The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.

Continue Reading FDA Reopens Comment Period for Drug Labeling Rule

The Federal Aviation Administration (FAA) has finally announced its proposed rules governing the commercial use of drones.  The proposed rules, which have been long-awaited by members of the emerging multi-billion dollar unmanned aerial vehicle industry, pave the way for the commercial use of drones in the United States.  The proposed rules, released on February 15, 2015, are applicable to all commercial drones under 55 pounds.  The rules would require such drones to operate only in daylight hours below a 500 foot altitude ceiling and under a 100 mph airspeed limit.

The proposed rule would also prohibit the operation of commercial drones in the vicinity of other aircraft or known flight paths and, significantly, would prohibit the operation of drones above any people not involved in the operation of the drone.  One restriction in particular is likely to receive significant attention during the upcoming comment section for the proposed rule.  That proposal requires that drones only be operated within the unaided visual-line-of-site of their operators. Such a limitation, combined with a proposed prohibition of dropping any objects from a drone, is certain to impact various publicized plans for commercial drone delivery services.
Continue Reading FAA Clears Way for Commercial Drone Use

For the first time in 18 years, the Food & Drug Administration (FDA) is proposing to overhaul nutrition labels. The proposed changes, if approved, will require manufacturers to make significant changes to their labels.  Preliminary recommendations have been issued, the comment period has closed, and the final rules should be announced before the end of 2015.

The FDA’s proposed rules recommend changes to both the form and substance of the nutrution labels.  The formatting changes are intended to help consumers absorb the most important information about the food they eat.  Some of the proposed changes include increasing the font of the number of calories and serving sizes, moving the “parentage of daily value” information to the left of the nutrition label so that it is the first thing buyers read, and making the footnote explaining what the “percentage of daily value” means more prominent.

If adopted, the proposed rules would require manufacturers to make several changes to substance of their nutrition labels, including the following:
Continue Reading FDA Proposes Overhaul of Nutrition Labels