Product Liability Update - May 2014
Making Sure Cybersecurity and Liability Concerns Don’t Ground the Drones; Summary of FDA’s Final Guidance on Dear Health Care Provider Letters
Making Sure Cybersecurity and Liability Concerns Don’t Ground the Drones
by Troy D. Roberts
Unmanned aerial systems (UAS), or drones, are slowly being integrated into U.S. and international airspace systems. Despite current legal and regulatory limitations on their use for civilian purposes, governmental and private entities are devoting significant resources to advancing UAS technology and applications. For example, internet industry giants Facebook and Google are exploring how to deliver internet connectivity to billions of unconnected people with fleets of solar-powered drones. Such creativity and technological exploration should be encouraged.
Summary of FDA’s Final Guidance on Dear Health Care Provider Letters
Daniel Wittenberg and Andrea Fitzgerald
At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a mass mailing from the FDA or a manufacturer of a drug, intended to alert health care providers about important new or updated drug information. The guidance was prompted by evaluations of DHCP letters, which have shown that there is a strong correlation between the quality of a DHCP letter and the extent to which physicians perceived the new information as important. The FDA therefore issued guidance providing specific recommendations to help improve the effectiveness of DHCP letters.