A bipartisan coalition of senators from the U.S. Senate Committee on Health, Education, Labor, and Pensions has reportedly urged action on a bill (S. 959) that would give the Food and Drug Administration (FDA) additional authority over compounded drugs, which have traditionally been subject to state oversight. They released an updated version of the proposal on July 25, 2013, to clarify which compounders and drugs would be within FDA’s bailiwick and address the concerns of opponents who have questioned the original bill’s approach since it was placed on the Senate calendar in June. At least one Senate Republican has reportedly indicated that more time and review will be required before it can be approved and suggested that it will not be passed before the August recess. See CQ News, July 25, 2013; U.S. Senate Committee on Health, Education, Labor, & Pensions News Release, July 25, 2013.
In a related development, a Massachusetts bankruptcy court has entered an order declaring that the New England Compounding Center, linked to a deadly nationwide meningitis outbreak that is the driving force behind the congressional bill, was insolvent when it filed for Chapter 11 bankruptcy. In re New England Compounding Pharmacy, Inc., No. 12-19882 (Bankr. D. Mass., E. Div., order entered July 24, 2013). The ruling will clear the way for victims to pursue claims against health care providers and other entities that distributed the products in a currently pending multidistrict litigation (MDL) or in proceedings subject to removal or transfer to the MDL proceeding.