FDA Attempts to Guide Industry on Device Advertising

Under the Federal Food, Drug, and Cosmetic Act (“FDC Act” or “the Act”), FDA has the authority to regulate and oversee the labeling accompanying all drugs and devices, as well as the advertising for prescription drugs and restricted devices—i.e., devices whose sale or distribution has been restricted by FDA, either by regulation or by order approving the initial marketing of the device.(1) While FDA’s statutory authority to regulate medical device advertisements is technically limited to advertisements for restricted devices, the agency has the broad authority to regulate labeling for all medical devices.  FDA and the courts have taken a broad view of the term “labeling;” under the Act and accompanying regulations, labeling is defined broadly to encompass a host of items such as brochures, literature, and most printed, audio, and visual materials related to a device.(2)  Thus, the agency has asserted its jurisdiction over advertising for non-restricted devices simply by calling the advertisements labeling.  Consequently, while the Federal Trade Commission (“FTC”) technically has the primary authority over device advertising, due to FDA’s expansive definition of labeling, FDA, in practice, takes the primary role in regulating advertising materials for medical devices. 

Under the FDC Act, it is illegal to adulterate or misbrand a medical device.(3)  A device is misbranded if its labeling, or advertising, is false or misleading in any particular.(4)  For example, failure to reveal material facts about the device, including facts about the consequences that may result from its use, can be considered misleading.(5)  In addition, advertisements for restricted devices must include a brief statement describing the device’s intended use, relevant warnings and precautions, as well as information on side effects and situations in which the device should not be used.(6)

In recent years, failure to include or minimizing information on the risks and side effects of drugs and devices has become the most common violation cited in advertising warning letters sent by FDA to the drug and device industry.(7)  In 2008 and 2009, FDA has issued 13 warning letters in which the agency cited minimization or omission of risk information in advertising as misbranding the product.(8)  In at least two of these warning letters, the agency emphasized that the sponsor failed to include any information regarding the risks of the product.(9) 

While the vast majority of warning letters were issued to drug manufacturers, the letters suggest that the agency may be increasing its enforcement efforts with respect to risk communications in drug and device advertisements.  Supporting this notion, FDA issued draft guidance on May 26, 2009, laying out recommendations for the presentation of risk information in drug and device promotional materials.(10)  The agency notes throughout the guidance that while many advertising regulations have focused on drugs in the past, the general principles outlined in these regulations have applicability to devices as well, as they represent FDA’s thoughts on what constitutes false or misleading advertising.(11)

In the draft guidance, FDA outlines its longstanding practice of focusing on the “net impression” of an advertisement when determining whether it adequately balances risk and benefit information about the advertised product.(12)  The agency outlines the general considerations it applies to advertisements, such as the use of appropriate language for the target audience and the framing of risk information, when evaluating whether the advertisement appropriately communicates risk information.  FDA also discusses how the agency will evaluate the content and format of risk information presented in an advertisement, which may include evaluating the pace and volume of the speaker and the use of background music during risk discussions.(13)  Thus, even if the actual promotional statements are not false or misleading on their face, when considered in conjunction with other audio or visual imagery presented in a given advertisement, the agency may determine that the total information is false and/or misleading.

Though both the drug and device industries recently devised guidelines of their own in an effort to self-police their advertising, the FDA guidance indicates that the agency will not allow the industry to rely on these voluntary guidelines alone.(14)  The agency specifically recommends that drug and device firms consider the factors outlined in the new draft guidance, which is available at http://www.fda.gov/cder/guidance/7427dft.pdf, when designing promotional materials.(15)  Comments regarding the draft guidance will be accepted until August 25, 2009, and can be submitted electronically at http://www.regulations.gov.