Taking a prudent approach to marketing and staying abreast of federal guidelines can mean better business for IVD makers.
Regulations & Standards
Philipp Novales-Li, DMedSc, PhD, DPhil, RAC, is manager of regulatory affairs at Abbott Diabetes Care Inc. He is currently based in the San Francisco Bay area and can be reached at firstname.lastname@example.org
The advertising and promotion of medical devices, including IVDs, are subject to both FDA and Federal Trade Commission (FTC) authority. FDA views IVD manufacturers' promotional activities as a form of labeling, which it regulates. FDA also has authority over device advertising, but this extends only to restricted devices. However, because manufacturers can use advertising to establish intended use, this reasoning can provide FDA with a backdoor regulatory route to oversee unrestricted-device advertising as well.
As a matter of policy, all unrestricted-device advertising is regulated by FTC. Although the division of oversight is clear in principle, a somewhat more ambiguous and powerful authority extends to FDA in practical application. In fact, according to an appellate court decision, most, if not all, advertising is labeling. The term labeling is defined by the FD&C Act as including all printed matter accompanying any article. Congress did not, and the appellate court also could not, exclude from the definition printed matter that constitutes advertising.
Advertisements include not just those appearing in print or online media, such as in journals, magazines, periodicals, and newspapers, but also those that are broadcast over the radio, television, or related telecommunication systems. This article discusses pertinent issues related to IVD device advertising and promotion.
As a general rule, promotional claims must be within the limits of a product's intended use and indications, as cleared or approved by FDA. To be in compliance, promotional claims must do the following:
• Be truthful; that is, not false or misleading in any respect.
• Contain a fair balance of the risks and benefits of the device, with clear context, layout, and format of the information presented.
• Have adequate substantiation, based on well-controlled studies or supporting evidence.
IVD devices that are exempt or marketed through a 510(k) or premarket approval (PMA) route are all subject to these rules. FDA's positions on other promotional practices that are relevant to IVDs are as follows.
Brief statement and broadcast advertising of restricted IVD devices. Consumer-directed broadcast advertisements of IVD devices that are deemed restricted devices (in a PMA order or by regulation) must fulfill the brief-statement requirement under regulation 21 USC 352(r). (This scenario applies to a narrow set of circumstances that may come up rarely; for instance, if an IVD company happens to promote a prescription IVD directly to consumers.) This requirement may be fulfilled by disclosing the most serious and common risks associated with the IVD device in the audio or audiovisual part of the ad, and by making adequate provisions for disseminating the approved package labeling. The latter may be done by providing a toll-free number or a Web address for obtaining package labeling. Alternative provisions can be made by referencing print ads or referring consumers to their healthcare providers for more information.
With respect to telephone-relayed advertisements, this information can be recorded or communicated in an interactive manner. The manufacturer can comply with the brief-statement requirement by having the information mailed or read over the phone, or by stating that healthcare professionals are a source of additional device information.
Finally, broadcast ads must not be false or misleading in any respect, and they must present product effectiveness and risk information in a balanced manner. A brief statement of the intended use of the IVD device and relevant warnings, precautions, side effects, and contraindications must also be presented in consumer-friendly language.1
Off-label promotion. Much of the guidance for off-label promotion of IVD devices is from the requirements for drugs. As a general rule, companies can promote only intended uses that have been cleared or approved by FDA. As such, FDA prohibits companies from creating materials that contain off-label promotion, because doing so creates an unapproved intended use and may cause the product to be deemed misbranded and/or adulterated, both of which are subject to FDA's intended use enforcement action. Even an implied use can be deemed an off-label promotion, as in the case of promotional labeling for a prostate cancer marker that depicts a picture of a young man, when the test is cleared only for men aged 50 and over. However, FDA allows dissemination of off-label medical information, as long as it is in response to unsolicited requests for scientific or medical information from healthcare professionals and is balanced to the positive and negative. That is, negative information is also distributed on request.
There is also a safe harbor, as described in FDA's Good Reprint Practices draft guidance, wherein manufacturers may disseminate off-label uses contained in scientific or medical journal reprints, articles, or publications that reference off-label uses. However, dissemination of off-label data or articles can only occur if the request comes from a medical professional; the company cannot be proactive in distributing this type of information without a request. In brief, the article or reference must be peer-reviewed and published by a journal that has an editorial board. Also, any conflicts of interest by authors or editors of the article must be disclosed. Furthermore, the draft guidance recommends against distribution of special supplements or publications that were funded by any of the product sponsors mentioned in the article, and articles that are not supported by credible medical evidence.2
Prelaunch promotions. Devices that are pending clearance or approval cannot be promoted. This applies to all product literature, labeling, communications, and advertising. Likewise, the indications for use may not be stated or implied, and no claims of safety or efficacy may be made. This is because prior to clearance or approval, the manufacturer cannot ascertain which claims will be accepted by FDA. Therefore, the device cannot be considered safe or effective. The investigational device exemption (IDE) regulations also prohibit promotion of devices that have not yet been cleared or approved for marketing by FDA. This includes promotion or test marketing of investigational devices, or representations made that a device is safe or effective for the purposes for which it is being investigated. It should be noted that companies can communicate prelaunch information about unapproved products by using press releases on product development activities and having scientists provide presentations at meetings, within the context of a scientific and educational activity.
