The promotion of medical technologies in the US can be generalised in targeting two broad audiences. The first audience is the widely diverse community of healthcare professionals. The second, smaller but growing, are the end users of products; consumers.

Through various promotional activities, manufacturers are beginning to educate and inform the public directly about the benefits of specific medical treatments. While the practice of promoting the benefits of medical technologies is widely accepted as crucial to informing patients and healthcare professionals about the benefits of products, it is closely monitored by the Food andDrug Administration (FDA).

In May 2009, the FDA released a proposal intended to provide guidance to the drug and device industries on how to structure and convey benefit and risk information. While the guidance from the FDA will likely remain non-binding on industry, it is intended to encourage best practices from device companies engaging in product promotion. Moreover, it offers insight into the FDA’s thinking on the issue.

“In May 2009, the FDA released a proposal intended to provide guidance to the drug and device industries on how to convey benefit and risk information.”

Marketing and promotion of medical devices takes place through numerous mediums and encompasses several formats. Unlike pharmaceutical products, marketing by the device industry is geared primarily towards prescribers of devices, such as physicians and surgeons.

The benefits and risks associated with a specific device are often delivered through one-on-one meetings with healthcare professionals, education seminars and even medical literature. The purpose behind this is so a prescriber may have the best information possible to make a proper medical device for their patient.

Despite the prominence of drug advertising, there has been an uptrend in the practice of device direct-to-consumer (DTC) advertising. DTC advertising, while not widespread in the US device industry, is intended to inform patients about specific medical therapies and start a dialogue with their physician.

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While conducted only in the US and New Zealand, it is one of the primary distinguishing mediums in promotion between the drug and device industries. DTC advertising constitutes primarily print, non-print and broadcast advertising and appears to be the focus of the recent FDA guidance.

May 2009 FDA guidance

In May 2009, the FDA released proposed guidance on the promotion of products for the drug and device industries. The guidance, entitled ‘Presenting Risk Information in Prescription Drug and Medical Device Promotion’ is being reviewed and analysed by drug and device companies engaging in marketing and promotion of their products. It is likely that the Agency will produce a final guidance document by the end of 2009.

Before highlighting the specific recommendations for devices in the guidance, it is necessary to outline the FDA’s authority in regulating the advertising and labelling of medical devices. By law, the watchdog maintains authority to regulate and monitor labelling of all cleared or approved medical devices. However, the task of regulating the majority of medical devices to the public is left to the Federal Trade Commission (FTC). The laws abiding to the FTC regulation of medical device advertising generally prohibit the misleading or false claims about a product regulated by the FDA.

The FDA does maintain authority to regulate the advertising of a small number of devices, categorised as being ‘restricted’. Medical devices can become restricted in several ways. If the Agency is unable to determine that there is a reasonable assurance of the device’s safety and effectiveness, then the device may become restricted. The sale and distribution of a Class III device may be restricted as a condition of approval. A device may also become restricted if the FDA establishes a performance standard with respect to the device.

In short, most Class III premarket approval devices under the Agency’s purview are categorised as being restricted devices and are therefore subject to regulation of the promotion and advertising of that particular product. Outside of that, for lower risk products and those that fall outside of the Agency’s three requirements to be deemed ‘restricted’, the promotion and advertising regulatory responsibility defers to the FTC.

Risk and delivery

The May 2009 guidance is intended to convey what the Agency believes to be proper and necessary in evaluating risk information. To this end, the draft guidance appears to suggest that patients having access to accurate and sufficient risk information is the most important aspect of any promotional material. One of the methods the FDA is looking to employ when assessing promotional material is using a ‘reasonable consumer’ standard. This standard essentially takes the perspective of a consumer and attempts to determine what standards they (the consumer) would use when assessing the benefit and risk information presented in advertising and labelling information.

Within this context, the FDA also proposes to consider information on a per-group basis. In other words, if the promotional material is intended for and directly targeted towards a particular group, such as physicians, that group’s level of knowledge and perspective in determining the reasonableness of the promotional material will be taken into consideration.

The FDA seems to leave open the door and consider that certain promotional material may have multiple interpretations of a marketing or promotional claim. The interpretations also must be considered to be reasonable by the FDA’s determination. However, promotional material will be determined to be false and misleading if any of the interpretations or representations are deemed false or misleading.

