Medical Apps Tricky for Pharma

FDA has been under pressure from Congress and IT firms to minimize its regulation of mobile medical apps (MMAs) to prevent stifling innovation in the burgeoning healthcare software field. In response, the agency has divided health-related IT products into three categories, based on whether they warrant more, some, or no oversight. FDA promotes this as a risk-based approach to MMA oversight, explained Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, at the recent Food and Drug Law Institute (FDLI) annual meeting. But industry continues to puzzle over just what MMAs fit into the the middle “hands-off” area, where FDA says it will use “enforcement discretion” in deciding where oversight is needed. Apps related to prescription drug use fall into all three groups, and those developed or marketed by pharma companies are likely to draw more scrutiny from the agency.

FDA issued guidance last February indicating which types of apps fall into its three categories. The most direct regulation is proposed for a fairly small group of products that operate as medical devices and can directly affect patient health. This includes systems that controls an insulin pump or that utilize a cell phone to identify a serious skin condition or eye problem. At the other end of the spectrum are low-risk information systems that transmit published health information or provide general educational tools. No regulation is indicated for “health improvement” products that track exercise or collect personal health data, or for “drug shopping” apps that provide information on local pharmacies and comparative drug prices.

The degree of oversight is somewhat gray for apps that link to patients’ health records and drug ordering systems or provide medication reminders and tools to help physicians select proper treatment for a specific disease or to calculate drug dosage. Apps that guide prescribing may fit the category of “clinical decision support” (CDS) software; much-anticipated guidance from FDA is slated to clarify how the agency plan to regulate this area. Many CDS products designed to help physicians diagnose patient conditions and recommend treatment may fall in the enforcement discretion area, but when developed by pharma companies to be used in conjunction with a certain product, FDA may consider them “drug labeling” that must conform to its broader rules for drug advertising and promotion, explains Epstein Becker attorney Bradley Thompson.

FDA’s regulatory approach continues to be shaped by efforts in Congress to enact further legislation to limit even more the agency’s jurisdiction over medical and health-related software. But enactment of new measures is not likely before FDA issues its CDS guidance, and probably not this year, noted Zach Rothstein, deputy senior counsel of Samsung Electric, during a recent FDLI webinar on MMAs.

At the same time, the Federal Trade Commission (FTC) is moving to fill any regulatory void by challenging health-related software products that make fraudulent or misleading claims. It recently imposed sanctions on MMAs using Smartphone photos to detect melanoma or diagnose moles, and has challenged a system that claims to help children with attention deficit hyperactivity disorder (ADHD) improve their school performance.

While crafting its regulatory policy, FDA is developing its own mobile apps to communicate more directly with stakeholders. A new “drug shortages” app aims to encourage pharmacists, providers and patients to send in information about drug supply problems, while also providing a mechanism for FDA to inform health care professionals about new shortages and alternative supply options. It can be downloaded via iTunes for Apple devices and from the Google Play Store.

And multiple software firms are tapping into FDA adverse event databases to develop apps to track adverse drug events and recalls. These IT and regulatory developments are important for pharma companies, as they continue to weigh options for incorporating MMAs into marketing and educational programs.

For more information, see http://www.fda.gov/medicaldevices/productsandmedicalprocedures/connectedhealth/mobilemedicalapplications/default.htm.