Pharmacoeconomic claims. Pharmacoeconomic claims, such as cost-effectiveness or cost comparison of health outcomes, compare the financial consequences of use of an IVD device with another product. There are strict limitations to this type of claim, and such promotion must only be targeted to individuals and groups responsible for making product-selection decisions for managed healthcare organizations. These include drug information groups, formulary committees, or similar groups that assess technologies and scientific studies in order to recommend IVD device purchasing contracts, tenders, etc. Pharmacoeconomic claims cannot compare off-label uses, and they must be presented in a credible way and be supported by valid data. Further, pharmacoeconomic information cannot be disseminated directly to healthcare professionals who prescribe IVD tests, nor can this information be used in the context of medical education.
FTC's truth-in-advertising policies require that advertising be truthful and nondeceptive, have evidence to back up its claims, and be fair. Some advertising practices that are subject to FTC's policies are as follows.
Comparative advertising. This pertains to advertising that objectively compares prices or measurable factors between different IVD device brands, as identified by name or illustration. FTC supports brand comparisons since this encourages product improvement and technology innovation, which may lead to competitive pricing. As a general rule, comparisons must be substantiated by head-to-head testing, as applicable. Although some industry codes prohibit disparagement practices in comparative advertising, FTC permits this as long as they are truthful and not deceptive.3
Endorsements and testimonials. Ads can leverage the experience or expert opinion of a third party in the form of verbal statements or a seal of approval. Such endorsements and testimonials must reflect the honest opinion or experience of the endorser. Although the advertising message need not use the exact words of the endorser, the paraphrased endorsement must not be reworded or taken out of context. Similarly, the advertisement may continue to run as long as the company has good reason to believe that the endorser continues to use the IVD device. Moreover, any material connection between the endorser and the manufacturer must be disclosed, since this relationship may impact the credibility of the endorsement.
Endorsements and testimonials can be made by consumers, experts, or professional organizations. In consumer endorsements, the advertising message must represent the typical experience of individuals or a group of consumers, based on actual conditions of the use of the IVD device. If actors or actual consumers are used in the advertisement, then such representations must be disclosed. With respect to expert endorsements, the endorser's qualifications must be commensurate with the expert opinion that is imparted in the advertising message. Such endorsers must support their testimonials by actually examining or testing the IVD device as extensively as possible to support the conclusions made in the endorsement. Finally, when organizations are used to endorse an IVD device, care should be taken in choosing professional organizations that have appropriate experts or have adopted standards that can support examinations of the relevant merits of an IVD device. Such endorsements must also reflect the collective judgment of the organization.4
Free claims, rebate offers, and samples. Offers such as “buy one, get one free” must be based on the product's regular price and must indicate that the customer is paying no more than the regular price for the product, while paying nothing to purchase another product tied to the offer. For rebate offers, the before-rebate price as well as the rebate amount must be prominently disclosed. The ad should also clearly and conspicuously disclose the terms and conditions of the offer. When free samples are being provided as part of a promotion, it may be prudent to add a disclaimer that “the product is supplied as a free sample and shall not be submitted to any third-party payer, public (e.g., Medicare/Medicaid) or private, for reimbursement.”5
Warranties and guarantees. If a warranty is advertised, the law requires that companies be able to provide a copy of the warranty to the customer prior to a sale. Or, the advertisement should clearly disclose how customers can get additional details. If claims such as “satisfaction guaranteed” or “money back guaranteed” are made, the company must be willing to give full refunds for any reason. Customers also have a right to know any limitations in the terms of warranties or guarantees, and these should be clearly disclosed.
New product claims. If an IVD device is advertised as being new because it has recently been launched in the market, FTC suggests a six-month limit on the use of this claim. As such, manufacturers must exercise due diligence to ensure that after this time period, all ads and promotional labeling must be revised to redact this claim, which by then could be construed as false and misleading.5
Country-of-origin claims. Such claims include “Made in U.S.A.” or “Made of U.S. and imported parts” or “manufactured in U.S. with Chinese components.” A country-of-origin claim means that the advertised product is all or virtually all made in the stated country, which in turn means that all significant parts or processing of the product are made in that country—or that the product contains negligible foreign content.5
Price advertisement. Pricing must be truthful, and in most jurisdictions, companies are legally required to charge no more than the advertised price for a product. Hence, adopting good pricing practices is a sensible approach for all IVD manufacturers to take. The same standard for truthfulness applies when making claims about price comparisons, sale prices, etc.5
Environmental claims. When making environmental claims, the environmental benefit must be stated in clear, specific, and definitive terms. If environmental symbols are used, it is important to explain what such symbols mean. Also, companies must make sure to verify each environmental claim in advance.5
Disclosures in advertising. As a practical matter, any disclosures or disclaimers that accompany an ad that are necessary to prevent it from being misleading or deceptive must be clear, conspicuous, and unambiguous so that the ad can be noticed and understood. Although there is no rule on the font size of disclosures or disclaimers used in print ads, or on the amount of time a disclosure or disclaimer is broadcast on television or radio ads, FTC has historically exercised enforcement on disclosures and disclaimers that are too small to read, are difficult to understand, are buried in other information, or—in the case of television ads—are flashed across the screen too quickly. A prudent approach is to place any disclosures or disclaimers close to the statement being qualified and avoid using small font sizes or any distracting statements or graphics that might overshadow the qualifying information.5
FTC's deception and unfairness policies. It is appropriate to mention that FTC considers unlawful any advertising and promotional acts or practices that are deemed deceptive. The commission uses three criteria to determine if an act or practice is deceptive.
