On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership from being typically composed of mid- to large-medical device companies to an ever-welcoming trend to include more start-up and small medical device company members. In addition, ten-year President and CEO Stephen J. Ubl stepped down to new leadership composed of a partnership of large- and smaller-sized members. AdvaMed also launched new and enhanced one-on-one partnering software platforms permitting easier meeting and larger meeting spaces devoted to the Exhibit Hall. Below represents a sampling of the programs that I watched, but there were many more offerings.
On the first day, there was an interesting panel on offlabel advertising and promotion in the wake of the Amarin decision: “Scientific Exchange: Interpreting the Available Guidance Regarding Dissemination of Data Regarding Off-Label Uses of Medical Devices”. (For background on this decision, please see our blog here). Lauren Silvis, Deputy Center Director for Policy, Office of the Center Director, Center for Devices and Radiological Health (CDRH), FDA, provided an overview of FDA’s position on offlabel use and promotion, noting that further FDA guidance is in development. Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic said that she welcomed FDA’s efforts to provide more guidance in this area. Kalter explained that medical device product development is a continual process, where physicians are consulted during and after product launch. As a result, it is important for device manufacturers to have avenues for communication about current and new or improved uses for their products. At times, she thinks it takes too much time to hear back from the agency to get out important safety information, where they are waiting for what they can say about their products.
Eve Ross, J.D., Public Policy and Strategy, W.L. Gore and Assoc., Inc. described it as an “uncomfortable dance” to navigate offlabel uses when the very nature of a mechanical device may be linked to human anatomy, e.g., limited to a certain blood vessel size or incision size, which suddenly is offlabel when used for another size vessel or incision, which may not make sense for certain medical procedures, even when not part of the approved uses. Ross and the other industry panelists agreed that there was a need for more specific FDA guidance on offlabel uses. Ross said it is difficult to adapt the drug-related guidances to medical devices, in part because of the clinical dynamic adapting devices to uses rather than taking a pre-developed dosage form, as for drugs. While everyone is looking at Amarin as an exciting and interesting case, industry is concerned about its potentially limited implications, Ross explained, because it is only one case in one circuit and still leaves FDA lots of space to pursue offlabel claims. Ross thinks that FDA will be very “judicious” moving forward to not create more precedent opening the door to off-label claims.
Two attorneys on the panel, Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom and Jaime Jones, Partner, Sidley Austin LLP, noted that Amarin could be signal of a potential paradigm change to come, but they did not think industry was ready to read too much into it yet. They thought Caronia was a more instructive case in terms of the Department of Justice’s (“DOJ’s”) approach, i.e., a totality of circumstances. Amarin had conducted certain clinical research that would have permitted it to make the labeling claims it wanted to, but before those claims were approved by the agency, the science had changed. So while Amarin’s studies met their clinical endpoint objectives to make the claims, FDA did not want to permit those claims. So they thought the facts of the case could limit its application, noting that DOJ was not likely going to “throw its hands up in the air and not do anything.”
Silvis agreed that FDA needs to provide more clarity around what “offlabel” use and claims means for medical devices, which is especially difficult without regulations in this space. Ross said that Amarin suggests that offlabel may be very temporal in nature, creating disincentives for manufacturers to conduct additional research for new claims or uses, when meeting clinical endpoints may not be rewarded. She thought that FDA needs to be more responsive to prevent patients from looking to Google for the most up-to-date information on medical devices. Ross thought it was important to make sure the quality of the information supports the statements, e.g., peer-reviewed journals. Kalter agreed that FDA could have taken a different approach with Amarin, permitting more disclosure and that she struggled with the decision. FDA had approved a special protocol for Amarin and then convened a special advisory committee meeting, leading to a decision not to let the communication go out as previously agreed if Amarin’s study hit certain clinical endpoints. She did not understand why FDA could not have permitted the information from that study to go out with appropriate disclosures regarding the meaningfulness of the information. She noted that all manufacturer sales forces think that the regulatory arms are too conservative, but she thinks it is important to get offlabel safety information out there, even if FDA may not have passed on it yet.
In response to a question about how smaller companies may go for a more specific claim that is more readily obtainable than what becomes the more common use, Kalter acknowledged that even larger companies may pursue this approach, when enrollment is a challenge. Silvis said that FDA hopes that labeling reflects the actual uses that medical devices are used for and making sure that “right” information makes its way to the labeling. Another question concerned diagnostics, and how in vitro devices may provide more information than needed for the indicated use, because it is of clinical value to physicians. In this instance, it was suggested that FDA should think about how to permit such information to be collected and reported, even if not the indicated use. Silvis said FDA appreciates that there are incredible incentives to get to the market, but her hope is that manufacturers engage the relevant review divisions at CDRH to consider ways to add relevant use information into product labeling.
In another panel, “The New Frontier of FDA & FCC Oversight and Innovative Medical Devices”, the panel began with Sonali Gunawardhana, Of Counsel, Wiley Rein, who provided audience awareness that there now are approximately 40,000 medical mobile apps available with new ones every day. In a standing room only discussion, Michael Gibbons, Federal Communications Commission’s (FCC’s) Distinguished Health IT Scholar, advocated awareness of their Connect2Health website, and the increasing wireless connectivity of providers, patients, consumers, and caregivers. Like Wayne Gretsky, Gibbons suggested skating to where the puck is, that is, working together to get regulators to where they need to be to help promote effective use of technology for healthcare, such as the smart systems to control insulin for diabetic patients.
Bakul Patel, Associate Center Director for Digital Health, FDA, agreed that regulators needs to work together with those in the technology, describing how FDA has been formalizing its discussion with the FCC for wireless concerns in medical devices, beginning back in 2010, resulting in guidance in 2012 mobile medical applications guidance. The National Institute of Standards and Technology (NIST) and the Federal Trade Commission (FTC) are also involved, Patel explained. FDA is trying to empower healthcare providers and let the technology develop without FDA oversight where not needed, e.g., low risk devices, as well as consider better ways to connect physicians and hospital networks. Patel described a public workshop FDA held that looked at these issues, noting that it uncovered many ideas, including other partnerships with the WiFi Alliance.
Robert Jarrin, Senior Director, Qualcomm Inc. said that Qualcomm is devoting more resources to digital health and that software has been increasingly important to the analytics. Jarrin said that venture capitalists and others are concerned when the answer is FDA is not regulating now out of enforcement discretion – and they may get spooked, whereas smaller companies are more willing to work with FDA and “follow the money.” When asked about wearable devices using Qualcomm chips and requirements for each supplier, Jarrin said the coordination issue of FCC and FDA has not really come up in part, because the products are still in the early stages. Jarrin added that when the information provided by wearable devices is “merely interesting information for users,” he did not believe it needed formal preapproval or regulation.