Medical Device Daily Washington Editor
WASHINGTON – In ever-increasing numbers, consumers – not physicians – are the targets of advertising by device companies.
Direct-to-consumer (DTC) advertising is not just for drug companies anymore, and device regulators at the FDA are slowly ramping up to deal with this new area of oversight, according to John Manthei, a partner with the law firm of Latham & Watkins (Washington).
“We have an agency that is looking to be much more aggressive and much more proactive on the device side in consumer advertising and off-label promotion,” Manthei said in a presentation during last week’s annual meeting of the Medical Device Manufacturers Association (MDMA; Washington).
Prescription drug advertisements targeting consumers have been around for many years in print, on television and now on the web. But this is still fairly new territory for device companies, and the FDA’s Center for Devices and Radiological Health (CDRH) still is in the process of testing the waters, Manthei said.
He said that while the Center for Drug Evaluation and Research (CDER) has formal advertising and promotion regulations in place, similar formalized recommendations have yet to come from CDRH.
“It’s hard to turn on the TV and not see direct-to-consumer advertising for pharmaceuticals,” he said. “But you’re seeing in more and more with devices.”
In 2004, however, the agency did issue two draft guidance documents intended to address the increase in DTC promotion of devices, the first dealing with consumer-directed broadcast advertising of restricted devices, the second covering disease awareness communications by device firms.
The FDA has accepted comment from industry in the guidance documents but, as yet, has not indicated when they may be finalized, Manthei said.
“Take it with a grain of salt,” he cautioned. “They are still in draft form.”
Though there is a “broad disparity” in the way device firms have complied with the draft guidance thus far, firms should familiarize themselves with what the agency has posted as an indicator of what to expect, going forward, he said.
In 2004, CDER’s Division of Drug Marketing, Advertising and Communications issued 12 warning letters, up from five in 2003. In contrast, CDRH issued only one advertising-related warning letter in 2004 and another in 2005 related to Internet advertising, according to Manthei.
Traditionally, CDRH has relied on consumer complaints in its policing of medical device promotion, he said. And although the FDA currently devotes “dramatically less” time and resources to its watchdog efforts, “you will see enforcement stats begin to rise significantly,” he said.
On the drug side, most of the warning letters issued related to patient-directed advertising target those companies leaving out or minimizing the risks of their products or unsubstantiated safety claims, he said.
For devices, the few warning letters that have been sent involve, he noted, unapproved uses, unsubstantiated efficacy and overly broad product indications.
Though there is controversy – both for drug and devices – surrounding the issue of DTC advertising, the strategy also comes with clear benefits, Manthei said.
He noted that the FDA has said that DTC advertising can provide valuable information about specific diseases, conditions and treatments, even though sponsored by companies with clear special interests in those sectors.
DTC advertising also can raise awareness of conditions that often go undiagnosed, untreated or under-treated, he said, and this kind of communication may encourage patients to talk to their physicians and be more proactive in their own care.
Critics argue that targeting consumers can lead to physicians feeling pressure for unnecessary prescriptions and can act as a barrier to good discussions between doctor and patient.
Though most medical devices are not great candidates for DTC advertising, he said, this approach is being seen more frequently for home use testing kits, such as glucose and blood-pressure monitors. And automated external defibrillators – approved last year for home use without a prescription – also are popping up in print and television ads.
Other areas he cited as seeing increased DTC advertising are cardiology-related devices, such as drug-eluting stents.
As with drug ads, marketing can have more impact when there is an opportunity for patients to do their own research about a condition or a procedure and then discuss device alternatives with their physician.
Manthei also pointed to some of the similarities in requirements for DTC marketing of drugs and devices.
The ads, according to the FDA, must convey all the most important product warning, precautions, side effects, and contraindications in consumer-friendly language, in addition to all information relevant to the product’s indication.
And there has to be some mechanism to make sure consumers are aware of the “fine print” qualifiers, such as pointers to a web site or a toll-free number for obtaining approved package labeling. There also is the ubiquitous recommendation that consumers consult their physicians.
A large gray area is advertising containing information about a specific disease or conditions, sponsored by a device company but not mentioning a specific device.
The FDA’s 2004 guidance tries to clarify the line between disease awareness communications – which in the most basic form, fall outside FDA jurisdiction – and promotion activities subject to agency regulation.
The FDA has expressed concern about this kind of communication being presented together with product-specific promotional materials. According to the agency, disease awareness communications should be health condition-specific; they should educate; identify a population at risk; and contain a “responsible” health message on prevention, diagnosis or treatment. And they should refer consumers to a healthcare provider for more information and avoid encouraging self-diagnosis and self-treatment.
An example of this would be a device company such as a pacemaker manufactures sponsoring a TV ad about leading a heart-healthy lifestyle and the warning signs of heart disease.
“This really has the potential to affect how companies interact with physicians,” Manthei said. “This has the potential for very drastic consequences, but FDA’s policy as it relates to device is still emerging.”