Everyone has seen the commercials on television for prescription drugs, such as Eliquis, Xeljanz, and Humira. In recent years, direct-to-consumer (DTC) advertising has expanded to include cancer drugs, such as Opdivo. At last tally, in 2016, the biopharmaceutical industry spent $30 billion on medical marketing, about a third of which was DTC advertising. Others forms of marketing, such as physician detailing, account for approximately two-thirds of aggregate spending.
When in 1997 the Food and Drug Administration (FDA) eased restrictions on prescription pharmaceutical broadcast advertising, it ushered in a new era of DTC advertising of prescription drugs on television. In the late 1990s, as the Internet gained in prominence, online advertising became another marketing tactic. Consequently, marketing expenditures increased dramatically.
The important question this begs is whether more marketing leads to a better informed patient or consumer. Surely, having more information is a good thing. Given the information gap and asymmetry that exist between the information physicians, drug manufacturers, and patients have access to, increasing the availability of information may address problems that have beset the healthcare market since time immemorial. The question then becomes whether DTC advertising fills the information gap appropriately. Public health campaigns designed without a profit motive provide information that generally does not favor a particular product. But promotional information is qualitatively different. The purpose is informational, but in order to drive sales of a specific product. This does not, however, negate the informational value that DTC adds. Some economists have suggested that on balance DTC advertising offers patients important information that boosts disease awareness, which in turn increases demand for classes of drugs that provide significant benefits.
In the jargon du jour, proponents of DTC advertising suggest that commercials can empower and engage patients to participate in their own healthcare. As such, DTC advertising may prevent underuse of effective treatments and potentially increase compliance with drug regimens. A survey conducted in 2004 by the FDA found that the majority of physicians surveyed believed that DTC advertising made their patients more aware of treatments and feel more engaged in their own healthcare. A more recent survey suggested a dip in physician support with less than half (48%) indicating that DTC advertising informed, educated, and empowered patients. And, a slight majority (53%) of physicians who responded to the survey were opposed to DTC advertising.
Indeed, critics in medical professional and policy circles have argued that DTC advertising can misinform patients by inflating treatment benefits, under-emphasizing treatment risks, and promoting drugs over certain non-pharmaceutical lifestyle choices. Additionally, an economic critique of DTC advertising points to its potentially being a driver of higher prescription drug costs due to inappropriate prescribing in certain instances and over-prescribing of branded products when cheaper generics are available.
DTC advertising is here to stay in all likelihood. The policy issue is how to improve its content, and possibly regulate it accordingly. Informed choices by patients depend on the level of quality of the information at their disposal. Furthermore, to address concerns voiced by medical professional societies FDA could add or buttress information requirements.
The FDA does not approve drug commercials in advance. Rather, it monitors advertising to ensure claims are not false or misleading. Prior approval by FDA of DTC advertisements would be time- and resource-consuming. But, monitoring efforts could improve. Citations issued by FDA regarding promotional advertising have been decreasing for quite some time. This does not necessarily mean FDA monitoring efforts are insufficient. But, it does give pause.
A study published in May last year in the Journal of General Internal Medicine concluded that “few broadcast DTC ads were fully compliant with FDA guidelines.”
Clearer FDA guidance on DTC advertising coupled with stronger enforcement could help reduce ambiguous claims and lead to improvement in the quality of the benefit/risk information being disseminated.
On a positive note, in October 2018, the FDA published guidance on how to improve quantitative information on safety and efficacy contained in labeling as well as DTC advertising. Moreover, the FDA issued guidance clarifying what it considers permissible off-label information for drug companies to convey to insurers and hospitals. The guidance – Medical Product Communications That Are Consistent With the FDA-Required Labeling – describes ways in which drug manufacturers can share information that is not contained in the labeling. According to FDA commissioner Scott Gottlieb, the “final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle.” From the drug industry’s perspective what is hoped is that this guidance grants them the ability to facilitate appropriate reimbursement decisions on off-label uses of pharmaceuticals.