Over the years we have noted in our coverage of FDLI’s Enforcement and Litigation Conference that DOJ and other officials expressed an interest and growing trend in bringing actions against medical device manufacturers. For example, Michael Blume, Director of DOJ’s Consumer Protection Branch noted that his office was seeing more medical device cases, involving defects or failure to make required reporting, and that this may be a growth area for the office.
Consequently, a recent article from FDLI’s Update Magazine analyzed the differences in promotion standards between drugs and medical devices. The article, written by John Bentivoglio, Jennifer Bragg and Maya Florence, attorneys at Skadden Arps, Slate, Meagher & Flom, LLP, analyzes the differences in these standards from “an enforcement perspective.”
The article confirmed that “prosecutors and other government enforcement officials have predicted an increased enforcement focus on medical device manufacturers.” In 2010, the Food and Drug Administration’s (FDA) Center for Device and Radiological
Health (CDRH) announced that its Office of Compliance had increased the size of its device advertising and promotion policy group from one person to three, and that the Office expected a concomitant increase in advertising and promotion enforcement efforts as well as policy development.
In late 2012, the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG) top enforcement officials predicted an uptick in marketing-related False Claims Act (FCA) cases against medical device manufacturers. Based on these events, some are concerned that FDA, OIG and DOJ “will pursue marketing and promotion-related actions against medical device manufacturers based on theories similar to those employed against pharmaceutical manufacturers.”
In reality, however, the authors explain that “significant differences exist in the relevant law and regulations applicable to the advertising and promotion of medical devices as compared to pharmaceuticals.”
The authors also note that other key differences between drugs and devices include “product life cycle and frequency of product modifications, the nature of manufacturers’ interactions with health care providers and the need for product training, and applicable reimbursement methodologies.
Consequently, the differences in advertising and promotional regulations between drug and devices “have led to a striking lack of guidance regarding the parameters of permissible medical device promotion,” the authors write. In exercising their enforcement discretion, prosecutors and regulatory officials “should be mindful of these differences, as well as the inherent unfairness of prosecuting violations of ambiguous legal and regulatory requirements.
The Relevant Statutory and Regulatory Framework Offer Little Guidance Regarding Medical Device Promotion
The Food, Drug, and Cosmetic Act (FDCA) generally provides that a “drug or device shall be deemed to be misbranded. . . [i]f its labeling is false or misleading in any particular.” The statute defines labeling to include any “written, printed, or graphic matter” (1) upon a drug itself, its immediate or other “containers or wrappers,” or (2) “accompanying such article.”
FDA and courts interpret labeling broadly to encompass a variety of printed or written materials supplied by a manufacturer, packer or distributor, or disseminated on behalf of a manufacturer or distributor.
FDA has jurisdiction over all drug and medical device labeling, including “promotional labeling,” a term which FDA uses but does not differentiate from “labeling” as deined in the FDCA and related regulations. In determining whether a drug or device is misbranded due to misleading labeling, FDA takes into account not only representations made about the drug or device, “but also the extent to which the labeling . . . fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article . . . under the conditions of use prescribed in the labeling or advertising . . . or under such conditions of use as are customary or usual.”
Consequently, the authors point out the first distinction between FDA’s regulation of drug and device promotion. Specifically, “while FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, it has limited jurisdiction over medical device advertising.” The authors explain that “FDA is only authorized to regulate the advertising of “restricted” medical devices. Restricted devices represent a subset of medical devices, which is not coextensive with prescription medical devices.”
Most Class III premarket approval devices have been restricted as a condition of approval, but only a few Class I and Class II devices (such as hearing aids) are restricted by regulation. The advertising of all non-restricted medical devices – the majority of marketed medical devices – is regulated by the Federal Trade Commission under Sections 12-15 of the Federal Trade Commission Act, the article explains.
As a result, “FDA has issued far less regulation and guidance regarding medical device promotion than regarding prescription drug promotion.” For instance, the FDCA includes just two specific provisions regarding restricted device advertising:
21 U.S.C. § 352(q) provides that a restricted device is misbranded if its advertising is false and misleading in any particular, and
21 U.S.C. § 352(r) provides that a restricted device is misbranded if its advertising does not contain a brief statement of the device’s intended use and relevant warnings precautions, side efects and contraindications.