First, there must be a representation, omission, or practice that is likely to mislead the consumer. These include making false oral or written representations, making misleading claims, or failing to disclose information or meet certain obligations. In the case of representations, FTC looks at both express and implied claims. Advertisers must have substantive proof to support their express and implied claims. When a product is sold, there is an implied representation that the product will serve its intended use. When the product does not deliver on its representation, then deception occurs. By the same token, FTC presumes that consumers are likely to arrive at false beliefs about a product or service because of an omission.
The second criterion requires that the act or practice be assessed from the vantage point of the reasonable consumer. The test is whether the average or typical consumer's interpretation or reaction to the advertisement is reasonable. However, when the act or practice is targeted to a specific audience, then the determination has to be assessed on the effect of the act or practice on a reasonable member of that target group. An interpretation is presumed reasonable if it dovetails with the message that the act or practice is intended to convey. Likewise, instead of focusing on specific items, FTC looks at how words, phrases, and pictures piece together to convey a message to the consumer.
The third criterion of deception is whether the misrepresentation, omission, or practice is deemed material. A material claim would involve representations made on a product's specifications, performance, features, benefits, safety, or efficacy. In brief, information that is important to consumers and is likely to affect the consumer's choice of or conduct regarding a product is deemed material in nature. As such, if misrepresentation or omission is deemed material, then there is the likelihood of serious injury.
Finally, FTC deems an act or practice unfair if it causes or is likely to cause substantial consumer injury that the consumer could not reasonably avoid, and if the risks to the consumer do not outweigh the benefits.5,6
IVD manufacturers must make every due diligent effort to achieve sustainable compliance of their advertising and promotional practices with FDA and FTC policies. Failure to comply may expose companies to operational risks, since FDA and FTC can exercise their enforcement actions to go after violations relating to false or deceptive promotional practices. FDA's enforcement tools include untitled letters, warning letters, product seizures, consent decrees, civil actions, and criminal fines or penalties. The remedies that FTC and the courts have imposed include cease-and-desist orders, civil penalties, consumer redress, monetary remedies, and corrective advertising remedies.
Historically, the types of violations that have received scrutiny include unsubstantiated comparative claims, unapproved uses or broadened indications, overstated efficacy, misleading claims, preapproval promotion, “new” claims, misleading economic claims, and minimizing risk information. Developing a best-practices approach for implementing advertisement and promotion compliance may serve as an efficient way to manage regulatory review of marketing collateral and mitigate potential commercial risks. This can be accomplished at a minimum by doing the following:
• Creating well defined ad and promotional procedures.
• Performing quality training of sales and marketing teams in these procedures.
• Performing due diligence reviews of marketing collateral.
• Keeping current with the latest FDA and FTC regulations in advertisement and promotional labeling, as well as any state laws and guiding principles or codes set by nongovernmental organizations
1. “Consumer-Directed Broadcast Advertising of Restricted Devices,” Center for Devices and Radiological Health Web site (Rockville, MD [cited 28 October 2008]); available from Internet: www.fda.gov/cdrh/comp/guidance/1513.pdf.
2. “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” Office of Policy, Office of the Commissioner, FDA Web site (Silver Spring, MD [cited 28 October 2008]); available from Internet: www.fda.gov/oc/op/goodreprint.html.
3. “Statement of Policy Regarding Comparative Advertising,” Federal Trade Commission Web site (Washington, DC [cited 28 October 2008]); available from Internet: www.ftc.gov/bcp/policystmt/ad-compare.htm.
4. “FTC Guides Concerning Use of Endorsements and Testimonials in Advertising,” Federal Trade Commission Web site (Washington, DC [cited 28 October 2008]); available from Internet: www.ftc.gov/bcp/guides/endorse.htm.
5. “General Advertising Policies,” Federal Trade Commission Web site (Washington, DC [cited 28 October 2008]); available from Internet: www.ftc.gov/bcp/edu/pubs/business/adv/bus35.shtm.
6. “FTC Policy Statement on Deception,” Federal Trade Commission Web site (Washington, DC [cited 12 November 2008]); available from Internet: www.ftc.gov/bcp/policystmt/ad-decept.htm.
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