October 18, 2011
Mr. Bakul Patel
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 5456
Silver Spring, MD 20993-0002
The Wireless-Life Sciences Alliance (“WLSA”) thanks you for the opportunity to respond to the Notice of Availability (“NOA”) published by the U.S. Food & Drug Administration (“FDA” or “Agency”) in the Federal Register on July 21, 2011. In the NOA, the Agency requested comments on Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (“Draft Guidance”) and on two specific issues: regulation of accessories and clinical decision support (“CDS”) software. This letter is intended to (1) establish our support for the thoughtfulness with which Agency staff are approaching the issues and (2) recommend certain policy considerations, human perspectives and specific recommendations for future action.
We do not intend to duplicate the detailed work of the mHealth Regulatory Coalition (“MRC”) that is presenting a detailed and well-reasoned analysis and recommendations.
The Wireless-Life Sciences Alliance
The WLSA, which formed in 2005, is a special purpose association of companies and organizations that are focused on all aspects of wireless connected health, which includes “mobile health” and “mHealth.” WLSA’s mission is to improve access to affordable high quality healthcare, globally, by accelerating innovation in wireless connected health devices, services and applications. We believe it is self-evident and universally acknowledged that current approaches to healthcare are severely dysfunctional and cannot scale to meet the healthcare demands of the U.S. or other countries. We are confident that the convergence of technology, life sciences knowledge and consumer engagement can deliver significant improvements to public health, which otherwise will begin or continue to degrade.
Perspective on the Regulation of Mobile Medical Applications
WLSA compliments the FDA on its thoughtful approach to the regulation of mobile medical applications. In all of our interactions with Agency staff over the past two years we have found them to be aware of the importance of the mobile health ecosystem and interested in seeing it succeed. We were encouraged by the joint FDA and FCC announcement in 2010 and joint session. WLSA provided comments for the record following that hearing (copy attached).
As much as we appreciate the thoughtfulness of the proposed guidance, and the careful and thoughtful comments and suggestions of the MRC, we believe that a fundamental preliminary step to regulation must first be taken. Without first considering the impact of delaying the introduction of useful mobile health products and applications on public health, any regulatory approach is likely to unduly delay significant potential improvements in the health status of U.S. citizens and residents.
The Agency has two equal and overarching roles, which must be balanced:
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.
“The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.” (http://www.fda.gov/AboutFDA/CentersOffices/default.htm – emphasis added.)
In the area of mobile health, these responsibilities are highly interdependent – the Agency must establish the optimal balance between the protection of public health and its promotion in order to maximize the achievement of both goals. Striking the right balance is a pre-condition to the appropriate regulation of mobile health applications and other wireless health products. In doing this we believe that the severity of the public health problems we face, the acuity of our need for new approaches to promoting health, and the mismatch between traditional approaches to regulation and the manner in which innovation in relevant fields occurs, call for an emphasis on safety, intended use and marketing claims, and less near term demand for proof of efficacy.
Classes of new products and applications offer affordable access to health knowledge and healthcare for the individuals who have little or no access and support today. Our society’s current approach to public health is failing by many measures and for millions of individuals, especially our uninsured and disadvantaged citizens. Even among insured and wealthy populations, increased morbidity associated with aging and the increase of chronic disease will overwhelm our society’s ability to provide support and services. Market experimentation with applications that pose little or no immediate risk can be harnessed by the FDA to carry out its goal of advancing public health through the encouragement of innovation.
Many if not most mobile health products and applications are categorically different from poisonous elixirs or thalidomide, which established the necessity of regulation. Furthermore, unlike traditional therapeutics and medical devices, mobile medical applications have the inherent capability of self-reporting. They can provide data about outcomes based on their use in the real world, a more relevant source of information than that created in randomized clinical trials. In addition, many mobile medical applications are creating new and useful information (e.g. monitoring individuals in their residence) for caregivers, improving access of individuals to information and tools that increases their ability to self-manage, and creating massive new sources of data that scientists will use to create new approaches to improving health.
We urge the Agency to first assess the potential of the mobile health sector to offer affordable access to healthcare and to reverse the negative trends in cost, access and outcomes. This does not require that dangerous products and applications be permitted to enter the market without supervision. It does require recognition that the status quo in public health is not satisfactory. It is deteriorating and we must embrace new approaches if we are to reverse this trend. The tools of innovation are available and are being focused on these problems. The Agency’s challenge is to adapt its processes to speed the time to market of these innovations and deliver to healthcare that which we enjoy in other sectors of commerce – the rapid creation of complex products, services and applications that improve in quality and decrease in cost over time.
WLSA encourages the Agency to adopt the following principles in determining the appropriate manner of regulation of mobile medical applications and indeed the broader wireless connected health sector:
1. Traditional medical device development and regulation is a slow process. Technology and behavior innovations are very fast. In order to promote public health and reverse adverse trends in health and healthcare, the power of innovation and scale established by the technology industry must be harnessed for public health. The FDA should accelerate its collaborative initiatives to define processes for speedier approaches to identifying risks, including alternatives to the use of Randomized Clinical Trials in select situations.