The FDA is considering in the guidance what it calls a ‘net impression’ of promotional information. What this means is that the net impression of each promotional campaign will be evaluated, not just risk-specific information. It will likely look at whether a claim is false or misleading, but also the manner in which it is delivered.

“The guidance suggests patients having access to accurate risk information is the most important aspect of a promotional material.”

For instance, if a print advertisement contains factual risk information that is accurate and adequate but is conveyed in a way a patient could making an alternate interpretation this may violate the proposed net impression standard.

The FDA is considering several factors in the proposed guidance when it evaluates risk information in advertising and labelling pieces. In short, using factors relating to format and content, as well as make general considerations. The starting point is ensuring that risk information is patient friendly. One factor being proposed is to ensure that promotional materials maintain consistent use of language appropriate for the target audience; for example, it should include non-technical language. In addition, the use of signals will be factored in.

The FDA will look, for example, as to whether risk information is in a subheading and benefit information is more prominent in print or other media advertisements. Risk and benefit information must be framed and presented in the same terms. It will also consider how specific risk information is ordered in promotional materials. It will look to employ a hierarchal approach to risk presentation, suggesting that the most important risks should be presented first in both print and non-print materials.

The FDA is examining factors related to the content presented in promotional material. It is also looking to consider the quantity of information presented in promotional material. Within this context, the FDA is proposing to balance the quantity of risk information against the quantity of benefit information. It will likely not be necessary for there to be an equal number of benefits or risk claims, but a fair amount of comparable balance may be required.

Finally, when considering the content of promotional information, an important factor is the comprehensiveness of benefit and risk information. Again, taking the perspective of a target audience, it will be expected that certain information will be present in promotional material. The material presented by a company should be comprehensive enough to achieve these expectations.

Advertisement formatting will also be assessed in the proposed guidance. Specific information relating to how the risk and benefit information is formatted in promotional materials is expected to be evaluated. In theory, the FDA will be able to look at a print or other media ad and attempt to determine if the formatting in the ad can be construed in a matter that would ultimately be determined to be false or misleading. Most of the factors assessed will apply to print and non-print promotions.

Proposals include examining aspects such as font size and style, location of risk information, contrast in colouring, the amount of white space and other audio, textual and visual elements. These factors suggest that the FDA is responding to use of imagery and ‘flashiness’, which has drawn criticism from several patient advocacy groups. However, most of this criticism was directed towards drug manufacturers’ advertisements’ use of DTC marketing.

A notable absence in the draft guidance is the lack of direction on internet-based advertisements and promotion. There are a few details on how manufacturers should tailor their internet advertisements and promotional materials, but substantive direction is lacking. Most of the guidance is targeted toward traditional advertisements and labelling information for drug and device manufacturers.

Effect on the industry

The May 2009 guidance issued by the FDA was only a proposal, with comments being accepted from the drug and device industries from 25 August 2009. While the proposal is not final it does provide relevant insight to the regulator’s thinking on the advertising and labelling practices by the industry.

Once the guidance becomes formalised, it will likely affect only a small proportion of the total device industry. The FDA maintains jurisdiction to regulate promotional activities over device manufacturers that produce ‘restricted’ devices; the Federal Trade Commission maintains jurisdiction over most other devices. For devices that will be affected, the FDA seems to provide thorough enough guidance for print and non-print material.

“A notable absence in the draft guidance is the lack of direction on internet-based advertisements and promotion.”

However, important to remember is that this guidance is intended for both drug and device manufacturers of restricted products, and there are distinctions in the statutory requirements for each. There is no legal or statutory requirement that promotional advertisements be submitted to the FDA for review prior to its widespread release.

The same legalities apply to drugs with a few rare exceptions. The difference occurs at the time of dissemination. Prior to a broadcast or release of promotional material, device companies are not required to submit promotion materials to the FDA.

On the other hand, most pharmaceutical companies are required to submit such information.

While this guidance will most likely remain non-binding, device companies engaging in promotion of restricted devices would be wise to adhere to the outlined principles. The guidance remains a patient-centred document; taking into consideration what the patient may interpret on the receiving end of promotional material. Manufacturers should remain vigilant in communication risk and benefit information accordingly.