1. FDA updates drug product shortages resulting from Hurricane Maria

Hurricane Maria's impact on drug manufacturing facilities on Puerto Rico has exacerbated the ongoing shortage of amino acids for injections, in addition to other medical supplies, Food and Drug Administration Commissioner Scott Gottlieb, M.D., said yesterday. According to the agency, the hurricane affected the amino acid production facilities of Baxter, one of the world's largest suppliers for the drug. The storm also disrupted Baxter's production of small-volume parenteral saline solution. However, Gottlieb says that with steps the agency and suppliers have taken, FDA "now believe[s] that the shortage situation related to IV saline products will improve by the end of 2017." Further, Gottlieb said FDA is working with Baxter to facilitate the temporary importation of amino acids for pediatric and adult formulations of IV amino acids from Baxter facilities in the United Kingdom and Italy. According to the agency, the amino acids are "of critical need for patients, including children and infants, who are not able to eat and need to receive their nutrition intravenously." For more, see Gottlieb's statement. AHA will host a Dec. 5 members-only webinar on critical drug product shortages of small volume IV solutions. On this webinar, leaders from the FDA and the Office of the Assistant Secretary for Preparedness and Response will explain how the shortages developed and efforts that the federal government is taking to resolve them. To register for the 1 p.m. ET webinar, please click here.