The FDA published in Friday's Federal Register the notice establishing the user fees for fiscal year 2015, with the rates for drugs, biologics and biosimilars all seeing increases over fiscal year 2014. For new drugs and biologics, the fee will be $2.3 million – about a 4.5 percent increase over fiscal year 2014 – for applications requiring clinical data. The fees for supplements requiring clinical data and other applications not requiring clinical data will be about $1.2 million, roughly 6 percent over the previous year. Both facility fees and product fees are increasing over 2014, with 2.6 percent and 6 percent jumps, respectively. Those fees are effective on Oct.1, 2014, and will remain in effect through Sept. 30, 2015.

The FDA is seeking comments on reserving proprietary names for drugs. The current system is wrought with uncertainty, as the agency can only tentatively accept a proposed name before the drug is approved. Because another new drug may launch first with a confusingly similar name, a sponsor may have to find a new name when its drug is approved. After meeting with agency officials to discuss the problem, the Pharmaceutical Research and Manufacturers of America submitted a draft guidance for FDA consideration.

The NIH announced a collaborative initiative aimed at exploring poorly understood genes that have the potential to be modified by medicines. As many as 3,000 genes express proteins that could have their activities altered by medicines, according to predictions based on genomic information. Yet only about 10 percent of those so-called "druggable genes" are targeted by FDA-approved drugs. The NIH Common Fund three-year pilot project, called Illuminating the Druggable Genome, is designed to address that gap by supporting research of understudied genes in four druggable gene families: nuclear receptors, ion channels, protein kinases and G protein-coupled receptors.