September 2010 Congressional Hearings

Congressional committees have held several hearings on health policy issues since returning from August break. For instance, on September 15, the House Energy and Commerce Subcommittee on Health held a hearing on “Medicare’s Competitive Bidding Program for Durable Medical Equipment: Implications for Quality, Cost, and Access.” The Senate Appropriations Committee also met to examine human embryonic stem cell research policy. In addition, on September 21, the House Energy and Commerce Subcommittee on Health is scheduled to hold a hearing on "Cutting Waste, Fraud, and Abuse in Medicare and Medicaid."

FDA Guidance Documents

This post was written by Paul Sheives.

FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following: