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The Food and Drug Administration (FDA) regulates the advertising and promotion of restricted medical devices. Restricted devices may only be sold, distributed or used upon the order of a prescription dispensed by an authorized healthcare provider.
A medical device is defined as:
“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
- located in the official National Formulary, or the United States Pharmacopeia
- designated for the diagnosis of disease and other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- designed to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The regulatory status of a device is determined via the intended use of a medical device by looking at labeling claims, advertising or oral or written statements, or circumstances that show the medical device is known by the sponsor to be used for a purpose for which it is neither labeled nor advertised. FDA considers statements or any other representations made or implied by “word, design, device or any combination” of these, as well as the “extent to which the labeling or advertising fails to reveal facts that are material, such as information about the risks from using the device either on or off-label."
The Federal Trade Commission’s (FTC) consumer protection arm monitors many advertising claims for medical devices, specifically those relating to 510(k) devices and acts against unapproved marketing. FDA, as noted, regulates the promotion of riskier devices and has robust regulations that set out the precise rules for pharmaceutical advertising.
A sponsor may not advertise or promote experimental or investigational devices or approved products that are marketed for off-label use. Such use is viewed by FDA as misbranding. Despite all of these instruments, the Federal Food, Drug, and Cosmetic Act actually lacks a definition for medical device advertising.
Misbranding occurs when advertising is false or misleading in any way. This standard applies to labeling and other printed materials. Misbranding also applies if a label does not contain required information (generic name of the product in type at least half the size of the trade name, a short statement of the intended uses and warnings, contraindications, side effects, caution statements, side effects and a description of the components of the device). It is worth noting that FDA does not acknowledge promotional labeling.
All of that said, FDA has found its regulatory regime increasingly under fire. In Amarin Pharma, Inc. v. FDA, 5×5. 119 F. Supp. 3d 196 (S.D.N.Y. 2015) the U.S. District Court for the Southern District of New York granted a preliminary injunction to prevent FDA enforcement action, holding that a drug manufacturer had a First Amendment right to circulate truthful and nonmisleading materials promoting off-label (unapproved) use of a drug, and that the materials in question — as acknowledged by the court — were truthful and nonmisleading.
Pharmaceutical advertising must be characterized by fair balance between the risks and benefits of the device. The regulations prohibit reliance on unsubstantiated efficacy, superiority and comparative and superiority claims. While there are no specific guidelines, most of the same rules apply to the advertising, marketing and promotion of medical devices. The agency enforces advertising and promotion of medical devices by reviewing labeling and other public materials. The company can inform potential customers that the device is cleared (for 510(k) devices) or approved (for PMA devices). Claiming that a 510(k) device is approved is false and misleading.
Companies often file complaints against FDA because the agency is not taking action against competitors that make unapproved claims. This also happens with promotional materials, about which complaints are directed to the National Advertising Division of the Better Business Bureaus (NAD).
Any agency must prioritize, and FDA is no exception. The agency uses risk analysis principles for evaluating products and determining enforcement priorities. The riskier the product, the tighter the enforcement environment. Sponsors must ensure the safety and efficacy of a device, most often through clinical studies.
Social media is a very large part of marketing and promotion, and is only expanding. FTC’s policy, not surprisingly, continues to evolve. The same rules apply: no misleading or inaccurate statements; risks must be communicated; all material facts must be included, including the full FDA cleared product name. Also, companies should ensure that they follow the policies of the online platforms they use.
Disclosures on social media must be prominent,, must be clearly understandable, placements must maximize the likelihood that consumers will see and understand clearly what is being communicated, and the disclosure must be as physically close as possible to the original claim in all written materials.
Some other key points to consider:
- clearly label hyperlinks
- accurately describe risks and benefits
- each post is a standalone—no multiple tweets
- avoid forcing readers to scroll
- consider the limitations of the respective technologies—what is visible on a laptop may not be as visible on a smart phone
- be attentive to risks inherent in responding to misinformation from third parties.
There is no doubt that compliance with the regulations surround the advertising and promotion of medical devices is both time and resource intensive, not to mention occasionally confusing. By keeping the above in mind, you can avoid enforcement action by FDA and/or FTC.