BAN ON DIRECT-TO-CONSUMER ADVERTISING FOR PRESCRIPTION DRUGS AND MEDICATION-CONTAINING DEVICES

To advocate that Congress ban direct-to-consumer advertising for prescription drugs and medication-containing devices.

Rationale

Direct-to-consumer advertising (DTCA) of prescription drugs and drug-containing implantable medical devices has both positive and negative potential effects. The positive potential effects include broader public awareness and use of therapies, increased patient engagement in their healthcare, and better return on investment in drug and medical device research. These potential benefits need to be weighed against the potential negative effects, however, which include higher drug and device costs, inappropriate prescribing of more costly new drugs or devices without any justifying improvement in patient outcomes, and increased adverse effects. In 2015, the American Medical Association (AMA) adopted a policy calling for a ban on DTCA of prescription drugs and implantable medical devices due to its impacts on drug prices and physician prescribing practices.

Public health researchers have characterized the U.S. experience with direct-to-consumer advertising (DTCA) of prescription drugs since 1997 as “a large and expensive uncontrolled experiment in population health, which to date shows decidedly mixed effects.”^[1] Those researchers and others^{[2],[3],[4],[5]} have identified major impacts of DTCA on public health, including an increase in inappropriate prescribing and adverse effects, medicalization of symptoms previously not defined as illness, and increased costs due to inappropriate prescribing.

The impact of DTCA on the prescriber-patient relationship is hard to quantify. In some surveys, physicians have indicated that they fulfilled questionable DTCA-prompted patient requests for prescriptions. A Food and Drug Administration (FDA) survey the found that “many physicians felt some pressure to prescribe something” when patients mentioned a drug they learned about through DTCA. Studies of claims data support the conclusion that DTCA led to inappropriate prescribing of COX-2 inhibitors and proton pump inhibitors, and experimental evidence suggests that DTCA could induce clinically questionable prescribing of antidepressants for adjustment disorder. Although the connection cannot be proved, it has been suggested that the increasing reliance of physician payments on patient satisfaction surveys could present an economic risk to prescribers who deny patient requests. Studies show that DTCA increases prescribing volume and patient demand, and shifts prescribing. DTCA’s effects include overuse of prescription drugs, a shift to less appropriate prescribing, and switches to less cost-effective treatment. In addition, differential effects by patient price sensitivity have been implicated in sustained sales despite a price increase. Researchers have concluded that the overall effects of DTCA on physician–patient communication are unclear, and that the effects of DTCA on improving the quality of care are mixed¹ or lacking in evidence.

The educational value of DTCA has also been questioned. Consumers of DTCA recall more benefit than risk information. Critics of the educational value of DTCA also note that DCTA could exacerbate health disparities due to differing levels of health literacy and lack of incentive to advertise to low-income populations. Researchers have questioned whether purported improvements in adherence, based mainly on negative trials, stand up to scrutiny.

ASHP recognizes that banning a constitutionally protected right to free speech, even commercial speech, must be reinforced by evidence that indicates the banned speech negatively impacts society. In the case of DCTA, those negative impacts, including intrusion on the patient-prescriber relationship and increased healthcare costs, are evident and overwhelming. Given the outsized role prescription drug products have as a cost driver to the healthcare system, the detrimental effects of DCTA, and the limited potential benefits, ASHP has concluded that a ban on DTCA of prescription drugs and drug-containing implantable medical devices is warranted.