January2011 Issues

CMS Panel Says Data Lacking on ESA Value in Kidney Dialysis Patients -- Quick Pulse
Summary: A Medicare Evidence Development and Coverage Advisory Committee (MedCAC) overwhelmingly agreed that there are not enough data – and that existing data are poor – to show that erythropoiesis stimulating agents (ESAs) improve outcomes for kidney transplant patients. The drugs, which are designed to boost hemoglobin levels, are used to reduce fatigue.

FDA Announces 510(k) Medical Device Pathway Changes -- Quick Pulse
Summary: The FDA plans to take 25 actions to improve the 510(k) pathway for medical devices. These include revising (streamlining) the de novo process, issuing guidance documents, providing training for CDRH staff and industry, and establishing a new Center Science Council of senior FDA experts.

FDA Advisory Committee Rejects Lilly/Alnara's Sollpura (liprotamase) for Pancreatic Enzyme Insufficiency -- Quick Pulse
Summary: Lilly and Alnara Pharmaceuticals, which is now a wholly owned subsidiary of Lilly, are seeking FDA approval to market Sollpura to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, pancreatectomy, or other conditions that may impair or limit function of the pancreas – across all age groups. However, the outlook for approval is now bleak. The FDA’s Gastrointestinal Drugs Advisory Committee voted that efficacy was not proven, so the benefits do not outweigh the risks, and the panel was split on the safety of the drug.