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Opinion: Off-Label Direct-to-Consumer Drug Advertising “Just Isn’t Healthy”

Opinion: Off-Label Direct-to-Consumer Drug Advertising “Just Isn’t Healthy” | Pharma Industry Regulation |

Many patients will insist on brand-name drugs they saw advertised on TV, and their doctors will write prescriptions rather than spend valuable time talking them out of it. For these reasons, the American Medical Assn. has called for a ban on direct-to-consumer drug advertising (read “AMA Calls for a Ban on Direct-to-Consumer Drug Ads”;


Yet the FDA is now considering a rule change that would expand direct-to-consumer drug marketing to so-called off-label uses — that is, for treatment of conditions that the drug wasn’t originally intended to remedy.


If adopted, the new rule, which was unveiled at a public hearing the day after the November election, could allow drug companies to forgo much of that extra testing and leave patients to hope for the best (read “Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?”; and “FDA Throws a ‘Regulatory Temper Tantrum’ Rebuffing Off-Label Drug Promotion Proponents”;


A study last year by Canadian and U.S. researchers found that patients using off-label drugs without strong scientific evidence of effectiveness were 54% more likely to experience adverse side effects, such as an allergic reaction, or gastrointestinal or respiratory complications. Or worse.


That’s not an easy thing to communicate in a slick 30-second ad on prime-time TV. In fact, it has no business being addressed in such a slapdash manner.


Some deregulation of the drug industry may help patients. The Trump administration is on the right track if it can safely accelerate drug approvals, promote production and use of generics, and lower drug prices through increased competition.


It absolutely shouldn’t permit pharmaceutical companies to expand their direct-to-consumer marketing. The administration should heed the medical community’s call to end the practice and bring us in line with nearly every other country.


Diagnosis: It just isn’t healthy.

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