At the same time, the White House officially nominated Acting Commissioner Andrew von Eschenbach to take over the top job permanently. Although von Eschenbach has provided strong support for the Critical Path initiative, his good efforts may not overcome the political issues blocking his confirmation as commissioner.
One Critical Path goal is to develop the capacity for reliable manufacturing of high-quality products at commercial scale. FDA notes that problems often occur during scale-up to mass production and that poor product design and inadequate characterization and testing can cause problems after a product comes to market.Biotech manufacturing raises particular concerns and also presents opportunities to develop new scientific tools able to identify and characterize critical product attributes and better control product manufacturing. FDA's list calls for efforts to improve these processes by developing:
"The aim of all these initiatives is to prevent drug manufacturing from creating a bottleneck in getting medicines to patients," said Scott Gottlieb, FDA deputy commissioner, in a recent speech on good manufacturing practices (GMPs). With more novel drug delivery systems and more complex drugs, Gottlieb noted that it is even more important to address key quality issues and to establish meaningful product specifications.
FDA recognizes that it lacks the resources to tackle the many opportunities on its list and hopes to spur manufacturers and research organizations to jointly meet these challenges. As a start, FDA has linked up with the National Cancer Institute (NCI) and the Centers for Medicare and Medicaid Services (CMS) to establish the Oncology Biomarker Qualification Initiative to generate information for developing more effective cancer treatments. The group's first project is to evaluate whether PET scans can provide a marker for early drug response in non-Hodgkin's lymphoma. Success could create a new tool for assessing how well molecular imaging technology reveals drug interaction with a target. The results may be useful, moreover, for tumor staging and helping health care providers, payers, and patients make treatment and coverage decisions.