January 25, 2022

Volume XII, Number 25

Advertisement
Advertisement

January 24, 2022

Subscribe to Latest Legal News and Analysis

FDA Launches OpenFDA To Ease Access to FDA Datasets — Which Creates Opportunities for Developers of Mobile Medical Apps

Last week, FDA launched openFDA­—its new, open government initiative.  Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets.  FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and researchers.

On June 2, 2014, the agency published a database with millions of drug adverse event reports—the first step for openFDA.  While adverse event report records were previously available under the Freedom of Information Act (FOIA) or by downloading large amounts of encoded files, the process of obtaining them can be slow and difficult.  The openFDA database makes the adverse event reports easier to access and search using an Application Program Interface (API).  “OpenFDA will make our publicly available data accessible in a structured, computer-readable format,” wrote Taha Kass-Hout, Chief Health Informatics Officer of FDA.

FDA’s hope is that pharmaceutical companies, researchers, and software developers will use this information about adverse events to identify emerging public health concerns.  FDA has stated that it will not release any data that could be used to identify individuals or reveal other private information.

Software developers and mobile app developers might have new opportunities to process and package the information in ways that consumers can use and understand.  For example, developers could create a mobile medical app that allows consumers to learn whether other users of a drug have suffered the same adverse events. OpenFDA’s adverse event datasets could be mined for numerous types of uses.  Drug companies will have easier access to adverse event statistics.  Consumers could obtain more information about adverse events occurring with drugs they are taking or might take.  Lawyers might mine the dataset for use in lawsuits involving adverse effects of prescription drugs.  The pharmaceutical industry is said to be “cautiously supportive” of the openFDA initiative, but urges that patients should receive information about a medicine in the context of both the benefits and the risks.

In the next few months, FDA expects to release additional information to openFDA, including records related to product labels and recalls of all FDA-regulated products, including medical devices.  We will continue to follow the evolution of openFDA.

© 2022 Covington & Burling LLPNational Law Review, Volume IV, Number 161
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Matthew Hegreness, Covington, Food regulations attorney
Associate

Matthew Hegreness is an associate in the firm’s Washington, DC office, specializing in the regulation of food, pharmaceuticals, dietary supplements, and cosmetics.  He counsels clients on compliance with state and federal regulatory regimes, especially those of the Food and Drug Administration and Federal Trade Commission.  Dr. Hegreness also provides advice and regulatory due diligence to support the corporate transactions and securities filings of the firm’s life sciences clients.  Dr. Hegreness’s legal counsel reflects a strong grasp of underlying scientific issues,...

202-662-5418
Advertisement
Advertisement
Advertisement