Off-label Drug Promotion and the First Amendment

Doctors can and often do prescribe medications for different purposes than what the FDA has approved them for. But drug companies face tight restrictions on communicating with physicians about these so-called “off-label” uses. If the pharmaceutical industry has its way, those restrictions may soon ease. Such a change would be healthy overall.

Drugs undergo clinical trials for specific indications, such as Avastin for colorectal cancer. The label received from the FDA upon approval allows the manufacturer to promote the drug to physicians for those specific indications only. But a drug that works for one disease may work for a related disorder (e.g., another form of cancer) or something that seems totally different, like macular degeneration. Often the drug company will follow its initial clinical trials with trials for other indications in order to broaden the label and expand sales, but salespeople can’t bring up these uses until they’re officially on-label.

Drug companies get in trouble all the time for off-label promotion. According to the Wall Street Journal (The Free Speech Pill), 15 off-label cases were settled between 1996 and 2010 for a total of $8.7B.

There is a rationale for restricting off-label promotion. After all, off-label use can be dangerous or useless. At a minimum the evidence is likely to be less complete. Lifting restrictions on off-label use would almost certainly drive up health care costs significantly. And yet there’s something unbalanced and unhealthy in the current setup, which relies on regulation of the drug industry to ensure proper use of products. In my view, physicians and to a lesser extent patients and health plans need to be more accountable for considering the evidence base for use of a particular drug –not just for off-label use but for on-label, too. Pharma reps should have to disclose when they are discussing an off-label use, but since physicians are already allowed to prescribe for whatever purpose, I don’t see why the reps need to be restrained so dramatically.

I don’t want my own physicians to be overly influenced by drug reps. I’d rather they obtain their information from more objective sources including UpToDate and Cochrane Reviews. If drug reps are unmuzzled on off-label promotion I do think it will lead to problems, but we should address those problems at the level of the physician, patient and health plan, not just the pharma company.

David E. Williams is co-founder of MedPharma Partners LLC, strategy consultant in technology enabled health care services, pharma,  biotech, and medical devices. Formerly with BCG and LEK. He writes regularly at Health Business Blog, where this post first appeared.

1 reply »

  1. You say that “Lifting restrictions on off-label use would [increase costs]” and everyone should “be more accountable for considering the evidence base” without saying how that accountability would develop. Regulations suck, but you seem to acknowledge they may be better than nothing while simultaneously proposing that this is what we should do. Without proposing something better, aren’t you just recommending dismantling one system of accountability we do have?