The medical device industry develops products that directly impact the lives of millions of Americans. With the increasing development of new implantable devices, such as hip and knee replacements and cardiac stents, manufacturers are spending more on direct-to-consumer (DTC) advertising every year, from $116 million in 2005 to $193 million in 2007.
The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act to regulate the labeling and promotion of all medical devices. Medical devices are assigned to 1 of 3 regulatory classes:
- Class I devices: devices posing the lowest risk to patients (eg, elastic bandages)
- Class II devices: devices that pose a greater risk and are subject to “special controls,” such as labeling requirements, performance standards, post-marketing surveillance, or other controls deemed necessary by the FDA to provide reasonable assurance of safety and effectiveness (eg, home HIV diagnostic kits)
- Class III (restricted) devices: high-risk prescription devices that are subject to premarket approval from the FDA before they can be legally marketed (eg, implants and life-supporting or life-sustaining devices)
Is DTC advertising for medical devices less regulated than DTC advertising for prescription drugs?
DTC advertising for medical devices is less regulated if:
- It does not meet FDA regulatory requirements for a DTC product claim ad.
To meet FDA regulatory requirements, a DTC product claim ad must:
- Identify the brand and generic name of the drug
- Communicate the indication for the drug
- Discuss both the risks and benefits of the drug
- Provide dosage
- Direct the reader to speak with a healthcare professional for more information
- Contain fair balance
- Not be false or misleading
- Provide substantiated claims
- Provide a brief summary of the important safety information for the product
- Ensure any art/illustrations are consistent with the drug’s indication
While the FDA has an extensive and detailed regulation (21 C.F.R. Part 202) that sets the requirements as well as the prohibitions for prescription drug advertising, it was not until May 2009, that the FDA released a draft guidance entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
A review of this document reveals several potentially important areas of concern.
1. While the FDA regulates all aspects of advertising and promotion for prescription drugs, the same is not true for medical devices. The FDA regulates the advertising and promotion of restricted medical devices only when the advertising and promotion are done by the medical device manufacturer. Restricted medical devices, particularly implantable devices such as coronary artery stents, are often advertised and promoted directly to consumers by healthcare institutions or individual healthcare practices and professionals that the FDA does not have jurisdiction over.
2. There is a dramatic difference in the amount of safety information provided in prescription drug and restricted medical device advertisements, and in the type of safety information that is necessary for consumers.
3. In contrast to DTC drug advertisements, DTC advertisements for restricted medical devices typically:
- Identify the medical device by its brand name only―there is no generic name
- Do not clearly communicate the indication for the device
- Show the benefits of the device, but not the risks
- Do not present fair balance
- Offer no means of ensuring that the ad is not false or misleading because efficacy claims are not substantiated by published references
4. FDA enforcement options are limited for DTC advertising of restricted medical devices. The relatively short 18-24-month life cycle of most innovative, restricted medical devices essentially negates the impact of the FDA’s sending warning letters to manufacturers about their DTC campaigns. Likewise, the FDA’s ability to regulate the advertising and promotion of restricted medical devices by hospitals, physicians, or surgical groups is nonexistent.
DTC advertising for restricted medical devices is less regulated than prescription drug advertising. DTC ads for restricted medical devices are potentially more misleading and subject to less enforcement.
In addition, there are dramatic differences in consumer knowledge and comprehension of restricted medical devices, and critical safety information consumers need to make educated decisions is routinely omitted from DTC advertising. Increased FDA scrutiny of DTC advertising of restricted medical devices merits significant consideration.
For more information on this issue, contact the Kulkarni Law Firm.