2. In order to improve public health, we must increase both personal knowledge of the factors that lead to chronic disease and personal responsibility for its avoidance and management. The key approach to implementing this principle is to couple the power of engagement that has been created by the consumer sector with the life sciences sector of providers, researchers and funders. Given the fickleness and inherent difficulty of quantifying and predicting human behavior, substantial leeway should be given to applications that promote consumer knowledge and attempt to improve healthy lifestyles. In general, the market will quickly determine the efficacy of these initiatives. Failure in the market eliminates future risk.
3. The public is harmed by the absence of mobile medical applications. Hence, as with therapeutics, there must be acceptable risks for imperfect products. The absence of access to a “perfect” device is more deleterious in some situations than affordable access to imperfect devices and services. In determining acceptable risk, consider the timing and severity of potential adverse consequences. If the consequences are immediate and severe (e.g. automated calibration of an insulin pump wirelessly connected to a glucose meter), great care must be taken. As the severity of potential harm declines and as the timing of its occurrence recedes into the future, after market reporting and subsequent product improvement will continually reduce the risk of adverse effects.
4. A key tactic in striking the correct balance between a specific device risk and the population risks posed by an unsatisfactory status quo is to focus on the marketing (intended use) claims. The Draft Guidance is correctly taking this approach. For example, inexpensive home monitoring platforms may have imperfect connectivity compared with institution-based systems, but even a partial solution improves the chance of a favorable outcome for the otherwise unmonitored individual. Similarly, applications that consolidate and analyze information from disparate sources will help clinicians, caregivers and patients to lower the costs of care and improve outcomes, but they will initially have imperfections and we can reasonably expect their improvement over time. These imperfect applications should be acceptable so long as they are associated with accurate marketing claims.
5. The post-market “transparency” associated with mobile medical applications should be leveraged by the Agency. This will enable potentially useful products and applications to more quickly be brought to markets and more quickly improved or withdrawn based on real world use. This approach offers the advantages of both reducing the costs and uncertainty of development prior to market and reducing the after-market risk that adverse effects will not be identified.
Comments on the Draft Guidance
1. Clarify the activities within which wireless carriers will have freedom from regulation in order to encourage their support for the regulated and non-regulated devices and applications.
2. We recommend that the Agency build on its current proactive and collaborative approach to address the challenges and opportunities posed by wireless and mobile health.
a. The early establishment of approved approaches for important challenges such as using mobile applications to collect, analyze, and display data that is derived from multiple devices and sources would be of substantial benefit to industry and the public.
b. Applications that only collect and display data should not be regulated.
c. Device companies should be regulated only on their own devices and applications, not third party applications that pull data from their device. Manufacturers should be encouraged to make their data available to third parties as the public will benefit from competition to build better solutions that consolidate data from multiple sources.
The mobile and wireless health sector includes many individuals and companies that have no prior experience with healthcare and thus are uninformed about FDA regulatory requirements. The success of the sector also requires the increased participation of investors. We need the engagement of these newcomers but they are daunted by the complexity of the regulatory structure and uncertainty about the scope of future regulation. To encourage broad (creative) participation in the sector, we encourage the Agency to take certain practical steps:
a. Create and maintain list of companies and products within the examples of regulated and non-regulated mobile health devices, applications and solutions.
b. Help innovators find predicate devices and applications for their mobile health solutions. This can include the explicit description of the rationale applied the regulation of devices and applications that are approved by the Agency.
c. Clarify “intended use” with concrete examples. Restrictions on marketing claims are well understood by those in the healthcare field but intended use is a new and often confusing concept for the consumer device and mobile applications developers who are new to the wireless and mobile health field Provide clearly defined examples of when a product or application crosses the line from a (non-regulated) wellness to (regulated) clinical solution.
4. Mobile computers should not be treated differently from desktop computers when used for the same purposes.
5. In order to encourage the acceleration of data sharing and increase both consumer and clinical access to data and knowledge, do not regulate compendia, databases and clinical decision support tools unless there is no alternative to the avoidance of a significant risk of patient harm.
6. Consider adopting approaches that will lead to a more efficient review process:
a. Self-certification of compliance for certain classes of manufacturers and device categories, based on efficient post-market reporting.
b. Identification of software and hardware components that are pre-approved for use in both regulated and non-regulated devices.
c. Simplification of manufacturer’s compliance for casual or small developers.
d. In order to encourage market experimentation, establishment of a threshold for the regulation of certain classes of devices and applications tied to number of end users. Based on registration and post-market reporting, this would enable the Agency to focus more of its attention on viable commercial offerings.
In conclusion, we reiterate our support for the constructive approach adopted by the agencies and pledge our support. The U.S. is a global leader in the life sciences and it can retain its role as the global leader in mobile and wireless health with the support of the agencies. Wireless health has significant policy benefits for the U.S. and the entire world:
- Improve access to services.
- Lower the cost of healthcare.
- Improve the quality of healthcare.
- Make healthcare services transparent and thus measurable and accountable.
- Improve health!
Robert B. McCray
President & CEO, Wireless-Life Sciences Alliance