A Preemptive Strike: US Medical Devices DTC Advertising Comes Under Fire
Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.
One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.”
Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”
The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry? Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?
On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.
Until next time…
Good Luck and Good Job Hunting!!!!!!!!!!!



