To determine and review the composition of the SNS Program assets, HHS and CDC consider many factors, such as current biological and/or chemical threats, the availability of medical materiel, and the ease of dissemination of pharmaceuticals. One of the most significant factors in determining SNS composition, however, is the medical vulnerability of the U.S. civilian population.
The SNS Program ensures that the medical materiel stock is rotated and kept within potency shelf-life limits. This involves quarterly quality assurance/quality control checks (QA/QC's) on all 12-hour Push Packages, annual 100% inventory of all 12-hour Push Package items, and inspections of environmental conditions, security, and overall package maintenance.
Statement from MDA Scientific Program Officer Laura Hagerty, Ph.D.:
“This is another important step forward for our Duchenne families. Now, two potential DMD treatments have had their NDAs accepted by the FDA for priority review and both companies will be hoping for a positive decision in early 2016. We’re nearing the finish line — this is as close as we’ve ever been to having approved therapies for one of the most common and debilitating forms of muscular dystrophy.
“MDA has provided support for the development of exon skipping since the 1990s and we are proud to have funded foundational research that has made these new treatments possible. It is a sign of great progress to witness multiple companies working on different therapies to get urgently-needed treatments to our families.
“MDA is committed to bringing safe and effective treatments and cures to children and adults living with life-threatening neuromuscular diseases as quickly as possible. Today, there are new treatments in the pipeline that were inconceivable just a few years ago and more potential treatments are expected during the next five years than in the past five decades. As these treatments enter the regulatory review phase, MDA continues to work hand-in-hand with families, health care professionals, scientists and the FDA to ensure it has the necessary information and support to efficiently make decisions on potential life-changing drugs and to move these treatments from the labs to our families’ living rooms.”