licensing exam. The year was 1970, and it had been a typically busy day behind the prescription counter in the retail pharmacy where I was interning. Although I was not yet licensed, wearing the white coat in an actual retail pharmacy setting was a thrill. Just out of college, I felt as though I could field any pharmaceutical question that came my way. I couldn’t wait to put my schooling to good use. The opportunity came sooner than expected. During a busy morning, a young woman approached the pharmacy counter and handed me a prescription. She caught me off guard by asking a question that startled me. Pointing to the prescription, she asked, “What is that drug used for?”

I thought the question odd, as she had just come from the doctor’s office up the block. I thought perhaps she didn’t agree with the physician’s diagnosis or simply did not ask the doctor about the medication he had prescribed. The prescription was for Valium 5 mg. Back then, Valium was a frequently prescribed drug, so I obviously knew much about it and thought to myself—with the cockiness of a fledgling pharmacist—that I could take care of this. I told her it was a drug used to alleviate generalized anxiety. Well, you would think I told her she only had a few days to live! She responded by asking, “Is he [her physician] crazy? I went in for a sore back!” Shortly after that I heard from the disgruntled physician, who, upon learning that I was just out of school, proceeded to give me a lecture on the off-label uses of certain drugs. Lesson learned!

To say my consultation skills have improved vastly over the years would be an understatement, but I am still very cautious about giving advice on certain drugs that have had off-label uses, some even recognized in professional journals. The pharmaceutical industry has been dealing with the legality of promoting off-label uses of the drugs they manufacture for many years, with some cases ending in civil liability and criminal lawsuits filed by the FDA under the False Claims Act. The resulting penalties total in the billions of dollars.

Some pharmaceutical marketers have argued that being prevented from promoting an FDA-approved drug for unapproved uses violates their First Amendment rights to free speech. This was recently debated in the University of Pennsylvania Law Review by two of its distinguished professors. According to the abstract, “Although an off-label prescription is legal and often beneficial, the Federal Food, Drug, and Cosmetic Act (FDCA) and corresponding FDA regulations effectively prohibit off-label promotion.” This puts pharmaceutical manufacturers in a classic catch-22 situation.

I suspect the U.S. Supreme Court will eventually settle this issue, but until then the debate rages on, and pharmacists may find themselves squarely in the middle of the controversy. Therefore, it is imperative that pharmacists who counsel patients be very cautious and transparent about discussing off-label uses of a particular drug until a specific court ruling is firmly in place. I personally hope it happens soon, because the contention and controversy over promotion of off-label uses have festered for way too long.

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