The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:

 Proposed Monograph Modifications

  •  Amending

In January 2011, the FSMA amended the Federal Food, Drug, and Cosmetic Act to give the Food & Drug Administration (FDA) authority to order the recall of all food products when a company fails to voluntarily recall the products. Until passage of this act, FDA could ask companies to voluntarily recall adulterated or misbranded food products, but could not order them to do so unless the product was infant formula. FSMA directed the Government Accountability Office (GAO) to report on issues associated with FDA’s new authority to order food recalls. Last week, the GAO published its report, entitled “Food Safety: FDA’s Food Advisory and Recall Process Needs Strengthening”.

According to the GAO, the report “examines key government entities having the authority to order product recalls and how FDA implements its authority; (2) examines the challenges FDA faces, if any, in advising the public about food recalls or outbreaks of foodborne illnesses and examines how FDA has addressed these challenges; and (3) identifies mechanisms that may compensate the food industry for erroneously ordered food recalls or erroneous food-related advisories.” The report notes far-reaching implications of FDA’s expanded food recall authority, including the substantial risk to the public and industry if advisories are issued erroneously. Specifically, the report notes that unwarranted food safety advisories and recalls “can trigger serious economic losses for the food industry and discourage the consumption of healthful food, such as fresh produce.”

To strengthen FDA’s process for ordering recalls, the report recommends that the Secretary of Health and Human Services direct the Commissioner of FDA to take the following actions:
Continue Reading GAO Report Encourages FDA to Strengthen Its Food Advisory and Recall Process

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, a relabeler, or any other person who applies a label to or modifies a label on a device that will not be modified again before sale—to place a unique device identifier (“UDI”) on the label and packaging of medical devices both in plain-text and also using automatic identification and data capture (“AIDC”) technology. The UDI itself will not hold any information. Manufacturers would have to submit identification information to FDA. FDA would aggregate the manufacturer-provided information in a new Global Unique Device Identification Database (“GUDID”). This public database would allow a physician to scan or manually enter the UDI of a device at a patient’s bedside and quickly access complete information regarding the device’s key attributes and proper use instructions.

The expected benefits of the new program include:
Continue Reading FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

This post was written by Sarah Roller.

On June 15, 2010, the Dietary Guidelines Advisory Committee issued the “Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010” (“Advisory Report” or “Report”). The Advisory Report is intended to provide the United States Department of Agriculture (USDA) and the Department of