“FDA has not promulgated any regulations relating to medical device promotion or advertising, nor has it issued any final or draft guidance documents specific to medical device promotion or advertising. Two current draft guidances address promotion and advertising of both prescription drugs and restricted medical devices.”
“In contrast, FDA has promulgated ten additional guidance documents relating to prescription drug advertising. These guidances supplement FDA’s detailed regulations regarding prescription drug advertising, which provide that such advertisements may not be false or misleading or omit materials facts, and must present a fair balance between benefit and risk information.”
“FDA’s regulations identify twenty types of prescription drug advertising communications that FDA considers “false, lacking in fair balance, or otherwise misleading,” as well as thirteen additional types of advertising communications that may be “false, lacking in fair balance, or otherwise misleading.”
“By contrast, FDA’s device regulations do not contain specific requirements regarding the content of advertisements for restricted devices. Regulation of restricted device advertising thus stems directly from” the FDCA sections discussed above.
One reason for this discrepancy, the authors pose, is that unlike drugs, there is no “statutory requirement that device advertisements and promotional material be submitted to FDA at the time of initial dissemination.” Moreover, there are significantly less FDA staff dedicated to device promotion/ads. FDA’s OPDP has more than 60 staffers, whereas CDRH’s Office of Compliance has only three employees to review restricted device promotion.
As a result, the authors note that much of what industry knows about FDA’s regulation of medical device promotion and advertising is gleaned from “warning and untitled letters.” While there is an abundance of warning and untitled letters for the pharmaceutical industry that has “introduced a higher standard for prescription drug promotional materials” without issuing guidance or regulation, the same does not ring true for medical devices.
“Absent a similar body of published untitled and warning letters to look to, medical device manufactures can only wonder whether FDA would apply the same standard to restricted medical device promotion.”
In addition, “the muddy landscape created by the lack of clear FDA guidance regarding medical device promotion is further complicated by the FDA/FTC jurisdictional split described above. While the FTC’s standards for “false advertising” in many respects track the requirements in FDA’s prescription drug advertising regulations, there are significant differences,” the authors write.
For instance, the FTC requires certain health-related advertising claims to be substantiated by “competent and reliable scientific evidence,” a standard generally recognized as more flexible and “allowing a broader range of claims” than FDA’s substantial evidence standard. Similarly, the FTC does not require “fair balance,” as that term is strictly deined by FDA, but holds advertisements to a “reasonable” standard of truthfulness. As such, non-restricted device advertisements may be subjected to quite different standards than those FDA would presumably apply to restricted device advertisements, the authors conclude.
Absent Clear Guidance, Increased Enforcement May Be Inappropriate
To the extent prosecutors and other government enforcement officials are focusing additional scrutiny on the medical device industry, “they should be mindful of the critical lack of guidance available to medical device manufacturers regarding advertising and promotion,” the authors recommend.
“It would be inherently unfair to establish new advertising and promotion rules through FDA enforcement action (such as warning and untitled letters) rather than through either
notice-and-comment rulemaking or the formal FDA guidance process, which includes an opportunity for comment by interested parties,” the authors conclude.
“It would be even more unjust if such standards were established through DOJ criminal and civil enforcement actions. In particular, because the vast majority of such actions end in negotiated settlements, companies and individuals are let in the difficult position of attempting to read the tea leaves of publicly available settlement documents to determine what is – and is not – permitted, and to adjust their conduct accordingly.”
Moreover, the article reminds government enforcement officials to “be mindful of the government’s litigation track record in cases involving promotional speech” when moving forward with this kind of enforcement and the burden the government bears in bringing such cases. Specifically, the authors pointed to the Caronia case as a reminder to FDA and DOJ when they consider whether to pursue enforcement action based on non-statutory interpretations of the statutory “false and misleading” standard applicable to medical device promotion.
Finally, it is important to note that, unlike the majority of laws carrying criminal penalties, the FDCA has been interpreted as a nearly strict-liability statute. To prove a criminal violation of the FDCA, the government is not required to prove “awareness of some wrongdoing” or “conscious fraud.” Coupled with the distinct lack of guidance defining what constitutes “false and misleading” medical device promotion, the low legal bar for criminal liability counsels heavily in favor of judicious use of the government’s enforcement authority in this area, the article exlplains.