Three years ago, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published its set of strategic priorities which ultimately lead to improved patient access to data and more efficient clearance of devices to market. This year, the Center’s 2013 Strategic Priorities continue and expand upon the work it started three years ago to reset its direction towards smart regulation – protecting public health by assuring that devices that enter and remain on the U.S. market are safe and effective, and promoting public health by facilitating device innovation.
A New Mission for 2013 Strategic Priorities
The 2013 Strategic Priorities differ from previous years, in that CDRH has restructured its Mission and Shared Values statement to focus on the patient. The primary purpose of CDRH’s 2013 Strategic Priorities is to inform the public of some of the most important actions it plans to implement this year, and to better understand the direction the Center is heading in.
The Center’s first priority this year is to provide patients in the U.S. with access to high-quality, safe and effective medical devices by strengthening its review programs, including its Personalized Medicine Program, and streamlining clinical trials, while advancing the adoption of connected health care – a model for healthcare delivery that uses technology to provide healthcare and patient access to information remotely. The Personalized Medicine Program was established to address regulatory and policy issues around use of diagnostic devices to specifically guide therapy, and to promote use of novel technologies as clinical diagnostics.
CDRH will finalize its draft guidance document for companion diagnostic devices this month, according to its Strategic Priorities, as well as a draft guidance addressing co-development of drugs and devices by September 30, 2013.
The Dawn of a New Era in Patient Access
A common thread throughout the CDRH 2013 Strategic Priorities is patient access to and availability of information. The shift toward connected healthcare aims to maximize resources, allowing increased flexibility and the opportunity for patients to engage with clinicians outside the hospital or doctor’s office for better self-managed care. In December, CDRH published its draft guidance on home use medical devices as part of its home use initiative, FDA explained.
“The draft guidance is intended to improve the design and quality of home use devices to eliminate or reduce errors that occur during use,” FDA wrote on its website. “It provides recommendations that take into account the device user, the use environment, the device itself, and its labeling.”
2013 could be the year that FDA steps up to the social media plate to address the use of the internet and social media tools in promoting drugs and devices and accessing information. More than three years ago, FDA held a public hearing on the topic, but has yet to issue guidance to a hungry industry. Since its public hearing, FDA has promised to provide guidance on responding to unsolicited requests, fulfilling regulatory requirements when using tools associated with space limitations, fulfilling post-marketing submission requirements, online communications for which manufacturers, packers, or distributors are accountable, the use of links on the internet, and correcting misinformation.
While no specific goals are outlined in the 2013 Strategic Priorities for the use of the internet and social media tools in promoting drugs and devices, the Agency is taking major strides this year in broaching the topic with a focus on consumer, patient, caregiver and provider access to understandable science-based information about medical devices to make health care decisions. CDRH is currently exploring methods to monitor and contribute to social media conversations about medical devices and radiation-emitting products in order to provide access to meaningful and timely information about the products it regulates and the decisions it makes. The Center plans to conduct and evaluate a social media utilization pilot next month and intends to incorporate social media into the CDRH communication process in September.
FDA is working on ways to help consumers safely operate and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient’s body) and respirators. These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development and patient access of clearer instructions for use. The Agency will complete a study of users of device labeling and hold a public workshop to discuss study findings in June.
As part of the 2013 Strategic Priorities to improve patient access to, as well as the usefulness of labeling, and the use of social media for gathering and sharing information with external constituents, CDRH is developing initiatives to improve consistency, usefulness, and accessibility of labeling for home use devices and will publish a proposed rule for an online repository of labeling for home use devices. The Agency will continue to focus on the availability and access to information throughout the year, reopening the possibility of guidance documents for the promotion of drugs and devices on the internet. These discussions could lead to further development in the rapidly growing mHealth arena.
mHealth – The New Age Snake Oil
In 2011, FDA outlined its proposed oversight of a select group of mobile medical applications designed for use on smartphones and other mobile computing devices in a draft guidance document. “The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
Medical apps like the recently launched, uChek, an iPhone urinalysis device, will remain readily accessible through mobile application download services, such as Apple’s App Store until FDA and other agencies release new regulations. US Rep. Mike Honda (D-CA) plans to reintroduce a measure in Congress that would seek to establish a new office at the FDA dedicated to the development and oversight of mobile health technologies. Many of these mobile medical applications walk a fine line and are marketed to the public in a gray area.
Last November, The New England Center for Investigative Reporting noted that US regulators are increasingly becoming aware of mobile medical applications sold and made available online that promise to do everything from cure acne with light to reducing the effects of tinnitus, and referred to the mobile applications as “modern day snake oil.” Alarmingly, such applications seem likely to become more common as more people around the globe acquire smartphones capable of using healthcare applications.
Last May, the US Department of Homeland Security (DHS) issued a warning regarding the potential for medical devices to be compromised by hackers, saying “health care entities need to take the threat very seriously.” For example, a mobile application that controls a diabetes pump or one that contains a patient’s medical records could both be tempting targets for those looking to do harm to a patient. The sector is also regulated in part by the Federal Trade Commission, which published a guidance document in September regarding acceptable claims practices by applications that are medical in nature, but do not make claims that subject them to regulation by FDA.
Unlike FDA guidance, FTC guidance speaks in more general terms regarding marketing claims that may be made for all applications, and not just those marketed for medical purposes.
Honda said he hopes that “someone with a lot of experience in technology” would lead the FDA Office of Wireless Health, if it were created, saying current FDA talent may be too antiquated to deal with the novelty of the sector.
“The situation today is kind of like the judicial system, back when there were early lawsuits about technology,” he told the Wall Street Journal’s Venture Capital Dispatch blog. “No judge really knew about that stuff. They had to be trained.” Regulators will either need to find or develop this expertise, he added.
Honda also said the need for such an office is clear to him, noting that the current app industry does not have confidence in the regulatory framework as it now stands. Without a “consistent, reliable framework,” people will be less able to actively participate in their own care by accessing medical records or other data, he added.
Honda does not expect resistance from FDA in establishing the new office, and plans to make a number of changes to the 2012 version of the bill when he reintroduces it. 2013 is shaping up to be the Year of Patient Data Accessibility and possibly the dawn of a new age for FDA.