Off-Label Promotion … By HHS

Like everyone else, we get more email in a day than we can possibly read, so sifting through the in-box is an exercise in triage and second-guessing. As in, “What were we thinking when we signed up for every HHS list-serve?”

Then there are days like today, when we saw the following gem glimmering in our over-crowded in-box:

Sender: US Dept. of Health & Human Services
Subject: Going Off-Label

Yeah, we opened that one. Given the billions upon billions paid (and to be paid) to settle prosecutions of manufacturers involving off-label use of medicine, we were keen to know exactly what HHS plans to do next.

Okay, so it turns out it was a link to HHS Healthbeat, a daily podcast for consumers, focusing on off-label use of medicine. (You can listen to the podcast here, or just read it—it's short—here).

“Everybody tells the patient to read and follow label directions. But sometimes the doctors themselves don’t. They prescribe a drug in ways – or for conditions – that the label doesn’t talk about,” HHS tells consumers.

Then some words of solace for those in industry who fear that off-label use is itself being criminalized in the context of recent enforcement actions: “That actually can be good for you. It’s called an off-label use, and the doctor may be acting based on the latest research.”

Now, HHS isn’t exactly encouraging off-label use. The podcast includes a quote from Agency for Healthcare Research and Quality Director Dr. Carolyn Clancy, who advises: “If it turns out that your doctor has given you an off-label drug, you should ask your doctor if the off-label drug is likely to work better than an approved treatment.”

Of course, that is also a question AHRQ can (and we assume will) help to answer, now that HHS has $1.1 billion to spend on comparative research…